Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2881 

(B) For subsequent Round bids. CMS 

has 90 days after the covered document 

review date to provide notify suppliers 

of any missing covered documents. 

(iii) Submission of missing covered 

documents. Suppliers notified by CMS 

of missing covered documents have 10 

business days after the date of such 

notice to submit the missing documents. 

CMS does not reject the supplier’s bid 

on the basis that the covered documents 

are late or missing if all the applicable 

missing covered documents identified 

in the notice are submitted to CMS not 

later than 10 business days after the date 

of such notice. 

* * * * * 

■ 7. Section 414.422 is amended by— 

■ A. Redesignating paragraph (f) as 

paragraph (g). 

■ B. Adding a new paragraph (f). 

The addition reads as follows: 

§ 414.422 Terms of contracts. 

* * * * * 

(f) Disclosure of subcontracting 

arrangements. 

(1) Initial disclosure. Not later than 10 

days after the date a supplier enters into 

a contract under this section the 

supplier must disclose information on 

both of the following: 

(i) Each subcontracting arrangement 

that the supplier has in furnishing items 

and services under the contract. 

(ii) Whether each subcontractor meets 

the requirement of section 

1834(a)(20)(F)(i) of the Act if applicable 

to such subcontractor. 

(2) Subsequent disclosure. Not later 

than 10 days after the date a supplier 

enters into a subcontracting 

arrangement subsequent to contract 

award with CMS, the supplier must 

disclose information on both of the 

following: 

(i) The subcontracting arrangement 

that the supplier has in furnishing items 

and services under the contract. 

(ii) Whether the subcontractor meets 

the requirement of section 

1834(a)(20)(F)(i) of the Act, if applicable 

to such subcontractor. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 13, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: December 5, 2008. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E9–863 Filed 1–15–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 423 

[CMS 4138–IFC4] 

RIN 0938–AP24 

Medicare Program: Medicare 

Advantage and Prescription Drug 

Programs MIPPA Drug Formulary & 

Protected Classes Policies 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period revises the regulations 

governing the Medicare prescription 

drug benefit program (Part D). This 

regulation makes conforming changes to 

reflect revisions to the rules governing 

Part D that were made as a result of 

provisions in the Medicare 

Improvements for Patients and 

Providers Act (MIPPA), which became 

law on July 15, 2008. These MIPPA 

provisions change the definition of a 

covered Part D drug, and add new 

requirements that apply to Part D 

formularies. 

DATES: Effective date: These regulations 

are effective January 16, 2009. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

March 17, 2009. 

ADDRESSES: In commenting, please refer 

to file code CMS–4138–IFC4. 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 specific issues 

in this regulation to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ and enter the file code to 

find the document accepting comments. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–4138– 

IFC4, P.O. Box 8016, Baltimore, MD 

21244–8016. 

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 (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–4138–IFC4, 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 (one original 

and two copies) before the close of the 

comment period to either of the 

following addresses: 

a. Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; 

(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 persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

b. 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. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Alissa DeBoy at (410) 786–6041)or 

Vanessa Duran at (410)786–8697. 

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 


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2882 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

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 

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 Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173) was 

enacted on December 8, 2003. Section 

101 of title I of the MMA added a new 

‘‘Part D’’ to title XVIII of the Social 

Security Act (the Act), creating the 

Medicare prescription drug benefit 

program. The prescription drug benefit 

program is one of the most significant 

changes to the Medicare program since 

its inception in 1965. The MMA also 

made revisions to the provisions in 

Medicare Part C, governing what is now 

called the Medicare Advantage (MA) 

program (formerly Medicare+Choice). 

The MMA directed that important 

aspects of the new Medicare 

prescription drug benefit program under 

Part D be similar to and coordinated 

with regulations for the MA program. 

A final rule implementing the Part D 

prescription drug program appeared in 

the Federal Register on January 28, 

2005 (70 FR 4194). The provisions of 

that rule became effective on March 22, 

2005. 

The Medicare Improvements for 

Patients and Providers Act (MIPPA) 

(Pub. L. 110–275) was enacted on July 

15, 2008. MIPPA made a number of 

changes to the statutory provisions 

governing both the MA program under 

Part C and the prescription drug 

program under Part D. On September 

18, 2008, we published an interim final 

rule with comment period that made a 

wide array of revisions to regulations 

governing the Part C and Part D 

programs to reflect changes in the 

statutory provisions governing these 

programs made in MIPPA [see 73 FR 

54226]. This interim final rule with 

comment period similarly makes 

conforming changes to the Part D 

regulations to reflect certain statutory 

changes made in MIPPA that were not 

addressed in the September 18, 2008 

interim final rule. 

II. Provisions of the Interim Final Rule 

A. Medically Accepted Indication 

(§ 423.100 Definitions) 

Section 182 of MIPPA amends section 

1860D–2(e)(1) of the Act to add a new 

definition for ‘‘medically accepted 

indication,’’ effective January 1, 2009, 

for Part D drugs used in anticancer 

chemotherapeutic regimens, 

specifically, and all other Part D drugs. 

Under new section 1860D–2(e)(4) of the 

Act, a ‘‘medically accepted indication’’ 

for Part D drugs used in anticancer 

chemotherapeutic regimens has the 

meaning given in section 1861(t)(2)(B) 

of the Act, except that in applying the 

1861(t)(2)(B) definition, the terms 

‘‘prescription drug plan’’ or ‘‘MA–PD 

plan’’ are substituted for ‘‘carrier,’’ and 

the compendia described in section 

1927(g)(1)(B)(i)(III) of the Act are added 

to those listed in section 

1861(t)(2)(B)(ii)(I) of the Act. Also, on 

and after January 1, 2010, this last 

requirement shall not apply unless the 

compendia described in section 

1927(g)(1)(B)(i)(III) of the Act meets the 

requirement in the third sentence of 

section 1861(t)(2)(B) of the Act. 

Also under section 182 of MIPPA, for 

all Part D drugs not used in anticancer 

chemotherapeutic regimens, ‘‘medically 

accepted indication’’ has the meaning 

given in section 1927(k)(6) of the Act, 

except that in applying this provision, 

the Secretary shall revise the list of 

compendia described in section 

1927(g)(1)(B)(i) of the Act as appropriate 

for identifying medically accepted 

indications for drugs, in a manner 

consistent with the process for revising 

compendia under section 1861(t)(2)(B) 

of the Act. 

Consistent with these new statutory 

requirements, we have amended 

§ 423.100 by revising the definition of a 

Part D drug at § 423.100 to incorporate 

the new definition of medically 

accepted indication in section 1860D– 

2(e)(4) of the Act. 

B. Access to Covered Part D Drugs 

(§ 423.120) 

Section 176 of MIPPA added a new 

section 1860D–4(b)(3)(G)(i) to the Act 

requiring, effective for plan year 2010, 

that CMS identify, as appropriate, 

certain categories or classes of drugs 

which meet the following two pronged 

test: (1) Restricted access to the drugs in 

the category or class would have major 

or life threatening clinical consequences 

for individuals who have a disease or 

disorder treated by drugs in such 

category or class; and (2) there is a 

significant need for such individuals to 

have access to multiple drugs within a 

category or class due to unique chemical 

actions and pharmacological effects of 

the drugs within the category or class, 

such as drugs used in the treatment of 

cancer. 

Under a new section 1860D– 

4(b)(3)(G)(ii) of the Act, subject to the 

authority in section 1860D– 

4(b)(3)(G)(iii) of the Act to provide for 

exceptions, Part D formularies must 

include all covered Part D drugs in each 

class identified under section 1860D– 

4(b)(3)(G)(i) of the Act. Section 1860D– 

4(b)(3)(G)(iii), in turn, provides CMS the 

discretion to establish exceptions 

permitting sponsors of a prescription 

drug plan to exclude from their 

formularies, or to otherwise limit access 

to (including through prior 

authorization or other utilization 

management restrictions), certain Part D 

drugs from the protected categories and 

classes established consistent with 

section 1860D–4(b)(3)(G)(i) of the Act. 

As provided in section 1860D– 

4(b)(3)(G)(iii)(I) of the Act, any such 

exception must be based on scientific 

evidence and medical standards of 

practice (and, in the case of 

antitretroviral medications, be 

consistent with the Department of 

Health and Human Services Guidelines 

for the Use of Antitretroviral Agents in 

HIV–1–Infected Adults and 

Adolescents). In addition, as provided 

in section 1860D–4(b)(3)(G)(iii)(II) of the 

Act, such exceptions must be provided 

under a process that includes an 

opportunity for public notice and 

comment. We have added 

§ 423.120(b)(2)(v) to reflect the new 

formulary requirements in section 

1860D–4(b)(3)(G) of the Act. 

Based on our program experience, and 

consistent with our formulary review 

process, we plan to conduct an 

examination, described below, of widely 

used treatment guidelines in order to 

establish protected categories and 

classes for Part D sponsors that meet the 

requirements established by section 

1860D–4(b)(3)(G) of the Act. 

Additionally, consistent with section 

1860D–4(b)(3)(G)(iii) of the Act and 

§ 423.120(b)(2)(v) of this interim final 

rule, we may establish exceptions to the 

requirement that Part D sponsors 

include all Part D drugs in the protected 

categories and classes. Given the 

complexity involved in modern 

medicine and changes in drug therapies 

with availability of new information 

reaching providers almost daily, we 

anticipate that exceptions to our 

regulatory requirements will be 

necessary. For example, we believe that 

in certain circumstances the application 

of prior authorization may be 

appropriate to ensure use of Part D 

drugs in line with medically necessary 


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indications. As described below, we 

will therefore establish exceptions to the 

protected categories and classes through 

notice-and-comment rulemaking to 

ensure that they are established in a 

manner that provides for meaningful 

public input, in a fully transparent 

manner (in which we will formally 

respond to the public comments), that 

also enables us to meet operational 

timeframes. 

We note that Part D sponsors may 

apply edits to make appropriate 

coverage determinations for drugs 

included in the protected classes that 

may be covered under Medicare Part B. 

Until the Part D sponsor is able to affirm 

there is no Part B reimbursement, we do 

not consider the definition of a Part D 

drug to be satisfied. Furthermore, the 

limitation of drug utilization 

management relating to drugs in the 

protected classes does not extend to the 

application of safety edits. Part D 

sponsors and their subcontracted 

network pharmacies must apply 

established safety edits to drugs from 

the protected classes to ensure their 

enrollees are not harmed by inadvertent 

medication errors. 

We also note that, as stated in our 

January 28, 2005 Part D final rule (70 FR 

4194, 4260), inclusion of ‘‘all covered 

Part D drugs’’ from a protected class or 

category does not extend to inclusion of 

all brand-name drugs and generic 

versions of the covered drug in 

question. Under our longstanding 

interpretation of the term ‘‘covered Part 

D drug,’’ Part D sponsors will only be 

required to include on their formularies 

all chemically distinct drugs from the 

protected classes or categories in order 

to the meet the provisions of 

§ 423.120(b)(2)(v). We have consistently 

held that two drug products that are 

determined to be therapeutic 

equivalents by the Food and Drug 

Administration (FDA) and identified as 

such in the FDA’s Orange Book are 

considered to be the same Part D 

‘‘drug.’’ (According to the Orange Book: 

‘‘Drug products are considered to be 

therapeutic equivalents only if they are 

pharmaceutical equivalents and if they 

can be expected to have the same 

clinical effect and safety profile when 

administered to patients under the 

conditions specified in the labeling.’’) 

Thus, therapeutic equivalents are not 

counted twice for purposes of satisfying 

the CMS minimum formulary 

requirements. 

In planning for the implementation of 

section 1860D–4(b)(3)(G) of the Act, we 

note that we have gained valuable 

experience since 2006 in evaluating 

various drug classification systems and 

ensuring that Medicare beneficiaries 

reliant on drugs contained in certain 

categories or classes are neither 

substantially discouraged from enrolling 

in a Part D plan nor experience 

unnecessary complications related to 

accessing these drugs. Our experience 

has provided insight into the type of 

evaluation process that will be required 

to ensure that the classes and categories 

of drugs we are protecting are 

appropriate. In this rule, below, we 

describe our current thinking on the 

process we believe will allow us to most 

appropriately identify the classes and 

categories of drugs that should be 

protected. We would welcome 

comments on this process. 

We believe that it is necessary to 

establish a multi-level review process to 

ensure that we are appropriately 

identifying classes or categories that 

meet the criteria set forth in section 

1860D–4(b)(3)(G)(i) of the Act. Under 

this multi-level process, we are 

planning on conducting an initial 

analysis that is predominantly research 

and data driven, followed by a 

secondary clinical analysis that will 

serve as a validation review. Both 

processes will involve the identification 

of potential exceptions to the protected 

categories or classes provision. 

We plan on initiating the first-level 

review by selecting a contractor familiar 

with our CMS Part D formulary process. 

This contractor will review all the 

widely used treatment guidelines and 

generate a list highlighting those 

categories or classes in which multiple 

drugs within classes or categories are 

typically used to treat a specific 

disorder. Simultaneously, CMS will 

provide information to the contractor on 

beneficiary utilization of multiple drugs 

within categories and classes based on 

analysis of prescription drug event 

(PDE) data. The contractor will relate 

these findings to the information 

obtained from the examination of 

widely used treatment guidelines. 

For the second level validation, an 

expert panel of physicians and 

pharmacists will be organized to review 

the initial data developed from the 

contractor and offer recommendations 

based on a consensus opinion on the 

identification of protected categories 

and classes under the statute. 

Information regarding the 

independence, potential conflicts of 

interest, expertise, and balance of the 

individuals chosen to participate in this 

expert panel will be made publicly 

available. 

We firmly believe an expert panel can 

assist us in appropriately weighing the 

data derived from the initial analysis 

against the statutory requirements to 

identify protected categories or classes 

of drugs in which ‘‘access to multiple 

drugs within a category or class’’ is 

needed and in which ‘‘major or life 

threatening clinical consequences’’ may 

arise if access is restricted. Furthermore, 

we believe the expert panel will be well 

positioned to consider the data 

suggesting possible exceptions and 

overlay this with the protected 

categories or classes in order to identify 

exceptions that are based upon available 

scientific evidence and medical 

standards of practice. These exceptions 

will be subject to notice and comment 

as previously described. 

The results from the panel on the 

protected classes and exceptions will 

then be published in the Federal 

Register in a notice of proposed 

rulemaking seeking public comment, to 

be followed by the issuance of a final 

rule that responds to the public’s 

comments. We believe that reliance on 

the rulemaking process will better 

facilitate openness and transparency of 

the process for identifying, as 

appropriate, classes and categories of 

drugs that meet the MIPPA criteria. 

Given the contracting activities and 

subsequent extensive analysis necessary 

for reviewing all widely used treatment 

guidelines relative to the requirements 

of section 1860D–4(b)(3)(G)(i) of the Act, 

as well as commonly-used drug 

classification systems, we have 

determined that we will be unable to 

complete a full evaluation of what 

constitutes a protected category or class 

under the criteria set forth in section 

1860D–4(b)(3)(G)(i) of the Act in time 

for the 2010 plan year, as this would 

require that we hire a contractor, 

convene an expert panel, and go 

through notice of proposed and final 

rulemaking prior to April 2009, when 

Part D sponsors are required to submit 

their formularies. Therefore, although 

the new regulation text at 42 CFR 

423.120(b)(2)(v) states that ‘‘Effective 

contract year 2010,’’ formularies must 

include all Part D drugs in the categories 

or classes CMS has identified as meeting 

the MIPPA criteria, in practice, CMS 

will not have identified any such 

categories or classes for the contract 

year 2010. 

Rather, for 2010, given the timeframes 

discussed above, as well as the need to 

ensure consistency in formulary 

coverage as we complete our analysis to 

implement the requirements of section 

1860D–4(b)(3)(G)(i) of the Act, in the 

meantime we will retain our existing six 

classes of clinical concern contained in 

Chapter 6 of the Medicare Prescription 

Drug Benefit Manual (section 30.2.5), 

which were incorporated into the 

Manual under the statutory authority set 

out in section 1860D–11(e)(2)(D)(i) of 


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2884 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

the Act. Accordingly, Part D sponsors 

will continue to be expected to include 

all or substantially all drugs in the 

antidepressant, antipsychotic, and 

anticonvulsant classes, 

immunosuppressant (for prophylaxis of 

organ transplant rejection), 

antiretroviral, and antineoplastic (those 

not generally covered under Part B) 

drugs for coverage year 2010. We are 

retaining the policy providing for 

coverage of all or substantially all drugs 

in these six classes under our existing 

authority in section 1860D–11(e)(2)(D)(i) 

of the Act in order to ensure that Part 

D sponsors do not discriminate against 

any class of beneficiary by substantially 

discouraging enrollment. 

For contract years 2011 and beyond, 

any modifications we make to the 

protected categories and classes, 

whether under the existing MMA nondiscrimination authority or new 

authority under MIPPA, will be made 

through notice-and-comment 

rulemaking. Specifically, prior to 

establishing the protected categories and 

classes under the new MIPPA authority, 

CMS will (i) engage in an identification 

and validation process, such as the 

process described above and (ii) engage 

in a process of notice and comment 

rulemaking for any modifications 

(including any additions, subtractions, 

or exceptions) to the protected 

categories and classes under the MIPPA 

authority. In such rulemaking, or a 

separate rulemaking, we may further 

articulate our interpretation of the new 

statutory criteria. We believe that asking 

for (and responding to) public comment 

on results from the contractor and 

expert panel will better facilitate 

openness and transparency of the 

process for identifying, as appropriate, 

classes and categories of drugs that meet 

the MIPPA criteria. 

Similarly, if CMS makes 

modifications to the existing protected 

categories and classes under the MMA 

authority (i.e., the existing six classes of 

clinical concern), we will (i) engage in 

an identification and validation process, 

such as the process described above and 

(ii) engage in notice and comment 

rulemaking for any such modifications 

(including any additions, subtractions, 

or exceptions). Any such rulemaking 

may also further articulate our 

interpretation of the statutory language 

at section 1860D–11(e)(2)(D)(i) of the 

Act. This process will mirror the 

process for establishing the protected 

categories and classes under the new 

MIPPA authority. Soliciting, and 

responding to, public comment on 

results from the contractor and expert 

panel will increase the openness and 

transparency of the process for 

protecting classes and categories of 

drugs under the MMA nondiscrimination authority. 

In the past, we have used annual Call 

Letters and other guidance 

memorandums to announce the policy 

of expecting plan sponsors to cover ‘‘all 

or substantially all’’ drugs in the six 

classes of clinical concern. We 

announced the policy to ensure that 

enrollees had as smooth of a transition 

as possible into the Part D program. We 

also wanted to minimize potential 

beneficiary concern about access to 

drugs in the six protected classes and 

categories. 

However, we now have much more 

experience with Part D since the 

program started in January 2006. Thus, 

we are in a better position to consider 

drug categories and classes that should 

receive protection either under MIPPA 

or the MMA. Further, the public now 

has greater experience with a fully 

implemented Part D program and can 

provide more comprehensive comments 

on our continuing considerations about 

the program. 

Hence, CMS has decided that any 

modifications to the current six 

categories and classes, whether under 

MIPPA or the MMA authority, will go 

through the process described above 

that includes notice of proposed and 

final rulemaking. The rulemaking 

process will provide for more 

transparency in the process of 

identifying protected categories and 

classes, enabling the public to comment 

on how modifications to the current six 

classes will impact various 

stakeholders, including beneficiaries, 

beneficiary advocates, plan sponsors, 

contractors of plan sponsors, and 

governmental entities, among others. 

In addition, CMS believes that 

identifying protected classes and 

categories in the Code of Federal 

Regulations will provide greater clarity 

and transparency about those drug 

classes that are protected. 

III. Waiver of Proposed Rulemaking 

and Delay in Effective Date 

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. We also usually provide for a 

delay in effective date under section 

553(d) of the APA (5 U.S.C. 553(d), as 

well as section 801(a)(3) of the 

Congressional Review Act (5 U.S.C. 

801(a)(3)) (when applicable). However, 

such delay in effective date may be 

waived for good cause, when such delay 

is impracticable, unnecessary, or 

contrary to the public interest, and the 

agency incorporates a statement of the 

finding and a brief statement of the 

reasons therefore in the notice. 5 U.S.C. 

553(d)(3), 808(2). Because this interim 

final rule simply makes conforming 

changes to the Code of Federal 

Regulations to reflect changes in the 

statute, we find it would be unnecessary 

and contrary to the public interest to 

seek public comment on these 

provisions. For the same reasons, we 

also find that it would be unnecessary 

and contrary to the public interest to 

delay the effective date of such 

provisions beyond January 16, 2009. 

IV. Collection of Information 

Requirements 

This document does not impose any 

new information collection and 

recordkeeping requirements. Currently 

approved and forthcoming controls 

account for any collection of 

information burden relative to the 

provisions of this interim final rule, as 

outlined below. 

Section 423.120 Formulary 

Requirements 

Section 423.120(b)(2)(v) requires Part 

D sponsors to include in their contract 

year 2010 formularies all drugs in 

certain protected categories of classes of 

drugs specified by CMS, with certain 

exceptions that CMS establishes. 

The burden associated with this 

requirement is the time and effort put 

forth by Part D sponsors to submit their 

formularies to CMS. These collection of 

information requirements are currently 

approved under the Office of 

Management and Budget (OMB) Control 

No. 0938–0763. 

V. Regulatory Impact Analysis 

A. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993, as further 

amended), the Regulatory Flexibility 

Act (RFA) (September 19, 1980, Pub. L. 

96–354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4), Executive Order 13132 

on Federalism (August 4, 1999), and the 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2885 

Congressional Review Act (5 U.S.C. 

804(2)). 

Executive Order 12866, as amended, 

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). We 

estimate that this interim final rule with 

comment is economically significant 

under the Executive Order 12866, as it 

contains impacts of $100 million or 

more in any one year, and hence also a 

major rule under the Congressional 

Review Act. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, if a rule has a significant 

impact on a substantial number of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

supplies are small entities, either by 

nonprofit status or by having revenues 

of $7 million or less to $34.5 million in 

any 1 year. Individuals and States are 

not included in the definition of a small 

entity. 

We estimate that the coverage of all 

drugs by Part D sponsors from the CMSestablished protected classes or 

categories to have a cost impact to the 

federal budget in an amount exceeding 

$100 million for any given calendar year 

(CY). Table 1 provides the costs 

associated with these provisions for CY 

2010 through CY 2018. The assumptions 

underlying these cost estimates are 

explained later in this section. 

With respect to economic benefits, we 

have no reliable basis for estimating the 

effects of the proposals contained in this 

IFC. Accordingly, we estimate that 

while there could be economic benefits 

associated with these proposals, they 

are difficult to gauge at this time. 

The economically significant costs are 

reflected below in table 1. 

TABLE 1—PROJECTED PART D COSTS FOR CY 2010—CY 2018 

[Amounts in $ millions] 

CY 2010 CY 2011 CY 2012 CY 2013 CY 2014 CY 2015 CY 2016 CY 2017 CY 2018 CY 2010– 

2018 

Formulary requirements with respect 

to certain categories or classes 

of drugs ................. 0 160 340 460 520 570 640 710 800 4200 

We note that the change in the 

definition of a Part D drug to revise the 

meaning of the term ‘‘medically 

accepted indication,’’ as provided under 

section 1860D–2(e)(4) of the Act, was 

scored at zero additional cost to the 

program. Most of the anticancer 

chemotherapeutic regimens utilized by 

Medicare beneficiaries are covered 

under Part B, and while this new 

provision may extend coverage for 

anticancer therapeutic regimens under 

Part D, we believe the number of Part D 

drugs claims impacted by this change 

will be minimal. Therefore, we do not 

expect that this provision will 

significantly impact program costs. 

a. Regulatory Flexibility Analysis 

Under the RFA, we are not required 

to conduct an initial regulatory 

flexibility analysis for interim final 

rules. However, it is our longstanding 

policy to provide an analysis whenever 

we believe it would aid in the 

understanding of the effects of the 

interim final rule with comment. 

The RFA requires agencies to 

determine whether a rule will have a 

‘‘significant economic impact on a 

substantial number of small entities.’’ 

Under the RFA, a ‘‘small entity’’ is 

defined as a small business (as 

determined by the Small Business 

Administration (SBA)), a non-profit 

entity of any size that is not dominant 

in its field, or a small government 

jurisdiction. HHS uses its measure of a 

significant economic impact on a 

substantial number of small entities to 

be a change in revenues of more than 3 

to 5 percent. 

With respect to the provisions 

contained in this interim final rule, we 

believe only retail pharmacies which are 

small businesses will be impacted. 

Other small businesses, such as 

physicians in private practice or small 

businesses that deliver prescriptions to 

beneficiaries, will be unaffected by this 

interim final rule since there is no direct 

impact to their operations or 

profitability. For example, private 

physicians will generally continue to 

follow current prescribing practices 

regardless of Part D formularies. Small 

delivery businesses will continue to 

deliver the same number of 

prescriptions regardless of the drug 

name or formulary inclusion. 

The Small Business Administration 

(SBA) considers pharmacies with firm 

revenues less than $7 million to be 

small businesses. The 2004 Business 

Census (the latest available detailed 

data) indicated that there were 

approximately 19,443 firms operating 

about 40,115 retail pharmacies and drug 

store establishments (NAICS code 

44611). Of these firms, 17,835 had 

revenues under $7 million and operated 

a total of 17,835 establishments. As a 

result, we estimate that more than 90 

percent of retail pharmacy firms are 

small businesses (as defined by the SBA 

size standards). 

We do not believe that retail 

pharmacies would be significantly 

impacted by the requirement for Part D 

sponsors to include all drugs in 

protected classes or categories specified 

by CMS. While the number of brand 

name drugs dispensed in these 

categories may increase, we do not think 

there will be a substantial increase in 

overall retail pharmacy profits. Retail 

pharmacies may incur some limited 

costs relative to this provision, since 

they may need to inventory more drugs 

within these classes given that Part D 

sponsors may not be able to concentrate 

volume on lower cost salts, esters and 

active moieties. 

As previously discussed, the other 

change contained in this interim final 

rule is not expected to affect small 

businesses in a significant manner, if at 

all. For example, section 182 of the 

MIPPA requires modification to the 

definition of a medically accepted 

indication for purposes of a Part D drug. 

While Part D sponsors will be expected 

to implement this new definition 

through their drug utilization 

management programs, small 


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businesses, such as retail pharmacies or 

physicians, will not require any changes 

to their existing operations. The 

application of drug utilization 

management is common in the 

commercial market, and small 

businesses already have processes (that 

is, administrative staff or pharmacy 

technicians) to supply the necessary 

information to address drug utilization 

management requirements. As a result, 

we do not anticipate any additional 

costs or burdens to be placed on other 

small businesses. 

Section 1102(b) of the Social Security 

Act requires us to prepare a regulatory 

flexibility 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. This interim final rule will not 

affect small rural hospitals since the 

program will be directed at outpatient 

prescription drugs, not drugs provided 

during a hospital stay. As required by 

law, prescription drugs provided during 

hospital stays are covered under a 

separate Medicare payment system. 

Therefore, we are not providing an 

analysis in this rule. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

requires that agencies assess anticipated 

costs and benefits and take certain other 

actions before issuing a final rule that 

includes any Federal mandate that may 

result in expenditure in any one year by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million. That threshold, updated 

for inflation, is currently approximately 

$130 million. We anticipate that this 

interim final rule will not impose costs 

above the $130 million UMRA threshold 

on State, local, tribal governments, in 

the aggregate, or by the private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it issues a final rule 

that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

The changes and additions contained in 

this interim final rule do not impose 

new costs on states or local 

governments. 

There are no anticipated Federalism 

implications because none of the 

provisions contained in this interim 

final rule place any requirements on 

States. 

B. Anticipated Effects on Health Plans 

and Pharmacy Benefit Managers (PBMs) 

Part D sponsors will be significantly 

impacted by this IFC rule. For example, 

we believe that the new provision 

relative to the establishment of certain 

protected classes and categories of Part 

D drugs will have a significant impact 

on Part D sponsors, a class of 

beneficiaries and the Federal 

Government. This new provision 

requires that Part D sponsors include all 

drugs in protected classes and categories 

of drugs that CMS specifies as meeting 

both of the following conditions: 

1. Restricted access to drugs in the 

category or class would have a major or 

life threatening clinical consequence. 

2. A significant clinical need exists for 

individuals to have access to multiple 

drugs within a category or class due to 

unique chemical actions and 

pharmacological effects. 

We expect these conditions will likely 

expand access to drugs for certain 

classes or categories and provide greater 

inclusion of manufacturers’ drugs 

associated with those classes or 

categories in the Part D program. If 

additional drug classes and categories 

are required to be included on Part D 

sponsor formularies, Part D sponsors’ 

costs could increase, since more drugs 

could need to be covered. Conversely, if 

fewer classes and categories are required 

to be included on Part D sponsors’ 

formularies, Part D sponsors’ costs 

could decrease, since less drugs could 

require coverage. Since we are only now 

beginning our examination of widely 

used treatment guidelines in order to 

establish the protected classes or 

categories that meet the aforementioned 

requirements, we estimate that this 

provision will add an additional $160 

million to the cost of the Part D program 

in CY 2011. We believe this will 

increase to $800 million in CY 2018, 

with total costs of approximately $4.2 

billion dollars for the period CY 2010 

through CY 2018. 

To arrive at the cost estimate for the 

implementation of the protected 

categories and classes, we began by 

putting drug spending into 3 groupings: 

(1) Drugs that were already included in 

the six classes of clinical concern; (2) 

drugs with a greater likelihood of being 

affected by this statutory change; and (3) 

drugs with a lesser likelihood of being 

affected by this statutory change. For 

each of these categories, we estimated 

the likelihood that they would 

ultimately be included in the protected 

categories and classes. A very 

preliminary review of commonly used 

classification systems revealed that 

additional categories and classes of 

drugs may be included in the protected 

categories and classes based upon the 

statutory requirements in section 

1860D–4(b)(3)(G)(i) of the Act. We 

assumed that it would take several years 

for the full impact of this policy to take 

effect as new formulary requirements 

are fully implemented and 

manufacturers discover their new 

negotiating positions. Finally, we 

estimated the impact on drug 

expenditures for those drugs that could 

potentially be moved into protected 

categories or classes of drugs based on 

the statutory requirements. These 

impacts reflect our best estimates of a 

range of possibilities that cannot be 

more accurately projected until actual 

decisions are made. 

There is a large amount of uncertainty 

in the cost impact presented above. As 

described above, the cost impact is 

calculated based on making a series of 

assumptions regarding potential classes 

that may become protected. It is 

possible that the actual number of 

classes that would be protected will be 

different than we’ve estimated. For 

example, if no classes beyond the 

current six become protected, there 

would be no cost impact at all. 

Alternatively, if a greater number of 

classes than we estimate become 

protected, the actual cost impact will be 

greater than presented above. Moreover, 

if this process only resulted in the 

elimination of the existing six classes, 

savings could accrue. 

If additional categories and classes are 

included on Part D sponsor formularies 

as a result of the new statutory 

provisions, we expect sponsors’ 

negotiating power to be diminished. If 

this were to occur, Part D sponsors 

could incur higher drug costs and could 

be forced to raise their bids, which 

could result in higher premiums and copays to offset these increases. We also 

anticipate that Part D sponsors could 

have additional costs associated with 

managing a larger overall formulary—for 

example, increased Pharmacy and 

Therapeutics Committee oversight and 

increased expenses in marketing more 

products on comprehensive formularies. 

Alternatively, however, the number of 

protected classes and categories meeting 

the MIPPA requirement could decline 

relative to the current six protected 

under the MMA authority. If this were 

the case, we expect Part D sponsors’ 

negotiating power to increase. As a 

result, Part D sponsors could incur 

lower drug costs and could lower their 

bids, which could result in lower 

premiums and co-pays. 

We are also uncertain at this time 

what exceptions to the requirement that 

Part D sponsor formularies include all 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2887 

drugs in the protected categories and 

classes of drugs will be established by 

CMS. We anticipate establishing 

exceptions similar to those available 

under our existing six classes of clinical 

concern policy. It is possible we will 

establish fewer exceptions, and Part D 

sponsors may have to include more 

drugs on their formularies than current 

policy. However, it is also possible that 

we may establish more exceptions than 

current policy. We are also uncertain 

how Part D sponsors will be permitted 

to apply drug utilization management to 

drugs in the protected classes until we 

finalize the exceptions to the protected 

categories and classes requirement. We 

believe that if we are unable to permit 

Part D sponsors to apply meaningful 

utilization management to these drugs— 

even if only for beneficiaries initiating 

therapy in these categories or classes— 

the result could be an increased use of 

brand-name or higher cost drugs and an 

increase in costs overall. These costs 

could be reflected in bids submitted to 

CMS by Part D sponsors and could 

result in increased premiums for 

Medicare beneficiaries. We plan on 

working closely with all of our Part D 

sponsors as our guidance in this area 

develops to ensure they have the 

information they need to negotiate as 

efficiently as possible and continue to 

provide high quality prescription drug 

coverage at the most economical price. 

Except for the potential impact of 

increased or decreased costs (that is, 

increased or decreased copayments and 

premiums) on beneficiaries, we do not 

believe that the implementation of the 

protected classes and categories 

requirement will negatively impact 

enrollment in Part D plans. We also do 

not believe that the provisions of this 

rule will lead to greater beneficiary 

confusion or any increased difficulty in 

making enrollment decisions. While 

increased copayments and premiums 

may dissuade some beneficiaries from 

enrolling in particular Part D plans, we 

continue to believe that overall 

enrollment will increase given 

demographic trends and the increasing 

cash prices for drugs. Accordingly, we 

believe Medicare beneficiaries will 

continue to find Part D to be a cost 

efficient method of obtaining robust 

drug coverage at a range of acceptable 

costs. 

We also believe that PBMs could 

experience higher administrative costs 

as a result of the provisions contained 

in this rule. The protected classes 

provision may increase a number of 

formulary maintenance expenses 

ranging from managing a larger 

formulary to increased support of 

technical call centers to address 

requests for assistance in processing a 

wider range of covered drugs. As a 

result, PBMs may increase their fees to 

Part D sponsors to offset these increased 

costs. We do not believe these 

additional costs will negatively impact 

the PBM industry given its ability to 

pass these onto the Part D sponsors. 

Similar to our ongoing communications 

with our Part D sponsors, we intend to 

work closely with the PBM industry to 

ensure as much efficiency as possible 

and minimize any resulting increases in 

beneficiary costs. 

C. Alternatives Considered 

All of the provisions in this interim 

final rule are a result of the recent 

passage of the MIPPA and are largely 

self-implementing. With the publication 

of this interim final rule, we desire to 

make our implementing regulations 

available to industry and the public as 

soon as possible to facilitate continued, 

efficient operation of the Parts C and D 

programs. 

D. Accounting Statement 

As required by OMB Circular A–4 

(available at http:// 

www.whitehouse.gov/omb/circulars/ 

index.html), Table 2 below provides an 

accounting statement showing the 

classification of the expenditures 

associated with the provisions of this 

IFC rule. This table provides our best 

estimate of the increase in costs as a 

result of the changes presented in this 

final rule. All costs, including increases 

and reductions, are classified as 

transfers by the Federal Government to 

Part D plans or MAOs. 

TABLE 2—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES

Category Transfers 

($ millions) 

Formulary requirements with respect to certain categories or classes of drugs, CYs 2010–2018: 

Undiscounted Annualized Monetized Transfers .................................................................................... 466.7. 

Annualized Monetized Transfers Using 7% Discount Rate .................................................................. 424.5. 

Annualized Monetized Transfers Using 3% Discount Rate .................................................................. 448.3. 

From Whom to Whom? ......................................................................................................................... Federal Government to Part D Plans. 

D. Conclusion 

Given that we expect the cost of 

implementing a number of the 

provisions contained in this IFC rule, as 

specified in Table 1, will exceed the 

$100 million threshold within a single 

year between CY 2010 and CY 2018, we 

conducted an economic impact analysis 

with regard to those entities potentially 

impacted by these provisions. As we 

stated previously in this preamble, we 

expect that entities such as pharmacies 

will benefit from these changes, whereas 

other entities, such as Part D sponsors, 

will experience additional costs which 

they will pass on to CMS through direct 

subsidy payments and to beneficiaries 

through additional premiums as 

reflected in their bids. In accordance 

with the provisions of Executive Order 

12866, this final rule was reviewed by 

the Office of Management and Budget. 

List of Subjects in 42 CFR Part 423 

Administrative practice and 

procedure, Emergency medical services, 

Health facilities, Health maintenance 

organizations (HMO), Medicare, 

Penalties, Privacy, Reporting and 

recordkeeping. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below: 

PART 423—VOLUNTARY MEDICARE 

PRESCRIPTION DRUG BENEFIT 

Subpart C—Benefits and Beneficiary 

Protections 

■ 1. The authority citation for part 423 

continues to read as follows: 

Authority: Secs. 1102, 1106, 1860D–1 

through 1860D–42, and 1871 of the Social 

Security Act (42 U.S.C. 1302, 1306, 1395w– 

101 through 1395w–152, and 1395hh). 

■ 2. Amend § 423.100 by revising the 

introductory text of paragraph (1) under 

the definition of ‘‘Part D drug’’ to read 

as follows: 


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2888 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

§ 423.100 Definitions. 

* * * * * 

Part D drug means— 

(1) Unless excluded under paragraph 

(2) of this definition, any of the 

following if used for a medically 

accepted indication (as defined in 

section 1860D–2(e)(4) of the Act)— 

* * * * * 

■ 3. Amend § 423.120 by— 

■ A. Revising (b)(2) introductory text. 

■ B. Revising (b)(2)(i). 

■ C. Adding (b)(2)(v). 

The revisions and additions to read as 

follows: 

§ 423.120 Access to covered Part D drugs. 

* * * * * 

(b) * * * 

(2) Provision of an Adequate 

Formulary. A Part D plan’s formulary 

must— 

(i) Except as provided in paragraphs 

(b)(2)(ii) and (v) of this section, include 

within each therapeutic category and 

class of Part D drugs at least two Part D 

drugs that are not therapeutically 

equivalent and bioequivalent, with 

different strengths and dosage forms 

available for each of those drugs, except 

that only one Part D drug must be 

included in a particular category or 

class of covered Part D drugs if the 

category or class includes only one Part 

D drug. 

* * * * * 

(v) Effective contract year 2010, a Part 

D Sponsor’s formulary will include all 

Part D drugs in a category or class that 

CMS has identified as meeting the two 

conditions set forth in section 1860D– 

4(b)(3)(G)(i) of the Act. CMS may 

establish certain exceptions, which may 

include the application of drug 

utilization management under certain 

circumstances, through a process that 

provides for public notice and 

comment, and ensures that any 

exception to such requirements is based 

upon scientific evidence and medical 

standards of practice (and, in the case of 

antiretroviral medications, is consistent 

with the Department of Health and 

Human Services Guidelines for the Use 

of Antiretroviral Agents in HIV–1– 

Infected Adults and Adolescents). 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 12, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: January 9, 2009. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E9–783 Filed 1–15–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Parts 88 and 89 

RIN 0991–AB46 

Office of Global Health Affairs: 

Regulation on the Organizational 

Integrity of Entities That Are 

Implementing Programs and Activities 

Under the Leadership Act; Correction 

OFFICE: Office of Global Health Affairs, 

HHS. 

ACTION: Rule; Correction. 

SUMMARY: This document corrects 

technical errors that appeared in the 

final rule published in the Federal 

Register on December 24, 2008, entitled 

‘‘Regulation on the Organizational 

Integrity of Entities That Are 

Implementing Programs and Activities 

Under the Leadership Act’’ (73 FR 

78997). 

DATES: Effective January 20, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Jeanne Monahan, Office of Global 

Health Affairs, Hubert H. Humphrey 

Building, Room 639H, 200 

Independence Avenue, SW., 

Washington, DC 20201, Tel: 202–690– 

6174, e-mail: Jeanne.monahan@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. E8–30686, published on 

December 24, 2008 (73 FR 78997), there 

were technical errors that are identified 

and corrected in the Correction of Errors 

section below. The correction of errors 

identified in this correction notice do 

not change any policies contained in the 

final rule published December 24, 2008, 

and thus are effective as if they had 

been included in the final rule. 

II. Summary of Errors 

HHS published a final rule entitled 

‘‘Regulation on the Organizational 

Integrity of Entities That Are 

Implementing Programs and Activities 

Under the Leadership Act.’’ This final 

rule provided for creation of a new Part 

88 of 45 CFR. A final rule published on 

December 19, 2008 (73 FR 78071), 

entitled ‘‘Ensuring That Department of 

Health and Human Services Funds Do 

Not Support Coercive or Discriminatory 

Policies or Practices in Violation of 

Federal Law,’’ however, also purported 

to create a new Part 88. We are 

correcting this error by creating a new 

Part 89 and moving the regulatory text 

from the final rule published on 

December 24, 2008 (73 FR 78997) to Part 

89. We are correcting text throughout 

the preamble and regulatory text to 

reflect this move. 

III. Correction of Errors 

In FR Doc. E8–30686, published on 

December 24, 2008 (73 FR 78997), make 

the following corrections: 

[Corrections to the preamble] 

1. On page 78997, in the heading, 

third line, ‘‘45 CFR Part 88’’ is corrected 

to read ‘‘45 CFR Part 89.’’ 

2. On page 78998, in the first column, 

following the sixth full paragraph, the 

heading ‘‘Section 88.1 Definitions’’ is 

corrected to ‘‘Section 89.1 Definitions.’’ 

3. On page 78998, in the second 

column, following the fifth paragraph, 

the heading ‘‘Section 88.2 Objective 

Integrity of Recipients’’ is corrected to 

‘‘Section 89.2 Objective Integrity of 

Recipients.’’ 

4. On page 78998, in the third 

column, in the first full paragraph, line 

6, ‘‘section 88.3’’ is corrected to ‘‘section 

89.3.’’ 

5. On page 78998, in the third 

column, following the first full 

paragraph, the heading ‘‘Section 88.3 

Certifications’’ is corrected to ‘‘Section 

89.3 Certifications.’’ 

6. On page 78998, in the third 

column, third full paragraph, line 3, 

‘‘section 88.3(d)(1)’’ is corrected to 

‘‘section 89.3(d)(1).’’ 

7. On page 78998, in the third 

column, fourth full paragraph, lines 3– 

4, ‘‘section 88.3(d)(2) and (3)’’ is 

corrected to ‘‘section 89.3(d)(2) and (3).’’ 

8. On page 79001, in the first column, 

following the second full paragraph, the 

heading ‘‘List of Subjects in the 45 CFR 

Part 88’’ is corrected to ‘‘List of Subjects 

in the 45 CFR Part 89.’’ 

[Corrections to the regulatory text] 

9. On page 79001, in the first column, 

in the words of issuance, immediately 

following paragraph captioned 

‘‘Editorial Note,’’ revise the paragraph to 

read ‘‘For the reasons stated in the 

preamble, the Office of Global Health 

Affairs amends 45 CFR subtitle A to add 

Part 89 as follows:’’ 

10. On page 79001, in the first 

column, in the part heading, ‘‘Part 88’’ 

is corrected to ‘‘Part 89.’’ 

11. On page 79001, in the first 

column, in the table of contents, ‘‘88.1 

Definitions’’ is corrected to ‘‘89.1 

Definitions.’’ 


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