2015-32171. Agency Information Collection Activities: Proposed Collection; Public Comment Request

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (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 February 22, 2016.

ADDRESSES:

Submit your comments to [e-mail] or mail the HRSA Information Collection Clearance Officer, Room 10C-16, 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 [e-mail] or call the HRSA Information Collection Clearance Officer at [phone].

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the information request collection title for reference.

Information Collection Request Title: 340B Drug Pricing Program Reporting Requirements.

OMB No. 0915-0176—[Revision].

Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act) “Limitation on Prices of Drugs Purchased by Covered Entities.” Section 340B provides that a manufacturer who participates in Medicaid must sign a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge enrolled covered entities a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities who choose to participate in the section 340B Drug Pricing Program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from requesting Medicaid reimbursement from a drug that has been discounted under the 340B Program. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity.

Section 340B(a)(5)(C) of the PHS Act permits the Secretary and manufacturers of a covered outpatient drug to conduct audits of covered entities in accordance with procedures established by the Secretary related to the number, duration and scope of the audits.

Manufacturers are permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer notifies the covered entity in writing when it believes the covered entity has violated these provisions of the 340B Program. If the problem cannot be resolved, the manufacturer will then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to the HRSA Office of Pharmacy Affairs (OPA) for review. OPA will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General (OIG).

In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, OPA developed an informal voluntary dispute resolution process for manufacturers and covered entities, who prior to filing a request for resolution of a dispute with OPA, should attempt in good faith to resolve the dispute. All parties involved in the dispute must maintain written documentation as evidence of a good faith attempt to resolve the dispute. If the dispute is not resolved and dispute resolution is desired, a party must submit a written request for a review of the dispute to OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations.

HRSA published a Notice in 1996 and a policy release in 2011 on manufacturer audit guidelines and the informal dispute resolution process. (61 FR 65406 (December 12, 1996) and “Clarification of Manufacturer Audits of 340B Covered Entities,” Release No. 2011-3).

The expected revision to this package includes additional background information on the dispute resolution process and clarifies the need and proposed use of information regarding the manufacturer audit guidelines and the informal dispute resolution process.

Need and Proposed Use of the Information: HRSA is proposing the collection of information related to the manufacturer audit guidelines. These guidelines contain the following reporting/notification elements:

1. Manufacturers should notify the entity in writing when it believes a violation has occurred;

2. Manufacturers should submit documentation to OPA as evidence of good faith of attempts to resolve a dispute.

3. Manufacturers must submit an audit work plan to OPA;

4. Manufacturers should submit the audit report to the OPA and informational copies to the HHS OIG; and

5. The covered entity should provide a written response to the audit report.

This information is necessary to ensure the orderly conduct of manufacturer audits. In addition, the informal dispute resolution process requires the participating manufacturer or covered entity requesting dispute resolution to provide OPA with a written request. The party alleged to have committed a section 340B violation, may provide a response or rebuttal to OPA. This information is necessary in order to ensure that the dispute will be resolved in a fair and equitable manner.

Likely Respondents: Drug manufacturers and 340B covered entities.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested during an audit. 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 for both covered entities and manufacturers. The total annual burden hours estimated for this Information Collection Request are summarized in the table below.

Total Estimated Annualized Burden Hours

Form name	Number of respondents	Number of responses per respondent	Total responses	Average burden per response (in hours)	Total burden hours
AUDITS:
Good faith Resolution 1	10	1	10	40	400
Audit Notification to Entity 1	10	1	10	4	40
Audit Workplan 1	40	1	18	8	144
Audit Report 1	8	1	8	8	64
Entity Response	8	1	8	8	64
DISPUTE RESOLUTION:
Dispute Request	10	4	40	10	400
Rebuttal	10	1	10	16	160
Total	96		104		1272
1 Prepared by the manufacturer.

Recordkeeping Burden

Recordkeeping requirement	Number of recordkeepers	Hours of recordkeeping	Total burden
Dispute Records	50	0.5	25

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.

Jackie Painter,

Director, Division of the Executive Secretariat.