[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65212-65215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23518]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Enrollment and Re-
Certification of Covered 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 of the Paperwork Reduction Act of 1995, 
HRSA has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period. OMB may act on HRSA's ICR only after the 
30-day comment period for this notice has closed.

DATES: Comments on this ICR should be received no later than November 
28, 2022.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Samantha Miller, the Acting 
HRSA Information Collection Clearance Officer, at [email protected] or 
call (301) 443-9094.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Enrollment and Re-
Certification of Covered 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 
(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. A 60-day 
notice was published in the Federal Register on June 14, 2022, vol. 87, 
No. 114; pp. 35983-85. There were five comments. Some comments 
addressed policy issues that are outside the scope of this information 
collection request. HRSA responded to technical comments that pertained 
to the ICR and revised the draft instruments based on the comments 
received.
    Need and Proposed Use of the Information: To ensure the ongoing 
responsibility to administer the 340B Program while maintaining 
efficiency, transparency and integrity, HRSA developed a process of 
registration for covered entities to enable it 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.
    In addition, section 340B(a)(1) of the PHS Act requires each 
participating manufacturer to enter into an agreement with the 
Secretary in order 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 several forms have been revised to increase program 
efficiency and integrity. Below are descriptions of each of the forms 
and revisions that are captured in both the registration and pricing 
component of the 340B Office of Pharmacy Affairs Information System 
(OPAIS).

[[Page 65213]]

Enrollment/Registration/Recertification

    To enroll and certify the eligibility of federally funded grantees 
and other safety net health care providers, HRSA requires covered 
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 covered entity level authorizing officials and primary 
contacts. To maintain accurate records, HRSA requests covered entities 
submit modifications to any administrative information that they 
submitted when initially enrolling into the 340B Program. Covered 
entities participating in the 340B Program have an ongoing 
responsibility to immediately notify HRSA in the event of any change in 
eligibility for the 340B Program. No less than on an annual basis, 
covered entities need to certify the accuracy of the information 
provided and continued maintenance of their eligibility and to comply 
with statutory mandates of the 340B Program.
    Registration and annual recertification information is entered into 
the 340B OPAIS by covered entities and verified by HRSA staff according 
to 340B Program requirements. In response to the comments received, 
HRSA has made technical and other revisions to the draft instruments 
and discusses the revisions below.
    1. 340B Program Registrations & Recertifications for Hospitals 
(applies to all hospital types): In September 2017, HRSA launched 340B 
OPAIS, which among other things, removed the attestation requirement 
from the Government Official for the classification of a parent 
hospital, but it was still required for the covered entity to enter the 
Government Official contact information. As covered entities are no 
longer required to obtain this attestation, HRSA is removing the 
requirement for the covered entity to enter the Government Official 
contact information in 340B OPAIS. During the first public review of 
this ICR, commenters agreed with removing the Government Official 
contact information for a parent hospital.
    2. 340B Registrations & Recertifications for Ryan White Covered 
Entities: Previously, HRSA requested that Ryan White covered entities 
provide a Notice of Funding Opportunity (NOFO) number at the time of 
registration and recertification. After reevaluation, HRSA has 
determined that the NOFO number is an unnecessary component to 
determine the eligibility of a Ryan White covered entity's 
registration. Since the NOFO number correlates to the Ryan White 
covered entity's Federal Grant Number, which is already required to be 
entered in 340B OPAIS during registration, the NOFO number is not 
needed. During the first public review of this ICR, commenters agreed 
with removing the requirement for Ryan White covered entities to 
provide a NOFO number at the time of registration and recertification.
    3. 340B Registration, Recertification & Change Requests for 
Shipping Address: In the 60-day notice (87 FR 35,983, June 14, 2022), 
HRSA proposed to include clarifying information for covered entities to 
complete the shipping address section in 340B OPAIS. This information 
was added to assist covered entities in determining the exact shipping 
address location and relationship to the covered entity. In response to 
comments submitted during the first public review of this ICR, HRSA is 
removing this section from the instrument and will plan to release 
guidance on shipping address locations in the future.
    4. 340B Program Registrations, Recertifications & Change Requests 
for Hospitals (applies to rural referral centers and sole community 
hospital covered entity types): HRSA proposed to revise the 340B OPAIS 
registration for the rural referral centers and sole community hospital 
covered entity types. If applicable, 340B OPAIS will prompt the covered 
entity for documentation that supports eligibility, which will be 
attached as part of its registration, recertification or change request 
submission. Currently, the request for the supporting eligibility 
documentation is obtained during the submission review process; 
therefore, this requirement would not change the burden on the covered 
entities.
    5. 340B Program Registrations and Recertification for Authorizing 
Official Certification/Attestation: In the 60-day notice (87 FR 35,983, 
June 14, 2022), HRSA proposed to make revisions to the Authorizing 
Official certification by removing the requirement that any contract 
pharmacy arrangement is performed in accordance with OPA requirements 
and guidelines. Several commenters questioned why HRSA was removing 
this statement from the Authorizing Official's certification of a 
covered entity's registration or recertification in the 340B Program. 
HRSA removed this information as it was duplicative with information 
found on other instruments (e.g., the contract pharmacy registration 
form) and already existed on the registration and recertification 
documentation. HRSA believes that this revision will reduce burden on 
covered entities.
    6. 340B Program Change Requests for Hospitals: HRSA proposed 
inclusion of hospital qualification information such as, the 
Disproportionate Share Adjustment Percentage, control type, hospital 
classification, and contract start date to be changed under a change 
request submission as well as during recertification. This requirement 
would not change the burden on the covered entities, as this is an 
option to change the information by the hospital.
    7. 340B Primary Contact and Authorizing Official Information: HRSA 
removed the FAX number field. This does not change the burden on 
covered entities, as this was an optional field.
    8. 340B Program Recertifications & Change Requests for Hospitals: 
HRSA proposed clarifying when a covered entity would initiate a name 
change in 340B OPAIS. If applicable, 340B OPAIS will prompt the covered 
entity for documentation that supports the name change, which will be 
attached as part of its recertification or change request submission. 
In response to comments received, HRSA has made general technical and 
editorial revisions to this instrument.
    9. Medicaid Billing Information: In the 60-day notice (87 FR 
35,983, June 14, 2022), HRSA proposed to make a minor clarification 
regarding whether a 340B drug to an outpatient at a pharmacy or as part 
of a medical encounter. In response to comments submitted during the 
first public review of this ICR and after further consideration, HRSA 
is removing this section from the instrument and will plan to release 
future guidance on this issue.

Contract Pharmacy Certification

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

Pharmaceutical Pricing Agreement and Addendum

    Section 340B(a)(1) of the PHS Act provides that a manufacturer who 
sells covered outpatient drugs to eligible covered entities must sign a 
Pharmaceutical Pricing Agreement (the ``Agreement'') with the Secretary 
in which the manufacturer agrees to charge a price for covered 
outpatient drugs that

[[Page 65214]]

will not exceed the average manufacturer price (``AMP'') decreased by a 
rebate percentage. In addition, section 340B(a)(1) of the PHS Act 
includes specific requirements, which have been incorporated in 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

    In order 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, in order 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: AMP, unit rebate amount, package size, case pack 
size, unit type, national drug code, labeler code, product code, period 
of sale (year and quarter), Food and Drug Administration 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 utilized 
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 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 &                 131               1             131            2.00             262
 Certifications for Hospitals *.
Certifications to Enroll                     620               7            4340            0.50            2170
 Hospital Outpatient Facilities
 *..............................
Hospital Annual Recertifications            2618              10           26180            0.25            6545
 *..............................
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                  Registrations and Recertifications for Covered Entities Other Than Hospitals
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340B Registrations for Community             679               1             679            1.00             679
 Health Centers *...............
340B Registrations for STD/TB                864               1             864            1.00             864
 Clinics *......................
340B Registrations for Various               166               1             166            1.00             166
 Other Eligible Covered Entity
 Types *........................
Community Health Center Annual              1277               7            8939            0.25            2235
 Recertifications *.............
STD & TB Annual Recertifications            4033               1            4033            0.25            1008
 *..............................
Annual Recertification for                  4472               1            4472            0.25            1118
 covered 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                3446              11           37906            1.00           37906
 Registration...................
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                                          Other Information Collections
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Submission of Administrative               19322               1           19322            0.25            4831
 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...............
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    Total.......................          38,178  ..............          99,542  ..............          58,159
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* Minor revisions since last the OMB submission, but burden was not affected.

    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

[[Page 65215]]

technology to minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-23518 Filed 10-27-22; 8:45 am]
BILLING CODE 4165-15-P