[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20373-20375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: 
Enrollment and Re-Certification of Entities in the 340B Drug Pricing 
Program, OMB Number 0915-0327--Revision

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Before submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than July 8, 
2019.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers 
Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title, below, for reference.
    Information Collection Request Title: Enrollment and Re-
Certification of Entities in the 340B Drug Pricing Program, OMB No. 
0915-0327--Revision.
    Abstract: Section 602 of Public Law 102-585, the Veterans Health 
Care Act of 1992, enacted section 340B of the Public Health Service 
(PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing 
Agreement (PPA) with manufacturers of covered outpatient drugs. 
Manufacturers are required by section 1927(a)(5)(A) of the Social 
Security Act to enter into agreements with the Secretary of HHS (the 
Secretary) that comply with section 340B of the PHS Act if they 
participate in the Medicaid Drug Rebate Program. When a drug 
manufacturer signs a PPA, it is opting into the 340B Drug Pricing 
Program (340B Program), and it agrees to the statutory requirement that 
prices charged for covered outpatient drugs to covered entities will 
not exceed statutorily defined 340B ceiling prices. When an eligible 
covered entity voluntarily decides to enroll and participate in the 
340B Program, it accepts responsibility for ensuring compliance with 
all provisions of the 340B Program, including all associated costs. 
Covered entities that choose to participate in the 340B Program must 
comply with the requirements of section 340B(a)(5) of the PHS Act. 
Section 340B(a)(5)(A) of the PHS Act prohibits a covered entity from 
accepting a discount for a drug that would also generate a Medicaid 
rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a 
covered entity from reselling or otherwise transferring a discounted 
drug to a person who is not a patient of the covered entity.
    Need and Proposed Use of the Information: To ensure its ongoing 
responsibility to administer the 340B Program while maintaining 
efficiency, transparency, and integrity, HRSA developed a process of 
registration for covered entities to address specific statutory 
mandates. Specifically, section 340B(a)(9) of the PHS Act requires HRSA 
to notify manufacturers of the identities of covered entities and of 
their status pertaining to certification and annual recertification in 
the 340B Program pursuant to section 340B(a)(7) and the establishment 
of a mechanism to prevent duplicate discounts as outlined at section 
340B(a)(5)(A)(ii) of the PHS Act.
    Also, section 340B(a)(1) of the PHS Act requires each participating 
manufacturer to enter into an agreement with the Secretary to offer 
covered outpatient drugs to 340B covered entities.
    Finally, section 340B(d)(1)(B)(i) of the PHS Act requires the 
development of a system to enable the Secretary to verify the accuracy 
of ceiling prices calculated by manufacturers under subsection (a)(1) 
and charged to covered entities.
    HRSA is requesting approval for existing information collections. 
HRSA notes that the previously approved collections are mostly 
unchanged, except that HRSA has transitioned completely to online 
versus hardcopy forms. In doing so, some of the forms have been revised 
to increase program efficiency and integrity. Below are descriptions of 
each of the forms and any resulting revisions in both the registration 
and pricing component of

[[Page 20374]]

the 340B Office of Pharmacy Affairs Information System (OPAIS).

Enrollment/Registration

    To enroll and certify the eligible federally funded grantees and 
other safety net health care providers, HRSA requires entities to 
submit administrative information (e.g., shipping and billing 
arrangements, Medicaid participation), certifying information (e.g., 
Medicare Cost Report information, documentation supporting the 
hospital's selected classification), and attestation from appropriate 
grantee level or entity level authorizing officials and primary 
contacts. The purpose of this registration information is to determine 
eligibility for the 340B Program. To maintain accurate records, HRSA 
requests entities to submit modifications to any administrative 
information they submitted when initially enrolling in the Program. 
340B covered entities have an ongoing responsibility to immediately 
notify HRSA of any change in eligibility for the 340B Program. No less 
than on an annual basis, entities must certify the accuracy of the 
information provided and continued maintenance of their eligibility and 
comply with statutory mandates of the Program.
    Registration and annual recertification information are entered 
into the 340B OPAIS by entities and verified by HRSA staff according to 
340B Program requirements. The following forms are being revised:
    1. 340B Program Registrations & Certifications for Hospitals 
(applies to all hospital types): With the launch of 340B OPAIS in 
September 2017, HRSA removed the requirement for a Government Official 
to attest to the hospital classification of a parent hospital. HRSA 
would like to require parent hospitals to attach documents supporting 
the hospital classification that they select during registration. This 
is a more accurate and efficient way to determine the eligibility of 
parent hospital registrations, without increasing the burden, since the 
Government Official attestation has been removed.
    2. 340B Program Registrations for STD/TB Clinics: HRSA is 
requesting that any STD entity provide its Notice of Funding 
Opportunity (NOFO) number at the time of registration. HRSA is also 
requesting that an entity describe the type of in-kind funding it 
receives, as well as the time period of the funding. This will assist 
HRSA in accurately determining the eligibility of the covered entity 
registration. This requirement would impose minimal burden on the 
public, as the NOFO number correlates to the Federal Grant Number, 
which is already required during registration.
    3. 340B Registrations for Ryan White Entities: HRSA is requesting 
that any Ryan White entity provide its NOFO number at the time of 
registration. HRSA is also requesting that an entity provide the time 
period of the assistance. This will assist HRSA to accurately determine 
the eligibility of the registration. This requirement would impose 
minimal burden on the public, as the NOFO number correlates to the 
Federal Grant Number, which is already required during registration.
    4. Medicaid Billing: HRSA is making a minor change to clarify the 
question about Medicaid billing.
    Accurate records are critical to the prevention of drug diversion 
to non-eligible individuals as well as duplicate discounts in the 340B 
Program. To maintain accurate records, HRSA also requires that covered 
entities recertify eligibility annually, and that they notify the 
program of updates to any administrative information that they 
submitted when initially enrolling in the program. HRSA expects that 
the burden imposed by these processes is low for recertification and 
minimal for submitting change requests.

Contract Pharmacy Self-Certification

    To ensure that drug manufacturers and drug wholesalers recognize 
contract pharmacy arrangements, covered entities that elect to use one 
or more contract pharmacies are required to submit general information 
about the arrangements and certify that signed agreements are in place 
with those contract pharmacies.

Pharmaceutical Pricing Agreement and Addendum

    In accordance with the 340B Program guidance issued in the May 7, 
1993, Federal Register, section 340B(a)(1) of the PHS Act provides that 
a manufacturer who sells covered outpatient drugs to eligible entities 
must sign a Pharmaceutical Pricing Agreement (the ``Agreement'') with 
the Secretary of HHS (the ``Secretary'') in which the manufacturer 
agrees to charge a price for covered outpatient drugs that will not 
exceed the average manufacturer price decreased by a rebate percentage. 
Also, section 340B(a)(1) of the PHS Act includes specific required 
components of the PPA with manufacturers of covered outpatient drugs. 
In particular, section 340B(a)(1) includes the following requirements:
    I. ``Each such agreement shall require that the manufacturer 
furnish the Secretary with reports, on a quarterly basis, of the price 
for each covered outpatient drug subject to the agreement that, 
according to the manufacturer, represents the maximum price that 
covered entities may permissibly be required to pay for the drug 
(referred to in this section as the ``ceiling price'') and
    II. ``. . . shall require that the manufacturer offer each covered 
entity covered outpatient drugs for purchase at or below the applicable 
ceiling price if such drug is made available to any other purchaser at 
any price.''

The burden imposed on manufacturers by submission of the PPA and PPA 
Addendum is low as the information is readily available.

Pricing Data Submission, Validation and Dissemination

    To implement section 340B(d)(1)(B)(i)(II) of the PHS Act, HRSA 
developed a system to calculate 340B ceiling prices prospectively from 
data obtained from the Centers for Medicare & Medicaid Services as well 
as a third party commercial database. However, to conduct the 
comparison required under the statute, manufacturers must submit the 
quarterly pricing data as required by section 340B(d)(1)(B)(i)(II). The 
340B OPAIS securely collects the following data from manufacturers on a 
quarterly basis: Average manufacturer price, unit rebate amount, 
package size, case pack size, unit type, national drug code, labeler 
code, product code, period of sale (year and quarter), FDA product 
name, labeler name, wholesale acquisition cost, and the manufacturer 
determined ceiling price for each covered outpatient drug produced by a 
manufacturer subject to a PPA. The burden imposed on manufacturers is 
low because the information requested is readily available and used by 
manufacturers in other areas.
    Likely Respondents: Drug manufacturers and covered entities.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install, and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the

[[Page 20375]]

information. The total annual burden hours estimated for this ICR are 
summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
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                                                     Number of
            Form name                Number of     responses per       Total         Hours per     Total burden
                                    respondents     respondent       responses      respondent         hours
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                                Hospital Enrollment, Additions & Recertifications
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340B Program Registrations &                 248               1             248            2.00             496
 Certifications for Hospitals *.
Certifications to Enroll                     665               8           5,320            0.50           2,660
 Hospital Outpatient Facilities.
Hospital Annual Recertifications           2,481              10          24,810            0.25           6,202
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                      Registrations and Recertifications for Entities Other Than Hospitals
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340B Registrations for Community             360               3           1,080            1.00           1,080
 Health Centers *...............
340B Registrations for STD/TB                535               1             535            1.00             535
 Clinics *......................
340B Registrations for Various               392               1             392            1.00             392
 Other Eligible Entity Types *..
Community Health Center Annual             1,277               7           8,939            0.25           2,235
 Recertifications...............
STD & TB Annual Recertifications           4,033               1           4,033            0.25           1,008
Annual Recertification for                 4,472               1           4,472            0.25           1,118
 entities other than Hospitals,
 Community Health Centers, and
 STD/TB Clinics.................
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                          Contracted Pharmacy Services Registration & Recertifications
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Contracted Pharmacy Services               2,048              11          22,528            1.00          22,528
 Registration...................
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                                          Other Information Collections
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Submission of Administrative              19,322               1          19,322         ** 0.25           4,831
 Changes for any Covered Entity.
Submission of Administrative                 350               1             350            0.50             175
 Changes for any Manufacturer...
Pharmaceutical Pricing Agreement             200               1             200            1.00             200
 and PPA Addendum...............
    Total.......................          36,383  ..............          92,229  ..............          43,460
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* Revised since last OMB submission, but burden was not affected.
** Burden changed from .5 to .25 due to the 340B OPAIS improvement.

HRSA specifically requests comments on (1) the necessity and utility of 
the proposed information collection for the proper performance of the 
agency's functions; (2) the accuracy of the estimated burden; (3) ways 
to enhance the quality, utility, and clarity of the information to be 
collected; and (4) the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-09601 Filed 5-8-19; 8:45 am]
BILLING CODE 4165-15-P