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
| Published date | 07 August 2019 |
| Record Number | 2019-16872 |
| Section | Notices |
| Court | Health Resources And Services Administration |
Federal Register, Volume 84 Issue 152 (Wednesday, August 7, 2019)
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38639-38642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16872]
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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 Paperwork Reduction Act of 1995, HRSA
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.
DATES: Comments on this ICR should be received no later than September
6, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to 202-395-5806.
A 60-day notice was published in the Federal Register on May 9,
2019, vol. 84, No. 90; pp. 20373-75. There were four public comments
received. Some comments addressed policy issues that are outside of the
scope of this information collection request. HRSA responded to
technical comments that pertain to the ICR and revised the draft
instruments based on technical comments received.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
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 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
[[Page 38640]]
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 address specific statutory
mandates. 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 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 instruments. In doing so, some of the instruments have
been revised to increase program efficiency and integrity. Below are
descriptions of each of the instruments and any resulting revisions
captured in both the registration and pricing component of 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 that they submitted when initially enrolling into the
Program. 340B covered entities 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, 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 is entered into
the 340B OPAIS by entities and verified by HRSA staff according to 340B
Program requirements. In response to the comments received, HRSA has
made technical revisions to the draft instruments and explains the
revisions below.
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. In response to
comments, HRSA notes that the 340B Program Hospital Registration
Instructions lists examples of the types of documentation that supports
the hospital's classification. The instructions are located at https://www.hrsa.gov/sites/default/files/hrsa/opa/340b-hospital-registration-instructions.pdf.
2. 340B Program Registrations for STD/TB Clinics: HRSA is
requesting that any STD and TB 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 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.
In response to comments submitted during the first public review of
this ICR, HRSA continues to believe there will be no additional burden
associated with providing what type of in-kind funding they receive as
it is expected to be provided as part of an audit of a covered entity.
The draft instruments explain that in-kind contributions may be in the
form of real property, equipment, supplies and other expendable
property, and goods and services directly benefiting and specifically
identifiable to the project or program.
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 period
of assistance. This will assist HRSA in accurately determining 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. In response to comments received, HRSA
has made general technical and editorial revisions to this instrument.
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 into the program. HRSA expects that
the burden imposed 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 utilize
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. In response to comments,
HRSA has made several technical corrections to this instrument.
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
[[Page 38641]]
outpatient drugs to eligible entities must sign a PPA with the
Secretary of HHS 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
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. One commenter suggested that HRSA list
FDA ``ingredient names'' in the 340B OPAIS to simplify the search
process for covered entities. HRSA will consider this for future
collections due to system changes that would need to occur to
operationalize this suggestion.
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 & 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 1,008
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 1 200
and PPA Addendum...............
Manufacturer Data Required to 600 4 2,400 0.50 1,200
Verify the 340B Ceiling Price..
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Total....................... 36,983 .............. 94,629 .............. 43,433
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* Revised since last OMB submission, but burden was not affected.
** Burden changed from .50 to .25 due to the 340B OPAIS improvement.
[[Page 38642]]
During the first public review of the ICR, HRSA inadvertently
omitted the burden estimate for the instrument pertaining to
manufacturer data required to verify the 340B ceiling price. The
estimate for that instrument has been included here and HRSA invites
comments to be submitted to OMB for consideration during the review and
approval period.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-16872 Filed 8-6-19; 8:45 am]
BILLING CODE 4165-15-P
