[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Rules and Regulations]
[Pages 24437-24449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10505]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 424 and 431
[CMS-6010-IFC]
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: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment period implements several
provisions set forth in the Patient Protection and Affordable Care Act
(Affordable Care Act). It implements the provision which 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. This interim final rule with comment period also requires
physicians and eligible professionals to order and refer covered items
and services for Medicare beneficiaries to be enrolled in Medicare. In
addition, it adds requirements for providers, physicians, and other
suppliers participating in the Medicare program to provide
documentation on referrals to programs at high risk of waste and abuse,
to include durable medical equipment, prosthetics, orthotics and
supplies (DMEPOS), home health services, and other items or services
specified by the Secretary.
DATES: Effective date: These regulations are effective on July 6, 2010.
Comment date: To be assured consideration, comments must be received at
one of the addresses provided below, no later than 5 p.m. on July 6,
2010.
ADDRESSES: In commenting, please refer to file code CMS-6010-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed).
Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the instructions for
submitting comments on the home page.
By regular mail. You may mail written comments to the
following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-6010-IFC, P.O.
Box 8013, Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
By express or overnight mail. You may send written
comments to the following address only: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-6010-
IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
By hand or courier. If you prefer, you may deliver (by
hand or courier) your written comments before the close of the comment
period to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Patricia Peyton, (410) 786-1812 for
Medicare issues. Rick Friedman, (410) 786-4451 for Medicaid issues.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: http://regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will be also available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
[[Page 24438]]
through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an
appointment to view public comments, phone 1-800-743-3951.
I. Background
The Medicare program, title XVIII of the Social Security Act (the
Act), is the primary payer of health care for 42 million enrolled
beneficiaries. Under section 1802 of the Act, a beneficiary may obtain
health services from an individual or an organization qualified to
participate in the Medicare program. Qualifications to participate are
specified in statute and in regulations (see, for example, sections
1814, 1815, 1819, 1833, 1834, 1842, 1861, 1866, and 1891 of the Act);
and 42 CFR chapter IV, subchapter E, which concerns standards and
certification requirements).
Providers and suppliers furnishing services must comply with the
Medicare requirements stipulated in the Act and in our regulations.
These requirements are meant to ensure compliance with applicable
statutes, as well as to promote the furnishing of high quality care. As
Medicare program expenditures have grown, we have increased our efforts
to ensure that only qualified individuals and organizations are allowed
to enroll or maintain their Medicare billing privileges.
Medicaid is a joint Federal and State health care program for
eligible low-income individuals. States have considerable flexibility
in how they administer their Medicaid programs within a broad Federal
framework and programs vary from State to State.
The Patient Protection and Affordable Care Act (the Affordable Care
Act) (Pub. L. 111-148) makes a number of changes to the Medicaid
program, strengthening tools for quality and integrity, adding new
benefits, and expanding coverage. To maintain program integrity and
assure quality, it is consistent with these changes to assure that only
qualified providers participate in the program and that these providers
bill accurately for their services. Although our regulations provide
States with considerable flexibility, the Federal framework includes
some key requirements to ensure program integrity and 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, our regulations
require timely filing of claims by providers.
Including the NPI on claims and enrollment applications is an
important step in controlling fraud and abuse, ensuring a unique
identifier so that States can assure that only qualified Medicaid
providers have provider agreements and maintain their Medicaid billing
privileges. This practice implements the requirement in section
1128J(e) of the Act, as added by section 6402(a) of the Affordable Care
Act and will also help in implementing other important protections
under the Affordable Care Act that ensure quality health care services
for program beneficiaries.
A. Statutory Authority
The following is an overview of the sections that grant this
authority.
Sections 1102 and 1871 of the Act provide general
authority for the Secretary of Health and Human Services (the
Secretary) to prescribe regulations for the efficient administration of
the Medicare program.
Section 1128J(e) of the Act, added by section 6402(a) of
the Affordable Care Act, requires that the Secretary require by
regulation that all providers of medical or other items or services and
suppliers under titles XVIII and XIX that are eligible for a national
provider identifier (NPI) include the NPI on all applications to enroll
in such programs and on all claims for payment under such programs.
Sections 1814(a), 1815(a), and 1833(e) of the Act require
the submission of information necessary to determine the amounts due a
provider or other person.
Section 1834(j)(1)(A) of the Act states that no payment
may be made for items furnished by a supplier of medical equipment and
supplies unless such supplier obtains (and renews at such intervals as
the Secretary may require) a supplier number. In order to obtain a
supplier number, a supplier must comply with certain supplier standards
as identified by the Secretary.
Section 1842(r) of the Act requires the Centers for
Medicare and Medicaid Services (CMS) to establish a system for
furnishing a unique identifier for each physician who furnishes
services for which payment may be made.
Section 1862(e)(1) of the Act states that no payment may
be made when an item or service was at the medical direction of an
individual or entity that is excluded in accordance with sections 1128,
1128A, 1156, or 1842(j)(2) of the Act.
Section 4313 of the Balanced Budget Act of 1997 (BBA)
(Pub. L. 105-33) amended sections 1124(a)(1) and 1124A of the Act to
require disclosure of both the Employer Identification Number (EIN) and
Social Security Number (SSN) of each provider or supplier, each person
with ownership or control interest in the provider or supplier, any
subcontractor in which the provider or supplier directly or indirectly
has a 5 percent or more ownership interest, and any managing employees
including Directors and Board Members of corporations and non-profit
organizations and charities. The ``Report to Congress on Steps Taken to
Assure Confidentiality of Social Security Account Numbers as Required
by the Balanced Budget Act'' was signed by the Secretary and sent to
the Congress on January 26, 1999. This report outlines the provisions
of a mandatory collection of SSNs and EINs effective on or after April
26, 1999.
Section 4312(a) of the Balanced Budget Act of 1997 amended
section 1834(a)(16) of the Act by requiring certain Medicare suppliers
of durable medical equipment, prosthetics, orthotics and supplies
(DMEPOS) to furnish CMS with a surety bond. Section 4312(b) requires
that a surety bond be in an amount of not less than $50,000.
Section 31001(i)(1) of the Debt Collection Improvement Act
of 1996 (DCIA) (Pub. L. 104-134) amended section 7701 of 31 U.S.C. by
adding paragraph (c) to require that any person or entity doing
business with the Federal Government must provide their Taxpayer
Identification Number (TIN).
Section 936(j)(1)(A) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173)
amended the Act to require the Secretary to establish a process for the
enrollment of providers of services and suppliers.
We are authorized to collect information on the Medicare enrollment
application (that is, the CMS-855, (Office of Management and Budget
(OMB) approval number 0938-0685)) to ensure that correct payments are
made to providers and suppliers under the Medicare program as
established by title XVIII of the Act.
Section 1902(a)(27) of the Act provides general authority
for the Secretary to require provider agreements under the Medicaid
State Plans with every person or institution providing services under
the State Plan. Under these agreements, the Secretary may require
information regarding any payments claimed by such person or
institution for providing services under the State plan.
B. Historical Enrollment Initiatives
Historically, Medicare has permitted the enrollment of providers
and suppliers whose qualifications for meeting all of our enrollment
standards were sometimes questionable. This has raised concern that
providers and
[[Page 24439]]
suppliers in our program may be underqualified or even fraudulent and
has led us to increase our efforts to establish more stringent controls
on provider and supplier entry into the Medicare program. The following
is a summary of the regulations that we have published over the past 10
years to ensure that only qualified providers and suppliers are
participating in the Medicare program.
In the October 11, 2000 Federal Register, we published the
Additional Supplier Standards final rule with comment period where we
established additional standards with which a DMEPOS supplier must
comply in order to receive and maintain Medicare billing privileges.
This final rule with comment period outlined the supplier requirements
to ensure that suppliers of DMEPOS are qualified to furnish DMEPOS and
to help safeguard the Medicare program and its beneficiaries from
fraudulent or abusive billing practices.
In the April 21, 2006, Federal Register, we published the
Requirements for Providers and Suppliers to Establish and Maintain
Medicare Enrollment final rule that implemented section 1866(j)(1)(A)
of the Act. In this final rule, we required that all providers and
suppliers (other than those who have elected to ``opt-out'' of the
Medicare program) complete an enrollment application and submit
specific information to CMS in order to obtain Medicare billing
privileges. This final rule also required that all providers and
suppliers must periodically update and certify the accuracy of their
enrollment information to receive and maintain billing privileges in
the Medicare program. These regulatory provisions include requirements
to protect beneficiaries and the Medicare Trust Fund by preventing
unqualified, fraudulent, or excluded providers and suppliers from
providing items or services to Medicare beneficiaries or from billing
the Medicare program or its beneficiaries.
In the December 1, 2006, Federal Register (71 FR 69624), we
published 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.'' In part,
this final rule with comment established performance standards for
independent diagnostic testing facilities.
In the April 10, 2007, Federal Register (72 FR 17992), we published
a final rule titled, ``Competitive Acquisition for Certain Durable
Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).''
This final rule implemented section 302 of the MMA requiring that
DMEPOS suppliers meet certain quality standards and established DME
competitive bidding.
In the November 27, 2007 Federal Register (72 FR 66222), we
published 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.'' In this final rule, we clarified
our interpretation of several of the existing independent diagnostic
testing facility (IDTF) performance standards found at Sec. 410.33(b)
and Sec. 410.33(g), proposed a new IDTF performance standard at Sec.
410.33(g)(15), and a new proposed IDTF provision at Sec. 410.33(i).
In the June 27, 2008, Federal Register (73 FR 36448), we published
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.'' This final rule implemented section 936 of the
MMA and extended appeal rights to all providers and suppliers,
including DMEPOS suppliers, whose enrollment applications for Medicare
billing privileges are denied or revoked by CMS or a Medicare
contractor (that is, carrier, fiscal intermediary, National Supplier
Clearinghouse Medicare Administrative Contractor (MAC), or Part A/Part
B MAC). This final rule also allowed providers and suppliers to seek
judicial review after they have exhausted the administrative appeals
process. In addition, this final rule also implemented provider
enrollment provisions that apply to all provider and supplier types.
In the November 19, 2008, Federal Register (73 FR 69726), we
published 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).'' In part, this final rule with
comment period established a number of provider enrollment provisions
affecting physicians, non-physician practitioners, and other providers
and suppliers, such as the re-enrollment bar of 1 to 3 years on revoked
providers and suppliers, as well as the limitation on retroactive
billing by providers and suppliers.
In the January 2, 2009, Federal Register (74 FR 166), we published
a final rule titled, ``Medicare Program; Surety Bond Requirement for
Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS); Final Rule.'' Consistent with section 4312(a) of the
BBA, this final rule implemented section 1834(a)(16) of the Act by
requiring certain Medicare suppliers of DMEPOS to furnish CMS with a
surety bond of no less than $50,000.
Historically, the States in operating the Medicaid program have
permitted the enrollment of providers and suppliers who meet the State
requirements for Medicaid enrollment. Due to the increased risk of
fraud and abuse in public health care programs of all types, the NPI
requirement will strengthen cross-program integrity efforts.
II. Provisions of the Interim Final Rule With Comment Period
A. Inclusion of the National Provider Identifier (NPI) on all Medicare
and Medicaid Enrollment Applications and Claims
1. Background
Section 1128J(e) of the Act builds on the past Congressional
mandate to require the adoption of a unique identifier for health care
providers and codifies the NPI requirements that Medicare is already
requiring for its fee-for-service (FFS) providers and suppliers.
``Health care provider'' is defined in the Health Insurance
Portability and Accountability Act (HIPAA) definitions found at 45 CFR
160.103. With the exception of organ procurement organizations and Part
B CAP drug vendors, the term ``health care provider'' includes all of
the providers and suppliers who are eligible to enroll in the Medicare
program and most who are eligible to enroll in the Medicaid program. In
this discussion, we use the term ``health care provider'' when
referring to HIPAA and HIPAA regulations, and we use ``providers and
suppliers'' when referring to those health care providers who are
eligible to enroll in the Medicare program.
In the January 23, 2004, NPI final rule (69 FR 3434), we adopted
the NPI as the standard unique health identifier for health care
providers. This fulfilled the
[[Page 24440]]
requirement of section 1173(b) of the Act, which was added by HIPAA.
The final rule stated that HIPAA does not prohibit health plans from
requiring their enrolled health care providers to obtain NPIs.
Accordingly, the Medicare program required enrolling fee-for-service
(FFS) providers and suppliers (and their subparts, in accordance with
the NPI Final Rule) to report their NPIs on their Medicare enrollment
applications beginning in May 2006. When FFS providers and suppliers
who had enrolled prior to May 2006 submitted enrollment applications to
update their enrollment information, they were required to report their
NPIs on those enrollment applications. These requirements ensured that
the Medicare provider and supplier enrollment records included the NPIs
and, in effect, already implemented one of the provisions of section
1128J(e) of the Act.
In accordance with the NPI final rule and the subsequent guidance
from the Secretary, beginning May 23, 2008, Medicare required its
enrolled FFS providers and suppliers to use NPIs in their electronic
claims to identify not only themselves as the billing providers, but
any other providers or suppliers who, according to the Implementation
Guides for the adopted standard claims transactions, were also required
to be identified in those claims. These other health care providers
include rendering providers, supervising providers, and ordering and
referring providers. The regulations that adopted the HIPAA standard
transactions are found at (65 FR 50312, 68 FR 8381, and 74 FR 3296). In
addition, at that same time, Medicare required its enrolled FFS
providers and suppliers to make this same use of NPIs in their paper
claims.
The Provider Enrollment, Chain, and Ownership System (PECOS),
implemented in 2003, is the national repository of enrolled Medicare
FFS providers and suppliers (except DMEPOS suppliers, who will be added
to PECOS later in 2010). PECOS contains the information furnished by
providers and suppliers in their Medicare FFS enrollment applications
and additional information added as required to keep the information
current and to protect the integrity of the Medicare program (for
example, fact and date of death, Office of Inspector General
exclusions). In 2007, PECOS began sending the NPIs in the daily
provider and supplier enrollment data extract going to the Part A and
Part B FFS claims systems. In 2009, Medicare added the NPIs to the
enrollment records of the DMEPOS suppliers, which are currently housed
in the DMEPOS supplier enrollment repository at the National Supplier
Clearinghouse MAC. After the DMEPOS supplier enrollment records are
added to PECOS, PECOS will send a daily DMEPOS supplier enrollment data
extract, which will include the NPIs, to the DMEPOS FFS claims system.
Medicare FFS claims systems link the NPIs that are reported in claims
with the appropriate enrollment records in order to properly price and
pay the claims.
In summary, Medicare has been requiring its providers and suppliers
to report their NPIs on their Medicare enrollment applications; its
enrolled providers and suppliers to report their NPIs, and the NPIs of
other providers and suppliers (as required and as explained previously)
in their electronic and paper Medicare claims; and suppliers who order
or refer covered items or services for Medicare beneficiaries to have
NPIs so that they can be identified, as required, in the claims for the
covered items and services that they have ordered and referred.
Similarly, consistent with 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. This IFC
now requires their NPIs be submitted for Medicaid provider agreements.
2. Provisions of the Affordable Care Act
Section 6402(a) of the Affordable Care Act added a new section
1128J of the Act, entitled ``Medicare and Medicaid Program Integrity
Provisions.'' Section 1128J(e), as added by section 6402(a) of the
Affordable Care 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 a 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 process for provider enrollment except that 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 IFC are thus
applicable to the reporting of NPIs--(1) Pursuant to Medicaid provider
agreements; (2) on Medicare provider and supplier enrollment
applications; and (3) on Medicare and Medicaid claims.
3. Requirements Established by This IFC
For the Medicare program, we are establishing, 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. We are also establishing, at
Sec. 424.506(b)(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. We are also establishing, at
Sec. 424.506(b)(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.hhs.gov/NPPES/NPIRegistryHome.do.
Furthermore, we are establishing, at Sec. 424.506(c)(3), that a
Medicare claim from a provider or a supplier will be rejected if it
does not contain the required NPI(s).
For the Medicaid program, we are establishing, at Sec.
431.107(b)(5), a requirement that the agreement between a State agency
and each provider furnishing services under the State plan include a
requirement that any Medicaid provider eligible for an NPI furnish its
NPI to the State agency under that agreement and on all Medicaid
claims.
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
[[Page 24441]]
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. Referring physicians are
those who order covered items or services for Medicare beneficiaries
from Medicare providers and suppliers as well as those who refer
Medicare beneficiaries to Medicare providers and suppliers for covered
services. We consider those who ``refer'' to also be authorized to
``order.'' In this IFC, we refer to physicians who both order and refer
as ``ordering and referring suppliers'' and the act of ordering items
or services for Medicare beneficiaries or referring Medicare
beneficiaries to other providers or suppliers for services as
``ordering and referring.''
The Implementation Guides for the adopted HIPAA standard
transactions do not use the word ``supplier'' in their descriptions of
the health care providers who must be identified in those transactions.
For example, and as stated earlier in this preamble, the Implementation
Guides use the terms ``billing provider, ordering provider, referring
provider'' and others. Because this section of this IFC relates only to
the Medicare program, and because the statute and regulations use the
term ``supplier'' (not ``provider'') when referring to physicians and
non-physician practitioners, we are using the term ``ordering and
referring suppliers'' in this IFC. This term corresponds to ``ordering
provider'' and ``referring provider'' described in the Implementation
Guides.
The Medicare providers and suppliers who furnish the covered
ordered or referred items and services send claims to Medicare for
reimbursement for those covered items and services.
With the establishment and implementation of surrogate Unique
Physician Identification Numbers (UPINs) in 1992, suppliers could be
identified, but not uniquely identified, in claims as ordering and
referring suppliers. These suppliers included physicians, physician
assistants, clinical nurse specialists, nurse practitioners, clinical
psychologists, certified nurse midwives, and clinical social workers.
Sections 6405(a) and (c) of the Affordable Care Act indicate that
orders and referrals for DMEPOS and for other categories of items and
services may be made by a physician or an ``eligible professional under
section 1848(k)(3)(B).'' Section 1848(k)(3)(B) of the Act discusses
covered professional services for which payment may be made under, or
is based on, the fee schedule, and which are furnished by: (1) A
physician; (2) a practitioner described in section 1842(b)(18)(C) of
Act; (3) a physical or occupational therapist or a qualified speech-
language pathologist; and (4) a qualified audiologist. Section
1842(b)(18)(C) of the Act discusses billing and payment for Medicare
services furnished by physician assistants, nurse practitioners,
clinical nurse specialists, certified registered nurse anesthetists,
certified nurse-midwives, clinical social workers, clinical
psychologists, and registered dietitians or nutrition professionals.
Neither section 1848(k)(3)(B) of the Act nor section 1842(b)(18)(C) of
the Act discuss the issue of ordering or referring covered items or
services for Medicare beneficiaries. Although section 6405(a) of the
Affordable Care Act indicates that DMEPOS may be ordered by enrolled
physicians or enrolled eligible professionals under section
1848(k)(3)(B) of the Act, our policy has not been to permit all of the
eligible professionals listed in that section or in section
1842(b)(18)(C) of the Act to order and refer. Section 6405(c) of the
Affordable Care Act gives the Secretary the discretion to determine the
professions that can order and refer for all covered items and services
under title XVIII that are not mentioned in sections 6405(a) and (b) of
the Affordable Care Act (DMEPOS and home health, respectively). In
addition, the claims processing edits that we established in 2009
require that the ordering and referring suppliers for DMEPOS and for
laboratory, imaging, and specialist services be those physicians and
professionals who were eligible for UPINs: Physicians, physician
assistants, clinical nurse specialists, nurse practitioners, clinical
psychologists, certified nurse midwives, and clinical social workers.
In this IFC, the term eligible professional means any of the
professionals listed in section 1848(k)(3)(B) of the Act. In this
preamble, we distinguish physicians from eligible professionals (even
though physicians are included in section 1848(k)(3)(B) as eligible
professionals) because sections 6405(a) and (b) of the Affordable Care
Act reference physicians separately from eligible professionals.
Section 6405(c) of the Affordable Care Act gives the Secretary the
discretion to determine the health professions that can order and refer
items and services other than DMEPOS and home health.
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 UPINs. 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.
Surrogate UPINs were established to be used in claims to
temporarily identify certain ordering and referring suppliers who had
not yet completed the Medicare enrollment process and, therefore, had
not yet been assigned UPINs. Surrogate UPINs were used to collectively
identify the following: (1) Physicians who were serving in the military
or with the Department of Veterans Affairs or the Public Health Service
(including the Indian Health Service); (2) interns, residents, and
fellows; and (3) retired physicians. There was also a surrogate UPIN
(OTH000) that could be used for any other supplier who ordered or
referred who could not be identified by any of the other surrogate
UPINs.
Over time, providers and suppliers began using surrogate UPINs in
their claims to identify ordering and referring suppliers who had been
assigned their own UPINs, as well as individuals who had never been
assigned UPINs. In addition, they also used UPINs that had been
assigned to physicians other than the physicians who they were
identifying in their claims as the ordering or referring suppliers. We
believe that many providers and suppliers became aware that the use of
any UPIN would get their claims processed and paid. They learned, over
time, that Medicare claims edits on the ordering and referring
suppliers were based on the format of the UPIN, and all UPINs had the
same format. The claims process did not verify the UPINs of ordering or
referring suppliers. These practices negated the intent of the UPIN,
which was to uniquely identify the ordering or referring supplier.
Analysis of Medicare claims data prior to 2008 (UPINs were not
permitted to be used in Medicare claims after May 23, 2008) revealed
that these practices were 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
[[Page 24442]]
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. Medicare required providers and suppliers who
were sending claims to Medicare for covered ordered and referred items
and services to use the NPI, rather than the UPIN, to identify the
ordering and referring suppliers in their claims. Because the NPI Final
Rule did not discuss the concept of ``surrogate NPIs'' nor did it
contain a provision for the establishment of ``surrogate NPIs,''
surrogate NPIs do not and cannot exist. Because physicians and non-
physician practitioners are eligible for NPIs, only the NPI may be used
in Medicare claims to identify ordering and referring suppliers.
We believe that the new requirements discussed below will address
concerns expressed by the Department of Health and Human Services'
(DHHS) Office of Inspector General (OIG) report titled, ``Durable
Medical Equipment Ordered with Surrogate Physician Identification
Numbers, OEI-03-01-00270, September 2002,'' which found that the use of
surrogate UPINs on Medicare claims poses a vulnerability to the
Medicare program. The HHS OIG found a substantial number of
documentation problems in the supporting evidence submitted by
suppliers for claims processed with surrogate UPINs. The DHHS OIG
estimated that, in 1999, Medicare paid $61 million for services ordered
with a surrogate UPIN that had missing or incomplete supporting
documentation. Finally, the DHHS OIG stated that the findings in its
report also revealed misuse of surrogate UPINs on Medicare claims. The
HHS OIG found that surrogate UPINs were incorrectly used for many
services since the ordering physician had already been issued a
permanent UPIN. The HHS OIG believed this to be a significant problem
given that the use of a surrogate UPIN on medical equipment claims
allows them to be processed automatically whether the equipment has
been ordered by a physician or not. The HHS OIG stated that the
inappropriate use of surrogate UPINs by suppliers goes unchecked, the
Medicare program becomes vulnerable to fraudulent billings and
inappropriate payments.
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. Claims edits are under development to
ensure that claims for Part A and Part B home health services identify
the physicians who ordered the home health services by their legal
names and their NPIs and that those physicians have enrollment records
in PECOS.
2. Provisions of the Affordable Care Act
Section 6405(a) 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) 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 10604 of the Affordable Care Act, amended section 6405(b)
of the Affordable Care Act as follows: (1) Section 1814(a)(2) of the
Act to specify, 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 to specify, 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) 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) 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. Requirements of This IFC
To ensure that ordering suppliers (physicians and eligible
professionals) are uniquely identified in Medicare claims for covered
items of DMEPOS as required by section 6405(a) of the Affordable Care
Act, and to ensure that those DMEPOS items are ordered by qualified
physicians or eligible professionals, we are requiring at a new Sec.
424.507(a), the following:
In Part B claims for covered items of DMEPOS that require
the identification of the ordering supplier, and with the exception
noted below, the ordering supplier be a physician or an eligible
professional with an approved enrollment record in PECOS (see the
exception below), and be identified in the claim by his or her legal
name and by his or her own NPI (that is, by the NPI that was assigned
to him or her by the National Plan and Provider Enumeration System
[NPPES] as an Entity type 1 [an individual]).
To ensure that ordering suppliers are uniquely identified in
Medicare Part A claims for covered Part A or Part B home health
services as required by section 6405(b), as amended by section 10604 of
the Affordable Care Act, and to ensure that those home health services
are ordered by qualified physicians, we are requiring at a new Sec.
424.507, the following:
In Part A claims for covered Part A and Part B home health
items or services that require the identification of the ordering
supplier, and with the exception noted below, the ordering supplier be
a physician with an approved enrollment record in PECOS
[[Page 24443]]
(see the exception below), and be identified in the claim by his or her
legal name and by his or her own NPI (that is, by the NPI that was
assigned to him or her by the National Plan and Provider Enumeration
System [NPPES] as an Entity type 1 [an individual]).
To ensure that ordering or referring suppliers are uniquely
identified in Part B claims for covered services of laboratories,
imaging suppliers, and specialists, under the discretion afforded the
Secretary in section 6405(c), and to ensure that those items or
services are ordered or referred by qualified physicians or eligible
professionals, we are requiring at a new Sec. 424.507(b), the
following:
In Part B claims for covered services of laboratories,
imaging suppliers, and specialists that require the identification of
the ordering or referring supplier, and with the exception noted below,
the ordering or referring supplier be a physician or an eligible
professional with an approved enrollment record in PECOS (see the
exception below), and be identified in the claim by his or her legal
name and by his or her own NPI (that is, by the NPI that was assigned
to him or her by the National Plan and Provider Enumeration System
(NPPES) as an Entity Type 1 (an individual).
We are requiring at a new Sec. 424.507(c) that Medicare
contractors will reject claims from providers and suppliers for the
above-described covered ordered or referred items or services if the
legal names and the NPIs are not reported in the claims or, with the
exception noted below, if the ordering or referring supplier does not
have an approved enrollment record in PECOS.
We are requiring at a new Sec. 424.507(d) that Medicare
contractors may deny a claim submitted by a Medicare beneficiary for
the above-described ordered or referred covered items and services if
the ordering or referring supplier is not identified by his or her
legal name or, with the exception noted below, if the ordering or
referring supplier does not have an approved enrollment record in
PECOS.
Our continuing outreach efforts stress the need for those who order
and refer to have approved enrollment records in PECOS.
While we are not including additional categories of ordered or
referred covered items or services in this IFC (such as Part B drugs),
we reserve the right to apply these requirements to additional
categories through future rulemaking once the policies have been
developed. We are considering proposing the requirements for covered
prescribed Part B drugs within the next year.
A physician or eligible professional who orders or refers must be
enrolled in the Medicare program by having an enrollment record in an
approved status in PECOS, even if he or she is enrolled only for the
purposes of ordering and referring. To ensure that orders and referrals
for Medicare beneficiaries are written by qualified physicians and
eligible professionals, it is necessary that their credentials be
verified; such verification can occur only as part of the Medicare
provider/supplier enrollment process. PECOS, as described earlier in
this preamble, is the national Medicare FFS provider and supplier
enrollment repository. All providers and suppliers who enrolled in
Medicare within the past 6 years, as well as those who enrolled more
than 6 years ago and who have submitted updates to their enrollment
information within the past 6 years, have enrollment records in PECOS
that contain verified credentials. Those who enrolled more than 6 years
ago and who have not updated their enrollment information in the past 6
(or more) years will need to submit enrollment applications to Medicare
to establish enrollment records in PECOS. They may do this by filling
out the paper Medicare provider enrollment applications (using the
appropriate form(s) from the CMS-855 series of forms) and mailing the
completed application(s) to the appropriate Medicare enrollment
contractor or by using Internet-based PECOS to submit their enrollment
application to the Medicare enrollment contractor over the Internet.
With the implementation in 2009 of the claims processing edits to
ensure the NPI and the name reported in claims to identify the ordering
or referring suppliers matched information in PECOS for physicians and
professionals of a profession eligible to order and refer, many
enrolled physicians and eligible professionals who do not have
enrollment records in PECOS are submitting enrollment applications in
order to establish those enrollment records. We expect that most, if
not all, of them will have submitted enrollment applications before the
end of 2010, including those who are enrolling solely to continue to
order and refer. A physician or eligible professional who is deceased,
retired, or excluded from the Medicare program, or who otherwise would
not have an approved enrollment record in PECOS, would not be eligible
to order or refer items or services for Medicare beneficiaries. Please
note the following exception for physicians and eligible professionals
who do not have an approved enrollment record in PECOS:
Under section 1802(b) of the Act and the implementing regulations
at 42 CFR 405.400 et seq., physicians and non-physician practitioners
can opt out of the Medicare program and enter into private contracts
with Medicare beneficiaries. By entering into these types of contracts,
these suppliers do not bill the Medicare program for services that they
furnish to Medicare beneficiaries. We require that physicians and
eligible professionals who have properly filed an appropriate affidavit
with a Medicare contractor in order to opt out of the Medicare program
be required to be identified in claims by their names and their NPIs if
they order or refer covered items or services for Medicare
beneficiaries. We are creating an exception to the requirement that
ordering and referring suppliers be required to have an approved
enrollment record in PECOS for those physicians and non-physician
practitioners who have validly opted out of the Medicare program.
Therefore, physicians and non-physician practitioners who have validly
opted out of Medicare are eligible to order and refer covered items and
services for Medicare beneficiaries. If they have properly completed
the appropriate affidavit in order to opt out of Medicare, they will
have records in PECOS that contain their NPIs and that indicate that
they have validly opted out of the Medicare program. In January 2009,
there were approximately 10,000 physicians and eligible professionals
who had opted out of the Medicare program. Compared to the more than
800,000 enrolled physicians and eligible professionals, there are
relatively few physicians and eligible professionals who have opted out
of Medicare.
Accordingly, the physicians or eligible professional that opted out
must meet the following:
A currently enrolled physician or eligible professional
who does not have an enrollment record in PECOS is required to
establish an enrollment record in PECOS so that he or she can order and
refer covered items or services for Medicare beneficiaries. A physician
or eligible professional who has validly opted out of the Medicare
program will have a valid opt-out record in PECOS and is not required
to submit an enrollment application.
A physician or eligible professional who is employed by
the Public Health Service, the Department of Defense, or the Department
of Veterans Affairs is required to have an approved enrollment record
in PECOS in order to order and refer covered items and services for
Medicare beneficiaries, even though he or she would not be
[[Page 24444]]
submitting claims to Medicare for services furnished to Medicare
beneficiaries. We require, therefore, that these physicians and
eligible professionals enroll in Medicare solely to order and refer
(and not to be paid for services furnished to Medicare beneficiaries).
A dentist furnishes many services that are not covered by
Medicare and, as a result, most dentists are not enrolled in Medicare.
However, a dentist may order services for patients who are Medicare
beneficiaries, such as sending oral specimens to laboratories for
testing. Doctors of dental medicine or dental surgery are considered
physicians and we require that they have approved enrollment records in
PECOS if they order or refer covered items or services for patients who
are Medicare beneficiaries.
A pediatrician may treat Medicare beneficiaries (for
example, those of any age who are enrolled in the Medicare end-stage
renal disease (ESRD) program or those who are entitled to Medicare
benefits under other Federal programs), although the volume of such
patients is generally so low that most pediatricians are not enrolled
in Medicare. We require that a pediatrician have an approved enrollment
record in PECOS if he or she orders or refers covered items or services
for patients who are Medicare beneficiaries.
Residents and interns order and refer covered items and
services for Medicare beneficiaries. Prior to the implementation of the
NPI, residents and interns were identified in claims as the ordering or
referring providers by surrogate UPINs. Interns are not issued medical
licenses by States; therefore, they are not eligible to enroll in
Medicare. Residents have medical licenses if they practice in States
that issue medical licenses to residents; as a result, some residents
are eligible to enroll in Medicare. Due to the variances in licensure
and the necessity for interns and residents to be able to continue to
order and refer covered items and services for Medicare beneficiaries,
we require that the teaching physician--not the resident or intern--be
identified in the claim as the ordering or referring provider whenever
a resident or intern orders or refers.
These ordering and referring requirements, when implemented, will
allow us to uniquely identify the ordering and referring supplier in
claims (except when the teaching physician is identified as the
ordering or referring supplier in situations where an intern or a
resident ordered or referred) and assure, because of the requirement to
have an approved enrollment or valid opt out record in PECOS, that the
ordering and referring supplier is qualified to order and refer items
and services for Medicare beneficiaries. This will enable us to edit
claims for ordering and referring suppliers who do not have approved
enrollment records in PECOS (that is, those who are excluded, deceased,
or retired, and those whose Medicare billing privileges have been
terminated through exclusion, revocation, or otherwise), and those who
have voluntarily terminated their relationship with Medicare or who
have validly opted out of Medicare.
Further, we are requiring that Part A claims for covered ordered
Part A and Part B home health services must include the legal name and
the NPI of the ordering supplier, who must be a physician. We are
requiring that Part B claims for covered, ordered, and referred Part B
items and services (excluding Part B drugs) must include the legal name
and the NPI of the ordering or referring supplier. We place these same
requirements (except for the NPI) on claims submitted by Medicare
beneficiaries for these same ordered or referred items and services.
Although suppliers are required to submit claims on behalf of
beneficiaries under the mandatory claim submission policy at section
1848(g)(4)(A) of the Act, we recognize that beneficiaries may submit
claims to Medicare for payment. In order to fully enforce the ordering
and referring requirement established by section 6405 of the Affordable
Care Act, we plan to deny a beneficiary claim for a service when the
legal name of the ordering or referring supplier is not included on the
claim.
We believe that these requirements will promote quality health care
services for Medicare beneficiaries because orders and referrals would
be written by qualified physicians and eligible professionals, as their
credentials would have been verified as part of the Medicare provider/
supplier enrollment process.
Additionally, we believe these requirements will eliminate the
abusive practice of reporting identifiers in claims as being assigned
to specific ordering or referring suppliers when, in fact, those
identifiers had not been assigned to those specific ordering or
referring suppliers. As a result, our requirements should eliminate
these types of problematic claims and ensure the qualifications of the
ordering and referring suppliers.
Our requirements will enable us to know the identity of the
individual who ordered or referred and, if appropriate, we could
establish edits to check for over-ordering specific items or services,
over-referring specific services, and/or over-ordering or over-
referring to specific providers of services and suppliers.
Furthermore, these requirements support our existing authority, at
Sec. 424.516(f), under which the ordering and referring suppliers, and
those providers of services and suppliers who furnish covered items or
services based on orders or referrals, are required to maintain
documentation (to include the NPI) that supports the orders and
referrals for 7 years in order to maintain an active enrollment status
in the Medicare program.
Lastly, these requirements may lead to a reduction in inappropriate
Medicare payments.
We are aware that, in some cases, Medicare beneficiaries may be
patients of physicians or eligible professionals who do not have
approved enrollment records in PECOS, or may be patients of
professionals who are not of a profession that is eligible to order or
refer, and that these physicians and professionals may be ordering and
referring covered items and services for these Medicare beneficiaries
at this time. We expect to conduct outreach activities to educate
Medicare beneficiaries, as well as Medicare providers of services and
suppliers who furnish covered items and services based on orders and
referrals, so that we can eliminate situations where those providers of
services and suppliers who would be furnishing covered ordered and
referred items and services would not be paid for those covered items
or services because their claims failed the edits.
Finally, we believe that the requirements will address the
recommendations offered by the DHHS OIG report titled, ``Medicare
Payments in 2007 for Medical Equipment and Supply Claims with Invalid
or Inactive Referring Physician Identifiers, OEI-04-08-00470, February
2009.'' Specifically, the OIG recommended that CMS:
(1) Determine why Medicare claims with identifiers associated with
deceased referring physicians continue to be paid;
(2) Implement claims-processing system changes to ensure that NPIs
for both referring physicians and suppliers be listed on medical
equipment and supply claims are valid and active.
(3) Emphasize to suppliers the importance of using accurate NPIs
for both referring physicians and suppliers when submitting Medicare
claims; and
(4) Determine the earliest date to end the provision that allows
suppliers to submit claims without referring
[[Page 24445]]
physician NPIs while maintaining beneficiary access to services.
With respect to recommendation (4), we began requiring Medicare
claims to identify ordering and referring providers by NPIs beginning
May 23, 2008. If the provider of services or the supplier submitting
the claim for the covered ordered or referred items or services could
not determine the NPI of the ordering or referring supplier, we
permitted the provider of services or the supplier submitting the claim
to use its own NPI in place of the NPI of the ordering or referring
provider. These types of claims for DMEPOS items now fail the claims
processing edits that were implemented in 2009. Medicare-enrolled
physicians and professionals are required to have NPIs. The NPI
Registry (available at https://nppes.cms.hhs.gov/NPPES/NPIRegistryHome.do) enables anyone with a computer with Internet access
to look up a health care provider's NPI by name or NPI, and the NPPES
downloadable file (downloadable from http://nppesdata.cms.hhs.gov/CMS_NPI_files.html) contains the NPIs of all health care providers who
have active NPIs, as well as identifying information about the health
care providers that is publicly disclosable under the Freedom of
Information Act. (The National Plan and Provider Enumeration System
Data Dissemination Notice, published in the May 30, 2007 Federal
Register, further describes the NPI Registry and the NPPES downloadable
file.) The existing claims processing edits described earlier in this
preamble check to ensure that the NPI reported on a Part B claim for
ordered or referred covered items or services (excluding Part B home
health services and Part B drug claims) belongs to the ordering or
referring supplier whose name is also reported in those claims, and not
to the supplier who submitted the claim. As stated previously, the
provisions of section 6405 of the Affordable Care Act are effective
July 1, 2010.
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
On November 19, 2008, we published a final rule with comment
titled, ``Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2009; Revisions to the
Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; and the Competitive Acquisition for Certain
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS)'' in the Federal Register. In this IFC, we established Sec.
424.516(f) to require providers and suppliers to maintain ordering and
referring documentation, including the NPI, received from a physician
or eligible non-physician practitioner. We also established in Sec.
424.516(f) that physicians and eligible professionals are required to
maintain written ordering and referring documentation for 7 years from
the date of service. Finally, we 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 amends section 1866(a)(1)
of the Act and added a new subparagraph (W) which requires providers to
agree 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 the
provider under this title, as specified by the Secretary.''
In addition, 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 of This IFC
In our requirements, in our revision of Sec. 424.516(f), we are
replacing the term ``eligible non-physician practitioner'' with
``eligible professional.'' This change is consistent with our
definition of ``eligible professional'' and correctly identifies the
professionals who, in addition to physicians, are eligible to order and
refer.
At this time, we are expanding Sec. 424.516(f) to include
requirements for documentation and access to documentation related to
orders and referrals for covered home health, laboratory, imaging, and
specialist services. Section 424.516(f) currently includes requirements
for documentation and access to documentation for orders for DMEPOS. We
reserve the right to, at a future date, publish proposed requirements
for documentation and access to documentation for additional items and
services that may be ordered or referred under title XVIII and that are
programs of high risk of waste and abuse.
We are revising the existing Sec. 424.516(f) to now read
``Maintaining and providing access to documentation.'' A provider or a
supplier who furnishes covered ordered DMEPOS or referred home health,
laboratory, imaging, or specialist services is required to maintain
documentation for 7 years from the date of service and, upon the
request of CMS or a Medicare contractor, to provide access to that
documentation. The documentation includes written and electronic
documents (including the NPI of the physician who ordered the home
health services and the NPI of the physician or the eligible
professional who ordered or referred the DMEPOS, laboratory, imaging,
or specialist services) relating to written orders and requests for
payments for items of DMEPOS and home health, laboratory, imaging, and
specialist services. A physician who ordered home health services and a
physician and an eligible professional who ordered or referred items of
DMEPOS or laboratory, imaging, and specialist services is required to
maintain documentation for 7 years from the date of the order,
certification, or referral and, upon request of CMS or a Medicare
contractor, to provide access to that documentation. The documentation
includes written and electronic documents (including the NPI of the
physician who ordered the home health services and the NPI of the
physician or the eligible professional who ordered or referred the
DMEPOS, laboratory, imaging, or specialist services) relating
[[Page 24446]]
to written orders or requests for payments for items of DMEPOS and home
health, laboratory, imaging, and specialist services. Note that we are
clarifying that the documentation includes both written and electronic
documentation.
We are revising Sec. 424.535(a)(10) to read, ``The Centers for
Medicare & Medicaid Services'' (CMS) may revoke enrollment, for a
period of not more than one year for each act, for a provider or a
supplier under section 1866(j) of the Act if such provider or supplier
fails to meet the requirements of Sec. 424.516(f). Providers and
suppliers will continue to have appeal rights afforded to them in
accordance with part 498.
III. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued. The NPI
requirements set forth in this IFC are necessary to implement the data
reporting requirements in section 1128J(e) of the Act, as amended 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 requirements specified in section 6405 of the
Affordable Care Act that are effective July 1, 2010. Section 6406 of
the Affordable Care Act was effective January 1, 2010. It is imperative
that the regulatory provisions be set forth as soon as possible to
deliver the guidance necessary to enact the provisions.
In addition, several of these provisions may be issued as an IFC
because they fall under the exception in Medicare to the section
1871(b)(1)(B) of the Act rulemaking requirements. Section 1871 of the
Act generally requires that we issue a notice of proposed rulemaking
prior to issuing a final rule under the Medicare program. However,
section 1871(b)(1)(b) 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 for the
implementation of a provision and the deadline is less than 150 days
after the date of the enactment of the statute in which the deadline is
contained.'' Section 6405 establishes an effective date of July 1,
2010, which is less than 150 days from the date of enactment of this
statute. Moreover, section 6406 establishes an effective date of
January 1, 2010, which has already passed.
We do not believe that the portions of this rule not exempted from
notice and comment rulemaking pursuant to section 1871(b)(1)(B) of the
Act add any new burdens for Medicare or Medicaid providers and
suppliers. Both Medicare and Medicaid programs generally require unique
provider identifiers, and thus delaying this rule is unnecessary.
Finally, a delay in implementing these provisions would be contrary to
the public interest and to CMS' efforts to reduce and eliminate fraud
and abuse in the Medicare and Medicaid programs. For these reasons, we
find good cause to waive the notice of proposed rulemaking and to issue
this final rule on an interim basis. We are providing a 60-day comment
period.
V. Collection of Information Requirements
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection included
in this interim final rule with comment period will be submitted for
emergency approval to the Office of Management and Budget (OMB). The
revised information collection requirements associated with 0938-0685,
0938-0931, and 0938-0999 (see sections V.A. and V.D. of this IFC) will
not be effective until approved by OMB.
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-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.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
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 solely to order and refer), a change of information, or to
respond to a revalidation request, a provider or supplier must complete
and submit the applicable CMS-855 enrollment application or complete
and submit the enrollment application 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 solely to order and refer. The
burden associated with the enrollment requirements found in Sec.
424.510,
[[Page 24447]]
Sec. 424.515, andSec. 424.516 is the time and effort necessary to
complete and submit applicable Medicare enrollment applications. 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 National Provider Identifiers
(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. While this requirement is subject to the PRA, the
associated burden is currently approved under OCN 0938-0999.
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 referring physician or eligible
professional. The burden associated with these requirements is the time
and effort necessary to submit a claim with the required information.
While these requirements are subject to the PRA, the associated burden
is currently approved under OCN 0938-0999.
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 referred
the item or service, relating to written orders or requests for
payments for items of DMEPOS and referrals for home health, laboratory,
imaging, and specialist.
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 referred the item or service,
relating to written orders or requests for payments for items of DMEPOS
and referrals for home health, laboratory, imaging, and specialist. 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 and home health, laboratory, imaging, and specialist services,
written, ordered, referred by such physician or non-physician
practitioner.
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 final rule that was
published November 19, 2008 (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. 431.507(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 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.
We are in the process of revising the information collection
requirements contained in OCNs 0938-0685, 0938-0931, and 0938-0999 in
accordance with the provisions of this rulemaking. These information
collection requirements will be sent to OMB for review and approval in
accordance with the emergency procedures of the PRA and will not go
into effect until approved by OMB.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
[CMS-6010-IFC]
Fax: (202) 395-6974; or E-mail: [email protected]
VI. Regulatory Impact Analysis
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), and Executive Order 13132 on Federalism, and the
Congressional Review Act (5 U.S.C. 804 et seq.). Executive Order 12866
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 1 year). Virtually all providers and suppliers
who wish to enroll in Medicare and Medicaid programs have already
obtained NPIs. Most enrolled Medicare and Medicaid providers and
suppliers who will be affected by the statutory and regulatory
requirements are already meeting those requirements. For example,
Medicare providers and suppliers have been reporting their NPIs on
their enrollment applications for 4 years and have been using NPIs in
their paper and electronic Medicare claims as well as electronic
Medicaid claims for 2 years. The majority of suppliers who submit
claims for ordered or referred DMEPOS and laboratory, imaging, and
specialist services are ensuring that their claims meet the
requirements of this IFC. In addition, the majority of Medicare
physicians and eligible professionals who order and refer but who do
not have approved enrollment records in PECOS are aware of the need to
establish those records and many have already submitted their
enrollment
[[Page 24448]]
applications to Medicare in order to do so. Medicare DMEPOS suppliers
and those physicians and eligible professionals who order DMEPOS are
already maintaining documentation in accordance with the requirements
of this IFC. Other Medicare providers and suppliers who will be
required to do so by this IFC are likely already in full or partial
compliance as part of their routine business operations. Therefore, we
do not believe this rule reaches the economic threshold and thus is not
considered a major rule.
The RFA requires agencies to analyze options for regulatory relief
for small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6.5 to
$31.5 million in any one year. Individuals and States are not included
in the definition of a small entity. We are not preparing an analysis
for the RFA because we have determined that this rule will not have a
significant economic impact on a substantial number of small entities.
We maintain that this final rule would not have an adverse impact on
small entities.
In addition, 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 because we have 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 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $135 million. This rule does not mandate expenditures by
either the governments mentioned or the private sector; therefore, no
analysis is required. Executive Order 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.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
B. Alternatives Considered
Since this final rule is a codification of statutory provisions
found in the Affordable Care Act, we did not consider alternatives to
this process.
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.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 424--CONDITIONS FOR MEDICARE PAYMENT
0
1. The authority citation for part 424 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. Section 424.506 is added to read as follows:
Sec. 424.506 National Provider Identifier (NPI) on all enrollment
applications and claims.
(a) Definition. Eligible professional means any of the
professionals specified in section 1848(k)(3)(B) of the Act.
(b) Enrollment requirements. (1) A provider or a supplier who is
eligible for an NPI must report its National Provider Identifier (NPI)
on its Medicare enrollment application.
(2) If a provider or a supplier who is eligible for an NPI enrolled
in the Medicare program prior to obtaining an NPI and the provider's or
the supplier's NPI is not in the provider's or the supplier's Medicare
enrollment record, the provider or the supplier must submit a Medicare
enrollment application that contains the NPI.
(3) A physician or an eligible professional who has validly opted
out of the Medicare program does not need to submit an enrollment
application.
(c) Claims reporting requirements. (1) A provider or a supplier who
is enrolled in Medicare and who submits a paper or an electronic claim
to Medicare include its National Provider Identifier (NPI) and the
NPI(s) of any other provider(s) or suppliers(s) who is required to be
identified.
(2) A Medicare beneficiary who submits a claim for service to
Medicare--
(i) Must include the legal name of any provider or supplier who is
required to be identified in that claim; and
(ii) May, if known to the beneficiary, include the National
Provider Identifier (NPI) of any provider or supplier who is required
to be identified in that claim.
(3) A Medicare contractor will reject a claim from a provider or a
supplier if the required NPI(s) is not reported.
0
3. Section 424.507 is added to read as follows:
Sec. 424.507 Ordering and referring covered items and services for
Medicare beneficiaries.
(a) Conditions for payment of claims for ordered or referred
covered Part B items and services (excluding home health services
described in Sec. 424.507(b) and Part B drugs). (1) Part B provider
and supplier claims. To receive payment for ordered or referred covered
Part B items and services (excluding home health services described in
Sec. 424.507(b), and Part B drugs), a provider's or supplier's must
meet all of the following requirements:
(i) The Part B items and services must have been ordered or
referred by a physician or, when permitted, an eligible professional
(as defined in Sec. 424.506(a) of this part).
(ii) The claim from the Part B 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 or referred.
(iii) The physician or the eligible professional who ordered or
referred must have an approved enrollment record or a valid opt-out
record in the Provider Enrollment, Chain and Ownership System (PECOS).
(iv) If the 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. The claim must identify the
teaching physician 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.
(2) Part B beneficiary claims. To receive payment for ordered or
referred covered Part B items and services (excluding home health
services described in Sec. 424.507(b), and Part B
[[Page 24449]]
drugs), a beneficiary's claim must meet all of the following
requirements:
(i) The Part B items and services must have been ordered or
referred by a physician or, when permitted, an eligible professional
(as defined in Sec. 424.506(a) of this part).
(ii) The claim must contain the legal name of the physician or the
eligible professional (as defined in Sec. 424.506(a) of this part) who
ordered or referred.
(iii) The physician or the eligible professional who ordered or
referred must have an approved enrollment record or a valid opt-out
record in the Provider Enrollment, Chain and Ownership System (PECOS).
(iv) If the 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. The claim must identify the
teaching physician by his or her legal name and he or she must have an
approved enrollment record or a valid opt-out record in PECOS.
(b) Conditions for payment of claims for ordered covered home
health services. (1) Home health provider claims. To receive payment
for ordered, covered Part A or Part B home health services, a
provider's home health services claim must meet all of the following
requirements:
(i) The Part A or Part B home health services must have been
ordered by a physician;
(ii) The claim from the provider of home health services must
contain the legal name and the National Provider Identifier (NPI) of
the ordering physician;
(iii) The ordering physician must have an approved enrollment
record or a valid opt-out record in the Provider Enrollment, Chain, and
Ownership System (PECOS); and
(iv) If the services were ordered by a resident or an intern, the
claim must identify the teaching physician as the ordering or referring
physician. The claim must identify the teaching physician 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.
(2) Home health beneficiary claims. To receive payment for ordered
covered Part A or Part B home health services, a beneficiary's home
health services claim must meet all of the following requirements:
(i) The Part A or Part B home health services must have been
ordered by a physician.
(ii) The claim from the provider of home health services must
contain the legal name of the ordering physician.
(iii) The ordering physician must have an approved enrollment
record or a valid opt-out record in the Provider Enrollment, Chain, and
Ownership System (PECOS).
(iv) If the services were ordered by a resident or an intern, the
claim must identify the teaching physician as the ordering or referring
physician. The claim must identify the teaching physician 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) A Medicare contractor will reject a claim from a provider or a
supplier for covered services described in paragraphs (a) and (b) of
this section if the claim does not meet the requirements of paragraph
(a)(1) and (b)(1) of this section, respectively.
(d) A Medicare contractor may deny 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
paragraphs (a)(2) and (b)(2) of this section, respectively.
0
4. Section 424.516 is amended by revising paragraph (f) to read as
follows:
Sec. 424.516 Additional provider and supplier requirements for
enrolling and maintaining active enrollment status in the Medicare
program.
* * * * *
(f) Maintaining and providing access to documentation. (1) A
provider or a supplier who furnishes covered ordered DMEPOS or referred
home health, laboratory, imaging, or specialist services is required to
maintain documentation for 7 years from the date of service and, upon
the request of CMS or a Medicare contractor, to provide access to that
documentation. The documentation includes written and electronic
documents (including the NPI of the physician who ordered the home
health services and the NPI of the physician or the eligible
professional who ordered or referred the DMEPOS, laboratory, imaging,
or specialist services) relating to written orders and requests for
payments for items of DMEPOS and home health, laboratory, imaging, and
specialist services.
(2) A physician who ordered home health services and a physician
and an eligible professional who ordered or referred items of DMEPOS or
laboratory, imaging, and specialist services is required to maintain
documentation for 7 years from the date of the order, certification, or
referral and, upon request of CMS or a Medicare contractor, to provide
access to that documentation. The documentation includes written and
electronic documents (including the NPI of the physician who ordered
the home health services and the NPI of the physician or the eligible
professional who ordered or referred the DMEPOS, laboratory, imaging,
or specialist services) relating to written orders or requests for
payments for items of DMEPOS and home health, laboratory, imaging, and
specialist services.
0
5. Section 424.535 is amended by revising (a)(10) to read as follows:
Sec. 424.535 Revocation of enrollment and billing privileges in the
Medicare program.
(a) * * *
(10) Failure to document or provide CMS access to documentation.
(i) The provider or supplier (as described in section 1866(j) of the
Act) did not comply with the documentation or CMS access requirements
specified in Sec. 424.516(f) of this subpart.
(ii) A provider or supplier that meets the revocation criteria
specified in paragraph (a)(10)(i) of this section, is subject to
revocation for a period of not more than 1 year for each act of
noncompliance.
* * * * *
PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION
0
6. The authority citation for part 431 continues to read as follows:
Authority: Sec. 1102 of the Social Security Act, (42 U.S.C.
1302).
0
7. Section 431.107 is amended by adding a new paragraph (b)(5) to read
as follows:
Sec. 431.107 Required provider agreement.
* * * * *
(b) * * *
(5)(i) Furnish to the State agency its National Provider Identifier
(NPI) (if eligible for an NPI); and
(ii) Include its NPI on all claims submitted under the Medicaid
program.
Dated: April 28, 2010.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: April 29, 2010.
Kathleen Sebelius,
Secretary.
Authority: Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program, and Program No.
93.778, Medical Assistance Program.
[FR Doc. 2010-10505 Filed 4-30-10; 4:15 pm]
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