[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Rules and Regulations]
[Pages 25284-25318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9994]
[[Page 25283]]
Vol. 77
Friday,
No. 82
April 27, 2012
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 424 and 431
Medicare and Medicaid Programs; Changes in Provider and Supplier
Enrollment, Ordering and Referring, and Documentation Requirements; and
Changes in Provider Agreements
Federal Register / Vol. 77 , No. 82 / Friday, April 27, 2012 / Rules
and Regulations
[[Page 25284]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 424 and 431
[CMS-6010-F]
RIN 0938-AQ01
Medicare and Medicaid Programs; Changes in Provider and Supplier
Enrollment, Ordering and Referring, and Documentation Requirements; and
Changes in Provider Agreements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule finalizes several provisions of the Affordable
Care Act implemented in the May 5, 2010 interim final rule with comment
period. It requires all providers of medical or other items or services
and suppliers that qualify for a National Provider Identifier (NPI) to
include their NPI on all applications to enroll in the Medicare and
Medicaid programs and on all claims for payment submitted under the
Medicare and Medicaid programs. In addition, it requires physicians and
other professionals who are permitted to order and certify covered
items and services for Medicare beneficiaries to be enrolled in
Medicare. Finally, it mandates document retention and provision
requirements on providers and supplier that order and certify items and
services for Medicare beneficiaries.
DATES: Effective June 26, 2012 the interim final rule amending 42 CFR
parts 424 and 431 that published on May 5, 2010 (75 FR 24437) is
confirmed as final with changes.
FOR FURTHER INFORMATION CONTACT:
Katie Mucklow Lehman, (410) 786-0537, for Medicare issues.
Donna Schmidt, (410) 786-5532 for Medicaid issues.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare program, title XVIII of the Social Security Act (the
Act), is the primary payer of health care for approximately 50 million
beneficiaries. Under section 1802 of the Act, a beneficiary may obtain
health services from an individual or organization qualified to
participate in the Medicare program.
Providers and suppliers furnishing services must comply with the
Medicare requirements stipulated in the Act and in implementing
regulations. These requirements are meant to promote the furnishing of
quality care, while protecting the integrity of the program. As
Medicare program expenditures have grown, the Centers for Medicare &
Medicaid Services (CMS) has increased its efforts to ensure that only
qualified individuals or organizations are allowed to enroll in
Medicare and maintain Medicare billing privileges.
The Medicaid program, established under title XIX of the Act pays
for medical benefits to tens of millions of people. Medicaid is a joint
Federal and State health care program for eligible low-income
individuals. The Medicaid program works within a broad Federal
framework and States have considerable flexibility in how the program
is administered.
The Patient Protection and Affordable Care Act (Pub. L. 111-148) as
amended by the Health Care and Education Reconciliation Act of 2010
(Pub. L. 111-152) (collectively known as the Affordable Care Act) makes
many changes to the Medicare and Medicaid programs, some of which
involve strengthening tools for quality and integrity. To maintain
program integrity and ensure quality, we must make certain that only
qualified providers and suppliers participate in the programs and that
they bill accurately for their services. With respect to Medicaid, our
regulations provide States with considerable flexibility. However, the
Federal framework includes some key requirements to ensure program
integrity while providing quality care. For example, Medicaid providers
must generally meet all State licensing and scope-of-practice
requirements, and may be subject to additional Federal and State
quality standards. Additionally, the Medicare and Medicaid regulations
require timely filing of claims by providers.
In the May 5, 2010 Federal Register (75 FR 24437), we published an
interim final rule with comment period (IFC) that implemented several
provisions of the Affordable Care Act regarding provider and supplier
enrollment, ordering and referring; documentation requirements, and
changes in provider agreements.
II. Provisions of the Interim Final Rule With Comment Period and
Summary of Responses to Comments
In this section of the final rule, we provide the following for
each of the provisions of the May 5, 2010 IFC:
Background.
Statutory changes based on the Affordable Care Act.
The provisions of the IFC.
Summary of the comments and responses to the public
comments received on the IFC. We received approximately 224 timely
comments on the May 5, 2010 IFC.
With regard to the Medicare provisions, we also note that the term
``provider,'' as used throughout the IFC and in this final rule, has
the meaning specified in Sec. 400.202.
For Medicaid, the term ``provider,'' as used throughout the IFC and
in this final rule, has the meaning specified in Sec. 400.203. That
is, for purposes of this rule provider means any individual or entity
furnishing Medicaid services under an agreement with the Medicaid
agency.
We also note that the use of the term ``supplier,'' in the IFC and
in this final rule, as defined at Sec. 400.202, with regard to the
Medicare provisions, is ``a physician or other practitioner, or an
entity other than a provider that furnishes health care services under
Medicare.'' In portions of this final rule, the commenters and CMS may
only use the term ``provider(s)'' or ``supplier(s).'' However, the
reader should consider these terms as relating to both providers and
suppliers, unless explicitly stated otherwise. The regulatory text,
however, uses precise language.
Finally, throughout this final rule, we have attempted to remain
consistent with our terminology regarding the term ``resident.'' We
draw the reader's attention to Sec. 413.75(b) where a resident is
defined as ``* * * an intern, resident, or fellow who participates in
an approved medical residency program, including programs in
osteopathy, dentistry, and podiatry, as required in order to become
certified by the appropriate specialty board.'' We want to be explicit
in stating that the term ``resident'' incorporates interns, residents,
and fellows and we will use this term to refer to all three
professionals throughout this final rule.
A. Inclusion of the National Provider Identifier (NPI) on All Medicare
and Medicaid Enrollment Applications and Claims
1. Background
Historically, we have identified vulnerabilities in Medicare
enrollment procedures that have permitted the enrollment of providers
and suppliers whose qualifications for meeting all of our enrollment
standards were sometimes questionable. This raised concerns that
certain providers and suppliers in our program may be under- qualified
or even fraudulent and has led us to increase our efforts to establish
more stringent controls on provider and
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supplier entry into the Medicare program. These efforts include the
publication of the following rules:
A final rule with comment titled, ``Additional Supplier
Standards'' (October 11, 2000, 65 FR 60366).
A final rule titled, ``Requirements for Providers and
Suppliers to Establish and Maintain Medicare Enrollment'' (April 21,
2006, 71 FR 20754).
A final rule titled, ``Medicare Program; Revisions to
Payment Policies, Five-Year Review of Work Relative Value Units,
Changes to the Practice Expense Methodology Under the Physician Fee
Schedule, and Other Changes to Payment Under Part B; Revisions to the
Payment Policies of Ambulance Services Under the Fee Schedule for
Ambulance Services; and Ambulance Inflation Factor Update for CY 2007''
(December 1, 2006, 71 FR 69624).
A final rule titled, ``Competitive Acquisition for Certain
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS)'' (April 10, 2007, 72 FR 17992).
A final rule titled, ``Medicare Program; Revisions to
Payment Policies Under the Physician Fee Schedule, and Other Part B
Payment Policies for CY 2008; Revisions to the Payment Policies of
Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and
the Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; Final Rule'' (72 FR 66222).
A final rule titled, ``Appeals of CMS or CMS Contractor
Determinations When a Provider or Supplier Fails to Meet the
Requirements for Medicare Billing Privileges'' (June 27, 2008, 73 FR
36448).
A final rule with comment titled, ``Payment Policies Under
the Physician Fee Schedule and Other Revisions to Part B for CY 2009;
E-Prescribing Exemption for Computer Generated Facsimile Transmissions;
and Payment for Certain Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)'' (November 19, 2008, 73 FR 69726).
A final rule titled, ``Medicare Program; Surety Bond
Requirement for Suppliers of Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS); Final Rule'' (January 2, 2009, 74 FR
166).
A final rule titled, ``The National Provider Identifier
Rule'' (January 23, 2004, 69 FR 3434).
A final rule titled ``Medicare, Medicaid, and Children's
Health Insurance Programs; Additional Screening Requirements,
Application Fees, Temporary Enrollment Moratoria, Payment Suspensions
and Compliance Plans for Providers and Suppliers'' (February 2, 2011,
76 FR 5862).
The NPI provisions of this final rule are an extension of the
aforementioned program integrity initiatives, consistent with the
direction of the Affordable Care Act as described later in this
section, designed to ensure that only legitimate providers and
suppliers that meet and maintain our standards can be enrolled and/or
paid by the Medicare program.
Similarly, consistent with the NPI final rule and subsequent
guidance from the Secretary, beginning May 23, 2008, Medicaid providers
have also been required to report their NPIs on their Medicaid claims.
2. Provisions of the Affordable Care Act
Section 6402(a) of the Affordable Care Act added a new section
1128J of the Act, titled ``Medicare and Medicaid Program Integrity
Provisions.'' Section 1128J(e) of the Act requires the Secretary to
promulgate a regulation that requires, not later than January 1, 2011,
all providers of medical or other items or services and suppliers under
the programs under titles XVIII and XIX that qualify for an NPI to
include their NPI on all applications to enroll in such programs and on
all claims for payment submitted under such programs. In Medicaid,
there is no Federally required ``enrollment application,'' although all
Medicaid providers are required to enter into a provider agreement with
the State as a condition of participating in the program under section
1902(a)(27) of the Act. Therefore, in the Medicaid context we are
including the submission of an NPI to the State agency as a requirement
under the provider agreement. The NPI requirements in this final rule
are thus applicable to the reporting of NPIs--(1) pursuant to Medicaid
provider agreements; (2) for inclusion in Medicare enrollment records;
and (3) on Medicare and Medicaid claims.
3. Requirements Established by the IFC
a. NPI and the Medicare Program
(1) NPI and the Medicare Program Requirements Established by IFC
For the Medicare program, we established the following:
At Sec. 424.506(a), the definition of ``eligible
professional'' refers to any of the professionals specified in section
1848(k)(3)(b) of the Act.
At Sec. 424.506(b), requirements that a provider or
supplier who is eligible for an NPI must report the NPI on the Medicare
enrollment application; and, if the provider or supplier enrolled in
Medicare prior to obtaining an NPI and the NPI is not in the provider's
or supplier's enrollment record, the provider or supplier must report
the NPI to Medicare in an enrollment application so that the NPI will
be added to the provider's or supplier's enrollment record in PECOS.
At Sec. 424.506(c)(1), a requirement that a provider or
supplier who is enrolled in fee-for-service (FFS) Medicare report its
NPI, as well as the NPI of any other provider or supplier who is
required to be identified in those claims, on any electronic or paper
claims that the provider or supplier submits to Medicare.
At Sec. 424.506(c)(2) that a claim submitted by a
Medicare beneficiary contain the legal name and, if the beneficiary
knows the NPI, the NPI of any provider or supplier who is required to
be identified in that claim. If a Medicare beneficiary does not know
the NPI of a provider or supplier who is required to be identified in
the claim that he or she is submitting, the beneficiary may submit the
claim without the NPI(s) as long as the claim contains the legal
name(s) of the health care provider(s). If a beneficiary so desires, he
or she can obtain a provider's or a supplier's NPI by requesting it
directly from the provider or supplier or from a member of his or her
office staff, or by looking it up in the NPI Registry at https://nppes.cms.gov/NPPES/NPIRegistryHome.do.
At Sec. 424.506(c)(3), a Medicare claim from a provider
or a supplier will be rejected if it does not contain the required
NPI(s).
(2) Summary of and Responses to the IFC Comments Regarding the NPI and
the Medicare Program
(a) Effective/Implementation Date
Comment: A commenter noted that the preamble states that the NPI
requirements set forth in the IFC, referencing section 6402(a) of the
Affordable Care Act, requires the Secretary to promulgate a regulation
to implement the NPI requirement no later than January 2011. Therefore,
there is confusion as to why July 6, 2010 is the effective date for NPI
requirements.
Response: Section 6402(a) of the Affordable Care Act requires the
Secretary to promulgate rules implementing the NPI requirement no later
than January 2011. However, we have had existing regulations since
2008, as mentioned in the IFC, requiring the use of NPIs on all
enrollment applications and claims forms, if NPIs were assigned to the
provider. The NPI requirements set forth in the IFC are necessary to
implement the data
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reporting requirements in section 1128J(e) of the Act, as added by
section 6402(a) of the Affordable Care Act, which require that the
Secretary promulgate a regulation to implement this requirement no
later than January 2011. Moreover these NPI requirements are needed to
implement the Medicare ordering and certifying requirements specified
in section 6405 of the Affordable Care Act (discussed in section
II.B.2. of this final rule) that are effective July 1, 2010. Section
6406 of the Affordable Care Act (discussed in section II.B.4.a. of this
final rule) was effective January 1, 2010. It was imperative that the
NPI regulatory provisions be set forth as soon as possible to deliver
the guidance necessary to enact the document retention provisions. For
this reason, the NPI requirement was included in the IFC published on
May 5, 2010, with an effective date of July 6, 2010.
(b) Deactivation
Comment: A commenter suggested that CMS permit the use of
Electronic File Interface (EFI), which is used for submitting NPI
applications to the National Plan and Provider Enumeration System
(NPPES), to reactivate Medicare Provider Transaction Access Numbers
(PTANs) that have been deactivated for non-billing for 12 consecutive
months. This would reduce the burden on physicians and other providers
and suppliers who must submit enrollment applications to re-enroll in
Medicare if they have been deactivated due to non-billing.
Response: We appreciate the commenter's concerns and desire to use
a fully electronic mechanism for reenrollment after deactivation.
Currently, all enrollees must sign their paper enrollment application
or the Certification Statement for their Internet-based PECOS
application. We continue to work with our Medicare contractors to
reduce the delays in the enrollment process. We believe these measures
will alleviate the concerns of the commenter.
After review of the public comments received, we are retaining the
provisions regarding the NPI for the Medicare program with the
modification specified in this section and in section III. of this
final rule.
To clarify, it is not necessary for the providers and suppliers to
fill out an entire enrollment application simply to provide an NPI, we
have revised the language in existing Sec. 424.506(b)(2), which has
been redesignated as Sec. 424.506(b)(1)(ii), to specify that providers
and suppliers that are eligible for an NPI must update their enrollment
records with this information. NPIs must be provided to the Medicare
contractors by using a CMS-855 paper form or through Internet-based
PECOS.
After consideration of the comments, we are finalizing our policy
as it relates to the NPI and the Medicare definitions, enrollment, and
claims reporting with a few modifications. We made some technical
changes to the language by redesignating and revising language,
specifically in Sec. 424.506(b). Section 424.506(b)(3) was
redesignated as Sec. 424.506(b)(2) and revised to clarify that opt-out
physicians and nonphysician practitioners will not be required to
submit an enrollment application for any reason, including to order and
certify. We also revised Sec. 424.506(c)(1) to specifically address
and clarify the NPIs that were required on the claims.
b. NPI and the Medicaid Program
(1) NPI Requirements for the Medicaid Program Established by IFC
Consistent with the requirements of section 6402(a) of the
Affordable Care Act, we added a new (b)(5)(i) and (ii) to Sec. 431.107
to require that the provider agreement between a State agency and each
provider delivering services under the State plan include a requirement
that the provider furnish to the State agency its NPI (if eligible for
an NPI); and include its NPI on all claims submitted under the Medicaid
program. In Medicaid, under section 1902(a)(77) of the Act, States are
required to comply with the provider screening, oversight, and
reporting requirements outlined in section 1902(kk) of the Act
including the process for screening providers established under section
1866(j) of the Act. In addition, there are new Federal regulatory
requirements for provider enrollment and screening, published in the
February 2, 2011 Federal Register (76 FR 5862). The requirements under
section 1902(a)(77) of the Act and under these new Federal regulatory
requirements for provider enrollment and screening provide guidance for
certain aspects of provider enrollment but do not provide Federal
requirements for the entire process. However, providers are required to
enter into a provider agreement with the State as a condition of
participating in the program under section 1902(a)(27) of the Act. For
purposes of the IFC, we interpreted the Affordable Care Act's reference
to ``applications to enroll'' to refer to provider agreements in the
Medicaid context. Additionally, we required that the NPI be submitted
on all claims for payment to the Medicaid program on and after July 6,
2010.
(2) Summary of and Responses to the Public Comments Related to the NPI
and the Medicaid Program
Comment: A commenter requested clarification regarding NPIs on
pharmacy claims specifically when a pharmacy submits a prescriber Drug
Enforcement Administration (DEA) number or State license number in lieu
of the NPI. Is it expected that the pharmacy and physician NPIs are
submitted on the claim for payment? Should the claims processor reject
the claim if one or both provider identification numbers are not NPIs?
Response: The statute and this regulation require that NPIs be
included on all claims for payment for Medicaid, including pharmacy
claims. The requirement for an NPI does not replace the function of the
DEA number, which must appear on all prescriptions for scheduled drugs,
or the State license number, which is issued by an applicable State
licensing authority; however, these numbers have different purposes and
are not to be used to identify the prescriber when billing a claim at
point of sale. The NPI was adopted to identify a health care provider
as a health care provider in standard transactions adopted under the
HIPAA. Effective July 6, 2010, NPI numbers are required on pharmacy
claims.
Comment: A commenter stated that if pharmacy claims must include
the NPI of the prescriber, the July 6, 2010 date will be impossible to
meet due to the systems changes that would need to be made. The
commenter believed that the date of January 1, 2011, which is the date
in the Affordable Care Act, would be a more realistic compliance date.
Response: We believe the commenter is inquiring about the
requirement that the NPI of the ordering or referring provider be
included on all Medicaid claims for payment. This requirement was
finalized in a February 2, 2011 final rule (76 FR 5862) and was
effective March 25, 2011. Thus, this comment is outside the scope of
this final rule, which, for purposes of Medicaid, only requires that
the NPI of the provider furnishing the services/submitting the claim
(for example, the pharmacy) be included on the claim.
Comment: A commenter requested clarification on the process for
physician assistants (PAs) under different State Medicaid programs. PAs
qualify for NPIs and are providers of medical services in some State
Medicaid programs. However, not all States enroll PAs and in some
States, the PA's NPI is not included on the claim form. Will this rule
mean a change in policy and
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procedure and that all States will now be required to include the PA's
NPI on claims?
Response: If a PA is independently licensed to practice in a State
and that State has included PAs as a provider type under the Medicaid
State plan, the NPI number for that PA is required to be included on
all claims for payment and pursuant to the PA's provider agreement. If
the PA is not independently licensed within the State but rather is
under the supervision of the physician, and/or is not described as a
provider type that bills for Medicaid services under the State Plan,
the NPI of the PA is irrelevant since the PA is not directly billing
Medicaid; however, the supervising physician must have an NPI on
submitted claims for payment and pursuant to the provider agreement.
Comment: Commenters expressed concern that adding and using NPI
numbers on claims could result in burdensome investigations or
liability for dentists in cases where their NPI numbers could be used
fraudulently or criminally. These commenters requested procedures to
protect practitioners from any unreasonable additional compliance
burden that may be incident to the misuse of their NPIs by others.
Other commenters acknowledged that the NPI registry permits anyone
with a computer and internet access to look up a provider's NPI by
name. The commenters inquired how CMS is able to determine whether the
NPI that is on a claim was put there by a physician who meant to order
the test, or by someone who simply downloaded the NPI from the open
file, thereby identifying attempts at theft and fraud?
Response: Under Medicaid, a claim submitted for payment that does
not include the provider's NPI will be denied. In cases where claims
submitted for payment do include an NPI number, the State's Medicaid
Management Information System will match NPI numbers for providers with
other data included in the State's provider enrollment file to ensure
the provider's identity. This cross-checking with other data within the
State ensures that the NPI number is valid and that it matches with all
data in the provider enrollment file in an effort to verify each
provider's identity. Additionally, this cross-checking is done at the
State level and does not impose any additional compliance burdens on
providers.
Comment: A commenter requested clarification regarding whether
States need only to collect NPIs through the usual annual agreements
and no additional actions for physicians will be required this year to
report NPIs.
Response: NPIs must be added pursuant to provider agreements for
new providers effective July 6, 2010. Existing providers must submit
their NPIs pursuant to their provider agreements at the time in which
they are revalidated or at the time in which changes are made to
existing provider agreements. The NPI for all providers in Medicaid
must be included on all claims submitted for payment effective July 6,
2010. We wish to note that since provider NPIs must be submitted on all
claims for payment under Medicaid effective July 6, 2010, it may make
sense for all providers (new and existing) to consider adding NPIs
pursuant to provider agreements at the time in which they also submit a
claim for payment.
Comment: A commenter questioned patient access and home health
agencies' requests for payments for dual Medicaid/Medicare patients in
the following scenario--a patient has been admitted to Medicaid Home
Health after meeting the Medicaid homebound criteria, but not Medicare
homebound criteria at the level of receiving skilled nursing care (for
example wound care). The patient regresses, and now meets Medicare
homebound criteria. A new Medicare Start of Care begins, and claims can
be submitted to Medicare. What would the process be if this patient's
physician is not enrolled in PECOS?
Response: Under the Medicaid program, the provider is required to
include an NPI number on all claims for payment and pursuant to the
provider agreement with the State. If the home health agency submits a
claim to Medicare for home health services and the certifying physician
is not enrolled in Medicare or has not validly opted-out, as required
by the provisions of this rule, the claim will be denied by Medicare
once the automated edits are activated.
After consideration of the comments, we are finalizing our policy
as it relates to the NPI and Medicaid claims; that is, the effective
date for the inclusion of the NPI on all Medicaid claims for payment
remains July 6, 2010. The effective date for submission of NPIs
pursuant to provider agreements for new providers also remains July 6,
2010. However, we are revising our policy as it relates to the NPI
pursuant to provider agreements for existing providers; that is, the
effective date for inclusion of the submission of NPIs pursuant to
provider agreements for existing providers will be upon the next date
that a change must be made to the provider agreement or upon the date
of revalidation. This policy revision does not impact the regulatory
text (Sec. 431.107(b)(5)) as specified in the IFC (75 FR 24437).
Therefore, we are not amending the regulatory text in this final rule.
B. Ordering and Referring Covered Items and Services for Medicare
Beneficiaries
1. Background
Section 1833(q) of the Act requires that claims for items or
services for which payment may be made under Part B and for which there
was a referral by a referring physician shall include the name and the
unique identification number of the referring physician. Physicians are
doctors of medicine and osteopathy, optometry, podiatry, dental
medicine, dental surgery, and chiropractic.
In the past, prior to the Medicare implementation of the NPI on May
23, 2008, physicians and eligible professionals were identified in
claims as ordering or referring suppliers by their Unique Physician
Identification Numbers (UPINs). Further discussion on Medicare's use of
UPINs can be found in the IFC (75 FR 24441 and 24442). Physicians and
eligible professionals applied for and were assigned UPINs as part of
the process of enrolling in the Medicare program; therefore, physicians
and eligible professionals were expected to be identified in claims as
ordering or referring suppliers by their UPINs.
Analysis of Medicare claims data prior to 2008 (UPINs were not
permitted to be used in Medicare claims after May 23, 2008) revealed
that unauthorized and incorrect use of UPINs was widespread and, as a
result, we had reason to believe that many physicians and eligible
professionals were unaware of the requirement that their assigned UPINs
were intended to uniquely identify them as ordering or referring
suppliers and, more importantly, that they needed to apply for UPINs.
As a result, Medicare may have paid claims for covered ordered and
referred items and services that may have been ordered or referred by
professionals who were not of a profession eligible to order and refer;
by physicians or eligible professionals who were not enrolled in the
Medicare program; or by physicians or eligible professionals who were
not in an approved Medicare enrollment status (for example, they were
sanctioned, their licenses were suspended or revoked, their billing
privileges were terminated, or they were deceased).
With the Medicare implementation of the NPI in May 2008, Medicare
discontinued the assignment of UPINs and no longer allowed UPINs to be
used in Medicare claims. Because physicians
[[Page 25288]]
and non physician practitioners are eligible for NPIs, only the NPI may
be used in Medicare claims to identify ordering and referring
suppliers. To ensure the unique identification of ordering and
referring suppliers and that they were qualified to order and refer,
Medicare implemented claims edits in 2009 that require the ordering and
referring suppliers identified in Part B claims for items of DMEPOS and
services of laboratories, imaging suppliers, and specialists be
identified by their legal names and their NPIs and that they have
enrollment records in PECOS. The claims edits implemented in 2009 do
not result in nonpayment. However, claims edits are under development
to ensure that claims for Part B covered items and services
(specifically DMEPOS, imaging and clinical laboratory services) and
Part A and Part B home health services covered under this final rule
identify the physicians and eligible professionals who ordered the item
or services by their legal names and their NPIs and that those
physicians and eligible professionals have enrollment records in
Medicare.
2. Provisions of the Affordable Care Act
Section 6405(a) of the Affordable Care Act amended section
1834(a)(11)(B) of the Act to specify, with respect to suppliers of
durable medical equipment, that payment may be made under that
subsection only if the written order for the item has been communicated
to the DMEPOS supplier by a physician who is enrolled under section
1866(j) of the Act or an eligible professional under section
1848(k)(3)(B) who is enrolled under section 1866(j) before delivery of
the item. Section 1128J(e) of the Act requires that he or she be
identified by his or her NPI in claims for those services. Medicare
requires the ordering supplier (the physician or the eligible
professional) to be identified by legal name and NPI in the claim
submitted by the supplier of DMEPOS.
Section 6405(b) of the Affordable Care Act, as amended by section
10604 of the Affordable Care Act, amended the Act, and establishes new
requirements for home health services. These provisions amended: (1)
Section 1814(a)(2) of the Act and specifies, with respect to home
health services under Part A, that payment may be made to providers of
services if they are eligible and only if a physician enrolled under
section 1866(j) of the Act certifies (and recertifies, as required)
that the services are or were required in accordance with section
1814(a)(1)(C) of the Act; and (2) section 1835(a)(2) of the Act
specifies, with respect to home health services under Part B, that
payments may be made to providers of services if they are eligible and
only if a physician enrolled under section 1866(j) of the Act certifies
(and recertifies, as required) that the services are or were medically
required in accordance with section 1835(a)(1)(B) of the Act. Section
1128J(e) of the Act requires that the physician be identified by his or
her NPI in claims for those services. Medicare requires the ordering
supplier (the physician) to be identified by legal name and NPI in the
claim submitted by the provider of home health services.
In addition, section 6405(c) of the Affordable Care Act gives the
Secretary the authority to extend the requirements made by subsections
(a) and (b) to all other categories of items or services under title
XVIII of the Social Security Act, including covered Part D drugs as
defined in section 1860D-2(e) of the Act, that are ordered, prescribed,
or referred by a physician enrolled under section 1866(j) of the Act or
an eligible professional under section 1848(k)(3)(B) of the Act.
Section 1128J(e) of the Act requires that he or she be identified by
his or her NPI in claims for those services. Medicare requires the
ordering or referring supplier (the physician or the eligible
professional) to be identified by legal name and NPI in the claims
submitted by the suppliers of laboratory, imaging, and specialist
services. These amendments are effective on or after July 1, 2010.
3. IFC Requirements Regarding Ordering and Referring of Covered Items
and Services for Medicare Beneficiaries
a. Claims From Providers and Suppliers for Ordered/Referred Part B
DMEPOS, Imaging, Laboratory, Specialist Items/Services (Sec.
424.507(a)(1))
The IFC required that claims from Part B providers and suppliers
for covered ordered or referred items or services (excluding home
health services and Part B drugs) meet the following requirements:
The Part B items and services must have been ordered or
referred by a physician or, when permitted by regulation or law, by an
eligible professional.
The claim from the Part B provider or supplier must
contain the legal name and the NPI of the physician or the eligible
professional who ordered or referred the item or service.
The physician or the eligible professional who ordered the
Part B item or service must have an approved enrollment record or a
valid opt-out record in PECOS.
The IFC also required that if the Part B items or services were
ordered or referred by a resident or an intern, the claim must identify
the teaching physician as the ordering or referring supplier, and the
teaching physician must be identified in the claim by his or her legal
name and NPI, and he or she must have an approved enrollment record or
a valid opt-out record in PECOS.
b. Claims From Medicare Beneficiaries for Ordered/Referred Part B
DMEPOS, Imaging, Laboratory, Specialist Items/Services (Sec.
424.507(a)(2))
The IFC stated that claims from Medicare beneficiaries for ordered
or referred covered Part B items and services (excluding home health
services and Part B drugs) must meet the following requirements:
The Part B items and services must have been ordered or
referred by a physician or, when permitted by regulation or law, an
eligible professional.
The claim must contain the legal name of the physician or
the eligible professional who ordered or referred the item or service.
The physician or the eligible professional who ordered or
referred the item or service must have an approved enrollment record or
a valid opt-out record in PECOS.
The IFC stated that if the Part B items or services were ordered or
referred by a resident or an intern, the claim must identify the
teaching physician as the ordering or referring supplier, and the
teaching physician must be identified in the claim by his or her legal
name, and he or she must have an approved enrollment record or a valid
opt-out record in PECOS.
c. Claims From Providers for Ordered Part A and Part B Home Health
Services (Sec. 424.507(b)(1))
The IFC stated that claims from home health agencies for covered
Part A or Part B home health services must meet these requirements:
The Part A or Part B home health services must have been
ordered by a physician.
The claim must contain the legal name and the NPI of the
physician who ordered the service.
The physician who ordered the service must have an
approved enrollment record or a valid opt-out record in PECOS.
The IFC stated that if the Part A or Part B home health services
are ordered by a resident or an intern, the claim must identify the
teaching physician as the ordering or referring supplier. The teaching
physician must be identified in the claim by his or her legal name and
[[Page 25289]]
NPI, and he or she must have an approved enrollment record or a valid
opt-out record in PECOS.
d. Claims From Beneficiaries for Ordered Part A and Part B Home Health
Services (Sec. 424.507(b)(2))
The IFC required that claims from Medicare beneficiaries for
ordered covered Part A or Part B home health services must meet the
following requirements:
The Part A or Part B home health services must have been
ordered by a physician.
The claim must contain the legal name of the physician who
ordered the services.
The physician who ordered the services must have an
approved enrollment record or a valid opt-out record in PECOS.
The IFC stated that if the Part A or Part B home health services
are ordered by a resident or an intern, the claim must identify the
teaching physician as the ordering or referring supplier, and the
teaching physician must be identified in the claim by his or her legal
name, and he or she must have an approved enrollment record or a valid
opt-out record in PECOS.
e. Rejecting Claims From a Provider or Supplier That Do Not Meet the
Requirements (Sec. 424.507(a)(1) or Sec. 424.507(b)(1) Through Sec.
424.507(c))
The IFC provided that a Medicare contractor will reject a claim
from a provider or a supplier for covered ordered or referred items and
services described in Sec. 424.507(a) and (b) if the claim does not
meet the requirements of Sec. 424.507(a)(1) (for Part B items and
services except Part B home health services and Part B drugs) and Sec.
424.507(b)(1) (for Part A and Part B home health services).
f. Denying Claims From Medicare Beneficiaries That Do Not Meet the
Ordering/Referring Supplier Requirements (Sec. 424.507(d))
The IFC stated that a Medicare contractor may deny a claim from a
Medicare beneficiary for covered ordered or referred items and services
described in Sec. 424.507(a) and (b) if the claim does not meet the
requirements of Sec. 424.507(a)(2) (for Part B items and services
except Part B home health services and Part B drugs) and Sec.
424.507(b)(2) (for Part A and Part B home health services).
4. Summary of and Responses to Public Comments Regarding Ordering and
Referring of Covered Items and Services for Medicare Beneficiaries
As a point of clarification, we use the term ``ordering/referring
provider'' in this preamble because that is the terminology used in the
implementation specifications for the standard Part B claim format and
in the Part B paper claim to denote the individual (the person) who
ordered, referred, or certified an item or service reported in that
claim. The term ``ordering/referring provider'' is used in several
contexts in this final rule. The term ``order'' for instance, refers to
a provider who orders non physician items or services for the
beneficiary, such as DMEPOS, clinical laboratory services, or imaging
services. A ``certifying'' provider generally means a person who
orders/certifies home health services for a beneficiary.
The terms ``ordered,'' ``referred,'' ``certified,'' and ``ordering
or referring'' and ``ordered or referred'' are often used
interchangeably within the health care industry and were used
interchangeably by parties that commented on the IFC. Generally, we
have used the terms applicable to this final rule, which are
``ordered'' when referring to items of DMEPOS, imaging and clinical
laboratory services, and ``certified'' when referring to home health
services. However, to be technically correct in every instance of the
use of these terms in this preamble would require that we qualify every
use in each instance. We believe that would be cumbersome and
unnecessary and, therefore, did not do so. However, the regulatory text
uses the technically correct terms.
a. Technical, Administrative, and Procedural Modifications and
Corrections
Comment: Several commenters suggested that the agency did not
provide a valid rationale for avoiding the procedural safeguards
specified in sections 1871(a)(2) and (b)(1) of the Act, which address
rulemaking. Moreover, they stated that the statute (at section 6405(a)
of the Affordable Care Act) merely authorized the Secretary to require
a PECOS enrollment date of July 1, 2010 but did not require it.
Response: Section 6405 of the Affordable Care Act requires
physicians or eligible professionals who order or refer DMEPOS or home
health services be enrolled in Medicare under section 1866(j) of the
Act, and authorizes the Secretary to extend those requirements to other
Medicare services. Section 6405(d) of the Affordable Care Act states
that the amendments made by section 6405 of the Affordable Care Act
``shall apply to written orders and certifications made on or after
July 1, 2010.'' We find section 6405(d) of the Affordable Care Act to
be a clear statutory imperative.
Section 6406 of the Affordable Care Act requires physicians to
retain necessary documentation and provide access to records for
orders, referrals, and certifications for home health services, DMEPOS,
and other items and services as designated by the Secretary, upon
request. Section 6406(d) of the Affordable Care Act states ``the
amendments made by this section shall apply to orders, certifications,
and referrals made on or after January 1, 2010.''
These two provisions fall within the exception to section 1871 of
the Act that generally requires us to issue a notice of proposed
rulemaking prior to issuing a final rule under the Medicare program.
Section 1871(b)(1)(b) of the Act provides that the Secretary is not
required to issue a notice of proposed rulemaking before issuing a
final rule if ``a statute establishes a specific deadline and the
deadline is less than 150 days after the date of enactment of the
statute in which the deadline is contained.'' Section 6405 of the
Affordable Care Act establishes an effective date of July 1, 2010, 100
days after March 23, 2010, and section 6406 of the Affordable Care Act
established an effective date of January 1, 2010 that passed before the
Affordable Care Act was enacted. Additionally, implementing section
6402(a) of the Affordable Care Act, which adds section 1128J(e) to the
Act and requires the use of the NPI on all enrollment applications and
claims, does not add significant new burdens because the Medicare and
Medicaid programs had already required the NPI on claims, applications,
and agreements. The Affordable Care Act instructed the Secretary to
promulgate a rule that adds this requirement no later than January 1,
2011, and the IFC executed that authority. Finally, a delay in
implementing these provisions would be contrary to the public interest
and to our efforts to reduce and eliminate fraud and abuse in the
Medicare and Medicaid programs. For these reasons, we found good cause
to waive the notice of proposed rulemaking and to issue these
provisions on an interim final basis.
Additionally, the IFC carried a 60-day public comment period, to be
followed by the publication of a final rule, as would a proposed rule.
As a result, the public was afforded an opportunity to comment.
[[Page 25290]]
Comment: A commenter stated that the Affordable Care Act names
DMEPOS and home health services as the only ordered or referred items
or services to which the statutory requirements apply. While the law
allows CMS to expand the scope, which CMS did by including laboratory
services, there is no compelling reason for CMS to have done so.
Response: As stated by the commenter, section 6405(c) of the
Affordable Care Act permits the Secretary to extend the requirement to
all other categories of items or services under title XVIII of the Act,
including covered Part D drugs as defined in section 1866(j) of Act. As
noted in the regulation text at Sec. 424.507(a), this regulation has
extended the requirements to both laboratories and imaging services. We
believe that in the past, some laboratories have abused the reporting
of the ordering or referring provider by reporting surrogate UPINs for
the ordering or referring providers in all of their claims, when UPINs
were permitted to be used in Medicare claims, instead of reporting
UPINs that had been assigned to specific physicians or other eligible
professionals. These laboratories have also used a single (the same)
NPI to identify the ordering or referring providers in all of their
claims, having had earlier claims paid when using that NPI. Later, many
laboratories used their own NPIs as the NPI of the ordering or
referring providers even though the NPI Registry and the NPPES
downloadable file were readily available for determining the NPI of the
ordering or referring provider. We believe that these are compelling
reasons to impose ordering or referring provider edits on clinical
laboratory service claims.
Additional efforts to ensure accuracy of claims has also led us to
impose NPI requirements on Part D sponsors through the final rule with
comment period titled, ``Changes to the Medicare Advantage and the
Medicare Prescription Drug Benefit Program for Contract Year 2013''
published in the April 12, 2012 Federal Register. This rule requires
Part D plan sponsors to submit an active and valid individual
prescriber NPI on all prescription drug event (PDE) records submitted
to CMS. This rule does not require all physician prescribers to enroll
in Medicare. Rather, it mandates that PDE records include active and
valid individual prescriber identifiers effective for January 1, 2013
dates of service and later.
Comment: A commenter noted that laboratory services were not
subject to the provisions of the Affordable Care Act; therefore, if CMS
exercises its statutorily-given discretion and determines that they
must meet the requirements of the IFC, CMS should give laboratories
until January 3, 2011 to be in compliance and must allow laboratories
to continue to use their own NPI as the ordering or referring
provider's NPI until that date.
Response: As stated previously, section 6405(c) of the Affordable
Care Act permits the Secretary to extend the requirement to all other
categories of items or services, including laboratories. The NPI is the
primary metric for us to verify Medicare enrollment and for that reason
the two requirements are being implemented simultaneously, as described
in the preamble of this final rule. We have been validating the
ordering or referring providers reported in clinical laboratory claims
since October 2009 to ensure they are properly identified in the claims
and have enrollment records in PECOS or in a Medicare legacy system as
of the claim receipt date. Such claims have not been denied or rejected
due to the lack of the ordering or referring provider's enrollment
record. However, our revalidation of the enrollment records in PECOS or
a Medicare legacy system has allowed us to alert these providers that
they do not have an enrollment record. Clinical laboratories have
information available to them that will indicate the NPI of the
physicians and other eligible professionals who order services from
them. Therefore, we will not permit clinical laboratories to report
their own NPIs as the NPIs of the ordering or referring providers. We
have not modified the compliance date.
Comment: A commenter stated that the Affordable Care Act does not
give the Secretary the authority to determine who may order or refer
items or services that are not covered and for which payment will not
be made under a Federal insurance plan. The commenter stated that State
medical practice acts determine the scope of practice of professionals,
and that this regulation is creating a Federalism issue.
Response: We agree with the commenter in so far as this rule does
not establish who may order or refer items or services that are not
covered and for which payment will not be made under a Federal
insurance plan. Although this rule finalizes conditions of payment for
ordered items and services, it does not address broader payment policy
questions. Rather, this rule implements the statutory requirement that
individuals who order and certify particular Medicare-covered services
be enrolled in the Medicare program. The Medicaid provisions relating
to ordering and referring were finalized in a February 2, 2011 final
rule (76 FR 5862).
Comment: Several commenters noted that the word ``must'' was
omitted from the regulatory text at Sec. 424.506(c), there was a
typographical error in another word in Sec. 424.506(c), and noted the
omission of the word ``claim'' in the regulatory text at Sec.
424.507(a)(1).
Response: We have corrected these errors.
Comment: Several commenters indicated that the preamble discussed
requirements for those who order DMEPOS, laboratory, imaging, and
specialist services, whereas the text at Sec. 424.507 indicates that
the requirements apply to ``Part B items and services (excluding home
health services and Part B drugs),'' which is broader in scope than
what was discussed in the preamble.
Response: We have revised the regulatory text in this final rule at
Sec. 424.507 to be consistent with the language in the preamble with
respect to clinical laboratory and imaging services. Further,
specialist services are discussed in greater detail later in this final
rule.
b. Terminology
Comment: A commenter stated that under Federal law, claims for
which payment may be made under Part B and for which there was a
referral by a physician must include the name and the UPIN of the
referring physician. The commenter stated that this provision
incorporates the Stark law definition of ``referral,'' and the preamble
suggests the term ``referral'' should be interpreted in that manner.
Response: Based upon review of the public comments received, we
have decided to remove specialist services from the requirements of
this rule. The covered items and services for this final rule include
imaging and clinical laboratory services, DMEPOS, and home health. The
terms ``ordered'' and ``certified'' more accurately reflect these
covered items and services. Therefore, we have removed reference to
``referrals'' in our regulatory text, due to the exclusion of
specialist services from this final rule.
Comment: Several commenters requested that CMS define ``specialist
services,'' as there is no requirement that a Medicare beneficiary
obtain a referral from a physician to receive services from another
physician, particularly since Medicare no longer pays for
consultations. Another commenter stated that, because patients can
determine for themselves the need to see a specialist, it will be
difficult for Medicare claims contractors to
[[Page 25291]]
determine that a referring physician should have been reported on a
claim. Also, the commenters questioned how a contractor would know that
the visit to the specialist was not based on the patient's own decision
and not that of another physician.
Response: We agree with the commenters that there are a number of
operational issues associated with a requirement that services of a
specialist be ordered or referred. We have removed such requirements
from this rule.
Comment: Several commenters questioned what is meant by ``imaging
services'' and ``imaging suppliers.'' Commenters questioned if the term
applies only to the technical component of imaging services (or global
services) or if it also applies to the professional component. They
also requested clarification on whether claims for imaging services
provided in the hospital outpatient setting would be affected, if
independent diagnostic testing facilities (IDTFs) and portable x-ray
suppliers are considered ``imaging suppliers'', and if ``services''
apply to claims for routine x-rays performed in a physician's own
office.
Response: The IFC and this final rule specifically refer to the
technical components of imaging services that are: (1) Ordered by
physicians and, where permitted, other eligible professionals; (2)
furnished by IDTFs, mammography centers, portable X-ray facilities, and
radiation therapy centers that are enrolled in Medicare via the CMS-
855B; and (3) billed by these Part B suppliers to the Part B claims
system (MCS) on an X12N 837P or a paper form CMS-1500.
Comment: A commenter stated that dentists order few clinical
laboratory tests but frequently submit orders to dental laboratories,
and the items and services provided by dental laboratories are unlikely
to be covered by Medicare; thus, such orders and services would pose
little risk of waste and abuse of Medicare funds. The commenter urged
CMS to define ``laboratory'' as to exclude dental laboratories in order
to clarify dentists' compliance requirements and to relieve dentists of
an unnecessary compliance burden.
Response: We do not believe that dental laboratories should be
excluded from the requirements of this final rule. We decline to define
laboratories in this final rule; however, dental laboratories are, in
fact, laboratories. These laboratories, from time to time, provide
covered services under the limited circumstances in which dental
services are covered by Medicare.
c. Beneficiary Submissions
Comment: Several commenters noted that the IFC contains
requirements for beneficiary-submitted claims for home health services.
These commenters stated that Medicare home health payments may only be
made to Medicare certified home health agencies under assignment, not
to beneficiaries.
Response: The commenter is correct in that beneficiaries do not
submit claims to Medicare for home health services. This is because
home health agencies are obligated by their institutional provider
agreement to do all of the billing for services that may potentially be
covered by Medicare. Therefore, we are removing the requirement that
was added at Sec. 424.507(b)(2) of the IFC and have revised the
language in other sections of this rule in accordance with this change.
Comment: A commenter stated that there is no mechanism for ordered
or referred items and services to be billed to a beneficiary when the
beneficiary requests that the provider or supplier submit a claim to
Medicare (which providers and suppliers are required to do under
Medicare rules) in situations where the provider or supplier is aware
that the ordering or referring provider does not have an approved
enrollment record or a valid opt-out record in PECOS.
Response: We adhere to a longstanding position that if a
beneficiary receives services that are certified by a physician who is
not enrolled in Medicare and if that certifying physician refuses to
enroll so that a proper claim can be submitted on the beneficiary's
behalf, then the beneficiary cannot be charged for those services. A
provider or supplier may be able to avoid the circumstances described
in the comment if they ask the ordering or certifying provider if they
are enrolled in Medicare before the ordered or certified services have
been provided.
d. Effective/Implementation Dates
Comment: A commenter pointed out that the preamble stated that CMS
expects that most, if not all, enrolled physicians and other eligible
professionals who do not have enrollment records in PECOS, would have
submitted enrollment applications by the end of 2010. Therefore, having
an effective date of July 6, 2010 for claims to be rejected if they do
not have records in PECOS is very confusing.
Response: The statement in the preamble was meant to convey the
historical transition and progression of program enrollment
requirements that occurred prior to the passage of the Affordable Care
Act, and that physicians and eligible professionals had been complying
with the previously stated deadline of January 3, 2011. However, it
does not preempt the effective date stated in the IFC. The effective
date for the provisions contained in sections 6405 and 6406 of the
Affordable Care Act, remains July 6, 2010. Because this rule was issued
as an interim final rule with comment period, the provisions that
implemented the statutory provisions became effective 2 months after
the publication in the Federal Register. That interim final rule
remains in effect until modified and finalized by this final rule.
Comment: A commenter stated that the Affordable Care Act gives CMS
the authority and discretion to maintain the original published
deadline of January 3, 2011 and urged CMS to adhere to that previously
announced deadline.
Response: As stated in an earlier response, section 6405(d) of the
Affordable Care Act states that the amendments made by section 6405
``shall apply to written orders and certifications made on or after
July 1, 2010.'' We find section 6405(d) of the Affordable Care Act to
be a clear statutory imperative.
Comment: Multiple commenters expressed concern that the July 1,
2010 date provided 6 months less time to implement these requirements
than previously stated by CMS. Commenters believed that the date leaves
inadequate time for CMS to notify the affected physicians (especially
those who order home health services) and eligible professionals of the
requirement to establish an enrollment record in PECOS if one does not
already exist. These commenters believed the July 6, 2010 date created
an undue burden on many providers, especially large medical groups,
because many of their physicians and other professionals are affected
by this requirement, creating an enormous workload on them, as well as
the CMS contractors. Other commenters believe that the Medicare
enrollment application for physicians is lengthy and complex and takes
a great deal of time to complete, and requires details and supporting
documents that only the physician would be able to provide. The
commenters also stated that there are postal delays when mailing
applications, and that physicians and their staff schedule vacations
around that time of year.
Response: The commenters have referenced an announcement during an
open door forum in February of 2010 wherein we noted a delay of in the
enforcement of the requirement to enroll
[[Page 25292]]
in PECOS to January 2011. However, this delay was preempted by the new
statutory effective date in the Affordable Care Act, passed on March
23, 2010. The Affordable Care Act includes amendments to the Act that
apply to written orders and certifications made on or after July 1,
2010. Because we must follow the statutory effective date, we have
instituted these regulations accordingly.
To provide the physician and eligible professional communities with
the opportunity to comply with this regulation, we have made some
modifications to the final rule which we believe will assist in that
effort. The Affordable Care Act mandated that physicians and eligible
professionals who order and refer must be enrolled in Medicare, the
program. This final rule mandates the same, mirroring the statutory
language. The IFC required an enrollment in PECOS, our data repository
system for storing enrollment records. The Medicare legacy systems
predate the PECOS system. However, those systems are being phased out
and in the near future will no longer be used. At this time, the only
way to enroll in Medicare is to establish an enrollment record in
PECOS. We have been working towards fully populating PECOS and
transferring those providers and suppliers in the legacy systems over
to PECOS. This is being done by requiring that providers and suppliers
revalidate their enrollment records, which we have separate and
established authority to do. By revalidating, providers and suppliers
will then have an enrollment record in PECOS. Those physicians and
eligible professionals who only have an enrollment record in a local
legacy system have been asked to revalidate first, so that they may be
included on the Ordering Referring Report (explained in subsequent
responses). We have made it clear to the physician and eligible
professional communities that we would not turn on the automated edits
that would cause a claim not to be paid until all physicians and
eligible professionals have been asked to revalidate and have been
given the opportunity to complete that process through their respective
Medicare Administrative Contractors (MACs). In this final rule,
although we have expanded our requirement from requiring enrollment in
PECOS to one requiring enrollment in Medicare, which includes
enrollment in PECOS or the local legacy systems, our requirements have
not practically changed.
We believe that the aforementioned modification of the IFC will not
create an additional burden because information will be gathered
through the normal revalidation process. To address the commenters'
concerns regarding the lengthy enrollment forms, we have modified the
enrollment process for those enrolling only to order and certify. The
CMS-855O form is available now for use and is significantly shorter
than the original enrollment forms. Additionally, although those
physicians and eligible professionals who wish to enroll in Medicare to
order and certify, but do not wish to bill the Medicare program, will
need to provide information to us via the CMS-855O form, they will not
be required to submit financial information, including filling out a
CMS-588 Electronic Funds Transfer (EFT) form. We believe that these
modifications have addressed the concerns raised by these commenters.
Comment: A commenter suggested that CMS should delay implementation
of these requirements until 5 percent or fewer physicians and other
eligible professionals lack approved enrollment records or valid opt-
out records in PECOS.
Response: The Affordable Care Act requires that physicians who
order certain items or services must be enrolled in Medicare. As
previously stated, we have changed the enrollment requirement from one
mandating enrollment in PECOS to one requiring enrollment in Medicare--
including PECOS or other legacy Medicare enrollment systems. In
addition, as we have indicated in this final rule and in open door
forums, we have not yet activated the automated edits that would cause
claims for services or supplies not to be paid for lack of an approved
enrollment record in Medicare. We will provide advance notice of
activation of the automated edits. We believe these changes alleviate
the concerns of the commenter.
Comment: A commenter suggested that if the July 6, 2010 date
remains in effect, consideration should be given to processing and
paying claims if the ordering or referring provider has an enrollment
application in process at a CMS contractor.
Response: We have changed the enrollment requirement from one
requiring enrollment in PECOS to one requiring enrollment in Medicare--
including PECOS or other legacy Medicare enrollment systems. However,
physicians and eligible professionals must have an approved enrollment
record in Medicare, not a pending record in Medicare to order and
certify services for Medicare beneficiaries.
Comment: Several commenters questioned whether the practice of
providers billing for services after July 6, 2010 and the ordering or
referring provider's failure to have a record in PECOS at that time,
could trigger liability under the False Claim Act.
Response: The False Claims Act (FCA), 31 U.S.C. 3729 through 3733,
imposes civil liability for the knowing submission of a false or
fraudulent claim for payment and the Department of Justice investigates
and litigates alleged FCA violations. Therefore, any question related
to FCA liability is beyond the scope of this rule.
Comment: Another commenter asked if providers that submitted claims
between July 2010 and December 2010 that fail the edits because the
ordering or referring provider or eligible professional did not have an
enrollment record in PECOS may eventually be held liable for non-
compliance and could face rejected claims and recoupment by Zone
Program Integrity Contractors (ZPICs), Contractor Error Rate Testing
(CERT), Durable Medical Equipment Medicare Administrative Contractors
(DME MACs), and Recovery Audit Contractors (RACs), and other
contractors at any point after July 1, 2010, noting that a tremendous
number of claims would have failed those edits during that timeframe.
Response: We have delayed the implementation of automated edits
that would cause a claim not to be paid due to the lack of an approved
enrollment record in Medicare for the ordering or certifying physician
or eligible professional. This final rule does not in any way provide
relief to providers whose claims would be subject to recoupment by any
CMS contractor, including ZPICs, RACs, and MACs, as well as any law
enforcement partner, due to improper payments resulting from any other
reason unrelated to the ordering or certifying requirements. We always
retain the right to pursue fraud and recoup money for claims that did
not meet the requirements of the IFC. However, for operational reasons,
we do not believe it would be a prudent use of resources to pursue
large-scale recoveries against claims with dates of service from July
2010 until such time as we activate prepayment edits that identify
claims that do not have proper documentation of enrolled ordering and/
or certifying suppliers.
Comment: Commenters stated that claims for home health services are
reimbursed on a 60-day episode basis, and claims submitted on or after
July 6, 2010 would be for services provided in April, May, and June.
The commenters stated that because the IFC was published on May 5,
2010, it may apply to home health services ordered before
[[Page 25293]]
May 5, and would not be fair to require retroactive compliance with a
new regulation.
Response: We will provide advance notice to providers and suppliers
of the date we plan to activate the automated edits that would cause a
claim not to be paid for the lack of an enrollment record in Medicare.
No part of this final rule will require retroactive compliance for
periods of time before July 6, 2010. Further, the edits will apply to
only those claims with a date of service on or after the date the edits
are activated.
Comment: Commenters argued that the July 6, 2010 date should apply
only to orders and referrals for DMEPOS and home health services, as
those are the only ordered or referred items or services specifically
named in the Affordable Care Act, and that those who order or refer
imaging, laboratory and specialist services (which are not named in the
law but CMS names in the IFC) should have been given until January 3,
2011 to enroll/re-enroll. Similarly, another commenter stated that
laboratory services were not subject to the provisions of the
Affordable Care Act; therefore, if CMS exercises its statutorily-given
discretion and determines that they must meet the requirements of the
IFC, CMS should have given laboratories until January 3, 2011 to be in
compliance.
Response: Extending the ordering and referring enrollment
requirements to other providers and suppliers is permitted by statutory
provisions in 6405(c) of the Affordable Care Act, including laboratory
and imaging services. However, as noted in the responses to comments,
we have eliminated from the final rule the requirements related to
referrals to physician specialists. The statutory effective date is
binding for all applicable provisions of this rule, including those
specifically mandated in the Affordable Care Act provisions, as well as
those added at the discretion of the Secretary. Therefore, we are not
able to make the suggested change.
Comment: Several commenters stated that CMS should flag claims with
a date of service after July 6, 2010 that have been rejected due to the
ordering or referring provider not having an enrollment record in PECOS
and that CMS should then communicate this information to the billing
provider and CMS should use this information to target outreach to non-
PECOS ordering or referring providers. Some commenters stated that
physicians do not understand why other providers/suppliers, instead of
CMS, are notifying them of the need to have records in PECOS.
Response: As stated previously, Medicare contractors have
communicated in writing with enrolled physicians and nonphysician
practitioners who do not have enrollment records in PECOS and have
urged them to establish those records through revalidation. Suppliers
who have submitted claims for items and services ordered and referred
by non-enrolled physicians have been receiving informational messages
that these claims are not in compliance with the enrollment
requirements but are not being denied at this time. We are aware that
some suppliers have been communicating with those individuals who
ordered and referred items and services about the requirement to enroll
in Medicare and we encourage all suppliers to do so. We believe that
our outreach documents and messages provided at our provider open door
forums are clear, comprehensive, and continue to stress the importance
of having an enrollment record in PECOS. We will continue our direct
outreach with these communities as we implement this final rule.
Comment: Due to the short timeframe for complying with the new
provisions, several commenters questioned that we allow the effective
date for ordering home health services by newly enrolling physicians be
the date the physician mails the signed CMS-855 Certification Statement
to the Medicare contractor.
Response: The statute requires that enrollment must be valid based
on the date of the order or referral. As noted in the preamble of this
final rule, the final rule requires enrollment based on the date of
service, not the mailing date of the CMS-855 Certification Statement.
In order for a physician or non physician practitioner to be enrolled
in Medicare, the Medicare contractor must process the enrollment
application to a final approved status. This process could take
approximately 45 days or more, depending upon various factors. To allow
physicians and eligible professionals sufficient time to enroll to
order and certify, we will provide ample notice of our plans to
activate the automated edits that will cause a claim not to be paid due
to the lack of an approved enrollment record in Medicare to order and
certify.
Comment: A commenter stated that because CMS recently implemented
the Outcome and Assessment Information Set (Oasis C) for home health
agencies, making the effective date of July 6, 2010 in the IFC would be
even more onerous and difficult to implement due to such short notice.
Response: The effective date for the enrollment requirements for
physicians and eligible professionals who order and certify covered
items and services was mandated by statute. Consequently, we are not
able to change the effective date.
e. Enrollment Records, PECOS, FISS, NPPES, and the Ordering Referring
Report
Comment: A few commenters questioned why CMS needs PECOS when there
is already an NPI database.
Response: PECOS is a Medicare enrollment repository and the ``NPI
database'' (NPPES) is the repository of information about health care
providers who have been assigned NPIs and their assigned NPIs. Any
health care provider who has an NPI has a record in NPPES. Not all
health care providers in NPPES are in PECOS, because not all health
care providers with NPIs are enrolled in the Medicare program. Please
see the CMS NPI Web page for more information about NPIs and NPPES
www.cms.gov/NationalProvIdentStand/.
Comment: A commenter did not understand why an ordering physician
had to have an enrollment record in PECOS when the physician already
has an NPI.
Response: Having an NPI does not mean that a physician is enrolled
in the Medicare program or that the physician has an enrollment record
in PECOS or in Medicare. The Affordable Care Act requires that
physicians who order certain items or services must be enrolled in
Medicare. We have changed the enrollment requirement language from one
requiring enrollment in PECOS to one requiring enrollment in Medicare--
including PECOS or other legacy Medicare enrollment systems. This final
rule requires that physicians report an NPI on new enrollment records
and on submitted claims for payment. We will use our existing authority
to revalidate enrolled providers, which will require the reporting of
the NPI on an enrollment application.
Comment: A commenter recommended that CMS consider a bi-directional
interface between PECOS and NPPES to permit both systems to contain the
information necessary for a provider to verify that the ordering or
referring physician is a qualified provider of Medicare services.
Response: While we appreciate the commenter's point of view, NPPES
is an entirely separate entity from Medicare and PECOS. NPPES simply
assigns NPIs and collects the corresponding information for those
numbers. NPPES does not collect Medicare enrollment information. PECOS
collects Medicare enrollment information, as do CMS's
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legacy systems. Medicare verifies the credentials of its enrolling
providers and suppliers as part of the provider and supplier enrollment
process that occurs when Medicare contractors process Medicare
enrollment applications. This verification does not occur when health
care providers apply for and are assigned NPIs by NPPES.
Comment: A commenter stated that providers and suppliers, including
practitioners, may not know whether they have NPIs in their enrollment
records in PECOS, or what they need to do in order to comply with the
NPI requirement to submit the NPIs to CMS by July 6, 2010.
Response: We have established a number of ways for providers and
suppliers to inquire about their status with Medicare.
Providers and suppliers may start by referring to the NPI
Registry online to search for their NPI. Those eligible for an NPI, who
are enrolled in Medicare, must establish an NPI and update their
enrollment records with Medicare.
Providers and suppliers may also refer to the Ordering
Referring Report to verify their enrollment records. The Ordering
Referring Report is a report published by CMS that reflects the
approval status of all physician and non physician practitioners who
have applied to order and refer. The report will show all practitioners
who have an approved record in PECOS to order and refer and
practitioners who have an application that has been received and is
pending approval. The report is available via the following link:
http://www.cms.gov/MedicareProviderSupEnroll/06_MedicareOrderingandReferring.asp#TopOfPage.
Providers and suppliers may also use Internet-based PECOS
to view their enrollment records. This will also enable the user to
determine whether their NPI is included in their enrollment record in
PECOS.
Comment: Several commenters, noting that not all Medicare providers
and suppliers who have enrollment records in PECOS have NPIs in those
records, believed that the requirement for such providers and suppliers
to submit, by July 6, 2010, enrollment applications that contain the
NPI would overwhelm the Medicare contractors, as this would be an
additional burden on the contractors that already have backlogs of
enrollment applications to process. They recommended that CMS issue
guidance to its contractors for establishing a process for those who
need to establish enrollment records in PECOS, as well as those who
need to add their NPIs to their enrollment records, and to hold such
providers and suppliers harmless for failure to submit the required
enrollment applications or add their NPIs to their enrollment records
prior to having been notified to do so by their designated Medicare
contractors.
Response: The Medicare provider/supplier enrollment Web site
assists providers and suppliers in determining whether they have
enrollment records in PECOS and also provides information on how to
enroll. We will continue to convey these messages, as appropriate, via
our provider/supplier open door forums, in CMS provider listserv
messages, in Medicare Learning Network products, and in our
conversations and discussions with national provider and supplier
organizations.
As stated previously, we will provide ample notice of our plans to
activate the automated edits that will cause a claim not to be paid due
to the lack of an approved enrollment record in Medicare to order and
certify. Therefore, there is no reason for us to hold providers
harmless for failing to be compliant with this requirement.
Comment: Many commenters stated that physicians' practices do not
understand the PECOS system and that CMS help is difficult to obtain.
The commenter stated that the help number is only available 4 hours per
day and providers cannot get through. Another commenter believed the
PECOS process to be quite difficult and time consuming.
Response: We have provided PECOS instructional guides for
physicians, nonphysicians and DMEPOS suppliers available at: http://www.cms.gov/MedicareProviderSupEnroll/04_InternetbasedPECOS.asp.
The CMS End User Services (EUS) Help Desk operates under our
direction and is equipped to respond to operational systems issues
related to Internet-based PECOS that are reported by providers and
suppliers. Examples of issues that should be reported to the CMS EUS
Help Desk include access problems (for example, user ID and password do
not work, forgotten User ID or password, help in setting set up User ID
or password), difficulty in understanding how to follow the screens in
the application process, error messages, and system performance issues.
The telephone number of the CMS EUS Help Desk is 1-866-484-8049 (TTY/
TDD 1-866-523-4759); the email address is [email protected]. The CMS
EUS Help Desk days and hours of operation are Monday through Friday, 7
a.m. to 7 p.m. Eastern Time. The CMS EUS Help Desk is unable to answer
enrollment policy questions; those questions must be directed to the
Medicare contractors. Medicare provider enrollment contact information
for each State can be found in the download section of http://www.cms.gov/MedicareProviderSupEnroll/. We will investigate all reports
of slowness or similar systems problems that Internet-based PECOS users
may experience and report to the CMS EUS Help Desk.
Providers and suppliers with questions regarding the use of PECOS
for the enrollment process should contact their jurisdiction's MAC.
Although each MAC's hours of operation may vary, their normal business
hours are generally established at 8 hours daily. Each MAC is required
to comply with certain training exercises; therefore, there may be
times when the hours of operation are shortened to 4 hours. The MACs
may also be closed on Federal holidays. We do not believe that these
limited interruptions significantly impact the MAC's ability to provide
assistance related to PECOS due to these limited periods of
interruption.
Comment: A commenter stated that CMS has confused physicians
unnecessarily by referring to PECOS interchangeably as both an
enrollment repository and as a Web site. They think that when they
``sign up'' to use the Web site, they have enrolled, only to find out
that they still need to submit an application, a much more cumbersome
process.
Response: Internet-based PECOS is a secure Web site providers can
log into and then submit an application to enroll. In order to use
Internet-based PECOS, a provider or supplier must log in by entering
his or her User ID and password or register to obtain log in
information in the PECOS Identity and Access (I&A) System. Logging on
or registering is not enrolling or updating an enrollment record. After
access to Internet-based PECOS is granted, the user must complete and
then submit the enrollment application electronically; then the user
must print the Certification Statement and have it signed and dated by
the appropriate individual, gather any required supporting paper
documentation, and send this material to the designated Medicare
contractor. After the designated contractor receives the signed and
dated Certification Statement and any additional paper documentation,
it begins to process the enrollment application to an approved
(approved or opt-out) or disapproved status. Once the application is
approved, the provider or supplier will have an approved enrollment
record or
[[Page 25295]]
a valid opt-out record in PECOS. We have revised some of the material
on the Medicare provider/supplier enrollment Web site in an attempt to
clarify requirements and processes to address the concerns expressed by
the commenter. PECOS can be accessed here: https://pecos.cms.hhs.gov/pecos/login.do.
We offer additional information on internet-based PECOS on our Web
site. This information includes several Medicare Learning Network (MLN)
articles that provide providers and suppliers with in-depth information
to assist them in navigating the enrollment process.
Comment: A commenter stated that the ``find a doctor'' link on the
Medicare.gov Web site does not inform beneficiaries of the PECOS
requirements or indicate whether the physicians it suggests to patients
are PECOS enrolled. Another commenter noted that it will be difficult
for Medicare beneficiaries to know if their physician has an enrollment
record in PECOS. The commenter also stated that if the physician does
not have an approved record in PECOS, and he/she orders or refers, and
the provider or supplier refuses to furnish the item or service, the
beneficiary will develop further health problems, causing more problems
for the beneficiary as well as the taxpayer and the provider. Another
commenter stated that beneficiaries should be made aware of the impact
of these requirements on their ability to access subsequent care.
Response: We use a number of communication vehicles to communicate
with beneficiaries about Medicare including the annual Medicare and You
Handbook describing the program, which refers to the requirements that
physicians and eligible professionals, were applicable, who order and
certify Medicare services for beneficiaries must be enrolled in
Medicare. The Medicare.gov Web site uses PECOS as the source of the
information it displays about physicians. We are continually updating
the information in PECOS to be sure that it is complete and accurate.
The Affordable Care Act requires that physicians who order certain
items or services must be enrolled in Medicare. We recognize that this
requirement may pose issues for beneficiaries who need care and who are
unsure whether their physician is enrolled in Medicare. As mentioned
earlier in this preamble, there are a number of ways a beneficiary can
determine whether a physician is actually enrolled in Medicare,
including to ask the physician whether he or she is enrolled. In
addition, for ease of access, we have created the Ordering Referring
Report that provides the public, including beneficiaries, information
on who is enrolled in Medicare to order and certify (available at
http://www.cms.gov/MedicareProviderSupEnroll/06_MedicareOrderingandReferring.asp). To ensure that Medicare
beneficiaries are aware of the need for the providers and suppliers
from whom they receive items and services to be enrolled in Medicare
(even if only to order and certify, when permitted) or to have validly
opted-out of Medicare, we will continue to share information with
senior citizens' organizations and create special messages for Medicare
beneficiaries about these issues and processes. We believe all of these
changes reduce the risk that beneficiaries will be disadvantaged by
implementation of the statutory requirements.
Comment: Many commenters stated that the Affordable Care Act
requires physicians who order or refer DMEPOS and home health services
to be enrolled in Medicare but does not require them to have enrollment
records in PECOS, whereas the IFC requires the latter. The commenters
suggested that CMS should focus on ensuring that those who order and
refer DMEPOS and home health services and who have never enrolled in
Medicare, must enroll in Medicare, and CMS should have let those who
are enrolled and not yet in PECOS have until January 2011 to get their
enrollment information into PECOS. This could help reduce the strain on
the enrollment contractors.
Response: The Affordable Care Act requires that physicians who
order certain items or services must be enrolled in Medicare. In
response to comments, we have changed the enrollment requirement
language from one requiring enrollment in PECOS to one requiring
enrollment in Medicare--including PECOS or other legacy Medicare
enrollment systems. However, as we explained in this preamble, we will
be transitioning all legacy system enrollees to PECOS via our
revalidation process and will delay the activation of the automated
edits. Once implemented, these edits will cause a claim, for the lack
of an approved enrollment record in Medicare for the ordering or
certifying physician or other eligible professional, not to be paid.
These edits will not be activated until the revalidation process is
completed for the relevant supplier groups that order and certify. The
Affordable Care Act does not authorize the Secretary to arbitrarily
implement this rule for certain providers and suppliers who enroll to
order and certify. We believe that the delay of the automated edits
alleviates the commenters' concerns. We require that providers and
suppliers be enrolled in the Medicare program or that they have validly
opted out of the Medicare program as of the date of service, beginning
with dates of service of July 6, 2010. However, as already stated, we
will provide advance notice of the activation of the automated edits
that pertain to these claims.
Comment: A commenter stated that physicians who have attempted to
enroll in order to get their enrollment data into PECOS have had their
applications returned to them with instructions that there is no need
for their applications to be updated at this time.
Response: We understand that there has been some confusion in the
past and have instructed our Medicare contractors to process these
applications. Our instructions to the enrollment contractors also state
specifically that physicians who are currently enrolled in PECOS and
have an NPI in their records need not resubmit an application to enroll
to meet the statutory requirements addressed in this final rule. Our
enrollment contractors receive on-going training to address these types
of issues and we do not expect any confusion in the future.
Comment: Several commenters stated that physicians have used
Internet-based PECOS to enroll but their names are not in the Ordering
Referring Report available on the CMS Web site at www.cms.gov/MedicareProviderSupEnroll.
Response: We are evaluating the reasons why physicians or other
eligible professionals do not appear on the Ordering Referring Report.
If a physician or other eligible professional believes that he or she
has been omitted from this report in error, we encourage them to
contact their respective Medicare contractor for assistance.
Comment: A commenter asked CMS to define what is meant by an
``approved enrollment record in PECOS.'' Further, the commenter thought
that Medicare contractors should retroactively approve each enrollment
application found in PECOS to the date the application was initially
submitted to CMS. The commenter believed this would be consistent with
the effective date of enrollment in Medicare for physicians, non
physician practitioners, and physician and non physician practitioner
organizations, which is defined at Sec. 424.520(d) as the latter of
the first date the individual began furnishing services at a new
[[Page 25296]]
practice location or the date of filing of the application that is
subsequently approved.
Response: For purposes of this final rule, an ordering or
certifying provider must be enrolled in Medicare in an approved or a
valid opt-out status as of the date of service on the claim. As the
commenter stated, under Sec. 424.520(d), the effective date of
Medicare billing privileges for physicians and practitioners is the
date of filing of a Medicare enrollment application that is
subsequently approved or the date an enrolled physician or non
physician practitioner first began furnishing services at a new
location, whichever is later. The provider may begin ordering or
certifying items and services as of the effective date of his/her
Medicare billing privileges.
Comment: Some commenters suggested that CMS provide more
information about the Medicare legacy claims system and how providers
can access it, as the legacy claims system is another way that ordering
or referring providers can be in compliance with existing ordering or
referring provider requirements.
Response: Providers are not permitted to access the Medicare legacy
claims systems and there is no need for them to do so. In earlier
responses, we have explained numerous ways for providers to access the
records that provide the information sought by the commenters.
Comment: Several commenters noted that the Ordering Referring
Report that is available on the CMS provider/supplier enrollment Web
page is difficult to use effectively.
Response: We revised this report so that it is more user-friendly.
The Ordering Referring Report is now available on the Medicare
provider/supplier enrollment Web site in two formats: PDF and CSV. The
PDF format enables a person to search for a particular physician or
other eligible professional, either by NPI or by name. We believe these
changes have alleviated the problems associated with conducting
searches and we will continue working to improve the quality of search
capabilities.
Comment: Some commenters requested that the report be made
available more frequently, such as daily.
Response: The Ordering Referring Report is replaced at a minimum of
once per week. We do not believe that more frequent availability
(daily, real-time) is necessary or practical. As mentioned in a
previous response, a report of physicians and other eligible
professionals whose enrollment applications are in process is also
available on the same Web site.
Comment: A commenter stated it has no way of knowing when an
enrolled physician establishes an enrollment record in PECOS in order
to resubmit a claim that had been submitted but had failed the ordering
or referring provider edit.
Response: The Ordering Referring Report is updated at a minimum of
once per week and is available in two formats, as noted earlier. By
comparing information in a provider's or supplier's previously
submitted claims to the information in this file, it is possible to
determine if the ordering or certifying providers identified in
previously submitted claims are enrolled in Medicare in an approved
status or have validly opted-out.
Comment: A commenter stated that PECOS must be updated daily or
patients will be incorrectly denied services.
Response: PECOS, the national Medicare FFS provider and supplier
enrollment system, is updated daily, and an extract of PECOS enrollment
data is transmitted electronically each night to the Medicare claims
systems.
Comment: A commenter stated that a physician who received an
enrollment letter from CMS could not be found on the Ordering Referring
Report.
Response: There were some errors in the generation of the Ordering
Referring Reports that were produced in the late spring of 2010 that
resulted in the omission of some physicians and other eligible
professionals from the Ordering Referring Report. We have corrected the
errors.
Comment: Several commenters stated that home health agencies should
be given the capability to access the Fiscal Intermediary Standard
System (FISS) to research the enrollment status of enrolled and opt-out
physicians, as FISS is updated daily.
Response: As stated in an earlier response, providers and suppliers
may not access the claims systems. Information regarding a provider or
supplier's enrollment status is available by checking the files we post
on the Medicare provider/supplier enrollment Web site, or by inquiring
with the ordering or certifying providers.
f. Enrollment Applications and Processing
Comment: Commenters stated that Medicare enrollment contractors are
not processing enrollment applications in a timely manner, are not
providing accurate information to inquiring physicians and others, are
not responding timely to questions, and that this made it impossible
for those physicians and other practitioners to have enrollment records
in PECOS by July 6, 2010. A commenter asserted that it has taken a
total of 90 days or more for contractors to process enrollment
applications and for CMS to include the physician in the Ordering
Referring Report, making the July 6, 2010 date unacceptable. The
commenter also suggested that the new future deadline will put even
more of a strain on the Medicare enrollment contractors, who are
already behind in processing enrollment applications.
Response: Additional resources have been allocated to Medicare
contractors to enable the processing of increased numbers of enrollment
applications. Furthermore, we have undertaken many activities to
streamline the process and assist the provider and supplier communities
in complying with this rule. These include: (1) Modifying the
enrollment requirement language from one requiring enrollment in PECOS
to one requiring enrollment in Medicare-- including PECOS or other
Medicare enrollment systems; (2) not immediately activating the
automated edits that would cause claims for items or services not to be
paid for lack of an approved enrollment record in Medicare; and (3)
providing a streamlined application for those providers and suppliers
who wish to enroll to order and certify (CMS-855O). We have worked with
the provider and supplier community to be responsive to application
processing concerns and are continuously working to make the enrollment
process faster and easier for the provider and supplier communities.
Comment: Many commenters suggested that CMS increase resources to
contractors to ensure that customer service lines are answered promptly
including the Internet-based PECOS call center and the NPI Enumerator
call center. The commenter also noted that customer service training
should be improved, and that information submitted by physicians should
not be lost.
Response: We agree with the commenter. We have taken a number of
steps to address the commenter's first concern. The CMS EUS Help Desk
(the Internet-based PECOS call center) is hiring more staff and is more
thoroughly educating its employees on how to properly handle issues and
problems related to Internet-based PECOS. We have made improvements in
the language used on the screens in Internet-based PECOS to help
eliminate confusion. We have also taken steps to ensure the system
operates more smoothly and consistently. The NPI Enumerator call center
remains fully staffed and funded to assist those
[[Page 25297]]
physicians and other eligible professionals who need to obtain or
establish NPIs, as well as those who have lost or forgotten their NPPES
User IDs and passwords to enable them to use Internet-based PECOS. In
addition, we are continuing to make major revisions to the enrollment
process that will significantly reduce delays and other problems
associated with PECOS enrollment.
Comment: A commenter stated that a Medicare contractor requires
physicians to submit multiple CMS-855I and 855R forms, one for each
Medicare-assigned Provider Transaction Access Number (PTAN). The
commenter was concerned that this is resource-intensive on the
physician and the contractor.
Response: We do not require physicians or other eligible
professionals to submit multiple enrollment applications (CMS-855I
forms) in situations where they have more than one PTAN unless the
PTANs represent practice locations that exist in more than one Medicare
contractor jurisdiction. In that situation, a physician or other
eligible professional would need to submit an enrollment application to
each Medicare contractor; a Medicare contractor has access only to the
PECOS enrollment records with practice locations within that
contractor's jurisdiction. The 855R form is not an enrollment
application, as such. This form is used to reassign benefits to another
provider or supplier, such as a physician group practice. This has a
very different function than the standard enrollment forms.
Additionally, in an effort to streamline our enrollment for this final
rule, we have developed the new CMS-855O form. This form will be
available to those physician and nonphysician practitioners who wish to
submit an enrollment application just for the purposes of ordering and
certifying.
Comment: A commenter stated that the enrollment processing time
should be more reasonable, such as 7 to 14 days.
Response: Many of the applications submitted to the Medicare
contractors are processed in as little as 14 days. However, Medicare
contractors must verify information reported in the Web-based and paper
enrollment applications, and sometimes need to obtain additional
information or clarification from enrolling providers and suppliers.
Providers and suppliers are not always timely in furnishing the
requested clarifications or additional information, which may add
substantially to the processing time and, if the requested information
is not furnished within the timeframe required by the Medicare
contractor, it may cause an enrollment application to be rejected.
Paper enrollment applications take longer to arrive at the Medicare
contractors and take longer to process than those submitted via
Internet-based PECOS for several possible reasons related to paper
applications that may be missing required data; may contain illogical
dates or incorrect, incomplete, missing addresses or telephone numbers;
or may be missing required supporting documentation. The increased
volume of enrollment applications has resulted in slightly longer
processing times. However, since we changed the enrollment requirement
from one requiring enrollment in PECOS to one requiring enrollment in
Medicare--including PECOS or other Medicare enrollment systems, we
believe we have eliminated some of those possible problems and delays
in processing during the revalidation process. This change has ensured
that claims of existing approved Medicare providers have not been
disrupted.
Comment: A commenter stated that CMS should make available data
regarding enrollment applications submitted due to these new
requirements and detail the success of the Medicare contractors in
processing the applications within the required timeframes.
Response: We make available on the Medicare provider/supplier
enrollment Web site a report showing the legal names and NPIs of
physicians and other eligible professionals who have enrollment
applications being processed by the Medicare contractors. For purposes
of this final rule, we do not believe it appropriate to include the
enrollment application processing times of the Medicare contractors.
Many factors influence the time it takes to process an enrollment
application, including the method (Web or paper) by which the
enrollment application was submitted and the completeness of the
application. Medicare contractors have several methods available to
them for managing their workloads successfully. However, we do monitor
application processing activities for timeliness and other performance
variables.
Comment: A commenter stated that the IFC expanded the scope of the
statute by including radiology and pathology services as ordered or
referred items and services. The commenter asserted that many more
physicians order these services than order DMEPOS, and that CMS has not
permitted adequate time for physicians to become aware of this
expansion and, if necessary, establish enrollment records in PECOS. The
commenter asked that CMS determine the number of physicians who must
establish enrollment records in PECOS and then establish manageable
timeframes for processing the revalidations. The commenter suggested
that CMS also consider having the Medicare contractors create special
processing units to process only voluntary revalidation applications.
Response: Section 6405(c) of the Affordable Care Act permits the
Secretary to extend the requirement to all other categories of items or
services, including imaging services and clinical laboratory services.
We have a general sense of the pool of affected physicians and other
eligible professionals who must establish enrollment records in
Medicare and have established manageable timeframes for processing the
revalidations. Additionally, we have engaged in outreach efforts with
the impacted medical communities. As a result, those who order imaging
services and clinical laboratory services should be fully aware that
they need to be enrolled in Medicare or have validly opted- out of
Medicare to continue to order those services. We do not believe there
is a need to provide additional time for those who order imaging
services and clinical laboratory services to enroll in Medicare.
By ``voluntary revalidation applications,'' we believe the
commenter is referring to enrollment applications submitted by enrolled
physicians and other eligible professionals absent the receipt of a
revalidation letter from a Medicare contractor. Revalidation requests
are generated by Medicare contractors, and providers and suppliers are
given a specific period of time in which to submit their enrollment
applications. Medicare contractors give priority to processing all
initial enrollment applications and to those who are enrolling just to
order and certify. We do not accept voluntary revalidation applications
and we do not intend to in the future.
g. CMS Outreach Activities and Education
Comment: Commenters stated that home health agencies, who learned
of these requirements when reading the IFC, need time to educate
physician and hospital communities on the dual issues of the physician
status in PECOS and potential adverse impact on access to post-acute
care services for their patients. A commenter requested that if the
July 6, 2010 date for the ordering or referring supplier requirement
for physicians is not moved to January 3, 2011, CMS should--(1) Fund
[[Page 25298]]
enrollment contractors for physician outreach and enrollment
application processing; (2) direct contractors to set up dedicated
lines to expedite inquiries and resolve problems related to enrollment
and PECOS; and (3) send out messages through electronic means, set up
open door meetings, and utilize other DHHS communications tools to
ensure physicians are aware of the accelerated deadline and have the
ability to meet it.
Response: We agree that provider communication and information is
central to the success of the requirements mandated by this final rule.
We have implemented a communications plan for the requirements.
Furthermore, the delay in the activation of the automated edits and the
changes made in this final rule will assist the provider and supplier
communities in complying with this rule. We will continue to convey
these messages via open door forums, Medicare Learning Network
articles, and other venues.
Comment: Many commenters stated that CMS should develop an
aggressive outreach enrollment campaign for physicians, as they may be
unaware of the need to establish enrollment records in PECOS if they
are enrolled and do not have records in PECOS, and they may be unaware
of the requirement to report their NPI on a Medicare enrollment
application if they were enrolled and later obtained their NPI and have
not yet reported it to Medicare on a Medicare enrollment application.
Response: As previously stated, we have changed the enrollment
requirements on mandating enrollment in PECOS to one requiring
enrollment in Medicare--including PECOS or other legacy Medicare
enrollment systems. We have pursued an aggressive outreach initiative
to educate the provider and supplier communities on the ordering and
referring requirements even before the IFC was published on May 5,
2010. Upon publication of this final rule, we plan to disseminate
guidance on specific provisions of the final rule by producing a
Medicare Learning Network product, placing additional or revised
information on the Medicare provider/supplier enrollment Web site,
making announcements at CMS provider/supplier open door forums, and
releasing messages via CMS provider/supplier listservs and to national
senior citizens' organizations.
Comment: A commenter stated that CMS should engage in special
outreach efforts to hospital clinics that may not understand that the
physician, as well as the clinic, must have an enrollment record in
PECOS.
Response: Enrollment has been a longstanding requirement. However,
we will be sure to address this in an upcoming update of the applicable
informational documents that are available on the Medicare provider/
supplier enrollment Web site and we will also continue our outreach
efforts to educate the provider and supplier communities.
Comment: A commenter suggested that CMS prepare a model letter and
make it available to the supplier community so that the suppliers can
forward the letter to those who order items and services who do not
have approved enrollment records or valid opt-out records in PECOS.
Response: We have and will continue to reach out to the provider
and supplier community by providing educational material using a number
of different media. On June 28, 2010, we announced through a Medicare
Learning Network article that Medicare contractors would be mailing
letters to physicians and non physician practitioners who are enrolled
in Medicare but who do not have enrollment records in PECOS. Our
numerous announcements at our provider/supplier open door forums
continue to remind physicians and other eligible professionals of our
goal of ultimately having all FFS providers and suppliers in PECOS. We
believe that these, and other outreach efforts, make it unnecessary to
generate a model letter at this time.
Comment: Many commenters suggested that CMS work collaboratively
with the medical community to ensure physicians clearly understand
their enrollment responsibilities.
Response: We have frequent communications with national medical
associations and other groups and organizations. We also deliver
provider/supplier enrollment information and messages at the regularly
scheduled CMS provider/supplier open door forums. In addition, we have
sponsored several open door forums dedicated to Medicare provider/
supplier enrollment and will continue to do so as the need arises. We
have created, and continue to create, special documents to inform the
provider/supplier community of the Medicare enrollment requirements and
to assist them in complying with those requirements.
h. Patient Care Implications and Access
Comment: A commenter suggested that the new deadline could
potentially cause serious disruption in payments and claim resolution
and could adversely affect millions of patients across the United
States. Another commenter stated that CMS is placing an enrollment
requirement above the interests of Medicare beneficiaries, and the
effective date should remain January 2011.
Response: We have taken action to address the commenter's concern
by not activating the automated edits that would cause a claim to not
be paid due to the lack of an approved enrollment record in Medicare.
In addition, we have made other changes in this final rule to reduce
the risk that Medicare beneficiaries will not have access to quality
care. Also, our enrollment requirements are an essential program
integrity function that permits us to screen providers and suppliers to
ensure that beneficiaries are receiving care from licensed, legitimate
providers and suppliers. The effective date is mandated by the
Affordable Care Act.
i. Impact on Individual Medical Communities
Comment: Commenters suggested that with the July 6, 2010 date,
suppliers will be compelled to either furnish the ordered or referred
items and services at their own cost or that of the beneficiary or to
hold their claims until the ordering or referring supplier has an
approved enrollment record or valid opt-out record in PECOS. Both
scenarios are unfair to suppliers and beneficiaries because neither
have control over physician enrollments in PECOS.
Response: In response to public comment, we changed the enrollment
requirement language from one requiring enrollment in PECOS to one
requiring enrollment in Medicare, including PECOS or other legacy
Medicare enrollment systems, so that those suppliers enrolled in a
legacy system can continue to order and certify during the revalidation
process. This will alleviate much of the commenters' concern. In
addition, we will provide notice well in advance of activation of the
automated edits that would cause claims for services or supplies not to
be paid for lack of an approved enrollment record in Medicare. At the
time we activate the edits, all eligible suppliers will have been given
the opportunity to enroll or revalidate enrollment for the purpose of
meeting the ordering and certifying requirement. Billing providers and
suppliers should continue to assess their business practices of taking
orders and certifications from non-Medicare enrolled providers and
proceed accordingly. In addition, as stated earlier in this preamble,
we have provided alternative approaches for providers and suppliers to
verify the enrollment status of individuals who order and certify
Medicare services. We
[[Page 25299]]
will continue with our extensive outreach efforts so that physicians
and eligible professionals have the opportunity to educate themselves
on these requirements.
Comment: Several commenters noted that there is no direct incentive
to have an enrollment record in PECOS because those who are enrolled,
but who do not have records in PECOS, continue to be paid. Some
commenters stated that some enrolled physicians told them they will
take no action to establish enrollment records in PECOS. Commenters
complained that the burden lies on the billing provider or supplier who
furnished the ordered or referred items and services to confirm the
ordering or referring provider's PECOS status and educate them if they
do not have enrollment records in PECOS. Many commenters added that
DMEPOS suppliers ultimately have no control over what referring
physicians do, yet the DMEPOS suppliers find their livelihoods and
businesses, not those of the physicians, to be at risk by this IFC.
Another commenter stated that CMS should, in a first phase, only reject
the claims from physicians who do not have enrollment records in PECOS
and then, once they establish their records in PECOS, in a second
phase, reject claims from providers who furnish ordered or referred
items or services whose claims identify ordering or referring providers
who do not have enrollment records in PECOS.
Response: Section 6405 of the Affordable Care Act, which this final
rule implements, does not address payment or nonpayment of claims from
physicians or eligible professionals who are not enrolled in Medicare.
However, we understand the concerns that the commenters raised about
physicians being enrolled only in PECOS. Consequently, we modified the
PECOS requirement and now will permit enrollment in Medicare. We
believe that the modification of the PECOS requirement will reduce the
likelihood that providers and suppliers will have claims denied that
were ordered or certified by a physician without a valid record in
PECOS. Generally, physicians who are not enrolled in Medicare would not
have their claims paid. However, this final rule deals only with the
requirement that services or supplies provided by rendering/billing
providers and suppliers must have been ordered or referred by a
provider or supplier with an approved enrollment record in Medicare or
the provider or supplier must have validly opted-out of Medicare.
Therefore, the commenter's phased-in approach would not work within the
context of this rule. However, Medicare has developed a simplified
enrollment process (form CMS-855O) for those who want to enroll in
Medicare solely for the purpose of ordering and certifying.
Comment: A commenter stated that the inability of a provider or
supplier to identify the correct teaching physician could cause that
provider or supplier to choose not to submit a claim for a medically
necessary item or service that is already furnished, meaning the
provider or supplier would not receive payment to which it is entitled.
Response: We understand that the implementation of new policy
requires providers and suppliers to adapt their processes. To assist in
this effort, we have modified the provision in this final rule to
permit individuals who are enrolled in an accredited graduate medical
education program in a State that licenses or otherwise enables such
individuals to practice or order and certify services, to enroll in
Medicare to order and certify. In situations where States do not
license or otherwise permit such individuals to practice or order and
certify services, the teaching physician's full legal name and NPI must
be included on the claim for services. In this last circumstance, the
claim will not be paid unless the ordering and certifying physician, in
this case, the teaching physician, is listed on the claim as the
ordering or certifying physician.
Comment: Some commenters stated that CMS should sanction or
otherwise penalize physicians who do not comply with the request to
establish enrollment records in PECOS but who order or refer and cause
the claims of other suppliers and providers to fail the ordering or
referring provider edits and be rejected by Medicare. Another commenter
asked that CMS modify this regulation by stating that beneficiaries
and/or DMEPOS suppliers who were adversely affected by a physician's
non-compliance should be able to initiate a complaint against the
physician and submit evidence in support of the complaint.
Response: As stated previously, in light of our decision to modify
the requirement that the ordering or referring providers must have
enrollment records in PECOS, we believe the likelihood of claims being
denied is greatly reduced because those physicians and eligible
professionals in our legacy systems have been able to order and refer
during the revalidation process. Further, we will not turn on the
ordering and certifying automated edits that will cause a claim not to
be paid for the lack of an enrollment record until those entitled to
order and certify have been notified of their need to revalidate. We
have been working with suppliers, providers, and beneficiaries to
educate them about the requirements of enrollment for ordering and
certifying.
The provider or supplier can avoid a situation like the one
described by the commenters by ensuring--prior to furnishing the
service or item in question--that the physician is enrolled. The
relationship that the commenters describe is between the physician and
the provider or supplier whose claims were denied. We cannot serve as
an intermediary in whatever dispute may arise between these parties
concerning the physician's failure to be enrolled. The matter must be
resolved between the parties themselves.
Comment: A commenter stated that it could potentially lose referral
sources if it does not provide the services referred by physicians who
do not have enrollment records in PECOS.
Response: As stated previously, we have changed the enrollment
requirement from one mandating enrollment in PECOS to one requiring
enrollment in Medicare--including PECOS or other Medicare systems. We
believe this modification will largely alleviate the problem raised by
the commenter. We will continue to engage in provider and supplier
outreach and education on this issue. The Affordable Care Act imposed
the ordering and referring requirement in section 6405 and we hope that
physicians and eligible professionals will enroll in the interest of
being able to order and certify items and services for their Medicare
patients. As previously stated, we encourage rendering providers and
suppliers to verify the ordering or certifying practitioners'
enrollment status prior to rendering services.
Comment: A commenter noted that all of the services furnished by
hospital- based radiologists are referred and that they have no way,
within the short time frame between publication of the IFC and July 6,
2010, to inform and verify that referring providers have records in
PECOS. Commenters also stated that because the billing provider will
not be paid if the referring provider is not in PECOS, there will be a
huge reduction in payments, resulting in the possibility of missing
filing deadlines with insurance plans, and the patient will not be
protected, and hospital-based radiology medical groups will have no
income, no payroll, and no ability to maintain services for patients.
Response: Due to the comments received, we are removing the
ordering or referring provider requirements on claims for physician
specialists' services. In-hospital services that are
[[Page 25300]]
covered by the hospital inpatient prospective payment system (IPPS)
payments will also not be subject to the requirements of this rule.
However, in- hospital diagnostic testing services that are not paid as
part of PPS (for example, imaging services furnished by an IDTF or
another entity) must be ordered by Medicare enrolled providers. We have
further clarified that we will provide ample notice to these providers
when we decide to activate the edits that will cause a claim not to be
paid for the lack of an approved enrollment record in Medicare or valid
opt-out record in Medicare.
Comment: Commenters were concerned because pharmacies are required
by law to include the name of the prescriber in prescriptions.
Commenters described the administrative difficulties that would be
present in trying to link a resident to his/her teaching physician in
order to comply with the stated requirements in the IFC and the issues
with respect to pharmacies that need to record, by law, the actual
prescriber, who could be a resident. A commenter stated that not all
pharmacy systems may allow the use of more than one identifier in a
claim which would be necessary if a resident or intern ordered the item
and the teaching physician needs to be identified as the ordering or
referring provider. The commenter asked that CMS clarify the logistics
and processes for pharmacists and pharmacy systems to identify, verify,
and submit claims for intern/resident-generated orders and to identify
teaching physician information. A commenter stated that because interns
and residents move frequently among rotations, it will be difficult if
not impossible for the pharmacies to contact the interns and residents
in order to obtain the identity of the teaching physician.
Response: Neither the IFC, nor this final rule places requirements
on prescribers identified in claims for drugs. As noted in the IFC, the
ordering requirement in this final rule does not apply to Part B or D
drugs.
Comment: A commenter stated that CMS should thoroughly consider the
implications of new policies such as the ordering or referring provider
edits before public release in order to thoroughly identify potential
pitfalls beforehand.
Response: We agree with the commenter and have been sharing
information with the public about these issues since 2009. In addition,
the IFC published May 2010 offered an opportunity to comment on all
aspects of the Affordable Care Act requirements. We believe it is
important to continue this kind of communication with the public and
will continue to do so. Moreover, we will provide advance notice of the
activation of the automated edits pertaining to these claims.
Comment: Commenters stated that nonprofit home health providers
will be financially vulnerable because their core mission is to serve
all patients regardless of their ability to pay. These commenters
stated that nonprofit home health agencies have limited budgets and
limited information technology (IT) support and personnel resources;
thus, they are unable to quickly compare individuals in the Ordering
Referring Report with their own list of ordering physicians or quickly
disseminate the PECOS requirement to the physicians who order home
health services from them. The commenters further stated that there is
inadequate time for nonprofit home health agencies to learn about and
efficiently use the ``complex PECOS.''
Response: In order to do business with Medicare, all home health
agencies, whether or not they are nonprofit, must submit claims that
comply with our regulations in order to be paid for the home health
services they provide. We believe the commenter is referring to
Internet-based PECOS in using the term ``the complex PECOS.'' We make
available at no charge the names and NPIs of those who are permitted to
order and certify, who have approved enrollment records in PECOS, and
who have validly opted out of the Medicare program. Also, a home health
agency can and should ask the ordering/certifying physicians if they
are enrolled in Medicare or have opted out of Medicare prior to
accepting the order and/or certification.
Comment: Some commenters stated that home health agencies stand to
suffer severe financial hardships because of reduced patient admissions
and the costs associated with issuing Advanced Beneficiary Notices of
Noncoverage (ABNs), causing patient dissatisfaction, which is long-
lasting and rebuilding the relationship can take years.
Response: We understand these concerns. However, after
consideration of our program integrity needs and the statutory mandate
to implement this provision, we are moving forward with this final
rule.
Comment: A commenter asked that CMS share the impact of this
regulation on all areas of practice--the physicians who order home
health, the HHAs, and the patients.
Response: We have interpreted this comment to suggest that we
should educate these distinct communities on how this rule will impact
them individually. As stated previously, we will continue to provide
additional information, education, resources, and guidance on this
final rule across the spectrum of affected parties.
j. Claims Submission and Edits
Comment: Several commenters requested an explanation of potential
future claim edits for over-ordering and over-referring items of home
health and DMEPOS. The commenters were unaware of any statutory basis
for such edits except to identify violations of the Stark law. Another
commenter stated CMS should be required to state how it determines
whether services are being ``over-ordered.''
Response: The commenters are referring to a statement on the middle
of page 24444 of the IFC which stated that based on the new NPI
requirements, '' * * * if appropriate, we could establish edits to
check for over-ordering specific items or services * * *'' We have
removed all references to these edits in the final rule. However, we
will continue to utilize our oversight functions that do not involve
edits, to monitor statistically anomalous ordering, certifying, and/or
billing patterns and investigate when appropriate.
Comment: A commenter asked what is meant by the date of the written
order or certification. The commenter asked if it is the date the
referral or order was verbally received from the physician, or the date
the physician signed the order.
Response: The language in the IFC used the term ``date of written
order or certification.'' We intended that term to mean the date the
physician signed the order or certification. Public comment indicated
that often times written orders are signed well after the service is
provided. We intended to mandate that the ordering and/or certifying
practitioner be enrolled at the time the service is performed.
Therefore, in response to public comment and for the purposes of this
final rule, we have changed our terminology and will use the ``date of
service'', not the date of written orders or certifications. This
change fully captures the purpose of this rule. Additionally, the date
of service is much more accurate for claims and record retention
purposes.
Comment: A commenter asked if the ordering and referring
requirements for the Part B services mentioned in the IFC apply to such
services when furnished in hospitals and billed using the Uniform Bill
(UB-04). Another commenter asked if the IFC applied to Part A
providers, such as hospitals or other entities, such as IDTFs and
[[Page 25301]]
freestanding imaging centers which provide services paid under Part B
(submitted on the UB-04 claim form).
Response: The requirements in this final rule are applicable to the
following ordered or certified items and services billed to Medicare by
Part B suppliers of DMEPOS, clinical laboratory and imaging services,
and for Part A and Part B home health claims:
Part A and Part B home health services, submitted in
claims from home health agencies to the Part A claims system at fiscal
intermediaries and A/B MACs in ANSI X12N 837I or UB-94 formats.
Part B clinical laboratory services, submitted in claims
from independent clinical laboratories to the Part B claims system at
carriers and A/B MACs in ANSI X12N 837P or CMS-1500 formats.
Part B imaging services, submitted in claims from
independent diagnostic testing facilities, portable X-ray suppliers,
mammography centers, and radiation therapy centers to the Part B claims
system at carriers and A/B MACs in ANSI X12N 837P or CMS-1500 formats.
Part B items of DMEPOS, submitted by DMEPOS suppliers to
DME MACs in ANSI X12N 837P, or CMS-1500 formats.
The requirements of this final rule are applicable to the following
ordered items billed to Medicare by Medicare beneficiaries:
Part B clinical laboratory services.
Part B imaging services.
Part B items of DMEPOS.
With the exception of claims for home health services that are
submitted by home health agencies, this final rule does not affect the
following:
Claims submitted to the Part A claims system at fiscal
intermediaries and A/B MACs.
Claims for drugs.
Part B claims from physician specialists.
Claims from beneficiaries for home health services
(beneficiaries are not permitted to submit claims for those services).
Comment: Two commenters were concerned that the ordering and
referring provider edits on Medicare DMEPOS claims are not item-
specific and that there are limitations in the claims processing system
which may result in Medicare claims for Part B drugs being denied if
the prescribers do not have approved enrollment records or valid opt-
out records in PECOS. Specifically, the commenters stated that claims
that are submitted in the National Council for the Prescription Drug
Programs (NCPDP) 1.1 batch format are not subject to the ordering and
referring provider edits, whereas claims submitted using the allowable
ANSI X12N 837P format are subject to the ordering and referring
provider edits. The commenter also stated that because the claims are
not edited based on the items in the claim, Medicare will reject claims
for Part B DMEPOS drugs if the physician who prescribed the Part B
DMEPOS drugs does not have an enrollment record in PECOS. The commenter
is asking that Medicare not edit the ordering and referring provider
(the prescriber) of Part B drugs regardless of which claim format is
used.
Response: This final rule does not change the allowances permitted
under HIPAA that allow retail pharmacies to submit claims on either the
NCPDP format or the 837P format. However, as the commenter correctly
points out, claims submitted in the NCPDP standard formats are not
subject to the ordering and referring provider edits at this time. If
an ANSI X12N 837P claim format is used to report drugs and DMEPOS and
there is no EY modifier on the claim or if the claim reports only drugs
and no EY modifier on the claim, the claim will be subject to the
ordering and referring requirements of this rule. An EY modifier is a
specific designation in the 837P format when, for example, the pharmacy
knows the claim will be denied so that it may then use the Medicare
denial for filing with secondary insurances that may allow for the
payment of the item or service. We acknowledge that we will need to
adjust claims payment processing to accommodate this rule. We are
working towards making these necessary changes. However, in the
interim, retail pharmacy claims that combine Part B drugs and DMEPOS
supplies may be submitted using the NCPDP format to avoid this
situation.
Comment: A commenter indicated that pharmacies that are also DMEPOS
suppliers may submit and be reimbursed for claims for ordered or
referred items after receiving an indication from the ordering
physician that he/she has an enrollment record in PECOS. If it is later
determined that the physician did not have an enrollment record in
PECOS, will the pharmacy be liable or at risk?
Response: As noted in earlier responses, the Affordable Care Act
requires that physicians who order certain items or services must be
enrolled in Medicare. It is the billing provider or supplier's
responsibility to ensure that the ordering or certifying physician or
eligible professional has a valid enrollment record or has validly
opted out. We have mentioned numerous ways billing providers and
suppliers can ensure compliance with this rule.
Comment: A commenter asked that pharmacies be provided with the
normal Part B timely filing period in order to re-submit claims that
fail the requirements of this regulation. The commenter then asks that
pharmacies have 1 year in which to re-bill if the failure of the claim
to pass the edits was beyond the control of a pharmacy. Another
commenter asked that CMS permit suppliers to re-bill claims that were
denied for PECOS edits for up to 1 year, and not apply the truncated
120 days normally provided for denied claims. Another commenter stated
that when a DMEPOS supplier claim would be rejected for failing to meet
the edit that the ordering or referring provider have an enrollment
record in PECOS, it would fail a ``front end'' edit. Failing a front
end edit means that the claim does not go to a DME Medicare
Administrative Contractor (MAC) for adjudication. As a result, neither
a remittance advice nor a Medicare Summary Notice would be produced,
and appeal rights are not offered with proof that the ordering or
referring provider is currently a Medicare provider. The commenter
requested that the regulation be changed to allow (1) beneficiary
liability using a proper ABN taking into consideration certain factors;
(2) the claim to be processed beyond the ``front end'' so that the
claim can be returned as unprocessable, which could enable the
beneficiary community to prompt their physicians or other eligible
professionals to establish their enrollment records in PECOS; or (3)
deny (not reject) the claim using Adjustment Reason Code 52: ``The
referring/prescribing/rendering provider is not eligible to refer/
prescribe/order/perform the service billed.''
Response: Unless specified otherwise, in addressing these comments
we are assuming that the commenters are referring to DMEPOS claims.
This rule does not change any of the existing requirements for the
resubmission of claims for payment. Although the IFC stated that we
would reject, not deny, claims from providers and suppliers that do not
comply with the requirements that those who order and refer services or
supplies must be enrolled in Medicare or validly opt out, we have
determined in this final rule that we will deny such claims. As stated
in previous responses, we have not yet activated the automated edits
that would cause a claim not to be paid because a physician or, where
applicable, eligible professional who ordered or certified the service
does not
[[Page 25302]]
have an approved enrollment record in Medicare, and we will provide
ample notice prior to activating the edits. However, the resubmission
and payment of a claim by pharmacies would not be possible under the
commenter's scenario because the physician or eligible professional was
not enrolled in Medicare or did not have a valid opt-out record on the
date of service.
Comment: Many commenters requested that CMS generate more
meaningful explanations as to why claims failed the ordering and
referring provider edits. For example, they want to know if the
rejection codes will be different for claims that fail the ordering and
referring supplier edits because the ordering or referring supplier is
a physician or other eligible professional but does not have an
enrollment record in PECOS and claims that fail the ordering or
referring supplier edits because the ordering or referring supplier is
not a physician or other eligible professional.
Response: We agree with these comments and we are in the process of
developing more descriptive informational messages. We will provide new
informational messages that provide these details and will describe
these new messages to the provider and supplier communities in a
Medicare Learning Network article shortly after publication of this
final rule.
Comment: A commenter stated that Medicare beneficiaries are limited
to the submission of one DMEPOS claim per lifetime. The commenter,
therefore, requests that a beneficiary-submitted claim for DMEPOS items
be rejected, not denied, if it fails the edits, in order to avoid
``wasting'' the once-per-lifetime claim benefit.
Response: The permissive, once-in-a-beneficiary's-lifetime, payment
of a beneficiary-submitted claim for an item of DME, or of a Medicare-
covered supply, is intended to apply only to incidental items that a
beneficiary might obtain from an entity that a beneficiary might
reasonably assume was enrolled in Medicare but was, in fact, not so
enrolled. This limited exception to the general rule furnishes notice
to the beneficiary of the supplier enrollment requirement (and the
beneficiary's duty to inquire of the supplier's Medicare enrollment
status in the future), while holding the beneficiary harmless for his
or her ignorance of the rule, this single time. Beneficiaries are able
to submit claims from enrolled Medicare suppliers as is necessary, and
are not in danger of ``wasting'' the once in a lifetime benefit under
this final rule.
Regardless of the applicability of the comment, claims from
beneficiaries will be denied, not rejected, to afford them appeals
rights. Under Medicare, a claim is rejected when the claim filing has a
defect or impropriety such that it cannot be processed. A claim that
was ordered by a non-enrolled physician or eligible professional is a
claim where a required element of the furnishing of the item to the
beneficiary does not meet Medicare requirements, and it must be denied,
not rejected.
Comment: Many commenters stated that home health agency providers
would have to discharge many home health patients because the IFC
requirement that certifying physicians have enrollment records in PECOS
by July 6, 2010 could not be met. The commenter stated that home health
patients would then end up in hospitals or other acute facilities. The
commenters wanted such home health agencies to be held harmless from
claim denials if they submitted claims for their services in order to
avoid putting beneficiaries into this situation.
Response: While efforts were underway to enroll physicians and
eligible professionals who order and refer prior to the passage of the
Affordable Care Act, the implementation date is statutorily mandated.
We conducted significant outreach on this effort and will continue to
do so when implementing this final rule. As already stated, we have
taken steps to help mitigate these circumstances; for instance, we have
not yet activated the automated edits that would cause claims for
services or supplies not to be paid for lack of an approved enrollment
record in Medicare. Consequently, we do not believe it is necessary to
hold home health agencies harmless if the ordering/certifying provider
reported in their claims is not enrolled in Medicare in an approved
status or has not validly opted out of Medicare.
Comment: Several commenters wanted assurance that home health
agencies would not face a retroactive recovery based on the application
of the ``without fault'' provision if they submitted claims in good
faith, believing that the physician had an approved enrollment record
in PECOS or had attempted to enroll in the Medicare program before
submitting the claim. They did not want the provision of home health
services to patients whose physicians do not have enrollment records in
PECOS to be considered a violation of any Medicare rule if the home
health agency has documented its efforts to determine if the physician
has an enrollment record in PECOS.
Response: The ``without fault'' provision under section 1870 of the
Act is not applicable in this scenario, as that provision refers to the
collection of overpayments. The billing provider has an affirmative
responsibility under this final rule to ensure that the physician has a
valid enrollment record or has validly opted-out. Additionally, records
for the orders and certification of home health must be maintained by
the ordering/certifying physician(s) and the home health agency that
bills for these services. Submitting a claim in good faith does not
meet our requirements and will be denied if the ordering/certifying
physicians do not have a valid enrollment or opt-out record. We note
that home health payment is always contingent on whether eligibility
requirements, including the requirement that a patient be under the
care of a physician, continue to be met. Typically, ``under the care of
a physician'' would require active physician involvement with updating
orders. It is difficult to envision a scenario where the patient could
be under the care of physician unless that physician is able to order
services. As such, as part of our eligibility requirements, the patient
must be under the care of a Medicare enrolled physician, because only
an enrolled physician can order home health services. HHAs are
responsible for coordinating patient care, as defined in Conditions of
Participation defined in 42 CFR Part 484. They are also responsible for
ensuring that all eligibility criteria, such as the need for a patient
being under the care of a physician, are met.
Additionally, we have modified the definition of ``enrolled in
Medicare'' to include PECOS and existing legacy Medicare claims payment
systems. We have also delayed the automated edits that will cause a
claim not to be paid for the lack of an approved enrollment record in
Medicare or a valid opt-out status. Of course, such claims are subject
to all other Medicare requirements, such as, coverage and medical
necessity. These changes will reduce the risk to home health suppliers
of having claims denied on the basis of enrollment of the ordering or
certifying physician. We have made the Ordering Referring Report,
containing the NPIs and legal names of physicians and other eligible
professionals who have approved enrollment or valid opt-out records in
PECOS, available and are encouraging suppliers to view this report.
However, documentation that a home health agency has done so does
[[Page 25303]]
not fulfill the requirements of this final rule. We also make available
four reports within the Ordering Referring Report that include the
following:
Physicians who are approved to order and refer.
Other eligible professionals who are approved to order and
refer.
Physicians who have pending Medicare enrollment
applications.
Other eligible professionals who have pending Medicare
enrollment applications.
These reports, collectively referred to as the Ordering Referring
Report, are available on the Medicare provider/supplier enrollment Web
page at (www.cms.gov/MedicareProviderSupEnroll). This information makes
it easier for home health agencies to determine the enrollment or opt-
out status of physicians who have ordered home health services prior to
submitting their claims.
Comment: A commenter indicated that while home health agencies
would attempt to secure the NPI of the ordering or referring provider
and report that NPI in claims, the information needed to do so is not
fully available and will not be provided by CMS in a manner that
assures providers and suppliers access to the most up-to-date
information when they are determining whether or not to accept a
referral from a physician. Other commenters expressed concern that the
requirement to report the NPIs of ordering and referring providers and
suppliers in claims may penalize billing providers if the ordering or
referring provider has not obtained an NPI or does not furnish the NPI
to the billing provider, and that such a penalty would disadvantage
otherwise compliant billing providers.
Response: If a home health agency provider or a supplier receives
an order or a certification from a physician or other eligible
professional and the NPI is not on the order or certification, the
provider or supplier can ask the physician or other eligible
professional to disclose his or her NPI. If that is not feasible, the
provider or supplier can use the NPI Registry (https://nppes.cms.hhs.gov/NPPES/NPIRegistryHome.do) to obtain the NPI. High-
volume providers and suppliers may wish to download the NPPES file each
month (http://nppes.viva-it.com/NPI_Files.html) and import it into its
claims and/or business processes to pull the NPIs from it and use them
in electronic processes. Ultimately, if a billing provider or supplier
who furnishes items or services based on orders or certifications is
unable to obtain this information from the ordering and certifying
provider, the billing provider should carefully consider, as part of
its business policy, whether or not it will accept an order or a
certification from a physician or other eligible professional who does
not have, or who refuses to obtain, an NPI.
Comment: A few commenters questioned if a full episode of home
health care would be paid if a physician terminates enrollment before
the end of a 60-day home health episode.
Response: Yes, this regulation requires enrollment in Medicare or a
valid opt-out status that would be assessed based upon the date of the
order and the date of the certification, for dates of service beginning
July 6, 2010. In the situation described by the commenter, Medicare
would not deny payment (for the lack of an approved enrollment or opt-
out record) for any portion of the full 60 days if the ordering
physician were to terminate enrollment or otherwise become not enrolled
in Medicare. However, Medicare may deny these claims based upon other
factors unrelated to enrollment status of the ordering or certifying
supplier.
Comment: A few commenters questioned if Medicare would pay a home
health claim if the certifying physician does not have an approved
enrollment record or a valid opt-out record in PECOS at the start of
care, but does establish such a record during the course of the episode
of care and prior to the submission of the claim from the home health
agency.
Response: Consistent with the provisions of this final rule, the
ordering/certifying physician(s) would have to be enrolled in Medicare
in an approved status or have validly opted- out of the Medicare
program as of the date of service in order for the home health agency's
claim to be paid.
Comment: A few commenters questioned if the ordering and referring
provider edit will be on the home health request for anticipated
payment (RAP), final claim, or both. A few commenters questioned if a
corrected RAP, final claim, or both could be submitted if a provider or
supplier submitted an incorrect ordering or referring provider name and
NPI in a claim but later learned the correct information.
Response: Home health episodes are paid in two pieces: A
anticipated payment amount at the beginning of the 60-day episode, and
the balance in the final claim at the end of the 60-day episode. The
RAP is the first submission of the claim. Therefore, the ordering/
certifying physician(s) must be in compliance with our regulations on
the date of service (that is, the date of the order or certification).
A RAP cannot be adjusted once it has been processed, but it can be
cancelled and resubmitted with corrected information including provider
name or NPI. If a home health agency learned that data on a RAP was in
error, the home health agency could cancel the RAP and resubmit it.
This is also the case for the home health final claim. Therefore, the
edit will apply to both the RAP and the final claim.
Comment: A commenter expressed concern that it is not always
possible for a home health agency to know for certain at the start of
care which physician will certify home care services. This commenter
questions whether only PECOS enrolled physicians will be able to make
referrals and certify home health episodes of care.
Response: In most cases the same physician would refer the patient
to home health, order the home health services, certify the
beneficiary's eligibility to receive Medicare home health services, and
sign the Plan of Care. It is the NPI of the ordering/certifying
physician that is required on the claim and in the medical record.
However, we recognize that in certain scenarios one physician may not
perform all of these functions. An example of such a scenario would be
a patient who is admitted to home health upon hospital discharge. While
we would still expect that in most cases, a patient's primary care
physician would be the physician who refers and orders home health
services, certifies eligibility, and signs the plan of care, there are
valid circumstances when this is not feasible for the post-acute
patient. For example, some post-acute home health patients have no
primary care physician. In other cases, the inpatient physician assumes
primary responsibility for the patient's care during the acute stay,
and may (or may not) follow the patient for a period of time post-
acute. In circumstances such as these, it is not uncommon for the
inpatient physician to refer a patient to home health, initiate orders
and a Plan of Care, and certify the patient's eligibility for home
health services. In the patient's hospital discharge plan, if the
inpatient physician would not be the one to follow up for the duration
of the home health service, he or she would identify the community
physician who would be assuming primary care responsibility for the
patient upon discharge. It would be appropriate for the physician who
assumes responsibility for the patient to sign the plan of care. The
patient would thus be considered ``under the care'' of that community/
personal physician
[[Page 25304]]
throughout the time the patient is receiving home health services.
In a scenario such as this, if the inpatient physician certifies
the patient's home health eligibility and initiates the orders for
services, that physician would need to be a Medicare enrolled
physician, and that physician's NPI would be in the medical record and
on the first home health claim. To be compliant with all Medicare home
health coverage and payment rules, the community physician who assumes
responsibility for the patient during the home health episode (updating
orders, signing the plan of care, etc.) would also need to be a
Medicare enrolled provider, and this NPI would also be documented in
the medical record and on the appropriate home health claim.
Comment: Given that the process by which home health care services
are ordered and because the process used for such referrals
(electronic, fax, telephone) almost never includes direct communication
from a physician to a home health agency, a commenter suggested that
Medicare require only that physicians who certify home health services
be required to be enrolled in PECOS. This commenter also asked that
claims that lack a PECOS-enrolled physician's NPI be rejected rather
than denied.
Response: The statute specifically references orders and
certifications for home health services. Therefore, we disagree that
only the physician who certifies the home health services be required
to be identified in the claim for home health services and meet the
requirement to be enrolled in Medicare in an approved status or have
validly opted out of Medicare. Claims from home health agencies that do
not meet the requirement that the ordering/certifying physician be
identified by legal name and NPI will be denied, not rejected, as noted
earlier in this final rule.
Comment: Several commenters stated that beneficiary notification of
nonpayment for home health services was not addressed in the IFC. The
commenter noted that home health agencies are required to notify
Medicare beneficiaries of noncoverage of all services through a Notice
of Medicare Noncoverage (Expedited Determination Notice), and that home
health agencies are required to notify patients of their right to
appeal a noncoverage determination while continuing services if orders
are in place from a physician through a Home Health Advance Beneficiary
Notice (HHABN). The commenters believe that beneficiaries will be
prevented from continuing to receive medically necessary services under
self-payment or other payment sources that are secondary to Medicare in
cases where expedited appeal decisions are delayed or are not in the
beneficiaries' favor. The commenters recommended that CMS permit the
HHABN to be used when home health services are not covered because the
order was written by a physician who does not have an enrollment record
in PECOS.
Response: As the commenter stated, HHABNs are for notification of
noncovered services. The home health services themselves are still
considered ``covered services'' if they meet the Medicare medical
necessity and benefit requirements, even if the ordering/certifying
physician is not enrolled in, or opted out of, Medicare. However, the
claim will be denied due to noncompliance with this regulation if the
ordering/certifying physician is not enrolled in Medicare or does not
have a valid opt-out status. The denial of a claim for lack of an
approved enrollment records in Medicare is not a coverage
determination; hence the HHABN is not applicable.
k. NPI Data and Requirements
Comment: A commenter asked how CMS would know that an NPI on a
claim was put there by a physician who meant to order the test and not
by someone who simply downloaded the NPI from the open file.
Response: Our systems are equipped to check for these types of
compromised numbers and initiate an investigation based upon the data.
While we understand the concerns of the commenter, verification of the
NPI is just one tool we use to validate a claim. Access to NPIs and the
associated names are crucial pieces of information to individuals
providing services and supplies. Penalties for this type of activity
can range from false claims liability to other criminal and civil
sanctions. CMS and law enforcement actively monitor this type of
activity and regularly engage in investigation and follow-up
activities, as appropriate.
Comment: A commenter believed that the widespread dissemination of
physicians' and other eligible professionals' NPIs could increase the
risk of fraudulent use of NPIs and urged CMS to implement procedures to
protect practitioners from any unreasonable additional compliance
burden that may be incident to the misuse of their NPIs by others.
Response: Providers and suppliers must determine if the ordering
and certifying physician or eligible professional is enrolled in
Medicare at least to order and certify. Inclusion of this information
on the claim is necessary for the payment of claims. We must provide
this information publicly so that service providers can ensure that
physicians and eligible professionals are enrolled in Medicare to order
and certify. If a health care provider suspects misuse of an NPI, that
health care provider should report the issue to law enforcement
authorities including, when appropriate, to the DHHS Office of
Inspector General (OIG). The OIG Hotline is 1-800-HHS-TIPS (1-800-447-
8477). Providers and suppliers can also report suspected misuse of an
NPI to 1-800-Medicare.
Comment: Several commenters noted the following:
There is no required OMB approved form for ordering home
health services.
The plan of care content requirements are based on the
Home Health Content of Plan of Care.
We have removed from our online manual the detailed
guidance on the required Content of the Plan of Care.
Inclusion of the physician's NPI on a Home Health Plan of
Care and interim orders has never been a requirement.
Response: The Secretary has adopted a standard electronic referral
transaction. However, most health plans have not implemented the
adopted electronic referral standard and continue to use their own
paper formats and issue their own instructions for the use of the paper
referral formats. The absence of the Plan of Care guidance in the
online manual does not impact the requirements of this final rule.
Regulation text at Sec. 424.516 currently requires that the NPI of
the physician who orders/certifies the home health services be part of
the documentation of the service in the medical record. It does not
stipulate that the NPI be included on the Plan of Care or
certification. Content requirements for the Home Health Plan of Care
are detailed in Sec. 484.18(a). So long as the NPI is part of the
medical record, and can be provided to CMS or a Medicare contractor
upon request, the home health agency will have met this requirement.
l. Legal Name Requirements
Comment: A commenter sought clarification as to whether the IFC
required that the provider of the service must also provide its legal
name and NPI on the claim.
Response: We are interpreting this question as asking whether the
IFC required the billing provider to list its NPI and legal name on the
claim. The requirement for the billing or rendering provider to list
its NPI was effective March 1, 2008. There is no requirement that the
legal business name of the
[[Page 25305]]
billing provider be explicitly listed on the CMS-1500 claim form. Note
that the IFC established a requirement that the eligible ordering and/
or referring supplier's legal name be listed on the claim. Those
requirements are now incorporated in Sec. 424.506 (rendering or
billing provider NPI on claims) and Sec. 424.507 (ordering and
certifying supplier NPI).
Comment: A commenter stated that ordering or referring suppliers do
not always write their legal names on their prescriptions or orders,
and thus it is a burden on the billing provider to do the research to
determine the legal name so that it can be included on the claim.
Response: Providers and suppliers who furnish items and services
based on orders or certifications should have business operations in
place to ensure that they collect the information necessary to submit a
proper claim for payment for those items and services. This would
include collecting the legal name of the individual who ordered or
certified these items or services.
Comment: A commenter stated that several medical practices have
contacted CMS about the name of the ordering or referring supplier
reported in their claim not matching CMS records, and were told that
the name on the claim had to match the name in NPPES. Several other
commenters stated that the NPI of the ordering or referring provider
should be sufficient to match PECOS records and that the legal name is
unnecessary.
Response: The only name that should be used for an enrollment
application or on a claim form should be the individual practitioner's
legal name that matches the name and NPI of record from NPPES. Those
records match the practitioner's legal name from the Social Security
Administration (SSA). The use of this name will ensure there is no
confusion at the time of enrollment and claims processing.
Existing regulations and policies require the reporting of the
legal name if the NPI is required to be reported. Requiring the name
that corresponds to the NPI further ensures the validity of the
ordering or certifying provider and eliminates the indiscriminate and
repeated use of any valid NPI simply to enable a claim to pass an edit.
The health care claim standard and the Medicare paper claims forms
capture three fields for a name: last name, first name, and middle
initial. The Medicare provider/supplier enrollment application also
captures those same three name fields. For the purposes of this rule
only, these three name fields (last name, first name, and middle
initial) constitute an individual's legal name.
Comment: Some commenters stated that CMS should eliminate the first
name match because many systems reference a physician by a nickname;
and only use the surname and NPI to match.
Response: As previously described, our rules require the full legal
name (that is, first name, middle initial, and last name). Reporting a
nickname in a Medicare enrollment application will likely cause that
enrollment application to fail the social security number verification,
which would delay the processing of the enrollment application or cause
it to be rejected. Similarly, use of a nickname on claims will likely
cause the claim to be denied.
Comment: Another commenter was concerned about name changes,
resulting from marriage, in which a physician's surname in PECOS is no
longer consistent with the married name being used in orders and
referrals.
Response: Any enrolled Medicare provider and supplier whose name
changes is required to report that change to the designated Medicare
contractor within 90 days of the effective date of the change. Other
appropriate files and systems are also updated with any new
information.
m. Enrolling in Medicare Just to Order and Refer
Comment: A commenter stated that the PECOS enrollment system does
not have flexibility to permit Department of Veterans Affairs (DVA)
employed physicians to enroll. Another commenter stated that a
representative of a Veterans Affairs hospital stated that their
physicians who order and refer items and services for Medicare
beneficiaries will not be enrolling in Medicare because they do not
send claims to Medicare. Another commenter stated that CMS should
develop a simplified enrollment process for dentists and others who do
not submit claims to Medicare. Another commenter stated that physicians
who care for patients in institutional settings will refer for home
care and DMEPOS, as do physicians in training (residents and fellows)
who are not eligible to enroll in Medicare. Several commenters
suggested that CMS simplify the enrollment process for those who must
enroll just to order and refer. Another commenter asked that DVA
providers be excluded from the requirement to enroll in PECOS in order
to continue to order and refer items and services for Medicare
beneficiaries.
Response: We agree with the previous commenters regarding the
development of a simplified process for individuals who enroll just to
order and certify. DVA and other professionals cannot be excluded from
the enrollment requirement because the statute requires that those who
order DMEPOS and who order/certify home health services be enrolled in
Medicare. We have had numerous detailed discussions with DVA officials,
as well as officials at the Department of Defense (DoD), the United
States Public Health Service (PHS), Indian Health Service (IHS), and
other Federal agencies whose physician employees order and certify
Medicare services or supplies but do not bill Medicare directly.
We have developed the CMS-855O enrollment form for eligible
providers and suppliers who wish to enroll only to order and certify.
The ordering and certifying suppliers who use the CMS-855O form may not
bill Medicare and submit claims. Those suppliers who wish to bill
Medicare for services and submit claims must fill out the CMS-855I
form. Internet-based PECOS has the capability to handle enrollment
applications from these physicians and other eligible professionals who
wish to enroll in Medicare just to order and certify. The CMS-855O form
has been approved by Office of Management and Budget (OMB) and has been
available for use since July 1, 2011. Additionally, information about
enrolling only to order and certify is available on the Medicare
provider/supplier enrollment Web site (http://www.cms.gov/MedicareProviderSupEnroll).
Examples of physicians and other eligible professionals who may
wish to enroll in Medicare only to order and certify, and not to submit
claims to Medicare for payment, include those who are one of the
following:
Employed by the PHS, DOD, DVA.
Employed by Medicare-enrolled Federally qualified health
centers (FQHCs), rural health clinics (RHCs), and critical access
hospitals (CAHs).
Pediatricians who traditionally have very few Medicare
patients and, therefore, only order or certify items for Medicare
beneficiaries.
Doctors of dental medicine or dental surgery whose
services are generally not covered by Medicare.
Residents, as defined in Sec. 413.75 (to include interns
and fellows), who are appointed by teaching hospitals and academic
medical centers who generally do not enroll in Medicare because their
services are not directly billed to Medicare. (Please see the
information under the ``residents'' section of this final rule.)
Comment: A few commenters stated that officials at DVA facilities
stated
[[Page 25306]]
they were unaware that their physicians needed to enroll in Medicare.
Some commenters stated that DVA physicians have told them that they
cannot enroll in Medicare until ordered to do so by the DVA.
Response: We have communicated with the DVA and expect that their
physicians and other eligible professionals will enroll in Medicare
just to order and certify if they wish to continue to order or certify
items or services for Medicare beneficiaries.
Comment: Several commenters stated that CMS should consider how
best to communicate with physician practices, including those in the
PHS, DoD, and DVA, as well as dental and pediatric practice settings
and teaching physicians and those who have opted out of Medicare to
ensure they understand the new requirements.
Response: We have been in communication with the PHS, DoD, DVA, and
the American Dental Association (ADA) about the requirements of the
Affordable Care Act that we are implementing with this final rule. We
anticipate additional communication in CMS provider/supplier open door
forums and in our regular conference calls with national provider/
supplier associations and organizations. We will be creating additional
outreach documents when we publish this final rule. Largely based on
provider and supplier concerns and in an effort to accommodate these
concerns we have created a new enrollment form, the CMS-855O. This form
is specifically designed for those providers and suppliers who want to
enroll in Medicare for the purpose of ordering and certifying only. We
believe this shortened form will streamline the enrollment process,
especially for this segment of the supplier communities.
Comment: A commenter suggested that there should be a longer phase-
in time for dentists and other eligible professionals who rarely refer
or order under Medicare.
Response: We have created a streamlined application process that
reduces the time it will take for dentists and other professionals to
enroll, since they generally do not bill Medicare but who need to
enroll in Medicare just to order and certify. The CMS-855O may be used
by providers and suppliers who simply wish to order and certify and who
do not wish to submit claims to Medicare. These changes, including the
new CMS-855O enrollment form, the change from the requirement to be
enrolled in PECOS to a requirement to be enrolled in Medicare, and the
delay in the activation of the automated edits that would cause a claim
to not be paid due to lack of an approved enrollment record in
Medicare, have simplified compliance for these types of professionals.
n. Interns, Residents, Fellows, and Teaching Physicians
Comment: A commenter supported the requirement that interns who are
not licensed, and therefore unable to enroll in Medicare should order
or refer through the teaching physician. The same commenter also asked
that CMS allow licensed residents to order or refer under their own
name (not the name of the teaching physician) to avoid artificially
increasing the ordering or referring patterns of teaching physicians.
The commenter did not believe this would have a negative impact on the
Medicare program and would still enable CMS to track ordered and
referred items and services. Another commenter stated that many
residents are licensed physicians who are qualified to practice
independently and who are undergoing specialty training. The commenter
believed that these residents should not be limited in their ability to
order and refer because of perceived shortcomings with PECOS's ability
to accommodate them.
Response: Physicians and eligible professionals must have an
appropriate State license in order to enroll in Medicare, and licensure
is determined by State laws. Based on provisions included in this final
rule, physicians and other eligible professionals who order/certify
DMEPOS, home health services, clinical laboratory, and imaging services
for Medicare beneficiaries must be enrolled in Medicare or have validly
opted out. The term ``resident'' is defined in Sec. 413.75 as `` * * *
an intern, resident, or fellow who participates in an approved medical
residency program, including programs in osteopathy, dentistry, and
podiatry, as required in order to become certified by the appropriate
specialty board.'' Licensed residents, as defined in Sec. 413.75,
usually do not enroll in Medicare because they do not bill the Medicare
program; their services are included in the hospitals' PPS claims and
Medicare reimburses the hospitals. We agree with the concerns expressed
by commenters and have modified the requirements of this final rule so
that if States allow residents who have a provisional license, or are
otherwise permitted by State law to practice or order and certify
services, we will permit them to enroll in Medicare to order and
certify, at the direction of their teaching institution. In situations
where States do not offer licensure or otherwise permit such
individuals to practice or order and certify services, the teaching
physician's legal name and NPI must be included on the claim for
services. In this latter circumstance, the claims will not be paid
unless the ordering and certifying physician, in this case, the
teaching physician, is listed on the claim as the ordering or
certifying physician.
Comment: Some commenters expressed concern about the amount of
resources that would be required by hospitals and academic medical
centers to enroll licensed residents and fellows so that they may
continue to order and certify. A commenter stated that a hospital-wide
process must be developed for residents to note their supervising
physician on orders, which adds a significant layer of complexity to
hospital operations. Another commenter believed that reporting the
teaching physician's name and NPI as the ordering or referring supplier
when a resident or intern orders or refers sounds like a practical
solution, but the administrative burden placed on teaching hospitals to
ensure a proper link between a resident and a teaching physician in
order to submit these claims is a huge cultural and administrative
paradigm switch that will take time to develop, communicate, and put
into operation.
Response: As stated previously, in order to comply with the
requirements of section 6405 of the Affordable Care Act, a Medicare-
enrolled physician must be identified for orders or certifications for
items and services that will be billed to Medicare. As stated in the
previous response, we have modified the final rule to accommodate
teaching hospitals by providing them the option of either enrolling
individuals enrolled in an accredited graduate medical education
program (when State law permits) or by identifying the teaching
physician in the claim. We have developed these options in an effort to
avoid disruption of existing practices in teaching institutions as much
as possible.
Comment: A commenter stated that physicians in training work in a
cost-efficient fashion under the supervision of attending physicians
and that to require that every order in a large teaching service be
written by an enrolled physician (an attending physician) or a mid-
level practitioner will place a considerable financial burden on
teaching hospitals and medical schools, many of which are struggling
financially. The commenter stated that these facilities would need to
have a large cadre of Medicare-enrolled physicians or mid-level
providers available at all hours, and that this
[[Page 25307]]
requirement will dilute the training experience of resident physicians
because they will be unable to independently order even the simplest
diagnostic test.
Another commenter believed that the requirements will make it
virtually impossible for resident physicians and fellows to order
diagnostic procedures, testing, and consults for Medicare
beneficiaries. Residents and fellows who are reasonably well supervised
will deliver less costly care than poorly trained residents. The
commenter contended that those who have never had to think
independently will become very costly suppliers because they will try
to compensate for their lack of clinical judgment with over-testing.
Response: We believe that the modifications we made to the final
rule should diminish the concerns of the commenter. As stated
previously, we have provided options for the teaching hospitals to
enroll individuals in an accredited graduate medical education program
in Medicare if permitted by State law or regulation.
Comment: Several commenters stated that residents who are licensed
physicians should be allowed to enroll in Medicare and order home
health services.
Response: Licensed residents are physicians and, as such, are
eligible to enroll in Medicare. Medicare regulations state that only
physicians who are doctors of medicine, osteopathy, or podiatry may
certify home health services.
Comment: Several commenters stated that CMS should consider
categorizing fellows who do not bill Medicare to be ``residents'' so
that the teaching physicians would be reported in the claim as the
ordering or referring provider. By doing so, the Medicare contractors
would have fewer enrollment applications to have to process, which
could help reduce their workload.
Response: We agree with the commenters' suggestion and have
modified this final rule to permit individuals who are enrolled in an
accredited graduate medical education program in a State that licenses
or otherwise enables such individuals to practice or order and certify
services to enroll in Medicare to order and certify. In situations
where States do not license or otherwise permit such individuals to
practice or order and certify services, the teaching physician's full
legal name and NPI must be included on the claim for services. In this
latter circumstance, the claims will not be paid unless the ordering
and certifying physician, in this case, the teaching physician, is
listed on the claim as the ordering or certifying physician. Therefore,
recategorizing fellows is unnecessary and we defer to State scope of
practice laws and regulations on who may order and certify.
Comment: A commenter suggested that CMS allow residents to enroll
and to be identified in PECOS as residents. Teaching hospitals could
enroll their residents using a new code to reflect this status. Because
this would take some time to implement, the commenter suggested that
CMS further delay (beyond the commenter's suggested implementation date
of January 3, 2011) the requirement that ordering or referring
providers have enrollment records in PECOS.
Response: The applicable statutory and regulatory provisions do not
permit Medicare to enroll an unlicensed physician. However, if States
provide provisional licenses or otherwise permit residents to practice
or order and certify services, we are allowing them to enroll to order
and certify, consistent with State law. Further, the timing of
licensure of a resident is determined by States and because we are now
permitting licensed residents to enroll in Medicare, it is not
necessary and may be duplicative, to develop an additional code in the
enrollment systems.
Comment: Commenters stated that it would be extremely difficult for
teaching hospitals to comply with the July 6, 2010 date because of its
timing with the start of the new academic year. Teaching hospitals are
focused on activities regarding the turnover of what is often 25
percent of their residents and there is no time to suddenly add a new
and disruptive component to those ongoing activities. They express
concern about ensuring that their graduates are prepared to practice or
continue with additional training and that the new residents are
appropriately credentialed so they can begin their training on July 1,
2010.
Response: We have been working closely with these institutions to
ensure effective compliance with our regulations by the statutorily
mandated effective date. We clarified in this final rule the
circumstances under which individuals enrolled in accredited graduate
medical education programs can enroll in Medicare to order or certify
Medicare services. Those residents, as defined in Sec. 413.75, who are
licensed may enroll in Medicare to order and certify in the same way
other as physicians and other eligible professionals. This final rule
states that if State law provides residents, as defined in Sec.
413.75, a provisional license, or otherwise permits them to practice or
order and certify services, we will enroll them to order and certify.
If State law does not provide licensure for residents, or otherwise
permit them to practice or order and certify services, claims for
services provided must identify the teaching physician as the ordering
or certifying physician by his or her legal name and NPI. This
modification from the IFC will provide these teaching institutions with
options to accommodate the policies mandated by the Affordable Care Act
and this final rule.
o. Deactivation
Comment: Many commenters noted that physicians and other eligible
professionals who will enroll just to order and refer and not to submit
claims to Medicare will be deactivated if they fail to send claims to
Medicare for 12 consecutive months, and that after deactivation, they
would then need to re-enroll in order to continue to order and refer.
Some of the commenters indicated that Sec. 424.540 states that CMS
``may'' deactivate the enrollment of a provider or supplier if no claim
is submitted for a year. They suggest that the use of ``may,'' gives
CMS discretion. These commenters suggested that CMS use this discretion
and exempt from this deactivation process dentists and others who would
be enrolling just to order and refer.
Response: Deactivation for non-billing does not apply to those
physicians and eligible professionals who have enrolled just to order
and certify.
Comment: A commenter asked that CMS terminate NPIs, not Medicare-
assigned PTANs, when a physician's billing privileges are deactivated.
The commenter pointed out that a physician may have multiple PTANs in
his/her PECOS enrollment record, and that if one PTAN is deactivated
voluntarily or due to non-billing, that physician is no longer eligible
to order and refer although the physician is still enrolled in Medicare
and is still sending claims with, or being identified in claims as the
rendering provider by his/her NPI. The commenter suggested that the
NPI, not the PTAN, should be the driver of ordering and referring
eligibility.
Response: The commenter is correct that a physician can have
multiple PTANs and currently deactivation for non-billing is driven by
PTAN rather than NPI. More than one PTAN may be assigned to a physician
if the physician reassigns his Medicare benefits to more than one
medical group (a PTAN for each reassignment), or works at multiple/
different practice locations (a PTAN for each practice location). Any
provider or supplier, including a
[[Page 25308]]
physician, whose billing privileges are deactivated for 12 consecutive
months of non-billing is deactivated by his or her PTAN. However, the
deactivation of one PTAN does not deactivate all PTANs. If the
physician or other eligible professional has more than one PTAN, and
not all PTANs were deactivated due to non-billing, he or she will
remain enrolled in Medicare to bill using the active PTANs and will
also remain on the Ordering Referring Report. In this situation, claims
in which he or she is identified as the ordering and referring provider
would not be denied because of one deactivated PTAN.
p. Validly Opting Out
Comment: A few commenters stated that Medicare contractors do not
enter opt-out physicians in PECOS. Another commenter stated that opt-
out physicians have records in PECOS only in situations where they were
first enrolled in Medicare and then opted out.
Response: Based on the Affordable Care Act provisions requiring
that ordering and referring physicians must be enrolled in Medicare, we
have instituted a consistent process for entering physicians who opt
out into PECOS. When processing an opt-out affidavit, Medicare
contractors may require, and the opting out physician or other
practitioner must provide, the NPI as well as other information that
may be requested by the Medicare contractor. Physicians and other
practitioners do not have to enroll in Medicare before opting out.
Those who opt out must submit opt-out affidavits every 2 years and all
who have opted out of Medicare will have opt-out records in PECOS.
Beneficiaries and other providers and suppliers may visit the
Physician Compare Web site at http://www.medicare.gov/find-a-doctor/provider-search.aspx to see if their physicians or other practitioners
are enrolled in Medicare. If the beneficiary's physician or other
practitioner is not enrolled in Medicare and has not opted out, the
beneficiary may wish to find another physician or practitioner. For
more information on opting out of Medicare, the public may refer to our
applicable regulations at Sec. 405.425, titled ``Effects of opting-out
of Medicare.''
Comment: Some commenters requested that CMS make available a list
of physicians and other eligible professionals who have opted out of
Medicare.
Response: Physicians and other practitioners who have validly opted
out of the Medicare program have opt-out records in PECOS. Physicians
and non physician practitioners who have validly opted out of the
Medicare program, and elect to order and certify, will be on the
Ordering Referring Report. The Ordering Referring Report does not
distinguish those who have opted out from those who have approved
enrollment records because both, if listed in the Ordering Referring
Report, may order and certify items and services for Medicare
beneficiaries.
q. Public Comments Outside the Scope of the IFC Provisions Regarding
Ordering and Referring Covered Items and Services
Comment: A commenter noted that the preamble in the IFC states that
CMS believes its enrollment requirements will promote quality health
care services for Medicare beneficiaries because their credentials will
have been verified as part of the Medicare enrollment process. The
commenter states that physicians' credentials have already been
verified by State licensure boards. The commenter believes that
additional verification by Medicare is redundant and a waste of
taxpayers' money and professionals' time.
Response: While we believe that additional verification is
necessary to ensure quality care is provided to Medicare beneficiaries,
this comment is outside of the scope of this final rule. This rule does
not modify or impose additional screening requirements needed for
enrollment in Medicare.
Comment: A commenter stated that dentists, who merely order and
refer, may be further burdened if they will be required, as a condition
of enrollment, to establish a compliance plan.
Response: Neither the IFC nor this final rule addresses the issue
of ``compliance plans.'' This comment is out of scope of this
regulation. We solicited comments related to compliance plans in the
September 23, 2010 proposed rule (75 FR 58204) titled ``Additional
Screening Requirements, Application Fees, Temporary Enrollment
Moratoria, Payment Suspensions and Compliance Plans for Providers and
Suppliers.''
Comment: A commenter who supports the new requirement to be
enrolled in Medicare to order and refer suggested that CMS develop a
program that rewards physicians for making appropriate referrals to the
lowest cost providers as a good second step in cost containment. The
commenter noted that there is no incentive for a physician to consider
costs in the referral process.
Response: This comment is outside the scope of this regulation and,
as such, is not addressed in this final rule.
Comment: A commenter referenced the professionals listed in the IFC
who are permitted to order and refer covered Part B DMEPOS, imaging,
laboratory, and specialist items/services and stated that certified
registered nurse anesthetists (CRNAs) should be eligible to order and
refer some of those items and services. The commenter stated that CRNAs
order blood work and electrocardiograms as part of the pre-anesthetic
assessment, order medications for the purpose of administering them
perioperatively, and also have occasion to order chest X-rays for
patients in the recovery room prior to the removal of the patient's
breathing tube. The commenter further stated that the November 27, 2006
final rule (71 FR 68683) titled ``Hospital Conditions of
Participation'' acknowledged CRNAs as ordering providers.
Response: This regulation does not change eligibility to order and
certify for any provider type and only addresses enrollment for those
professionals eligible to order and certify under existing law.
Therefore, this suggestion is outside the scope of this final rule.
Comment: A few commenters questioned if enforcement of the enrolled
physician requirement would be limited to payment prohibitions for
ordered and referred items and services only, or if there would be
survey and certification implications for a home health agency that is
furnishing home health services based on a certification from a
physician who is licensed but who does not have an approved enrollment
record or a valid opt-out record in PECOS.
Response: Nothing in the IFC or this final rule changes our current
survey and certification policies.
r. Summation and Final Decisions
After reviewing the public comments summarized in this section
(section II.B.4. a. through q. of this final rule), we are finalizing
the provisions regarding ordering and certifying of covered items and
services for Medicare beneficiaries with several modifications. We want
to start by clarifying two major modifications to this final rule from
the IFC. First, we stated in the IFC that we would reject, not deny,
claims from providers and suppliers that do not comply with these
ordering and certifying requirements. After reviewing the comments, we
have determined that we will deny such claims to provide the suppliers,
providers, and beneficiaries with appeal rights. However, until further
notice, we will not activate the automated edits that would cause a
claim not to be paid for lack of an approved enrollment record in
Medicare
[[Page 25309]]
or a valid opt-out status. We want to assure the beneficiary, provider,
and supplier communities that we will provide advance notice before
activating the edits by conducting appropriate outreach through our
established channels including listservs, Medicare Learning Network
(MLN) articles, and open door forums.
Second, we modified this final rule to permit residents, as defined
in Sec. 413.75, who are enrolled in an accredited graduate medical
education program in a State that licenses or otherwise enables such
individuals to practice or order these items or services to enroll in
Medicare to order and certify. In situations where States do not
license or otherwise permit such individuals to practice or order and
certify services, the teaching physician's full legal name and NPI must
be included on the claim as the person who ordered or certified the
service. In this latter circumstance, the claims will not be paid
unless the ordering and certifying physician, in this case, the
teaching physician, is listed on the claim as the ordering or
certifying physician. We made this change to assist teaching hospitals,
as well as the providers and suppliers who render the items and
services in complying with this rule.
Among the other changes to this section and in response to numerous
comments received, we have changed the enrollment requirement language
from one requiring enrollment in PECOS to one requiring enrollment in
Medicare--including PECOS or other Medicare enrollment systems. We
believe that this will reduce the number of claims that are denied or
rejected and enable more currently enrolled physicians and
practitioners to order or certify services.
We clarified our language in this provision to refer to the
specific items and services the rule covers. After review of the public
comments we received, we removed the language referring to ``ordered or
referred covered Part B items and services (excluding home health
services described in Sec. 424.507(b) and Part B drugs).'' In this
final rule, we specifically designate the covered items and services as
follows: DMEPOS items, clinical laboratory, imaging, and home health
services. Note that we have removed specialist services from the
requirements of this rule.
We have also clarified our language with respect to the home health
provision of this final rule. The IFC stated that physicians who order
home health services must be listed on the claim for payment. However,
to be technically correct, we have clarified our language in this final
rule to state that those who order/certify must be listed on the claim
for payment. A commenter noted that these physicians may be one single
physician or separate physicians. To that end, we have clarified our
regulatory language to accommodate this public comment. Further, the
statutory language at section 6405 of the Affordable Care Act
specifically mentions application to the ordering and certifying
physician. Therefore, we have clarified this language to be precise and
more in conformity with the statutory language.
Finally, as more of a technical correction, we have removed all
references to beneficiary-submitted home health claims. After
considering comments received on this topic, we now agree that home
health claims cannot be submitted by beneficiaries and thus, should not
be included in this final rule.
C. Requirement for Physicians, Other Suppliers, and Providers to
Maintain and Provide Access to Documentation on Referrals to Programs
at High Risk of Waste and Abuse
1. Background
We believe it is imperative to establish accountability measures to
ensure compliance with the ordering and referring provisions. To this
end, the IFC implemented an Affordable Care Act provision by adding a
new provision at Sec. 424.516(f) that required providers and suppliers
to maintain ordering and referring documentation, including the NPI,
received from a physician or eligible non physician practitioner for 7
years from the date of service. The IFC also established in Sec.
424.535(a)(10) that failure to comply with the documentation
requirements specified in Sec. 424.516(f) is a reason for revocation.
2. Provisions of the Affordable Care Act
Section 6406 of the Affordable Care Act amended section 1842(h) of
the Act by adding a new paragraph which states, ``The Secretary may
revoke enrollment, for a period of not more than one year for each act,
for a physician or supplier under section 1866(j) if such physician or
supplier fails to maintain and, upon request of the Secretary, provide
access to documentation relating to written orders or requests for
payment for durable medical equipment, certifications for home health
services, or referrals for other items or services written or ordered
by such physician or supplier under this title, as specified by the
Secretary.''
Section 6406(b)(3) of the Affordable Care Act amends section
1866(a)(1) of the Act to require that providers and suppliers maintain
and, upon request, provide to the Secretary, access to written or
electronic documentation relating to written orders or requests for
payment for durable medical equipment, certifications for home health
services, or referrals for other items or services written or ordered
by the provider as specified by the Secretary. Section 6406(b)(3) does
not limit the authority of the Office of Inspector General to fulfill
the Inspector General's responsibilities in accordance with applicable
Federal law.
3. Requirements Established by the IFC
The IFC amended paragraph (f) of Sec. 424.516 to require the
following:
A provider or supplier that furnishes covered ordered
items of DMEPOS or home health, laboratory, imaging, or specialist
services, to maintain written and electronic documentation (to include
the NPI of the ordering or referring physician or eligible
professional) relating to written orders and requests for payments for
those items or services for 7 years from the date of service, and
provide CMS or a Medicare contractor access to that documentation.
A physician who ordered home health services and a
physician or an eligible professional who ordered or referred DMEPOS,
laboratory, imaging, and specialist services to maintain documentation
relating to the written orders and requests for payments for those
items or services for 7 years from the date of the order,
certification, or referral and, upon request of CMS or a Medicare
contractor, provide access to that documentation.
The IFC added paragraph (10) to Sec. 424.535(a) to state that the
Secretary may revoke Medicare enrollment and billing privileges for a
period of not more than 1 year for each act of noncompliance for
failure of a provider or supplier, including physicians and other
eligible professionals, to comply with the document retention and
access to documentation requirements at Sec. 424.516(f).
4. Summary of and Responses to Public Comments on the Medicare
Requirement for Physicians, Other Suppliers, and Providers to Maintain
and Provide Access to Documentation on Referrals to Programs at High
Risk of Waste and Abuse
a. Document Retention
Comment: A commenter asked if a home health agency would be
[[Page 25310]]
considered to have forged documentation if the documentation to be
required could not be produced by the physician but could be found in
the home health agency's documentation.
Response: This final rule places the responsibility for the
maintenance of records on both the ordering and certifying physician
and the provider and supplier. We require that a good faith effort is
made to comply with this rule. However, we understand that from time to
time situations arise that are outside of the control of these
custodians. In such a case, we may conduct an analysis based on the
specific facts and circumstances involved in a particular case.
Comment: A commenter noted that it will take some time for eligible
professionals who will be enrolling in Medicare only to order and refer
to fully understand their compliance obligations. In addition, dentists
with practice management software and/or electronic records may be
required to consult with their vendors and reconfigure their systems in
order to comply with the documentation and disclosure requirements.
Response: Dentists and others who will be enrolling only to order
should be fully aware of the documentation retention and disclosure
requirements beforehand. We have already published considerable
information about these requirements and have communicated directly and
in numerous open door forums about these requirements. We will publish
additional guidance, as appropriate, via a Medicare Learning Network
product, messages in our provider/supplier listservs, and presentations
at our provider/supplier open door forums. We will also continue to
provide information directly to the ADA, DoD, DVA, PHS, and other
affected employers of physicians and other eligible professionals who
enroll in Medicare just to order and certify.
Comment: A commenter requested that CMS create exceptions to the
penalty for non-compliance with the documentation retention and
disclosure requirements. The commenter stated that there could be
situations where documentation is destroyed or lost prior to the end of
the 7-year required retention period, despite a provider's good faith
efforts, due to circumstances beyond the provider's control, such as a
systems malfunction or a natural disaster. The commenters stated that
such providers or suppliers should not be penalized in the same manner
as a provider or supplier who intentionally or carelessly disregards
the documentation requirements. The commenter noted that the Act gives
the Secretary the authority to modify the penalties, as it states that
``* * * the Secretary may revoke enrollment, for a period of not more
than one year for each act.'' (Italics added for emphasis.) The
commenter believed that blanket penalties may be inequitable in
practice and may create a potential disincentive to participate in
Medicare.
Response: Medical documentation must be stored in a manner
consistent with applicable security and privacy rules. However, we
recognize that there could be circumstances in which an event could
occur as indicated by the commenter. Therefore, as provided in Sec.
424.535(a), a revocation action is discretionary and we would base a
revocation decision on a complete analysis of the facts and
circumstances prior to making a determination.
Comment: A commenter stated that a referral to home health care or
for DMEPOS at a hospital or nursing home discharge would typically be
retained in that hospital's or nursing home's records, not by the
physician in his/her records.
Response: The physician or other eligible professional who signed
the order or certification is responsible for maintaining and
disclosing the documentation. We will provide further guidance on this
after the publication of this final rule.
Comment: A commenter suggested that CMS only require document
retention related to billable services for home health services by
physicians (that is, the certification documents and, when care plan
oversight reimbursement is sought, supporting documentation of time
spent on such activities). The commenter stated that the documentation
retained by physicians who are employed by providers or suppliers is
governed by the requirements of the provider or supplier, not the
physician. The commenter also stated that while revocation in Medicare
of the physician may be appropriate for evidence of fraud or abuse, it
would not be appropriate if a physician's employer lost or misfiled
records. Several commenters stated that the added documentation
requirements for DMEPOS and home health services are not clear and do
not specify the specific kinds of documents that must be retained.
Another commenter asked for specifics concerning the preferred format
of retained information.
Response: This rule does not address the content or format of
documentation that must be maintained and disclosed. However, for
purposes of clarification, we suggest that a reasonable approach is for
providers and suppliers to retain documentation that supports the
payment of the claim. This could include laboratory or other test
results or findings and office visit notes in addition to copies of
signed orders and certifications. We note that this documentation
requirement applies to paper and electronic documents, as indicated in
the statute and this final rule.
Comment: A commenter questioned whether the documentation
requirements require that a supplier use electronic medical records.
The commenter states that if a supplier is going to be required to use
electronic medical records, the financial burden would put many small
suppliers out of business.
Response: The requirements at Sec. 424.516 does not require
providers and suppliers to use electronic medical records.
Comment: A commenter questioned if the failure of a physician to
retain a copy of the CMS-485 could lead to denial of claims and
recoupment of prior payments from home health agencies.
Response: As stated earlier, this rule does not modify or address
the content requirements for documents to be retained. Therefore, this
comment is outside of the scope of this final rule.
Comment: Some commenters requested that CMS to specifically
identify the entities or individuals to whom such documentation must be
disclosed (for example, CMS or its contractors, an Administrative Law
Judge, a DMEPOS supplier, and a beneficiary).
Response: Disclosure is required to be made, upon request, to CMS
or CMS contractors. Disclosure may also be requested by DHHS OIG for
fulfillment of the Inspector General's responsibilities and under its
independent authority. However, this list is not exhaustive and other
agencies such as the Department of Justice (DOJ) and the Internal
Revenue Service (IRS) have separate authority to request documentation.
Comment: A commenter stated that interns and residents may be
responsible for creating, and the dental school clinic may be
responsible for retaining, the records required to comply with section
Sec. 424.516(f)(2); and that other dentists, such as locum tenens
dentists and those who are employed by a government agency or a group
practice, may not be capable of maintaining independent documentation
of orders and referrals and may not be able to grant CMS or a Medicare
contractor access to those records. This commenter asked CMS to
[[Page 25311]]
clarify how the requirements in this section would apply to dentists.
This commenter also urged that a dentist who is unable to comply with a
disclosure request because another person or entity has control over
the documentation not be subject to revocation of enrollment and
billing privileges in Medicare under Sec. 424.535(a)(10).
Response: The requirements of Sec. 424.516(f)(2) apply to interns,
residents, and dentists in the same way they apply to enrolled
physicians and to other eligible professionals. We will provide further
guidance on this during the implementation of the provisions contained
in this final rule.
Comment: Several commenters stated that the document retention
requirements vary considerably depending on different parts of the
Medicare program. Physicians do not know how long they need to retain
certain records. We should provide education to physicians on document
retention requirements for various parts of the Medicare program.
Response: This final rule does not address documentation
requirements (for example, those found in Sec. 420.300 through Sec.
420.304) for other parts of the Medicare program other than
documentation retention and provision requirements related to
particular items and services that are ordered and certified. Some
aspects of this comment are outside the scope of this final rule. We
are requiring that documentation pertaining to ordered and certified
services and supplies be retained for 7 years, as specified in Sec.
424.516(f). We will continue to provide educational material to the
public as we implement the specific provisions in this final rule.
Comment: Several commenters stated that the documentation
requirements should apply only to the imaging facility (the technical
component provider) and not the ordering or referring provider or the
interpreting physician. To require the ordering or referring provider
or the interpreting physician to maintain documentation is unnecessary
and is a duplication of effort and expense, and many such providers are
currently ill-equipped to do this. Ordering physicians do not
differentiate between the technical and professional components of
their order; they assume both will occur.
Response: We are not placing documentation requirements on
physicians who interpret imaging tests. Section 1866(a)(1)(W) of the
Act authorizes the Secretary to extend these requirements to other
items and services. Section 424.516(f)(1) and at Sec. 424.535(a)(10)
apply to home health agencies, DMEPOS suppliers, clinical laboratories,
imaging centers, and those physicians and other eligible professionals
who ordered or certified home health, DMEPOS, clinical laboratory, and
imaging services.
Comment: Many commenters stated that Sec. 424.516 should not
require maintenance of documentation related to requests by a physician
that the patient see another physician. Section 424.516 should apply
only to items and services for which Medicare requires a written order
or referral (such as DMEPOS, home health, laboratory, and diagnostic
tests).
Response: As stated earlier in this preamble, we have removed
requirements for specialist services in Sec. 424.507 and Sec. 424.516
from this final rule.
Comment: Several commenters recommended that Sec. 424.535 be
revised to reflect less severe penalties for failure to retain and/or
disclose documentation of orders and referrals. They suggested that
allowing the recovery of applicable Medicare payments and the
establishment of and compliance with a corrective action plan be the
required penalties for noncompliance.
Response: This regulation implements section 6406 of the Affordable
Care Act which amended section 1843(h) of the Act. Section 1842(h)(9)
of the Act states,
The Secretary may revoke enrollment, for a period of not more
than one year for each act, for a physician or supplier under
section 1866(j) if such physician or supplier fails to maintain and,
upon request of the Secretary, provide access to documentation
relating to written orders or requests for payment for durable
medical equipment, certifications for home health services, or
referrals for other items or services written or ordered by such
physician or supplier under this title, as specified by the
Secretary.
We believe that the penalties to be imposed are appropriate and in
accordance with the statute.
Comment: A commenter recommended that the stated documentation
requirements at Sec. 424.516(f) be revised to limit physician
documentation requirements to a copy of the home health Plan of Care
and the certification/recertification forms, and not to require
retention of interim orders except when they are for added billable
services and not to require a physician's NPI on the certification/
recertification form or interim orders for added billable services
until CMS issues detailed guidance for the content of the Plan of Care,
including specific physician's NPI requirements.
Response: As noted in earlier responses, this final rule does not
provide an exhaustive list of the documentation to be retained and
produced if requested. However, any documentation that supports the
payment of the claim should be retained and must be made available upon
request. The NPI of the ordering or certifying provider must be
included in the retained documentation.
b. Technical, Administrative, and Procedural Modifications and
Corrections
Comment: Several commenters noted that the requirements added at
Sec. 424.507 apply to Part B items and services (excluding Part B
drugs) and Part A and Part B home health services, whereas the
documentation requirements added at Sec. 424.516 apply to a narrower
set of services (that is, Sec. 424.516 specifically states DMEPOS,
home health, laboratory, imaging, and specialist services). The
commenters stated that CMS should apply the document retention
requirements and the ordering or referring provider enrollment
requirements to the same types of orders and referrals.
Response: We have revised the regulatory text for consistency. The
ordering and certifying requirements and the documentation requirements
apply to the same items and services, specifically: DMEPOS, imaging and
clinical laboratory services, and home health services.
c. Public Comments Outside the Scope of the Requirement To Maintain and
Provide Access to Documentation of Referrals
Comment: A commenter stated that the documentation requirement
could have a significant impact on patients who present for services or
supplies with an order that is not signed. The patient may be delayed
in receiving medically necessary care while the provider or supplier
who would furnish the item or service requests a signed order.
Obtaining the signature places a burden on the provider or supplier who
would furnish the service.
Response: We believe this comment is outside of the scope of this
final rule because we are not modifying requirements for orders to be
signed.
Comment: A commenter stated that the need to produce I-9 forms for
foreign born suppliers is administratively burdensome on large provider
groups.
Response: Production of an I-9 form for foreign born suppliers is
not a requirement of this final rule and therefore outside of the scope
of issues to be addressed.
[[Page 25312]]
d. Summation and Final Decisions
After review of the all of public comments presented this section
(section II.C.4. a. through c. of this final rule), we are finalizing
the document retention requirements with several modifications. We are
revising the provisions to follow the ordering and certifying
provisions' covered items and services to include DMEPOS, laboratory,
and imaging services, and home health services. We have also clarified
that document maintenance and affording access to documentation, with
regard to the home health provision, applies to orders and
certifications. This provision has been clarified for the same reasons
we clarified Sec. 424.507, as described herein.
We have clarified that documents must be retained from the date of
service, rather than the date of the order or certification- as
specified in the IFC. Specialist services are no longer included in
either the ordering and referring provision of Sec. 424.507 or the
document retention provision in Sec. 424.516.
Section 424.535 remains unchanged in the fact that a provider or
supplier that does not meet the requirements of Sec. 424.516 is
subject to revocation for not more than 1 year for each act of
noncompliance. Finally, as a technical correction, we removed a
provision in Sec. 424.535 that references section 1866(j) of the Act.
III. Provisions of the Final Rule
In this section of the final rule, we discuss the changes made from
the IFC. We are finalizing the provisions of the IFC with the
modifications based on our response to comments and other statutory and
technical changes stated in this section of the final rule.
In section II.A. of this final rule, we discuss the inclusion of
the NPI on all Medicare enrollment applications, pursuant to Medicaid
provider agreements, and on Medicare and Medicaid claims. We note that
the main objectives of that section remain constant from the IFC to
this final rule in that providers and suppliers must provide their NPIs
as a part of their enrollment record. Furthermore, this NPI must be
reported on any claims for payment, along with the NPI of any other
provider or supplier listed on the claim form. We made a few
modifications to the NPI provisions included in the IFC. In Sec.
424.506, we made the following changes:
Revised paragraph (b)(1) to include the text of paragraph
(b)(2).
Removed the existing paragraph (b)(2) and redesignated
paragraph (b)(3) and paragraph (b)(2).
Paragraph (c)(1) was revised to insert the word ``must''
between the words ``Medicare'' and ``include'' because the word was
inadvertently omitted in this requirement in the IFC.
In section II.B. of this final rule, we discuss our provisions
regarding ordering and certifying covered items and services for
Medicare beneficiaries. In that section of this final rule, set forth
are specific provider and supplier mandates for enrolling in Medicare
to order and certify certain, specified items or services including
DMEPOS, laboratory and imaging services, and home health services. We
stress that this rule finalizes conditions of payment for ordered items
and services, and it does not address broader payment policy questions.
It neither changes eligibility requirements that permit certain
provider types to order or certify, nor does it detail which items or
services they are permitted to order or certify. This rule, in its
applicable sections, only addresses the enrollment requirements for
those eligible professionals who are permitted to order and certify
under existing rules. We are making the following modifications
regarding ordering and certifying covered items and services for
Medicare beneficiaries:
In Sec. 424.507, we made the following changes:
++ Revised the introductory text for paragraph (a) to clarify the
items and services to which this paragraph applies (covered Part B
DMEPOS items and clinical laboratory and imaging services). We also
deleted the reference to specialist services.
++ Revised paragraph (a)(1) by inserting the word ``claim'' between
the words ``supplier's'' and ``must.''
++ Revised paragraph (a)(1)(iii) to state that the physician or
other eligible professional, when permitted, must be enrolled in
Medicare in an approved status or have validly opted- out of the
Medicare program.
++ Revised paragraph (a)(1)(iv) to require that claims identify the
teaching physician as the ordering or certifying provider when an
unlicensed resident or a non-enrolled licensed resident orders or
certifications. We are also providing the option of enrollment if
residents possess a provisional license or are otherwise permitted by
their State to practice or order and certify.
++ Revised paragraph (a)(2)(iii) to be consistent with paragraph
(a)(1)(iii).
++ Revised paragraph (a)(2)(iv) to be consistent with paragraph
(a)(1)(iv) by requiring that claims identify the teaching physician as
the ordering or certifying provider when an unlicensed resident or a
non-enrolled licensed resident orders or certifications. We are also
providing the option of enrollment if residents possess a provisional
license or are otherwise permitted by their State to practice or order
and certify.
++ Revised paragraph (b)(3) (formerly paragraph (b)(1)(iii)) to be
consistent with paragraph (a)(1)(iii) by requiring that home health
claims identify the teaching physician as the ordering/certifying
provider when an unlicensed resident or a non-enrolled licensed
resident certifies. We are also providing the option of enrollment if
residents possess a provisional license or are otherwise permitted by
their State to order/certify or practice.
++ Removed the requirements for home health claims submitted by
Medicare beneficiaries in paragraph (b)(2). This change resulted in the
rewording of the title of paragraph (b) to read: ``Conditions for
payment of claims from home health providers for covered home health
services'' and the renumbering of the requirements in paragraph (b).
++ Revised paragraph (b) by removing the word ``ordered'' from the
provision. This change will result in the wording as follows: ``To
receive payment for covered Part A or Part B home health services, a
provider's home health services claim must meet all of the following
requirements:''
++ Revised paragraph (b)(1) and (b)(2) (formerly paragraph (b)(1))
to include certifications, not simply orders for home health.
++ Revised paragraph (c) to state that we will deny a claim from a
provider or supplier for covered services described in Sec. 424.507(a)
and Sec. 424.507(b) if the claim does not meet the requirements of
Sec. 424.507(a)(1) and Sec. 424.507(b), respectively. We also changed
the reference from Sec. 424.507(b)(1) to Sec. 424.507(b).
++ Revised paragraph (d) to remove the references to sections that
relate to home health services and home health claims, as Medicare
beneficiaries do not submit claims for home health services.
In section II.C. of this final rule, we discuss the IFC provisions
regarding document retention requirements. We are finalizing these
requirements with the following modifications:
In Sec. 424.516, we made the following changes:
++ Removed the words ``specialist services'' in paragraph (f)(1)
and we more specifically described the items and services to which the
final rule applies.
++ Revised paragraph (f)(2) to more specifically describe the items
and services to which this final rule applies.
[[Page 25313]]
++ Revised paragraphs (f)(1) and (f)(2) to more explicitly describe
the home health events to which this final rule applies by specifically
referring to orders and certifications.
In Sec. 424.535(a)(10)(i), we removed the reference to
section 1866(j) of the Act.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
A. ICRs Regarding National Provider Identifier (NPI) on All Medicare
Enrollment Applications and Claims (Sec. 424.506)
Section 424.506(b)(1) states that providers and suppliers who are
eligible for NPIs be required to report their NPIs on their enrollment
applications for Medicare. Similarly, Sec. 424.506 (b)(2) states that
if providers or suppliers enrolled in Medicare prior to obtaining NPIs
and their NPIs are not in their enrollment records, they must submit
enrollment applications containing their NPIs.
The burden associated with the requirements in Sec. 424.506(b) is
the time and effort necessary for a provider or a supplier to apply for
an NPI and the time and effort necessary to report the NPIs on their
enrollment applications for Medicare.
Sections Sec. 424.510 and Sec. 424.515 state that providers and
suppliers must submit enrollment information on the applicable
enrollment application and update, resubmit, and recertify the accuracy
of their enrollment information every 5 years. In addition, Sec.
424.516 lists reporting requirements for providers and suppliers. To
submit enrollment information for an initial application (even if
enrolling just to order and certify), a change of information, or to
respond to a revalidation request, a provider or supplier must complete
and submit the applicable CMS-855 form or complete and submit the form
over the Internet using Internet-based PECOS. Although we are unable to
quantify the number, we do not believe that a significant number of
physicians and eligible professionals will enroll in Medicare just to
order and certify. The burden associated with the enrollment
requirements found in Sec. 424.510, Sec. 424.515, and Sec. 424.516
is the time and effort necessary to complete and submit applicable
Medicare form. While this burden is subject to the PRA, it is currently
approved under existing OMB control numbers (OCN). Specifically, the
burden associated with obtaining an NPI is currently approved under OCN
0938-0931. The burden associated with submitting initial Medicare
enrollment applications and updating Medicare enrollment information to
include NPI is approved under OCN 0938-0685 (Applications CMS-855 A, B,
I, and R) 0938-1056 (Application CMS-855 S).
Section 424.506(b)(1) states that providers and suppliers who are
enrolled in Medicare must report their NPIs and the NPIs of any other
providers or suppliers who are required to be identified in their
claims on all paper and electronic claims that they send to Medicare.
The burden associated with this requirement is the time and effort
necessary to complete and submit a claim form. The burden associated
with this collection is accounted for under OCN 0938-0999. We are
currently seeking reinstatement of the control number.
B. ICRs Regarding Ordering and Referring Covered Items and Services for
Medicare Beneficiaries (Sec. 424.507)
Section 424.507 states that to receive payment for covered Part A
or Part B home health services, the claim must contain the legal name
and the NPI of the ordering physician; and to receive payment for
covered items of DMEPOS, and certain other covered Part B items or
services (excluding Part B drugs), the claim must contain the legal
name and the NPI of the ordering or certifying physician or eligible
professional. The burden associated with these requirements is the time
and effort necessary to submit a claim with the required information.
The burden associated with this collection is accounted for under OCN
0938-0999. We are currently seeking reinstatement of the control
number.
C. ICRs Regarding Additional Provider and Supplier Requirements for
Enrolling and Maintaining Active Enrollment Status in the Medicare
Program (Sec. 424.516)
Section 424.516(f)(1) discusses the documentation requirements for
providers and suppliers. A provider or supplier is required for 7 years
from the date of service to maintain and upon request of CMS or a
Medicare contractor, provide access to documentation, including the NPI
of the physician or the eligible professional who ordered or certified
the item or service, relating to written orders or requests for
payments for items of DMEPOS, home health, laboratory, and imaging
services. Similarly, Sec. 424.516(f) discusses the documentation
requirements for providers and suppliers. At Sec. 424.516(f)(1),
providers and suppliers are required for 7 years from the date of
service to maintain and, upon request of CMS or a Medicare contractor,
provide access to documentation, including the NPI of the physician or
the eligible professional who ordered or certified the item or service,
relating to written orders or requests for payments for items of
DMEPOS, home health, laboratory, and imaging services. At Sec.
424.516(f)(2), physicians and eligible professionals are required for 7
years from the date of service to maintain and, upon request of CMS or
a Medicare contractor, provide access to written and electronic
documentation relating to written orders or certifications for items of
DMEPOS, home health, laboratory, and imaging services.
The burden associated with the requirements in Sec. 424.516(f) is
the time and effort necessary to both maintain documentation on file
and to furnish the information upon request to CMS or a Medicare
contractor. While the requirement is subject to the PRA, we believe the
associated burden is exempt. As discussed in the November 19, 2008
final rule (73 FR 69726), we believe the burden associated with
maintaining documentation and furnishing it upon request is a usual and
customary business practice and thereby exempt from the PRA under 5 CFR
1320.3(b)(2).
D. ICRs Regarding the Reporting of National Provider Identifier by
Medicaid Providers (Sec. 431.107(b)(5))
Section 431.107(b)(5) states that a Medicaid provider has to
furnish its NPI (if eligible for an NPI) to its State agency and
include its NPI on all claims submitted under the Medicaid program. The
burden associated with the Medicaid requirements in
[[Page 25314]]
Sec. 431.107(b)(5) is the time and effort necessary for a provider to
report the NPIs to the State agency and on claims submitted to the
Medicaid program.
1. Enrollment Applications
We have considered the burden associated with enrollment
applications for Medicaid by estimating the number of providers.
Specifically--
There will be 56,250 Medicaid and CHIP providers in a
given 12-month period that seek to enroll in Medicaid; and
According to State Program Integrity Assessment data for
FFYs 2007 and 2008, there has been an average of 1,855,070 existing
Medicaid and CHIP providers nationally over the 2-year period of FFYs
2007 and 2008. Of these 1,855,070 providers, approximately one-fifth of
them, or 371,014 (1,855,070 x .20), would be required to revalidate
their enrollment each year under Sec. 431.107(b).
For purposes of this paperwork burden assessment only, we assumed
that 427,264 providers (56,250 + 371,014) will either initially enroll
in or be required to revalidate their enrollment in Medicaid and, as
part of this, be required to report their NPI.
We recognize that not all of these providers will have NPIs to
report; a very small percentage of them may be exempt from having to
obtain an NPI. We further understand that: (1) Some States may choose
to allow (or even require) providers to submit their NPIs via
mechanisms that are potentially less burdensome than submitting an
initial enrollment or revalidation application; and (2) the previous
figures include CHIP providers, who are not subject to the requirements
of Sec. 431.107(b). However, we chose to utilize the 427,264 figure
and the application reporting mechanism for this paperwork burden
assessment, so as not to underestimate the potential burden of this
particular requirement. We estimated that it will take an average of
less than 1 minute (or 0.01666 hours) for a medical technician to
report a Medicaid provider's NPI to the State agency on an enrollment
or reenrollment application. However, we assumed 1 minute for purposes
of this burden. This results in an annual hour burden of 7,118 hours
(or 427,264 x 0.01666). At a per hour cost of $14.51, according to the
Bureau of Labor Statistics (BLS) for May 2011 for the mean hourly wage
of a medical assistant, we projected a total annual cost of $103,282.
2. Claims
In FY 2008, approximately 2.5 billion Medicaid claims were
submitted. This number has remained relatively constant since then.
As of May 23, 2008, and consistent with 45 CFR 162.410, the NPI has
been required for all HIPAA-standard transactions. This means that
Medicaid providers have been required since that date to disclose their
NPI on all HIPAA-standard transactions, which we estimate to represent
about 95 percent of all Medicaid claim submissions. We arrived at this
percentage because we polled 10 States and using their individual
percentage of electronic claims submission compiled an average of 95
percent. We then applied that percentage to the nation since 10 States
we polled represent a sample of small and large States as well as
States with a low and high Medicaid population and therefore we believe
can be considered an adequate sample.
We will not be furnishing an estimated burden for the requirement
that a provider furnish its NPI on claims because this requirement
already applies to the vast majority of Medicaid claims under Sec.
431.107(b)(5), and 45 CFR 162.410. The burden we estimate here will be
for those claims--in general, paper claims--that are not HIPAA-standard
transactions but that now must contain the NPI per Sec. 431.107(b)(5).
It is true that some States have been requiring the submission of the
NPI on all Medicaid claims, even those that are not subject to Sec.
431.107(b)(5). However, no burden has been prepared for this. We do so
in this final rule.
We projected that 5 percent of the 2.5 billion claims previously
referenced--or 125 million--will not qualify as HIPAA-standard
transactions. These claims will need to contain the provider's NPI. We
estimate that it will take the provider/medical assistant less than 1
minute to add the NPI to the claim but for purposes of the burden we
estimated 1 minute--or 0.01666 hours--to furnish its NPI on the claim.
This results in an annual burden of 2,082,500 hours. At a per hour cost
of $14.51, we project the annual cost of this requirement to add the
NPI to paper or non-HIPAA standard transactions to be $30,317,075. We
wish to point out that as a result of this final rule, all claims will
be required to have an NPI so as States implement these requirements,
the burden will continue to decrease. Of note, while we received no
comments on the burden for appending the NPI to the Medicaid provider
agreement and/or the Medicaid claims for payment, we have updated these
estimates to account for a medical assistant rather than a medical
technician, since we believe a medical assistant is more likely to
provide administrative support to the provider and to account for the
May 2011 BLS mean hourly wage of a medical assistant rather than the
2008 mean hourly wage of the medical technician.
Table 1 indicates the paperwork burden associated with the
requirements of this final rule. The only two requirements listed are
those involving the Medicaid NPI provisions described in Sec.
431.107(b)(5). The remaining requirements, as explained above, are
either exempt from the PRA requirement or the burden for them has been
addressed in other PRA packages/assessments.
Table 1--Estimated Average Annual Reporting/Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly
Burden Total labor cost Total labor Total
Regulation section OMB Control No. Respondents Responses per annual of cost of capital/ Total cost
response burden reporting reporting maintenance ($)
(hours) (hours) ($) ($) costs ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
431.107(b)(5)--Enrollment...... 0938-New....... 427,264 427,264 0.01666 7118 14.51 103,282 0 103,282
431.107(b)(5)--Claims.......... 0938-New....... 2,500,000,000 125,000,000 0.01666 2,082,500 14.51 30,217,075 0 30,217,075
------------------------------------------------------------------------------------------------------------------------
Total...................... ............... 2,500,427,264 125,427,264 ......... 2,089,618 .......... ........... ........... 30,320,357
--------------------------------------------------------------------------------------------------------------------------------------------------------
If you comment on these information collection and recordkeeping
requirements, please submit your comments to the Office of Information
and Regulatory Affairs, Office of Management and Budget,
Attention: CMS Desk Officer, CMS-6010-F.
Fax: (202) 395-6974; or
[[Page 25315]]
Email: [email protected].
In response to our solicitation of comments on these issues, we
received the following comments:
Comment: A commenter believed that CMS should re-estimate the
actual burden of completing the CMS-855I enrollment applications with
respect to the burden required by this final rule, including contractor
processing time and the interruption of Medicare reimbursement for the
physician.
Response: With respect to the completion of CMS-855 form pursuant
to the final rule, we believe that the overall burden will, in general,
be increased only by the number of individuals who are enrolling just
to order and certify via the new CMS-855O form, as most other
physicians and eligible professionals who order and certify have
already enrolled in Medicare via the CMS-855I. In other words, the new
burden relates to the CMS-855O, not the CMS-855I. As explained later in
this section, the burden associated with completing the new CMS-855O
form was addressed in the Paperwork Reduction Act (PRA) package for
that form.
Comment: A commenter stated that the costs of preparing and filing
correspondence and records (paper, or scanned from paper and put into
an electronic record) would be astronomical, with no evidence of
benefit in fraud prevention or detection.
Response: This final rule does not address the format, context, or
mode of documentation. However, for purposes of clarification, we do
not require that paper documentation be converted into electronic
format in order to meet the documentation and disclosure requirements
of this final rule. Moreover, we believe that such document retention
is a normal and customary business practice. As such, we do not foresee
additional costs associate with a practice that is already in existence
for many providers.
Comment: Several commenters questioned what is meant by the phrase
``providing access to that documentation.'' If this means that
physician specialty practices will have to allow CMS or its contractor
access to their patient records, it would be burdensome and disruptive
to the practices and could create potential patient privacy problems.
This would be even more difficult for electronically maintained
records.
Response: CMS, its contractors, and/or the DHHS OIG may request
access to required documentation. It is the responsibility of the
provider and supplier, and of the physician or other eligible
professional, or their provider/supplier employers, where appropriate
and as discussed earlier, to determine the method of storage of the
required documentation, the location of the stored required
documentation, and the means by which it will disclose the required
documentation to CMS, its contractors, and/or the DHHS OIG in order to
comply with this final rule. Medical practices and other employers that
are responsible for the documentation and disclosure requirements must
ensure that they can meet these requirements in order to remain active
in the Medicare program.
Comment: Several commenters stated that the IFC does not include an
adequate analysis of the impact of the expanded documentation
requirement for physicians. Repeated audits over a 7-year period of
time is not part of a regular administrative work flow and will cause
considerable financial burden, absorb staff time, and require
investment in the maintenance of documentation. Small medical practices
do not have the necessary resources to do this.
Response: We do not foresee providers, suppliers, physicians, etc.,
being subjected to ``repeated'' audits. To the contrary, such audits
will, in general: (1) Be performed only as an ``as needed'' basis, and
(2) merely involve requests for limited numbers of documents. Moreover,
we believe that such infrequent audits are, like documentation
retention, normal business practices. It is not altogether uncommon,
for example, for a private health insurance plan--as part of an
investigation--to request certain documentation from a supplier in
order to support the need for a particular service that was provided.
V. Regulatory Impact Analysis
A. Statement of Need
This final rule is necessary to finalize provisions of the May 5,
2010 IFC. As discussed earlier, the IFC implemented several provisions
of the Affordable Care Act:
Section 6402(a), which requires all Medicare and Medicaid
providers of medical or other items or services and suppliers that
qualify for a National Provider Identifier (NPI) to include the NPI on
all Medicaid provider agreements, Medicare enrollment records, and
Medicare and Medicaid claims for payment.
Section 6405, which requires physicians or eligible
professionals who order and/or certify Medicare services to be enrolled
in Medicare.
Section 6406, which requires physicians and suppliers to
maintain and provide access to documentation relating to written orders
or requests for payment for DMEPOS, HHA, and other services as
specified by the Secretary.
We also believe that this final rule is needed to help ensure that
(1) accurate claims are submitted; (2) the Medicare items and services
being ordered and/or certified are valid and necessary; and (3)
appropriate records of orders and certifications for Medicare items and
services are maintained.
B. Overall Impact
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulations and Regulatory review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
Executive Order 13132 on Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 directs agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any single
year). As discussed in more detail later in this section, we believe
that the savings resulting from this final rule will exceed $100
million in each of the next 10 fiscal years, beginning in fiscal year
(FY) 2013. Therefore, this is an economically significant rule based
upon section 3(f)(1) of Executive Order 12866.
The Regulatory Flexibility Act (RFA) requires agencies to analyze
options for regulatory relief for small entities, if a rule has a
significant impact on a substantial number of small entities. For
purposes of the RFA, we estimate that small entities include small
businesses, nonprofit organizations, and small governmental
jurisdictions. The great majority of hospitals and most other health
care providers and suppliers are small entities, either by being
nonprofit organizations or by meeting the SBA definition of a small
business (having revenues of less than $7.0 million to $34.5 million in
any one year.
[[Page 25316]]
Individuals and States are not included in the definition of a small
entity. As we stated in the IFC, we do not believe that this rule will
have a significant economic impact on a substantial number of small
entities. Nonetheless, we recognize that the potential effects of this
final rule could impact some providers of covered imaging, clinical
laboratory, DMEPOS, and home health items and services. We have
therefore, elected to prepare a voluntary RFA analysis. As many of the
requirements of the RFA are contained in our RIA, this RIA section also
constitutes the RFA. Section 1102(b) of the Act requires us to prepare
a regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We are not preparing an
analysis for section 1102(b) of the Act. The Secretary has determined
that this final rule will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2011, that
threshold is approximately $136 million. This final rule does not
mandate expenditures by either the governments mentioned or the private
sector; therefore, no analysis is required.
Executive Order (EO) 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation does not impose significant costs
on State or local governments, the requirements of E.O. 13132 are not
applicable.
C. Anticipated Effects
As previously stated, we project, based on internal CMS data, that
the total savings to the Federal government resulting from this final
rule will exceed $100 million in each of the next 10 fiscal years. The
total savings at the end of this 10-year period is estimated to be
$1.59 billion. This figure accounts for our estimates that: (1)
Approximately 5 percent of physicians will not be enrolled; (2) such
physicians have only 50 percent as many Medicare enrollees as other
physicians; and (3) 10 percent of patients of those physicians will not
seek out enrolled physicians. The product of these is inflated by 25
percent to account for other providers who could potentially order
services. The net result is roughly a 0.3 percent--or $1.59 billion--
reduction in DMEPOS, imaging and clinical laboratory services, and Part
A and Part B home health costs over the next 10 years attributable to
patients who will choose not to seek out an enrolled physician to
obtain such services. In addition, some claims without proper
documentation will be denied, including some fraudulent claims, but we
do not have a basis for quantifying the value of such claims.
Table 2 outlines the year-by-year projected savings to the Federal
government over the next decade.
Table 2--Projected Savings
------------------------------------------------------------------------
Savings * (in
Fiscal year $millions)
------------------------------------------------------------------------
2013................................................. 110
2014................................................. 120
2015................................................. 130
2016................................................. 140
2017................................................. 150
2018................................................. 160
2019................................................. 180
2020................................................. 190
2021................................................. 200
2022................................................. 210
------------------
Total............................................ 1,590
------------------------------------------------------------------------
* In actual dollars for the years presented.
We believe that the rule's other effects will be minimal. With
respect to Sec. 424.506, practically all providers and suppliers that
wish to enroll in Medicare and Medicaid programs have already obtained
NPIs and are currently meeting requirements regarding the need to
report their NPIs on, as applicable, enrollment applications and
claims. Regarding Sec. 424.516(f), we believe that most providers and
suppliers already retain such documentation as a usual and customary
business practice.
D. Alternatives Considered
Since this final rule is a codification of statutory provisions
found in the Affordable Care Act, we did not consider alternatives to
the overall processes described in the IFC. We did consider the
possibility of including additional items and services on the list of
those affected by this final rule. However, while we have the authority
under section 6405(c) of the Affordable Care Act to expand the
requirements of section 6405(a) and (b) of the Affordable Care Act to
all other categories of items or services under Title XVIII of the Act,
we chose to expand these requirements only to clinical laboratory and
imaging services, rather than to many other types of services.
(Specialist services, moreover, are no longer covered by the
requirements of this final rule.) We believe that the application of
these requirements to limited categories of items and services will
ease the overall burden on the provider and supplier communities.
Moreover, in response to comments on the IFC, we considered and adopted
the following alternatives that we believe will further the impact of
these provisions.
First, we state in Sec. 424.507 that in order for a claim to be
paid, the ordering physician/practitioner must be enrolled in Medicare
in an approved status or must have validly opted-out of the Medicare
program. The IFC required that the ordering physician/practitioner have
an approved enrollment record in PECOS. However, we have changed the
enrollment requirement language from one requiring enrollment in PECOS
to one requiring enrollment in Medicare--including PECOS or other
Medicare enrollment systems. We believe that this will reduce the
number of claims that are denied or rejected and enable more currently
enrolled physicians and practitioners to order or certify for services.
Second, we will provide ample advanced notice of our intention to
activate the automated edits that would cause a claim to not be paid
for the lack of a valid: (1) Enrollment record to order and certify; or
(2) a valid opt-out record in Medicare.
For Medicaid, again, we codified the statutory provisions found in
the Affordable Care Act. However, we considered alternatives to the
statute, since the provision requires all providers of medical or other
items or services and supplies to include their NPI on all
applications. Medicaid, until recently, had no Federally required
process for provider enrollment outside of the requirement to enter
into a provider agreement with the State. Further, Medicaid has no
Federal process for applications to enroll in the Medicaid program.
Thus, in order to comply with the statutory requirement outlined in
6402 of the Affordable Care Act to append the NPI to the application
for enrollment, Medicaid considered codifying additional regulatory
requirements outlining a Federal process for the application to enroll
in Medicaid. Because of the Administration's goal to provide for
greater administration simplification, we determined that Medicaid
would not
[[Page 25317]]
prepare additional regulatory requirements but would provide that the
NPI must be appended to the provider agreement. Since entering into a
provider agreement with the State is currently a requirement in the
Medicaid program, we believe this option provides States and providers
with an alternative that is less burdensome.
Again, the main purpose of this final rule is to implement the
previously referenced provisions of the Affordable Care Act. However,
we also believe that these requirements will help to ensure that
Medicare and Medicaid payments are correctly and properly made.
E. Accounting Statement
As required by OMB Circular A-4 (available at link http://www.whitehouse.gov/sites/default/files/omb/assets/regulatory_matters_pdf/a-4.pdf), we have prepared an accounting statement. In calculating
the annualized savings in the accounting statement, we applied the 7
and 3 percent discount rates to the full 10-year period assessed.
Table 3--Accounting Statement
[In $millions]
----------------------------------------------------------------------------------------------------------------
Primary Discount rate
Category estimate Year dollars (percent) Period covered
----------------------------------------------------------------------------------------------------------------
Transfers from Providers to the $136.8 2012 7 FYs 2013-2022.
Federal government.
139.1 2012 3 FYs 2013-2022.
----------------------------------------------------------------------------------------------------------------
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare, Reporting and recordkeeping requirements.
42 CFR Part 431
Grant programs--health, Health facilities, Medicaid, Privacy,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services is confirming as final the interim final rule
amending 42 CFR parts 424 and 431 that published on May 5, 2010 (75 FR
24437) with the following changes:
PART 424--CONDITIONS FOR MEDICARE PAYMENT
0
1. The authority citation for part 424 continues to read as follows:
Authority: Sec. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. Section 424.506 is amended by revising paragraphs (b) and (c)(1) to
read as follows:
Sec. 424.506 National Provider Identifier (NPI) on all enrollment
applications and claims.
* * * * *
(b) Enrollment requirements. (1) A provider or a supplier that is
eligible for an NPI must do the following:
(i) Report its NPI on its Medicare enrollment application.
(ii) If the provider or supplier was in the Medicare program before
obtaining an NPI and the provider's or the supplier's NPI is not in the
provider's or supplier's Medicare enrollment record, the provider or
supplier must update its Medicare enrollment record by submitting its
NPI using either of the following:
(A) The applicable paper CMS-855 form.
(B) Internet-based PECOS.
(2) A physician or eligible professional who has validly opted-out
of the Medicare program is not required to submit a Medicare enrollment
application for any reason, including to order or certify.
(c) * * *
(1) A provider or supplier that is enrolled in Medicare and submits
a paper or an electronic claim must include its NPI and the NPI(s) of
any other provider(s) or supplier(s) identified on the claim.
* * * * *
0
3. Section 424.507 is revised to read as follows:
Sec. 424.507 Ordering covered items and services for Medicare
beneficiaries.
(a) Conditions for payment of claims for ordered covered imaging
and clinical laboratory services and items of durable medical
equipment, prosthetics, orthotics, and supplies (DMEPOS).
(1) Ordered covered imaging, clinical laboratory services, and
DMEPOS item claims. To receive payment for ordered imaging, clinical
laboratory services, and DMEPOS items (excluding home health services
described in Sec. 424.507(b), and Part B drugs), a provider or
supplier must meet all of the following requirements:
(i) The ordered covered imaging, clinical laboratory services, and
DMEPOS items (excluding home health services described in paragraph (b)
of this section, and Part B drugs) must have been ordered by a
physician or, when permitted, an eligible professional (as defined in
Sec. 424.506(a) of this part).
(ii) The claim from the provider or supplier must contain the legal
name and the National Provider Identifier (NPI) of the physician or the
eligible professional (as defined in Sec. 424.506(a) of this part) who
ordered the item or service.
(iii) The physician or, when permitted, other eligible
professional, as defined in Sec. 424.506(a), who ordered the item or
service must--
(A) Be identified by his or her legal name;
(B) Be identified by his or her NPI; and
(C)(1) Be enrolled in Medicare in an approved status; or
(2) Have validly opted-out of the Medicare program.
(iv) If the item or service is ordered by--
(A) An unlicensed resident (as defined in Sec. 413.75), or by a
non-enrolled licensed resident (as defined in Sec. 413.75), the claim
must identify a teaching physician, who must be enrolled in Medicare in
an approved status, as follows:
(1) As the ordering supplier.
(2) By his or her legal name.
(3) By his/her NPI.
(B) A licensed resident (as defined in Sec. 413.75), he or she
must have a provisional license or be otherwise permitted by State law,
where the resident is enrolled in an approved graduate medical
education program, to practice or order such items and services, the
claim must identify by legal name and NPI the--
(1) Resident, who is enrolled in Medicare in an approved status to
order; or
(2) Teaching physician, who is enrolled in Medicare in an approved
status.
[[Page 25318]]
(2) Part B beneficiary claims. To receive payment for ordered
covered items and services listed at Sec. 424.507(a), a beneficiary's
claim must meet all of the following requirements:
(i) The physician or, when permitted, other eligible professional
(as defined Sec. 424.506(a)) who ordered the item or service must--
(A) Be identified by his or her legal name; and
(B)(1) Be enrolled in Medicare in an approved status; or
(2) Have validly opted out of the Medicare program.
(ii) If the item or service is ordered by--
(A) An unlicensed resident (as defined in Sec. 413.75) or a non-
enrolled licensed resident, (as defined in Sec. 413.75) the claim must
identify a teaching physician, who must be enrolled in Medicare in an
approved status as follows:
(1) As the ordering supplier.
(2) By his or her legal name.
(B) A licensed resident (as defined in Sec. 413.75), he or she
must have a provisional license or are otherwise permitted by State
law, where the resident is enrolled in an approved graduate medical
education program, to practice or to order such items and services, the
claim must identify by legal name the--
(1) Resident, who is enrolled in Medicare in an approved status to
order; or
(2) Teaching physician, who is enrolled in Medicare in an approved
status.
(b) Conditions for payment of claims for covered home health
services. To receive payment for covered Part A or Part B home health
services, a provider's home health services claim must meet all of the
following requirements:
(1) The ordering/certifying physician must meet all of the
following requirements:
(i) Be identified by his or her legal name.
(ii) Be identified by his or her NPI.
(iii)(A) Be enrolled in Medicare in an approved status; or
(B) Have validly opted-out of the Medicare program.
(2) If the services were ordered/certified by--
(i) An unlicensed resident, as defined in Sec. 413.75, or by a
non-enrolled licensed resident, as defined in Sec. 413.75, the claim
must identify a teaching physician who must be enrolled in Medicare in
an approved status--
(A) As the ordering/certifying supplier;
(B) By his or her legal name; and
(C) By his or her NPI.
(ii) A licensed resident (as defined in Sec. 413.75), he or she
must have a provisional license or are otherwise permitted by State
law, where the resident is enrolled in an approved graduate medical
education program, to practice or to order/certify such items and
services, the claim must identify by legal name and NPI the--
(A) Resident, who is enrolled in Medicare in an approved status to
order; or
(B) Teaching physician, who is enrolled in Medicare in an approved
status.
(c) Denial of provider- or supplier-submitted claims.
Notwithstanding Sec. 424.506(c)(3), a Medicare contractor denies a
claim from a provider or a supplier for covered items and services
described in paragraph (a) or (b) of this section if the claim does not
meet the requirements of paragraphs (a)(1) and (b) of this section,
respectively.
(d) Denial of beneficiary-submitted claims. A Medicare contractor
denies a claim from a Medicare beneficiary for covered items or
services described in paragraphs (a) and (b) of this section if the
claim does not meet the requirements of paragraph (a)(2) of this
section.
0
4. Section 424.516 is amended by revising paragraphs (f)(1) and (2) to
read as follows:
Sec. 424.516 Additional provider and supplier requirements for
enrolling and maintaining active enrollment status in the Medicare
program.
* * * * *
(f) * * *
(1)(i) A provider or a supplier that furnishes covered ordered
items of DMEPOS, clinical laboratory, imaging services, or covered
ordered/certified home health services is required to--
(A) Maintain documentation (as described in paragraph (f)(1)(ii) of
this section) for 7 years from the date of service; and
(B) Upon the request of CMS or a Medicare contractor, to provide
access to that documentation (as described in paragraph (f)(1)(ii) of
this section).
(ii) The documentation includes written and electronic documents
(including the NPI of the physician who ordered/certified the home
health services and the NPI of the physician or, when permitted, other
eligible professional who ordered items of DMEPOS or clinical
laboratory or imaging services) relating to written orders and
certifications and requests for payments for items of DMEPOS and
clinical laboratory, imaging, and home health services.
(2)(i) A physician who orders/certifies home health services and
the physician or, when permitted, other eligible professional who
orders items of DMEPOS or clinical laboratory or imaging services is
required to--
(A) Maintain documentation (as described in paragraph (f)(2)(ii) of
this section) for 7 years from the date of the service; and
(B) Upon request of CMS or a Medicare contractor, to provide access
to that documentation (as described in paragraph (f)(2)(ii) of this
section).
(ii) The documentation includes written and electronic documents
(including the NPI of the physician who ordered/certified the home
health services and the NPI of the physician or, when permitted, other
eligible professional who ordered the items of DMEPOS or the clinical
laboratory or imaging services) relating to written orders or
certifications or requests for payments for items of DMEPOS and
clinical laboratory, imaging, and home health services.
Sec. 424.535 [Amended]
0
5. In Sec. 424.535, paragraph (a)(10)(i) is amended by removing the
parenthetical phrase ``(as described in section 1866(j) of the Act)''.
Authority: (Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance Program; and Program No. 93.778,
Medical Assistance Program)
Dated: January 18, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: March 29, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-9994 Filed 4-24-12; 8:45 am]
BILLING CODE 4120-01-P