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Pharmaceutical Access

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Photo: Olaf Starorypinski, Lehigh Valley Children’s Hospital, Allentown, Pennsylvania

Understanding Pharmaceuticals

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On Jan. 4, the Health Resources and Services Administration (HRSA) released a final rule regarding 340B ceiling price calculations and civil monetary penalties for manufacturers that knowingly and intentionally overcharge covered entities for 340B drugs. The rule, which will go into effect April 1, specifies how manufacturers must calculate ceiling prices, instills the HHS Office of Inspector General with the responsibility of imposing 340B civil monetary penalties on manufacturers and maintains HRSA policy on requiring penny pricing when the 340B ceiling price is zero.

Resources

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Letter or Testimony
CHA Comments on the Delayed 340B Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
September 20, 2017

CHA comments on the delayed 340B ceiling price and manufacturer civil monetary penalties regulation from Oct. 1 to July 1, 2018.

Issue Brief
340B Drug Pricing Program
July 7, 2017

The federal 340B program enables children's hospitals to provide care for the program's intended beneficiaries—vulnerable, low-income patients.

Letter or Testimony
Allied Organizations Urge Congress to Include Pediatric Provisions within FDARA
May 5, 2017

CHA, in conjunction with allied provider and disease groups, sent a letter to House and Senate leadership within the Energy and Commerce Committee ...

Letter or Testimony
CHA Submits Joint Comments on the 340B Administrative Dispute Resolution Proposed Rule with the 340B Coalition
October 12, 2016

CHA, in coordination with the 340B Coalition, submitted comments to the Health Resources and Services Administration (HRSA) on the proposed ...

Letter or Testimony
340B Coalition Submits Comments on 340B Drug Pricing Program
May 25, 2016

The 340B Coalition submitted supplemental comments on the proposed rule addressing the ceiling price and manufacturer civil monetary penalties.

Article
Working Together on Drug Pricing and Shortages
April 26, 2016

Children's hospitals are working together to address drug pricing and drug shortages to improve affordability and access to lifesaving drugs.

Letter or Testimony
CHA Comments on Medicare Off-campus Provider-based Requirements
February 19, 2016

CHA submitted comments to the House Committee on Energy & Commerce to provide feedback on changes to Medicare payment policies included in the ...

Presentation or Recording
Recent Changes to Medicare Off-campus Provider-based Requirements and Implications for Children's Hospitals
February 18, 2016

Alston & Bird, LLP, prepared a presentation for CHA members on Medicare off-campus provider-based requirements.

Analysis or Summary
2015 State Policy Trends Identified Through Member Outreach
January 29, 2016

During the summer and fall of 2015, the Policy Analysis team reached out to government relations professionals to inform our understanding of the ...

Letter or Testimony
340B Omnibus Guidance Comments to HRSA
October 27, 2015

CHA submitted comments to HRSA in response to the proposed 340B omnibus guidance.

Presentation or Recording
Implications of Proposed 340B Omnibus Guidance
September 21, 2015

CHA and the AAMC held a joint webinar reviewing the implications of the proposed 340B omnibus guidance.

Analysis or Summary
340B Drug Pricing Program Omnibus Guidance
September 10, 2015

HRSA issued a proposed omnibus guidance to provide clarity on the current 340B Drug Pricing Program guidelines.

Analysis or Summary
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties
August 17, 2015

HRSA issued a proposed rule for all drug manufacturers under the 340B program addressing ceiling price calculations and civil monetary penalties.

Announcement or News
House Energy & Commerce Health Subcommittee 340B Hearing
March 23, 2015

Brief summary of a hearing to analyze the 340B program and hear from HRSA and related agencies.

Reference Material
Children's Hospitals Enrolled in the 340B Drug Pricing Program
March 2, 2015

The 340B Drug Pricing Program allows eligible health care organizations to purchase outpatient drugs at discounted prices. The following children's ...

Reference Material
340B Drug Pricing Program Participation Criteria for Children's Hospitals
December 18, 2014

Freestanding children's hospitals must meet certain qualifications and criteria to participate in the 340B Drug Discount Program.

Letter or Testimony
Drug Disposal Regulation Comments to Drug Enforcement Agency
October 6, 2014

Hospital groups are requesting a delay to allow time to comply and revisit alternative ways to meet the DEA’s objectives.

Presentation or Recording
340B Teleconference with Krista Pedley, Director of HRSA's Office of Pharmacy Affairs
April 29, 2014

Krista Pedley, Director of HRSA's Office of Pharmacy Affairs discussed the 340B Drug Pricing Program in a joint teleconference with the CHA and AAMC.

Letter or Testimony
340B Regulations - Issues to Consider
March 21, 2014

The Association, with other hospital groups, submitted a letter on a variety of issues regarding the 340B Drug Discount Program to the Health ...

Letter or Testimony
Pharmaceutical Quality, Security, and Accountability Act - Joint Support Letter
July 31, 2013

In response to S. 959, the Pharmaceutical Quality, Security, and Accountability Act, legislation regarding drug compounding, the Association and the ...

Letter or Testimony
Senators Franken and Roberts Senate Pediatric Drug Shortages Sign-on Letter to FDA
May 6, 2013

In response to the severe drug shortage involving total parenteral nutrition (TPN) components in early 2013, 15 senators signed a letter to FDA ...

Letter or Testimony
Sens. Klobuchar and Casey Drug Shortages Letter to Manufacturers
May 3, 2013

Senators Casey and Klobuchar organized a Senate sign-on letter to Luitpold Pharmaceuticals, Hospira and AAP Pharmaceuticals asking for cooperation ...

Letter or Testimony
Pharmacy Compounding - Senate Comment Letter
May 3, 2013

In response to a draft legislative proposal regarding drug compounding and related issues released in the Senate, the Association sent a comment ...

Analysis or Summary
The Food and Drug Administration Safety and Innovation Act (FDA-SIA) - Overview and Key Provisions
July 9, 2012

Legislation to reauthorize industry user fees that fund FDA drug and device reviews, became law in July 2012. Children's hospitals secured language ...

Letter or Testimony
BPCA & PREA Coalition Conference Sign-on Letter
June 8, 2012

The Association joined other health care groups in a coalition letter to thank Congress for their bipartisan leadership on passage of legislation ...

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