Regulatory Letters & Responses
- Letter to HHS Secretary Becerra: Regarding Urgent Request To Allow All Ryan White Clinics To Fully Engage In COVID-19 Relief Effort (April 8, 2021)
- Letter to HHS Secretary Alex Azar: Manufacturer Actions Violating 340B Statute Requirements (September 14, 2020)
- Letter to HRSA: Regarding Patient Definition and Telehealth Policies (September 11, 2020)
- Press Statement: Ryan White Clinics Call on Congress, HHS, & HRSA to Stop Drug Manufacturers from Undermining Our Use of the 340B Program to Care for People with HIV (August 27, 2020)
- Statement to White House: Executive Orders Undermine 340B (July 28, 2020)
- Comment Letter to HRSA: Regarding Revision to Allocation and Expenditure Reports (April 13, 2020)
- Comment Letter to CDC/HRSA Advisory Committee: Regarding HIV, Viral Hepatitis, and STD Prevention (November 5, 2019)
- Comments Letter on Changes to: Registration Requirements for Ryan White Clinics and STD Clinics (July 8, 2019)
- Letter to HHS Office: Regarding HIV/AIDS and Infectious Disease Policy’s (OHAIDP) (March 11, 2019)
- Comments on Delay of Effective Date of 340B Drug Pricing Program: Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (November 21, 2018)
- Letter to HHS Secretary Azar (October 3, 2018)
- Comments on Delay of Effective Date of 340B Drug Pricing Program: Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (May 22, 2018)
- Comments on Proposed Changes to: Hospital OPPS Payments for 340B Drugs Dispensed at Off-Campus Facilities
- Comments on Proposed Rule on Medicare Advantage Part C and Part D regulations
- Comments on Reduction to Hospital OPPS Payments for 340B Drugs
- Letter to the Energy and Commerce Committee (July 7, 2017)
- Letter to U.S. Department of Justice: Regarding proposed acquisition by Aetna of Humana (December 1, 2016)
- Letter to HRSA: Regarding notices on program income (October 21, 2016)
- Letter to PhRMA: Regarding continued dialogue related to the 340B Program Mega-Guidance (February 22, 2016)
- Comment on Mega-Guidance (October 27, 2015)
- Comment of 340B Coalition on Mega-Guidance (October 27, 2015)
- Comments on HRSA: Proposed Rule regarding 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (August 17, 2015)