[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Notices]
[Pages 39762-39764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19061]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Notice Regarding Section 602 of the Veterans Health Care Act of 
1992 Patient and Entity Eligibility

AGENCY: Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: Section 602 of Public Law 102-585, the ``Veterans Health Care 
Act of 1992,'' enacted section 340B of the Public Health Service Act 
(PHS Act), ``Limitation on Prices of Drugs Purchased by Covered 
Entities.'' Section 340B provides that a manufacturer who sells covered 
outpatient drugs to eligible entities must sign a pharmaceutical 
pricing agreement with the Secretary of Health and Human Services in 
which the manufacturer agrees to charge a price for covered outpatient 
drugs that will not exceed that amount determined under a statutory 
formula.
    The purpose of this notice is to inform interested parties of 
decisions regarding certain issues of program implementation. The 
notice will discuss the determination of covered entity status (i.e., 
PHS entity and disproportionate share hospital eligibility) and the 
administrative program requirements for ``covered entity'' status. 
Further, PHS is proposing a definition of eligible covered entity 
``patient'' in section III for public comment.

DATES: The public is invited to submit comments on the proposed 
definition of ``patient'' in section III by September 5, 1995. After 
consideration of the comments submitted, the Secretary will issue the 
final guidelines.

FOR FURTHER INFORMATION CONTACT: Marsha Alvarez, R. Ph., Attn: Drug 
Pricing Program, Bureau of Primary Health Care, 4350 East West Highway, 
10th Floor, Bethesda, MD 20814, Phone (301) 594-4353.

SUPPLEMENTARY INFORMATION: The Office of Drug Pricing has developed the 
following guidelines to facilitate program implementation and is 
proposing a definition of ``patient'' in section III for public 
comment.

I. Covered Entity Status

PHS Entities

    Section 340B(a)(4) of the PHS Act lists the various categories of 
PHS programs eligible to receive section 340B outpatient drug discount 
pricing. For each category, there is a Federal program office which 
oversees the grant program. The respective Federal program offices 
determine which individual facilities receive the grant funds specified 
by section 340B or are eligible under other criteria and compile a list 
of such entities. The Federal program office then submits this list to 
the Office of Drug Pricing (ODP) for inclusion on the master list of 
eligible facilities (``covered entities'').
    Each program office is responsible for maintaining a current data 
file of eligible entities and submitting all updated information to the 
ODP. This information may either be submitted on a quarterly or yearly 
basis, depending upon the number of entity status changes in a given 
period. Each program office determines how often updates are necessary 
to maintain current entity information on the ODP master list of 
covered entities and notifies the ODP of their respective update time 
periods. The update file data is submitted to ODP in either a dbf or 
ASCI file, the formats of which are available from the ODP. Program 
offices submit their updates to the ODP on the following dates: (a) 
December 1 for the January 1 update, (b) March 1 for the April 1 
update, (c) June 1 for the July 1 update, and (d) September 1 for the 
October 1 update.
    The ODP will update the master covered entity file on a quarterly 
basis. The name of an entity will not be added or deleted at any other 
time. For example, if an entity becomes an eligible PHS grantee, its 
name will not appear on the ODP master list until the program office 
submits the name in its update package and the ODP subsequently updates 
the ODP master list during the next quarterly cycle. ODP will not 
directly add to or delete an entity name from the ODP master list. An 
entity name to be added or deleted must be submitted by the program 
office during a scheduled update period.
    The following is a list of the Federal program offices which 
oversee the 340B eligible programs and contact persons (except as 
otherwise indicated, references are to sections of the Public Health 
Service Act):
    1. Federally-qualified health center, as defined in section 
1905(1)(2)(B) of the Social Security Act (42 U.S.C. 
Sec. 1396d(1)(2)(B)), means an entity that:
    (a) receives a grant under section 329 (migrant health center), 
section 330 (community health center), section 340 (health services for 
the homeless), and section 340A (health services for residents of 
public housing); or
    (b) (i) receives funding from such a grant under a contract with 
the recipient of the grant, and (ii) meets the requirements to receive 
a grant under section 329, 330, 340 and 340A; or
    (c) based on the recommendation of the Health Resources and 
Services Administration (HRSA) within the Public Health Service, is 
determined by the Secretary to meet requirements for 

[[Page 39763]]
receiving such a grant (i.e., ``look-alikes''); or
    (d) was treated by the Secretary, for purposes of part B of Title 
XVIII of the Social Security Act, as a comprehensive Federally funded 
health center as of January 1, 1990; or
    (e) an outpatient health program or facility operated by a tribe or 
tribal organization under the Indian Self-Determination Act (Public Law 
93-638) or by an urban Indian organization receiving funds under title 
V of the Indian Health Care Improvement Act for the provision of 
primary health services. (Norma Campbell, Division of Community and 
Migrant Health, 301-594-0287), (Marie Garramone, Division of Community 
and Migrant Health {for look-alikes}, 301-594-4335), (Charles Woodson, 
Division of Programs for Special Populations, homeless and public 
housing health centers, 301-594-4430: Laura Visser, {for 340S school 
based programs}, 301-594-4470), (Elmer Brewster, DCSP, Special 
Initiatives Branch {for Urban Indian}, 301-443-4680), and (Merry Elrod, 
Office of Tribal Activities {for P.L. 93-638}, 301-443-1044).
    2. Family planning projects receiving grants or contracts under 
section 1001, 42 U.S.C. 300. (Sophia Lawson, Office of Population 
Affairs, 301-594-4000).
    3. An entity receiving a grant for outpatient early intervention 
services for HIV infection under subpart II of part C of title XXVI, 42 
U.S.C. 300ff-51 et seq. (Laverne Green, Office of Programs for Special 
Populations, HIV, 301-594-4451).
    4. A State-operated AIDS drug purchasing assistance program 
receiving financial assistance under section 2616 of the Act, 42 U.S.C. 
300ff-26. (Richard Schulman, Division of HIV Services, 301-443-9091).
    5. A black lung clinic receiving funds under section 427(a) of the 
Black Lung Benefits Act, 30 U.S.C. 937(a). (Norma Campbell, Division of 
Community and Migrant Health, 301-594-0287).
    6. A comprehensive hemophilia diagnostic treatment center receiving 
a grant under section 501(a)(2) of the Social Security Act, 42 U.S.C. 
701(a)(2). (Patrick McGuckin, National Hemophilia Program, 301-443-
9051).
    7. A Native Hawaiian Health Center receiving funds under the Native 
Hawaiian Health Care Act of 1988, 42 U.S.C. 11701 et seq. (Julia 
Tillman, Division of Programs for Special Populations, 301-594-4460).
    8. Certain covered facilities must be certified by the Secretary 
before they become eligible for the discount drug prices, pursuant to 
section 340B(a)(7) of the PHS Act. The facilities requiring 
certification are those that
    (a) receive grant funds related to the treatment of sexually 
transmitted diseases through a state or local government under section 
318 of the PHS Act, 42 U.S.C. 247c, or related to the treatment of 
tuberculosis through a state or local government under section 317 E 
(a) of the PHS Act, 42 U.S.C. 247b-6, (Carmine Bozzi, Centers for 
Disease Control and Prevention, National Center for Prevention 
Services, 404-639-8008), or
    (b) receive assistance under title XXVI of the PHS Act, 42 U.S.C. 
300ff et seq., other than a State or unit of local government or a 
grantee for HIV outpatient early intervention services (subpart II of 
part C of title XXVI of the PHS Act). (Richard Schulman, Division of 
HIV Services, 301-443-9091).
    The criteria for eligibility include State certification that the 
facility does receive Federal grant funds and is a facility described 
in (a), or (b) above.
    Electronic Data Retrieval System (EDRS) which can be accessed by 
dialing (301) 594-4992.
Disproportionate Share Hospitals

    Certain hospitals are eligible for section 340B discount outpatient 
drug pricing if they meet the eligibility criteria. First, section 
340B(a)(4)(L)(ii) provides that a hospital must be a ``disproportionate 
share'' hospital (DSH) as defined in section 1886(d)(1)(B) of the 
Social Security Act, which (for the most recent cost reporting period 
that ended before the calendar quarter involved) had a disproportionate 
share adjustment greater than 11.75 percent. This percentage is 
determined by the Health Care Financing Administration (HCFA), and a 
list of DSHs which meet this criteria is provided to the Office of Drug 
Pricing.
    Second, section 340B(a)(4)(L)(i) provides that DSHs eligible for 
PHS pricing must meet one of the following requirements: (1) is owned 
or operated by a unit of State or local government, (2) is a public or 
private non-profit corporation which is formally granted governmental 
powers by a unit of State or local government, or (3) is a private 
nonprofit hospital which has a contract with a State or local 
government to provide health care services to low income individuals 
who are not entitled to benefits under title XVIII or XIX of the Social 
Security Act. All DSHs wishing to have access to section 340B discount 
outpatient drug pricing must provide the ODP a certification of their 
compliance with one of the three alternative requirements.
    Third, a DSH is prohibited from participating in a group purchasing 
organization or any group purchasing association, pursuant to section 
340B(a)(4)(L)(iii). DSHs wishing to access the discount pricing must 
provide the Office of Drug Pricing with a certification of their 
compliance with this prohibition.
    DSHs must submit all necessary certifications to the Public Health 
Service DSH contact person--Elizabeth Hickey, Office of Drug Pricing, 
Bureau of Primary Health Care, West Tower, 10th Floor, 4350 East West 
Highway, Bethesda, Maryland, 20814, telephone (301) 594-4353.

II. Entity Participation Requirements

    Section 340B(a)(4) of the PHS Act defines a ``covered entity'' as 
belonging to one or more of the eligible categories of PHS grantees or 
disproportionate share hospitals listed in subparagraph (4) and meeting 
the requirements of subparagraph (5). Subparagraph (5)(A) requires HHS 
to develop a mechanism to prevent a double PHS discount/Medicaid rebate 
potential; therefore, as part of this mechanism, each eligible entity 
must provide the ODP with certification of its pharmaceutical Medicaid 
billing status. Any entity which does not comply with this requirement 
will not be deemed a ``covered entity'' and will not be eligible for 
section 340B drug discounts. Those entities currently listed on the ODP 
master list which have not certified their Medicaid billing status will 
be removed from the ODP master list unless they certify their current 
billing status by the next quarterly update. Entities listed on 
subsequent program updates will be given one quarter from the date of 
the program update or until the next ODP update to certify their 
Medicaid billing status to ODP. Once the entity has certified its 
Medicaid billing status, its name will be included on the master list 
as a covered entity on the next ODP update.
    A certification of the following information must be provided to 
the ODP before an entity will be deemed a ``covered entity:'' First, a 
covered entity, billing on a cost basis for covered outpatient drugs, 
must provide the ODP with a pharmaceutical Medicaid number (the number 
which the entity uses to bill Medicaid for such drugs). Second, a 
covered entity using an all-inclusive rate (either per encounter or 
visit) must provide the ODP with certification of this billing status 
and whether the all-inclusive rate includes covered outpatient drugs. 
Third, if a covered entity does not bill Medicaid for covered 
outpatient drugs, the entity 

[[Page 39764]]
must notify the ODP of this decision. Fourth, a facility which houses 
many different clinics, only one or several of which are eligible, must 
obtain a separate Medicaid provider number for the eligible clinics. 
For those States which cannot generate additional Medicaid provider 
numbers for entities, the covered entity must discuss and implement an 
alternative arrangement with the States to prevent the duplicate PHS 
discount/Medicaid rebate potential. See 59 FR 25112 (May 13, 1994). 
Please note that only covered entities wishing to access the PHS 
discount pricing should certify their pharmaceutical Medicaid billing 
status to ODP.

III. Definition of Eligible Entity ``Patient''

    Section 340B(a)(5)(B) of the PHS Act states that the covered entity 
must provide drugs, discounted under the statute, only to its patients 
and not resell or otherwise transfer such drugs to individuals who are 
not patients of the entity. To address the potential for drug resale or 
transfer, PHS published final entity guidelines concerning drug 
diversion. See 59 Fed. Reg. 25112, May 13, 1994. In part, covered 
entities are required to ``develop and institute adequate safeguards to 
prevent the transfer of discounted outpatient drugs to individuals who 
are not eligible for the discount.'' To accomplish this end, entities 
are encouraged to utilize a separate purchasing account and separate 
dispensing records. To further address the potential for drug 
diversion, PHS is now proposing a definition of a covered entity 
``patient.''
    An individual is a ``patient'' of a covered entity (with the 
exception of State-operated AIDS drug purchasing assistance programs) 
only if:
    1. the covered entity has established a relationship with the 
individual, such that the covered entity maintains records of the 
individual's health care; and
    2. the individual receives health care services from a health care 
professional who is either employed by the covered entity or provides 
health care under contractual or other arrangements (e.g. referral for 
consultation) such that responsibility for the care provided remains 
with the covered entity; and
    3. the individual receives a health care service or range of 
services from the covered entity which is consistent with the service 
or range of services for which grant funding or Federally-qualified 
health center look-alike status has been provided to the entity. 
Disproportionate share hospitals are exempt from this requirement.
    An individual will not be considered a ``patient'' of the entity 
for purposes of 340B if the only health care service received by the 
individual from the covered entity is the dispensing of a drug or drugs 
for subsequent self-administration or administration in the home 
setting.
    An individual registered in a State-operated AIDS drug purchasing 
assistance program receiving financial assistance under title XXVI of 
the PHS Act will be considered a ``patient'' of the covered entity for 
purposes of this definition if so registered as eligible by the State 
program.

    Dated: June 5, 1995.
Ciro V. Sumaya,
Administrator, Health Resources and Services Administration.
[FR Doc. 95-19061 Filed 8-2-95; 8:45 am]
BILLING CODE 4160-15-P