Notice2022-23518
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.
Primary source
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Published
October 28, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 208 (Friday, October 28, 2022)</title>
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[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65212-65215]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#f28293829780859d8099b29a808193dc959d84"><span class="__cf_email__" data-cfemail="f88899889d8a8f978a93b8908a8b99d69f978e">[email protected]</span></a> 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
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