Notice2022-12776
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
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Published
June 14, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Full Text
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<title>Federal Register, Volume 87 Issue 114 (Tuesday, June 14, 2022)</title>
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[Federal Register Volume 87, Number 114 (Tuesday, June 14, 2022)]
[Notices]
[Pages 35983-35985]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB Number 0915-0327--Revision]
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
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). Prior to 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 August 15,
2022.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#1c6c7d6c796e6b736e775c746e6f7d327b736a"><span class="__cf_email__" data-cfemail="1b6b7a6b7e696c7469705b7369687a357c746d">[email protected]</span></a> or by mail to the
HRSA Information Collection Clearance Officer, Room 14N136B, 5600
Fishers Lane, Rockville, MD 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 <a href="/cdn-cgi/l/email-protection#afdfcedfcaddd8c0ddc4efc7dddcce81c8c0d9"><span class="__cf_email__" data-cfemail="d9a9b8a9bcabaeb6abb299b1abaab8f7beb6af">[email protected]</span></a> or call Samantha Miller,
the acting HRSA Information Collection Clearance Officer at (301) 443-
9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
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
(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 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 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 that are captured in both the
registration and pricing component of the 340B Office of Pharmacy
Affairs Information System (OPAIS).
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 entity level authorizing officials and primary
contacts. To maintain accurate records, HRSA requests entities to
submit modifications to any administrative information that they
submitted when initially enrolling into the 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 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. The following forms are being revised:
1. 340B Program Registrations & Recertifications for Hospitals
(applies to all hospital types): In September 2017, HRSA launched 340B
OPAIS, which
[[Page 35984]]
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. This will not change the burden on the
entities.
2. 340B Registrations & Recertifications for Ryan White Entities:
Previously, HRSA requested that any Ryan White entity provide its
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 entity's registration. Since the NOFO number correlates to
the Ryan White entity's Federal Grant Number, which is already required
to be entered in 340B OPAIS during registration, the NOFO number is not
needed. This will not change the burden on the covered entities.
3. 340B Registration, Recertification & Change Requests for
Shipping Address: HRSA is providing additional clarification for
covered entities to complete the shipping address section in 340B OPAIS
to assist in determining the exact shipping address location and
relationship to the covered entity. This clarification will not change
burden on entities.
4. 340B Program Registrations, Recertifications & Change Requests
for Hospitals (applies to rural referral centers and sole community
hospital entity types): HRSA is revising the 340B OPAIS registration
for the rural referral centers and sole community hospital types, in an
effort to provide guidance that determines the eligibility criteria. 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 entities.
5. 340B Program Change Requests for Hospitals: HRSA will allow
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 entities, as this is an option to change the information
by the hospital.
6. 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.
7. 340B Program Recertifications & Change Requests for Hospitals:
HRSA is clarifying when the 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. Currently,
the request for the supporting name change documentation is obtained
during the submission review process, therefore, this requirement would
not change the burden on covered entities.
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. There is no change in burden on the entities.
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 Health and Human Services (the ``Secretary'') in which
the manufacturer agrees to charge a price for covered outpatient drugs
that 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 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
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), 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 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.
[[Page 35985]]
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 4,340 0.50 2,170
Hospital Outpatient Facilities
*..............................
Hospital Annual Recertifications 2,618 10 26,180 0.25 6,545
*..............................
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Registrations and Recertifications for 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 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 3,446 11 37,906 1.00 37,906
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 .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 technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-12776 Filed 6-13-22; 8:45 am]
BILLING CODE 4165-15-P
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