[Federal Register Volume 69, Number 66 (Tuesday, April 6, 2004)]
[Rules and Regulations]
[Pages 17935-17941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7715]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 414
[CMS-1380-IFC]
RIN 0938-AN05
Medicare Program; Manufacturer Submission of Manufacturer's
Average Sales Price (ASP) Data for Medicare Part B Drugs and
Biologicals
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 will implement the
provisions of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) related to the calculation and
submission of manufacturer's average sales price (ASP) data on certain
Medicare Part B drugs and biologicals to CMS by manufacturers.
DATES: Effective date: These regulations are effective on April 30,
2004.
Comment date: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on June 7,
2004.
ADDRESSES: In commenting, please refer to file code CMS-1380-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Submit electronic comments to http://www.cms.hhs.gov/regulations/ecomments or to http://www.regulations.gov. Mail written comments (one
original and three copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1380-IFC, P.O. Box 8010, Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be timely
received in the event of delivery delays.
If you prefer, you may deliver (by hand or courier) your written
comments (one original and three copies) to one of the following
addresses: Room 445-G, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201, or Room C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH 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 commenters wishing to retain a proof of filing by
stamping in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and could be considered late.
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. After the close of the comment period, CMS posts all
electronic comments received before the close of the comment period on
its public website.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Marjorie Baldo, (410) 786-0548.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-1380-IFC and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: Comments received timely will be
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 through Friday of
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view
public comments, call telephone number: (410) 786-7197.
I. Background
[If you choose to comment on issues in this section, please include
the caption ``BACKGROUND'' at the beginning of your comments.]
Section 303(c) of the MMA amends Title XVIII of the Social Security
Act (the Act) by adding new section 1847A. This new section establishes
the use of the ASP methodology for payment for drugs and biologicals
described in section 1842(o)(1)(C) of the Act furnished on or after
January 1, 2005. For calendar quarters beginning on or after January 1,
2004, the statute requires manufacturers to report manufacturer's ASP
data to CMS for Medicare Part B drugs and biologicals paid under
sections 1842(o)(1)(D), 1847A, or 1881(b)(13)(A)(ii) of the Act.
Manufacturers are required to submit their initial quarterly ASP data
to us beginning April 30, 2004. Subsequent reports are due not later
than 30 days after the last day of each calendar quarter. The types of
Medicare Part B covered drugs and biologicals paid under sections
1842(o)(1)(D), 1847A, or 1881(b)(13)(A)(ii) of the Act include drugs
furnished incident to a physician's service, drugs furnished under the
durable medical equipment (DME) benefit, certain oral anti-cancer
drugs, and oral immunosuppressive drugs.
All Medicare Part B covered drugs and biologicals paid under
sections 1842(o)(1)(D), 1847A, or 1881(b)(13)(A)(ii) of the Act are
subject to the ASP reporting requirements. Certain drugs and
biologicals, for example, radiopharmaceuticals, are not paid under
these sections of the Act and will not be subject to the ASP reporting
requirements.
We are issuing this interim final rule with comment period in order
to allow us to implement the manufacturer ASP reporting requirement of
section 303(i)(4) of the MMA within the time frames established by the
MMA. Therefore, effective April 30, 2004, this interim final rule with
comment period will provide implementation guidelines for manufacturers
to submit their ASP data to us. We expect to publish a proposed rule on
the 2005 ASP based payment system later this year.
II. Provisions of the Interim Final Rule
[If you choose to comment on issues in this section, please include
the caption ``Provisions of the Interim Final Rule'' at the beginning
of your comments.]
In this interim final rule with comment period, we are adding a new
subpart J (Submission of Manufacturer's Average Sales Price Data) to
Part 414 that implements section 1927(b)(3)(A)(iii) of the Act by
specifying the requirements for submission of a manufacturer's ASP data
for certain drugs and biologicals covered under Part B of Title XVIII
of the Act that are paid under sections 1847A, 1842(o)(1)(D), or
1881(b)(13)(A)(ii) of the Act.
[[Page 17936]]
A. Calculation of ASP Data
New section 1847A(c)(1) of the Act defines the manufacturer's ASP
for a National Drug Code (NDC) associated with a drug or biological to
be the manufacturer's sales to all purchasers in the United States
(excluding units associated with sales exempted below) for the NDC for
a quarter divided by the total number of units of that NDC sold by the
manufacturer in that quarter (excluding units associated with sales
exempted below). Section 1847A(c)(6)(A) of the Act adopts the
definition of ``manufacturer'' set forth in section 1927(k)(5) of the
Act. In that section, the term ``manufacturer'' means any entity that
is engaged in the following (This term does not include a wholesale
distributor of drugs or a retail pharmacy licensed under State law):
Production, preparation, propagation,
compounding, conversion or processing of prescription drug product,
either directly or indirectly by extraction from substances of natural
origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis.
Packaging, repackaging, labeling, relabeling, or
distribution of prescription drug products. (Manufacturers that also
engage in wholesaler activities are required to report ASP data for
those drugs that they manufacture.)
In performing this calculation, manufacturers must use the NDC at
the standardized 11-digit level. For the purposes of the ASP
calculation, the ``unit'' is the product represented by the 11-digit
NDC as defined in section 1847A(b)(2)(B) of the Act. In other words,
the denominator is the total number of the ASP applicable sales of that
NDC.
B. Sales Exempted From ASP Calculation Other Than Nominal Sales
Section 1847A(c)(2)(A) of the Act requires that in calculating the
manufacturer's ASP, a manufacturer must exclude sales that are exempt
from the Medicaid best price calculation under sections
1927(c)(1)(C)(i) and 1927(c)(1)(C)(ii)(III) of the Act.
C. Sales to an Entity That Are Nominal in Amount Are Exempted From the
ASP Calculation
Section 1847A(c)(2)(B) of the Act requires that sales to an entity
that are nominal in amount are to be exempted from the ASP calculation.
Sales to an entity that are nominal in amount are defined for purposes
of section 1927(c)(1)(C)(ii)(III) of the Act for the Medicaid drug
rebate program in the Medicaid drug rebate agreement.
D. Inclusion of Rebates and Other Price Concessions in the ASP
Calculation
1. General Rule
Section 1847A(c)(3) of the Act requires that in calculating the
manufacturer's ASP, a manufacturer must include volume discounts,
prompt pay discounts, cash discounts, free goods that are contingent on
any purchase requirement, chargebacks, and rebates (other than rebates
under the Medicaid drug rebate program).
2. Estimation Methodology
a. Use of the Most Recent 12-Month Period Available
Section 1847A(c)(5)(A) of the Act states that the ASP is to be
calculated by the manufacturer on a quarterly basis. To the extent that
data on volume discounts, prompt pay discounts, cash discounts, free
goods that are contingent on any purchase requirement, chargebacks, and
rebates are available on a lagged basis, the manufacturer is required
to apply a methodology based on the most recent 12-month period
available to estimate costs attributable to these price concessions.
Specifically, a manufacturer should add the volume discounts, prompt
pay discounts, cash discounts, free goods that are contingent on any
purchase requirement, chargebacks, and rebates for the most recent 12-
month period available and divide by 4 to determine the estimate to
apply in calculating the manufacturer's ASP for the quarter being
submitted.
b. Allocation to Individual NDCs
For situations in which a manufacturer is unable to associate
volume discounts, prompt pay discounts, cash discounts, free goods that
are contingent on any purchase requirement, chargebacks and rebates,
with a specific NDC, the manufacturer will allocate those discounts,
rebates, free goods, and chargebacks to associated NDCs. This
association will be based on the percentage of sales (in dollars)
attributable to each particular NDC within the group of NDCs for which
the manufacturer can associate discounts, rebates, free goods, and
chargebacks.
c. Future Changes to the Methodology
As we gain more experience with the ASP system, we may seek to
change the methodology to estimate costs attributable to rebates and
chargebacks and the scope of price concessions for years after 2004.
Pursuant to section 1847A(c)(5)(A) of the Act, the Secretary may
establish a uniform methodology to estimate and apply those costs. For
years after 2004, the Secretary may include in the calculation of the
ASP, other price concessions which may be based upon recommendations of
the Inspector General that would result in a reduction of the cost to
the purchaser.
E. Reporting of ASP Data to CMS
1. Format
Manufacturers must report the ASP data to us in Microsoft Excel
using the template provided in Addendum A. Manufacturers are required
to calculate and report the ASP information to us at the 11-digit NDC
level, along with the associated units used in the calculation of the
ASP. As we gain more experience with the ASP system, we may seek to
modify these requirements in the future.
2. Contacts
As indicated in Addendum B, manufacturers must submit the names of
one or more individuals that we may contact if we have questions or
issues with respect to the data submission.
3. Certification by the Chief Executive Officer or Chief Financial
Officer
Due to the consequences of failing to submit accurate and timely
ASP data, each quarterly ASP data submission must be certified by one
of the following: the manufacturer's Chief Executive Officer (CEO), the
manufacturer's Chief Financial Officer (CFO), or an individual who has
delegated authority to sign for, and who reports directly to, the
manufacturer's CEO or CFO.
F. Penalties Associated With the Failure To Submit Timely and Accurate
ASP Data
Section 1847A(d)(4) of the Act specifies the penalties for
misrepresentations associated with ASP data. If the Secretary
determines that a manufacturer has made a misrepresentation in the
reporting of ASP data, a civil money penalty in an amount of up to
$10,000 may be applied for each price misrepresentation and for each
day in which the price misrepresentation was applied. Section 1927 of
the Act, as amended by section 303(i)(4) of the MMA, specifies the
penalties associated with a manufacturer's failure to submit timely
information or the submission of false information.
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
[[Page 17937]]
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-commentprocedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued. In
addition, the Administrative Procedure Act normally requires a 30-day
delay in the effective date of a final rule. Furthermore, the
Congressional Review Act generally requires an agency to delay the
effective date of a major rule by 60-days in order to allow for
congressional review of the agency action. Section 1871 of the Act
provides for publication of a notice of proposed rulemaking and
opportunity for public comment before CMS issues a final rule. However,
section 1871(b)(2)(B) of the Act provides an exception when a law
establishes a specific deadline for implementation of a provision and
the deadline is less than 150 days after the law's date of enactment.
The MMA was enacted by Congress on November 25, 2003, and signed into
law by the President on December 8, 2003. The provisions of this
interim final rule with comment period are required to be implemented
by April 30, 2004. Therefore, these provisions are subject to waiver of
proposed rulemaking and public comment in accordance with section
1871(b)(2)(B) of the Act.
Even if section 1871(b)(2)(B) of the Act were not directly
applicable here, we would find good cause to waive the requirement for
publication of a notice of proposed rulemaking and public comment on
the grounds that it is impracticable, unnecessary, and contrary to the
public interest. This interim final rule with comment period sets forth
non-discretionary provisions of MMA with respect to the calculation and
submission of ASP data for certain Medicare Part B drugs and
biologicals. Because the rule is generally ministerial, we believe that
pursuing notice and comment is unnecessary. Moreover, because that
process would delay the implementation of congressionally-mandated
submissions of drug payment-related data, we find that pursuing that
process would be both impracticable and contrary to the public
interest.
With respect to the requirement of a 60-day delay in the effective
date of any final rule pursuant to the Congressional Review Act (CRA),
see 5 U.S.C. section 801, the CRA provides that the 60-day delayed
effective date shall not apply to any rule ``which an agency for good
cause finds * * * that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.'' (5
U.S.C. section 808(2)). For the reasons set forth above, we believe
that additional notice and comment rulemaking on this subject would be
impracticable, unnecessary, or contrary to the public interest.
Therefore, we do not believe that the CRA requires a 60-day delay in
the effective date of this interim final rule with comment period.
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 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, however, requesting an emergency review of the information
collection referenced below. In compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have
submitted to the Office of Management and Budget (OMB) the following
requirements for emergency review. We are requesting an emergency
review because the collection of this information is needed before the
expiration of the normal time limits under OMB's regulations at 5 CFR
Part 1320. This is necessary to ensure compliance with a statutory
deadline. We cannot reasonably comply with the normal clearance
procedures because of an unanticipated event.
CMS is requesting OMB review and approval of this collection by
April 23, 2004, with a 180-day approval period. Written comments and
recommendations will be accepted from the public if received by the
individuals designated below by April 16, 2004. During this 180-day
period, we will publish a separate Federal Register notice announcing
the initiation of an extensive 60-day agency review and public comment
period on these requirements.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:
In summary, this interim final rule with comment period requires
manufacturers of Medicare Part B covered drugs and biologicals paid
under sections 1847A, 1842(o)(1)(D), or 1881(b)(13)(A)(ii) of the Act
to submit manufacturer's quarterly ASP data to CMS beginning April 30,
2004. This interim final rule with comment period lays out the
requirements and provides the template manufacturers should use to
report their ASP data to CMS.
The burden associated with the requirements in this rule is the
time and effort required by manufacturers of Medicare Part B drugs and
biologicals to prepare and submit the required data to CMS. We estimate
that it will take approximately 4 hours for each submission. We also
estimate that this requirement will affect approximately 120
manufacturers. Therefore, we estimate the total reporting burden to be
approximately 480 hours per quarter for a total of 1920 hours annually.
As required by section 3504(h) of the Paperwork Reduction Act of
1995, we have submitted a copy of this document to OMB for its review
of these information collection requirements.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following: Centers for
Medicare & Medicaid Services, Office of Strategic Operations and
Regulatory Affairs, Regulations Development and Issuances Group, Attn:
Dawn Willinghan, CMS-1380-IFC, Room C5-14-03, 7500 Security Boulevard,
Baltimore, MD 21244-1850; and Office of Information and Regulatory
Affairs, Office of Management and Budget, Room 10235, New Executive
Office Building, Washington, DC 20503, Attn: Brenda Aguilar, CMS Desk
Officer, [email protected]. Fax (202) 395-6974.
VI. Regulatory Impact
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory
[[Page 17938]]
Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section
1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4), and Executive Order 13132.
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). This rule
does not reach the economic threshold and thus is not considered a
major rule.
The RFA requires agencies to analyze options for regulatory relief
of 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
million to $29 million in any 1 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.
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 for final rules
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 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 $110 million. While this interim final rule with comment
period does implement a new statutory data reporting requirement for
drug manufacturers, the costs associated with this requirement are
expected to be below the $110 million annual threshold established by
section 202 of the Unfunded Mandates Reform Act.
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 any 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.
List of Subjects in 42 CFR Part 414
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, 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 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
1. The authority citation for part 414 continues to read as follows:
Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
0
2. Part 414 is amended by adding a new subpart J to read as follows:
Subpart J--Submission of Manufacturer's Average Sales Price Data
Sec.
414.800 Purpose.
414.802 Definitions.
414.804 Basis of payment.
414.806 Penalties associated with the failure to submit timely and
accurate ASP data.
Sec. 414.800 Purpose.
This subpart implements section 1847A of the Act by specifying the
requirements for submission of a manufacturer's average sales price
data for certain drugs and biologicals covered under Part B of Title
XVIII of the Act that are paid under sections 1842(o)(1)(D), 1847A, and
1881(b)(13)(A)(ii) of the Act.
Sec. 414.802 Definitions.
As used in this subpart, unless the context indicates otherwise--
Drug means both drugs and biologicals.
Manufacturer means any entity that is engaged in the following
(This term does not include a wholesale distributor of drugs or a
retail pharmacy licensed under State law):
(1) Production, preparation, propagation, compounding, conversion
or processing of prescription drug products, either directly or
indirectly by extraction from substances of natural origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis.
(2) The packaging, repackaging, labeling, relabeling, or
distribution of prescription drug products.
Unit means the product represented by the 11-digit National Drug
code.
Sec. 414.804 Basis of payment.
(a) Calculation of manufacturer's average sales price.
(1) The manufacturer's average sales price for a quarter for a drug
or biological represented by a particular 11-digit National Drug Code
must be calculated as the manufacturer's sales to all purchasers in the
United States for that particular 11-digit National Drug Code (after
deducting the types of items and transactions listed in paragraph
(a)(2) of this section and excluding sales referenced in paragraph
(a)(4) of this section) divided by the total number of units sold by
the manufacturer in that quarter (after excluding units associated with
sales referenced in paragraph (a)(4) of this section).
(2) In calculating the manufacturer's average sales price, a
manufacturer must deduct the following types of transactions and items:
(i) Volume discounts.
(ii) Prompt pay discounts.
(iii) Cash discounts.
(iv) Free goods that are contingent on any purchase requirement.
(v) Chargebacks and rebates (other than rebates under the Medicaid
drug rebate program).
(3) To the extent that data on volume discounts, prompt pay
discounts, cash discounts, free goods that are contingent on any
purchase requirement, chargebacks and rebates (other than rebates under
the Medicaid drug rebate program) are available on a lagged basis, the
manufacturer should add the data for the most recent 12-month period
available and divide by 4 to determine the estimate to apply in
calculating the manufacturer's average sales price for the quarter
being submitted.
(4) In calculating the manufacturer's average sales price, a
manufacturer must exclude sales that are exempt from the Medicaid best
price calculation under sections 1927(c)(1)(C)(i) and
1927(c)(1)(C)(ii)(III) of the Act.
[[Page 17939]]
(5) The manufacturer's average sales price must be calculated by
the manufacturer every calendar quarter and submitted to CMS within 30
days of the close of the quarter. The first quarter submission must be
submitted by April 30, 2004. Subsequent reports are due not later than
30 days after the last day of each calendar quarter.
(6) Each report must be certified by one of the following:
(i) The manufacturer's Chief Executive Officer (CEO).
(ii) The manufacturer's Chief Financial Officer (CFO).
(iii) An individual who has delegated authority to sign for, and
who reports directly to, the manufacturer's CEO or CFO.
Sec. 414.806 Penalties associated with the failure to submit timely
and accurate ASP data.
Section 1847A(d)(4) specifies the penalties associated with
misrepresentations associated with ASP data. If the Secretary
determines that a manufacturer has made a misrepresentation in the
reporting of ASP data, a civil money penalty in an amount of up to
$10,000 may be applied for each price misrepresentation and for each
day in which the price misrepresentation was applied. Section
1927(b)(3)(C) of the Act, as amended by section 303(i)(4) of the MMA,
specifies the penalties associated with a manufacturer's failure to
submit timely information or the submission of false information.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: March 4, 2004.
Dennis G. Smith,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: March 23, 2004.
Tommy G. Thompson,
Secretary.
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