Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices 29555 

Written comments should be received 

within 60 days of this notice. 

Dated: May 17, 2010. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. 2010–12644 Filed 5–25–10; 8:45 am] 

BILLING CODE 4126–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4151–NC] 

RIN 0938–AQ04 

Medicare Program; Medicare Coverage 

Gap Discount Program Model 

Manufacturer Agreement and 

Announcement of the June 1, 2010 

Public Meeting 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period contains a draft model agreement 

for use by the Secretary and 

manufacturers under the Medicare 

Coverage Gap Discount Program 

established by section 3301 of the 

Patient Protection and Affordable Care 

Act, as amended by section 1101 of the 

Health Care and Education 

Reconciliation Act of 2010. Under the 

agreement, manufacturers of applicable 

covered Part D drugs must provide 

applicable discounts to applicable 

Medicare beneficiaries for applicable 

covered Part D drugs while in the 

coverage gap beginning in 2011. It also 

announces the June 1, 2010 public 

meeting regarding the draft model 

agreement. 

DATES: Meeting Date: Tuesday, June 1, 

2010, 9 a.m. to 5:30 p.m., eastern 

daylight time (e.d.t.). 

Meeting Registration and Request for 

Special Accommodations Deadline: 

Register between May 21, 2010 and June 

1, 2010. 

Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. 

e.d.t on June 21, 2010. 

ADDRESSES: Meeting Location: The 

meeting will be held in the Sheraton 

Baltimore City Center Hotel, 101 West 

Fayette Street, Baltimore, MD 21201. 

Registration and Special 

Accommodations: Register and request 

special accommodations at http:// 

cmsconference.hcmsllc.com. 

Submitting Comments: In 

commenting, please refer to file code 

CMS–4151–NC. 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): 

1. Electronically. You may submit 

electronic comments on this notice to 

http://www.regulations.gov. Follow the 

instructions ‘‘For submitting a 

comment.’’ 

2. 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–4151–NC, 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. 

3. 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–4151–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. 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– 

9994 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. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Craig Miner, for questions regarding the 

model agreement, (410) 786–7937. Sonia 

Eaddy, for questions regarding the 

meeting registration, 410–786–5459. 

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:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

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, 

phone 1–800–743–3951. 

I. Background 

Section 101 of the Medicare 

Prescription Drug, Improvement and 

Modernization Act of 2003 (MMA) 

which was enacted on December 8, 2003 

established the Voluntary Prescription 

Drug Benefit Program (hereinafter 

referred to as ‘‘Part D’’). The Part D 

program is available for individuals who 

are entitled to Medicare Part A or 

enrolled in Medicare Part B. The 

Centers for Medicare & Medicaid 

Services (CMS) contracts with private 

companies, referred to as Part D 

sponsors, to administer the Part D 

program via stand alone prescription 

drug plans (PDPs) and prescription drug 

plans offered by Medicare Advantage 

Organizations (MA–PDs). The Part D 

program became effective January 1, 

2006. 

Standard Part D prescription drug 

coverage consists of coverage subject to 

an annual deductible, 25 percent 

coinsurance (or an actuarially 

equivalent cost-sharing design) up to the 

initial coverage limit (ICL), and 

catastrophic coverage for individuals 

that exceed the annual maximum true 

out-of-pocket (TrOOP) threshold with 

cost-sharing equal to the greater of a $2/ 

$5 copayment or coinsurance of 5 


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percent. Under the standard coverage, 

individuals that do not receive 

additional cost-sharing subsidies from 

CMS or additional coverage by other 

secondary payers (for example, State 

Pharmaceutical Assistance Programs) 

are responsible for paying 100 percent 

of the Part D negotiated price for 

covered Part D claims above the ICL 

until their TrOOP costs exceed the 

annual threshold amount. 

Section 3301 of the Patient Protection 

and Affordable Care Act (Pub. L. 111– 

148), as amended by section 1101 of the 

Health Care and Education 

Reconciliation Act of 2010 (Pub. L. 111– 

152) (these public laws are collectively 

known as the Affordable Care Act), 

establishes the Medicare Coverage Gap 

Discount Program (Discount Program) 

by adding sections 1860D–43 and 

1860D–14A of the Social Security Act 

(Act). Effective January 1, 2011, the 

Discount Program will make 

manufacturer discounts available to 

applicable Medicare beneficiaries 

receiving applicable covered Part D 

drugs while in the coverage gap. In 

general, the discount on each applicable 

covered Part D drug is 50 percent of an 

amount equal to the negotiated price (as 

defined in section 1860D–14A(g)(6) of 

the Act). 

Beginning January 1, 2011, an 

applicable Part D drug will only be 

covered under Part D if the 

manufacturer has a signed agreement 

with the Secretary to participate in the 

Discount Program, provides applicable 

discounts on coverage gap claims for all 

of its applicable drugs, and remains in 

compliance with the terms of that 

agreement. The requirement to sign an 

agreement applies to manufacturers of 

applicable Part D drugs. However, the 

Secretary reserves the right to require all 

manufacturers to sign the agreement in 

the future if we discover that access to 

applicable Part D drugs is restricted. We 

also encourage manufacturers of nonapplicable drugs to enter into an 

agreement if they intend to manufacture 

applicable Part D drugs in the future. 

While section 1860D–43(c) of the Act 

permits us to allow coverage of drugs 

not covered under an agreement if we 

determine that availability of the drug is 

essential to the health of beneficiaries 

or, for 2011 only, that there are 

extenuating circumstances, we do not 

intend to apply this authority as we 

fully expect all manufacturers of 

applicable drugs to sign the agreement 

so that there will be no changes in the 

availability of coverage for Part D drugs. 

We will notify the public as early as 

possible if certain manufacturers have 

failed to sign an agreement. 

II. Provisions of the Notice 

A. Draft of the Model Manufacturer 

Agreement 

Pursuant to section 1860D–14A(d)(5) 

of the Act, the Secretary is authorized to 

implement the Discount Program ‘‘by 

program instruction or otherwise.’’ 

Accordingly, in the Addendum to this 

notice with comment period, we 

provide a draft of the model 

manufacturer agreement for use in the 

program that a manufacturer must enter 

into with the Secretary agreeing to 

provide the applicable discount on 

coverage gap claims by applicable 

beneficiaries for all of its applicable 

drugs if it wants its drugs to be covered 

under Part D. We intend to use the 

model manufacturer agreement as a 

standard agreement that will not be 

subject to further revision based on 

negotiations with individual 

manufacturers. The model manufacturer 

agreement will be finalized and posted 

on the CMS Web site after we have 

considered the public comments and 

consulted with manufacturers as 

required by section 1860D–14A(a) of the 

Act. 

B. Meeting Regarding Draft Model 

Manufacturer Agreement 

The following is the tentative agenda 

for the June 1, 2010 meeting: 

9–9:30 Opening Remarks 

9:30–10:30 CMS Overview of 

Administration of Discount 

Program—15 minutes 

CMS Overview of PDE Records–45 

minutes 

10:30–11 Q&A Session 

11–11:15 Break 

11:15–11:45 CMS Review of Draft 

Manufacturer Agreement 

11:45–12:15 Q&A Session 

12:15–1:30 Lunch 

1:30–2:30 Beneficiary Advocate Panel 

2:30–3:30 Part D Plan Sponsor/PBM 

Panel 

3:30–3:45 Break 

3:45–5:15 Pharmaceutical 

Manufacturer Panel 

5:15–5:30 Closing remarks. 

III. Collection of Information 

Requirements 

In accordance with section 1860D– 

14A(d)(6) of the Affordable Care Act, 

Chapter 35 of title 44, United States 

Code shall not apply to the program 

under this section. Consequently, it 

need not be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995. 

IV. 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. 

ADDENDUM—Draft Model Agreement 

Medicare Coverage Gap Discount 

Program Agreement Between the 

Secretary of Health and Human 

Services (Hereinafter Referred to as 

‘‘the Secretary’’) and the Manufacturer 

Identified in Section IX of This 

Agreement (Hereinafter Referred to as 

‘‘the Manufacturer’’) 

The Secretary, on behalf of the 

Department of Health and Human 

Services, and the Manufacturer, on its 

own behalf, for purposes of sections 

1860D–14A and 1860D–43 of the Social 

Security Act (the Act), as set forth in the 

Patient Protection and Affordable Care 

Act of 2010, Public Law 111–148, and 

the Health Care and Education 

Reconciliation Act of 2010, Public Law 

111–152, collectively known as the 

Affordable Care Act, hereby agree to the 

following: 

I. Definitions 

The terms defined in this section will, 

for the purposes of this Agreement, have 

the meanings specified in sections 

1860D–1 through 1860D–43 of the Act 

as interpreted and applied herein: 

(a) ‘‘Applicable Beneficiary’’ means an 

individual who, on the date of 

dispensing a covered Part D drug: 

1. Is enrolled in a prescription drug 

plan or an MA–PD plan; 

2. Is NOT enrolled in a qualified 

retiree prescription drug plan; 

3. Is NOT entitled to an incomerelated subsidy under 1860D–14(a) of 

the Act; 

4. Has reached or exceeded the initial 

coverage limit under section 1860D– 

2(b)(3) of the Act during the year; and 

5. Has NOT incurred costs for covered 

Part D drugs in the year equal to the 

annual out-of-pocket threshold specified 

in section 1860D–2(b)(4)(B) of the Act. 

This does not mean that an applicable 

beneficiary who has already moved 

through the coverage gap is not eligible 

for applicable discounts for applicable 

drugs dispensed while the applicable 

beneficiary was in the coverage gap. 

(b) ‘‘Applicable Drug’’ means, with 

respect to an applicable beneficiary, a 

covered Part D drug— 

1. Approved under a new drug 

application under section 505(b) of the 

Federal Food, Drug, and Cosmetic Act 


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(FDCA) or, in the case of a biological 

product, licensed under section 351 of 

the Public Health Service Act (PHSA) 

(other than a product licensed under 

subsection (k) of such section 351 of 

PHSA); and 

2.i. If the PDP sponsor of the 

prescription drug plan or the MA 

organization offering the MA–PD plan 

uses a formulary, which is on the 

formulary of the prescription drug plan 

or MA–PD plan that the applicable 

beneficiary is enrolled in; 

ii. If the PDP sponsor of the 

prescription drug plan or the MA 

organization offering the MA–PD plan 

does not use a formulary, for which 

benefits are available under the 

prescription drug plan or MA–PD plan 

that the applicable beneficiary is 

enrolled in; or 

iii. Is provided through an exception 

or appeal. 

(c) ‘‘Applicable Discount’’ means 50 

percent of the portion of the negotiated 

price (as defined in section I.(m) of this 

agreement), of the applicable drug of a 

Manufacturer that falls within the 

coverage gap (as defined in section I.(f) 

of this agreement). 

(d) ‘‘Centers for Medicare & Medicaid 

Services (CMS)’’ means the agency of the 

Department of Health and Human 

Services having the delegated authority 

to operate the Medicare program. 

(e) ‘‘Contractor’’ means the CMS 

contractor responsible for administering 

the requirements established by the 

Secretary to carry out section 1860D– 

14A of the Act. 

(f) ‘‘Coverage Gap’’ means the gap 

phase in prescription drug coverage that 

occurs between the initial coverage limit 

(as defined in 1860D–2(b)(3) of the Act) 

and the out-of-pocket threshold (as 

defined in section 1860D–2(b)(4)(B) of 

the Act). For purposes of applying the 

initial coverage limit, Part D sponsors 

shall apply their plan-specific initial 

coverage limit under basic alternative 

actuarially equivalent or enhanced 

alternative Part D benefit designs. 

(g) ‘‘Covered Part D drug’’ has the 

meaning as set forth in 42 CFR 423.100. 

(h) ‘‘Discount Program’’ means the 

Medicare Coverage Gap Discount 

Program established under section 

1860D–14A of the Act. 

(i) ‘‘Labeler Code’’ means the first 5 

digits in the 11-digit national drug code 

(NDC) format that is assigned by the 

FDA and identifies the Manufacturer. 

(j) ‘‘Manufacturer’’ means any entity 

which is engaged in the 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. Such 

term does not include a wholesale 

distributor of drugs or a retail pharmacy 

licensed under State law. 

(k) ‘‘Medicare Part D Discount 

Information’’ means information sent 

from CMS, or its contractor, to the 

Manufacturer for the Manufacturer’s 

applicable drugs received by applicable 

beneficiaries for Medicare Part D 

consisting of summary-level information 

showing the total units dispensed and 

total applicable discounts paid by Part 

D sponsors for each Manufacturer’s NDC 

number during the applicable calendar 

quarter. This information will be 

derived from applicable data elements 

available on the prescription drug 

events (PDEs) as determined by CMS. 

(l) ‘‘National Drug Code (NDC)’’ means 

the identifying prescription drug 

product number that is registered and 

listed with the Food and Drug 

Administration (FDA). For the purposes 

of this Agreement, the NDC refers to 

either the 9-digit (inclusive of 5 digit 

labeler code and 4 digit product code) 

or 11-digit (inclusive of 5 digit labeler 

code, 4 digit product code, and 2 digit 

package size code) NDC, as designated 

by the Secretary. 

(m) ‘‘Negotiated Price’’ has the 

meaning given such term in 42 CFR 

423.100 (as in effect on the date of 

enactment of section 1860D–14A of the 

Act), except that such negotiated price 

shall not include any dispensing fee for 

the applicable drug. 

(n) ‘‘Part D drug’’ has the meaning 

given such term in 42 CFR 423.100. 

(o) ‘‘Part D Sponsor’’ The term Part D 

sponsor has the meaning given such 

term in section 42 CFR 423.4. 

(p) ‘‘Prescription Drug Event (PDE)’’ 

refers to a summary record that 

documents the final adjudication of a 

Part D dispensing event. 

(q) ‘‘Qualified Retiree Prescription 

Drug Plan’’ The term qualified retiree 

prescription drug plan has the meaning 

given such term in section 1860D– 

22(a)(2) of the Act. 

(r) ‘‘Secretary’’ means the Secretary of 

the United States Department of Health 

and Human Services, or any successor 

thereto, or any officer or employee of 

the Department of Health and Human 

Services or successor agency to whom 

the authority to implement this 

Agreement has been delegated. 

II. Manufacturer’s Responsibilities 

In order for Part D coverage to be 

available for covered Part D drugs of a 

Manufacturer, the Manufacturer agrees 

to the following: 

(a) To reimburse the applicable 

discount for all applicable discounts 

provided by Part D sponsors on behalf 

of the Manufacturer for all of the 

Manufacturer’s applicable drugs based 

upon PDE information reported to CMS 

by Part D sponsors. 

(b) To pay to each Part D sponsor 

within 14 days of being invoiced by the 

contractor the total quarterly applicable 

discounts provided by each Part D 

sponsor on behalf of the Manufacturer 

for all of the Manufacturer’s applicable 

drugs provided during a previous 

specified quarter based upon PDE 

information utilized by CMS (or the 

contractor) to calculate the applicable 

discounts. 

(c) To collect and have available 

appropriate data, including data related 

to Manufacturer’s labeler codes, 

expiration date of NDCs, utilization and 

pricing information relied on by the 

Manufacturer to dispute the CMS 

contractor’s discount calculations, and 

any other data the Secretary determines 

is necessary to carry out the discount 

program, for a period of not less than 10 

years to ensure that it can demonstrate 

to the Secretary compliance with the 

requirements of the Discount Program. 

(d) To comply with conditions in 

sections 1860D–14A and 1860D–43 of 

the Act, and any changes to the 

Medicare statute that affect the Discount 

Program. 

(e) To comply with the requirements 

imposed by the Secretary for purposes 

of administering the Discount Program. 

(f) To pay all applicable discounts 

provided by Part D sponsors on behalf 

of the Manufacturer for all of the 

Manufacturer’s applicable drugs for 

applicable dates of service except for 

those dates of service after the 

marketing end date, which is the last lot 

expiration date, specified in a product’s 

structured product labeling 

electronically submitted to the FDA if 

such marketing end date was submitted 

to the FDA prior to such date. 

(g) To submit to periodic audits of 

data and documentation referenced in 

section II.(c) of this agreement. 

(h) To comply with the payment 

amount dispute resolution process in 

section V. of this agreement. 

(i) To comply with all applicable 

confidentiality requirements of the 

Health Insurance Portability and 

Accountability Act and 45 CFR parts 

160, 162, and 164. 

(j) To electronically list and maintain 

an up-to-date electronic FDA 

registration and listing of all NDCs so 

that CMS and Part D sponsors can 

accurately identify applicable drugs (as 

defined in section I.(b) of this 

agreement). 


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(k) To enter into and have in effect, 

under terms and conditions specified by 

the Secretary, a contract with a third 

party that the Secretary has entered into 

a contract with under section 1860D– 

14A(d)(3) of the Act. 

(l) To provide to CMS or its 

contractor, electronic connectivity to 

receive ‘‘Medicare Part D Discount 

Information’’ reports. 

(m) To make quarterly payments 

directly to accounts established by Part 

D sponsors via electronic funds transfer 

within the time period specified in 

subsection (b) of this section and within 

1 business day of the transfer to provide 

CMS with electronic documentation in 

a manner specified by CMS that details 

the successful transmission of such 

payments. 

III. Secretary’s Responsibilities 

(a) The Secretary shall require Part D 

sponsors to make applicable discounts 

available at the pharmacy, by mail order 

service, or at any other point of sale for 

applicable drugs beginning January 1, 

2011. 

(b) The Secretary is responsible for 

monitoring compliance by the 

Manufacturer with the terms of this 

Agreement. 

(c) The Secretary is responsible for 

collecting PDE information from Part D 

sponsors for monitoring and tracking 

the applicable discounts provided by 

Part D sponsors on behalf of 

Manufacturers for applicable drugs and 

implementing internal control measures 

designed to ensure the accuracy and 

appropriateness of discount payments 

provided by Part D sponsors. 

(d) The Secretary may audit the 

Manufacturer periodically with respect 

to the Manufacturer’s labeler codes, 

expiration date of NDCs, and utilization 

and pricing information relied on by the 

Manufacturer to dispute the CMS 

contractor’s discount calculations, and 

any other data the Secretary determines 

is necessary to carry out the Discount 

program. 

(e) The Secretary shall contract with 

one or more third parties (the 

contractor) to: 

1. Receive and transmit information, 

including Medicare Part D Discount 

Information (as defined in section I.(k) 

of this Agreement), between the 

Secretary, manufacturers, and other 

individuals or entities the Secretary 

determines appropriate; 

2. Receive, distribute, or facilitate the 

distribution of funds of manufacturers 

to appropriate individuals or entities in 

order to meet the obligations of 

manufacturers under this agreement; 

3. Provide adequate and timely 

information to manufacturers as 

necessary for the manufacturer to fulfill 

its obligations under this Agreement; 

4. Permit manufacturers to conduct 

periodic audits, directly or through 

contracts, of the data and information 

used by the contractor to determine 

discounts for applicable drugs of the 

manufacturer under the Discount 

Program. 

(f) The Secretary shall not disclose 

any identifying beneficiary information 

in these reports or otherwise under this 

Discount Program except as may be 

required by a court with competent 

jurisdiction. 

(g) The Secretary shall be the sole 

source of information regarding 

beneficiary eligibility to receive the 

applicable discount and the Secretary’s 

determination regarding beneficiary 

eligibility is not subject to audit or 

dispute by Manufacturer. 

(h) The Secretary shall make public a 

list of Manufacturer’s labeler codes that 

are subject to an existing Discount 

Program Agreement. 

IV. Penalty Provisions 

(a) The Secretary may impose a civil 

monetary penalty on a Manufacturer 

that fails to pay applicable discounts 

under the Program. The amount for each 

such failure is the amount the Secretary 

determines is commensurate with the 

sum of the amount that the 

Manufacturer would have paid with 

respect to such discounts under the 

Agreement, which will then be used to 

pay the applicable discounts which the 

Manufacturer had failed to provide, plus 

an additional 25 percent of the amount 

the Manufacturer would have paid with 

respect to such discounts under the 

agreement. 

(b) The provisions of section 1128A of 

the Act (other than subsections (a) and 

(b)) shall apply to a civil money penalty 

in the same manner as such provisions 

apply to a penalty or proceeding under 

section 1128A(a) of the Act. 

V. Payment Amount Dispute Resolution 

(a) In the event that a Manufacturer 

disputes the Medicare Part D Discount 

Information provided by CMS on the 

periodic summary, the Manufacturer 

shall provide written notice of the 

disputed information, by NDC number, 

to CMS and its contractor within 60 

days of receipt of the information. The 

disputed information must be material, 

specific and related to the dispute at 

issue, and supported by evidence 

provided to the Secretary that 

establishes the basis of such dispute. 

(b) The Manufacturer shall not 

withhold any invoiced discount 

payments pending dispute resolution. 

(c) The Manufacturer and contractor 

will use their best efforts to resolve the 

dispute within 60 days of receipt of 

such notification. If the dispute is not 

resolved within 60 days, CMS will 

provide for an independent review and 

determination by an entity specified by 

CMS within 120 days of receipt of 

notification. If the Manufacturer 

disagrees with the determination, the 

Manufacturer may request review by the 

CMS Administrator. The decision by the 

CMS Administrator is final and binding. 

(d) Adjustments to future applicable 

discount payments shall be made if new 

information demonstrates that either 

there have been material changes in 

Medicare Part D Discount Information 

or the negotiated prices originally used 

to compute previous applicable 

discount payments. 

VI. Confidentiality Provisions 

(a) Information disclosed by the 

manufacturer and deemed by the 

manufacturer and the Secretary to be 

confidential in connection with this 

Agreement is confidential and will not 

be disclosed by the Secretary in a form 

which reveals the manufacturer, except 

as necessary to carry out provisions of 

section 1860D–14A of the Act and for 

purposes authorized in section 1860D– 

15(f)(2) of the Act. 

(b) Information disclosed to 

Manufacturers pursuant to this 

agreement shall only be used for 

purposes of paying the discount under 

the Discount Program. CMS or the 

contractor will only disclose to 

manufacturers the minimum data 

necessary for manufacturers to fulfill 

their obligations under this Agreement. 

(c) Except where otherwise specified 

in the Act or Agreement, the 

Manufacturer will observe applicable 

State confidentiality statutes, 

regulations and other applicable 

confidentiality requirements. 

(d) Notwithstanding the nonrenewal 

or termination of this Agreement for any 

reason, the confidentiality provisions of 

this Agreement will remain in full force 

and effect with respect to information 

disclosed under this Agreement prior to 

such nonrenewal or termination. 

VII. Nonrenewal and Termination 

(a) Unless otherwise terminated by 

either party pursuant to the terms of this 

Agreement, the Agreement shall be 

effective for an initial period of not less 

than 24 months beginning on January 1, 

2011 and shall be automatically 

renewed for a period of 1 year unless 

terminated under section VII.(b) or (c) of 

this Agreement. 

(b) The Secretary may terminate this 

Agreement for a knowing and willful 


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violation of the requirements of the 

Agreement or other good cause shown. 

The termination shall not be effective 

earlier than 30 days after the date of 

notice to the Manufacturer of such 

termination. 

(c) The Secretary shall provide, upon 

request, a Manufacturer a hearing with 

a hearing officer concerning such 

termination if requested in writing 

within 15 days of receiving notice of the 

termination, and such hearing shall take 

place prior to the effective date of the 

termination with sufficient time for 

such effective date to be repealed if the 

Secretary determines appropriate. If the 

Manufacturer receives an unfavorable 

decision from the hearing officer, the 

Manufacturer may request review by the 

CMS Administrator. The decision of the 

CMS Administrator is final and binding. 

(d) The Manufacturer may terminate 

this Agreement for any reason. Any 

such termination shall be effective as of 

the day after the end of the plan year if 

the termination occurs before January 30 

of a plan year or as of the day after the 

end of the succeeding plan year if the 

termination occurs on or after January 

30 of a plan year. 

(e) Any termination shall not affect 

applicable discounts for applicable 

drugs of the Manufacturer that were 

incurred under the Agreement before 

the effective date of its termination. 

(f) Manufacturer reinstatement will be 

available only upon payment of any and 

all outstanding applicable discounts 

incurred during any previous period of 

the Agreement. The timing of any such 

reinstatements will be consistent with 

the requirements for entering into an 

Agreement under section 1860D– 

14A(b)(1)(C) of the Act. 

VIII. General Provisions 

(a) Any notice required to be given 

pursuant to the terms and provisions of 

this Agreement will be sent in writing. 

1. Notice to the Secretary will be sent 

to: Center for Medicare, Division of 

Pharmaceutical Manufacturer 

Management, Mailstop C1–26–16, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

2. The CMS address may be updated 

upon written notice to the 

Manufacturer. 

3. Notices to the Manufacturer will be 

sent to the address as provided with this 

Agreement and updated upon 

Manufacturer notification to CMS at the 

address in this Agreement. 

(b) In the event of a transfer in 

ownership of the Manufacturer or 

product, this Agreement is 

automatically assigned to the new 

owner, and all terms and conditions of 

this Agreement remain in effect. 

(c) Nothing in this Agreement will be 

construed to require or authorize the 

commission of any act contrary to law. 

If any provision of this Agreement is 

found to be invalid by a court of law 

with competent jurisdiction, this 

Agreement will be construed in all 

respects as if any invalid or 

unenforceable provision were 

eliminated, and without any effect on 

any other provision. 

(d) Nothing in this Agreement shall be 

construed as a waiver or relinquishment 

of any legal rights of the Manufacturer 

or the Secretary under the Constitution, 

the Act, other Federal laws, or State 

laws. 

(e) This Agreement shall be construed 

in accordance with Federal law and 

ambiguities shall be interpreted in the 

manner which best effectuates the 

statutory scheme. 

(f) The terms ‘‘Medicare’’ and 

‘‘Manufacturer’’ incorporate any 

contractors which fulfill responsibilities 

pursuant to the Agreement unless 

specifically provided for in this 

Agreement or specifically agreed to by 

an appropriate CMS official in 

accordance with paragraph (g) of this 

section. 

(g) Except for the conditions specified 

in section VIII.(a) of this Agreement, this 

Agreement once finalized, will not be 

altered by the parties. 

(h) Nothing in this Agreement shall be 

construed as requiring coverage under 

Part D of a Manufacturer’s product if 

that product does not otherwise meet 

the definition of a covered Part D drug 

under 42 CFR 423.100. 

IX. Signatures 

FOR THE SECRETARY OF HEALTH 

AND HUMAN SERVICES 

By: llllllllllllllll

(please print name) 

lllllllllllllllllll

(signature) 

Title: lllllllllllllll

Date: llllllllllllllll

ACCEPTED FOR THE 

MANUFACTURER 

I certify that I have made no 

alterations, amendments or other 

changes to this Coverage Gap Discount 

Program Agreement. 

By: llllllllllllllll

(please print name) 

lllllllllllllllllll

(signature) 

Title: lllllllllllllll

Name of Manufacturer: lllllll

Manufacturer’s Mailing Address: lll

Manufacturer’s E-mail Address: lll

Manufacturer labeler Code(s): llll

Date: llllllllllllllll

Authority: Section 3301 of the Patient 

Protection Affordable Care Act and section 

1101 of the Health Care and Education 

Reconciliation Act of 2010 (Sections 1860D– 

43 and 1860D–14A of the Social Security 

Act) Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program). 

Dated: May 13, 2010. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: May 20, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–12559 Filed 5–21–10; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

The 13th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference in Irvine, California: 

‘‘Regulatory Affairs: The Business of 

Regulatory Affairs’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of conference. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 13th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

drug, device, biologics and dietary 

supplement industries with an 

opportunity to interact with FDA 

reviewers and compliance officers from 

the centers and District Offices, as well 

as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the four medical 

product areas. Industry speakers, 

interactive Q & A, and workshop 

sessions will also be included to assure 

open exchange and dialogue on the 

relevant regulatory issues. 

Date and Time: The conference will 

be held on June 16 and 17, 2010, from 

7:30 a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, Voice: 949–608–4413, 

FAX: 949–608–4417; or Orange County 

Regulatory Affairs Discussion Group 


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