Alston & Bird Healthcare Week in Review, June 24, 2017

I. Regulations, Notices, & Guidance

• On June 19, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions. According to the FDA, the Pre-Submission Facility Correspondence (PFC) process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned abbreviated new drug application (ANDA) submission. The draft guidance describes PFC content and format, as well as the FDA’s approach to assessing this information. Comments are due by September 18, 2017.
•  On June 19, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Awards Unsolicited Proposal for the Professionalism and Integrity in Research Program. The notice announces an award of a single-source unsolicited grant to Washington University in St. Louis, Missouri. The grant is to provide remediation training through the Professionalism and Integrity in Research Program (PI Program) to promote research integrity and prevent research misconduct.
• On June 20, 2017, the FDA issued a draft guidance entitled, Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations--Questions and Answers. The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. Comments are due by August 21, 2017.
•  On June 20, 2017, HHS issued a notice entitled, Awards Unsolicited Proposal for the Professionalism and Integrity in Research Program. The notice announces he award of a single-source, grant in response to an unsolicited proposal from Washington University, St. Louis, Missouri. The proposal submitted was not solicited either formally or informally by any federal government official.
• On June 20, 2017, the FDA issued a notice entitled, Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications. The notice announces the FDA is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the FDA in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
• On June 20, 2017, the Office of Management and Budget (OMB) received a proposed rule from the Centers for Medicare & Medicaid Services (CMS) entitled, FY 2018 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update. The proposed rule would update the prospective payment rates for inpatient psychiatric facilities with discharges beginning on October 1, 2017.
• On June 21, 2017, CMS issued a proposed rule entitled, Medicare Program; CY 2018 Updates to the Quality Payment Program. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. The proposed rule provides proposed updates for the second and future years of the Quality Payment Program. Comments are due by August 21, 2017.
•  On June 22, 2017, the FDA issued a notice entitled, Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee. The notice announces that the FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. Nominations are due by August 22, 2017.
•  On June 22, 2017, the United States Patent and Trademark Office (USPTO) issued a notice entitled, Extension of the Cancer Immunotherapy Pilot Program. The notice announces the USPTO is extending the pilot program until December 31, 2018. All pilot parameters will remain the same as the original pilot.
• On June 23, 2017, CMS issued a final notice entitled, Medicare and Medicaid Programs: Approval of an Application from the Center for Improvement in Healthcare Quality for Continued CMS Approval of its Hospital Accreditation Program. The final notice announces CMS’ decision to approve the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

• July 18, 2017: The National Institutes of Health (NIH) announced a meeting of the Office of AIDS Research Advisory Council. The Council will discuss OAR Director’s Report; Update on NIH Activities; OAR Task Force on Cost Sharing; OAR Task Force on Implementation and Behavioral and Social Science Research.
• July 18, 2017: The FDA announced a public meeting entitled, The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access. The public meeting is intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.
• July 19, 2017: The FDA announced a public workshop regarding scientific and clinical trial design considerations for the development of new tuberculosis (TB) treatment regimens. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders regarding scientific and clinical trial design considerations related to the development of new TB regimens.
• September 11, 2017: The FDA announced public meeting on “Patient-Focused Drug Development for Alopecia Areata.” The FDA will post the agenda approximately 5 days before the meeting here.

II. Congressional Legislation & Committee Action

• On June 20, 2017, the Senate Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittee held a hearing on the FY 2018 FDA proposed budget. The sole witness is Dr. Scott Gottlieb, FDA Commissioner.
• On June 21, 2017, the Senate Appropriations Military Construction, Veterans Affairs and Related Agencies Subcommittee held a hearing on the FY 2018 and FY 2019 VA budget. The sole witnesses was VA Secretary, Dr. David Shulkin.
• On June 22, 2017, the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held a hearing on the FY 2017 National Institutes of Health (NIH) proposed budget. The witnesses included Dr. Francis Collins, Director, NIH; Dr. Anthony Fauci, Director of NIH’s National Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons, Director of NIH’s National Heart, Lung and Blood Institute; Dr. Joshua Gordon, Director of NIH’s National Institute of Mental Health; Dr. Doug Lowy, Acting Director of NIH’s National Cancer Institute (NCI); and Dr. Nora Volkow, Director of NIH’s National Institute of Drug Abuse.

• On June 21, 2017, the House Natural Resources Indian, Insular and Alaska Native Affairs Subcommittee held a hearing on H.R. 2662, the “Restoring Accountability in the Indian Health Service Act of 2017." The witnesses included  Rear Admiral Chris Buchanan, Assistant Surgeon General, SUPHS, Deputy Director, Indian Health Service; The Honorable William Bear Shield, Chairman, Rosebud Sioux Tribal Health Board; The Honorable Andy Joseph, Business Council Member, Confederated Tribes of the Colville Reservation; Mr. Robert TwoBears, District 5 Representative, Ho-Chunk Nation Legislature; and Ms. Victoria Kitcheyan, Great Plains Area Representative, National Indian Health Board.
• On June 22, 2017, the House Veterans’ Affairs Health Subcommittee held a hearing on the FY 2018 Department of Veterans Affairs Budget Request for the Veterans Health Administration. The witnesses included Joy Ilem, National Legislative Director, Disabled American Veterans (DAV); Carl Blake, Associate Executive Director of Government Relations, Paralyzed Veterans of America (PVA); Carlos Fuentes, Director, National Legislative Service, Veterans of Foreign Wars (VFW); Matthew Shuman, Director, Legislative Division, The American Legion (American Legion); and Dr. Poonam Alaigh, Acting Under Secretary for Health, VHA, VA.
• On June 23, 2017, the House Energy & Commerce Health Subcommittee held a hearing entitled, Examining the Extension of Safety Net Health Programs. The witnesses included Mr. Michael Holmes, Chief Executive Officer, Cook Area Health Services; Cindy Mann, Partner Manatt Health; and Ms. Jami Snyder, Associate Commissioner for Medicaid/SCHIP Services, State of Texas, Health and Human Services Commission.

• On June 21, 2017, the Government Accountability Office (GAO) released a report entitled, Veterans Affairs: Improved Management Processes Are Necessary for IT Systems That Better Support Health Care. The report that the IT systems at the VA are generally aligned to core business functions defined by VHA; however, among new service requests, which identify unmet needs of business owners, 817 out of a total of 2,772 IT needs identified for VHA since 1998 had not been met as of October 2016. About 39 percent of these open requests had been open for more than 5 years.
• On June 21, 2017, the Office of Inspector General (OIG) released a report entitled, Management and Development for Health Did Not Always Manage the President's Emergency Plan for AIDS Relief Funds in Accordance With Award Requirements. The report found the Management and Development for Health (MDH) did not always manage PEPFAR funds in accordance with award requirements. Of the 60 financial transactions in our sample, 51 transactions totaling $6.8 million were allowable, but 9 transactions totaling $181,000 were not. Additionally, MDH used $23,000 in PEPFAR funds to pay unallowable ValueAdded Taxes (VAT) on purchases that have not been reimbursed by the Tanzania Revenue Authority.

IV. Other Health Policy News

• The Congressional Budget Office (CBO) expects to have a cost estimate on the Senate’s version of the American Health Care Act (AHCA) early next week. The press release can be found here.

V. ACA Repeal News

• On June 22, 2017, the Senate released a discussion draft of its version of the AHCA, the Better Care Reconciliation Act of 2017 (BCRA). It is expected this draft may change somewhat over the next few days as the Senate GOP works to gain the required votes. A copy of the discussion draft can be found here.