Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On June 25, 2018, the Health Resources and Service Administration (HRSA) issued a notice entitled. Proposed Standards for the Children’s Hospitals Graduate Medical Education Payment Program’s Quality Bonus System. HRSA published a notice in the Federal Register on October 11, 2017, soliciting feedback on the establishment of the Children’s Hospital Graduate Medical Education Payment Program’s Quality Bonus System. In particular, HRSA requested feedback on the fiscal year 2019 and beyond multi-step implementation of the systems, including demonstration of engagement in state or regional-level initiatives, documentation, and payment structure. This notice summarizes and responds to the comments received during the 60-day comment period.
- On June 26, 2018, the Department of Health and Human Services (HHS) issued a final rule entitled, Removing Outmoded Regulations Regarding the Rural Physician Training Grant Program, Definition of “Underserved Rural Community.” This action removed the regulations for the Rural Physician Training Grant Program, definition of “Underserved Rural Community.” Funding was authorized at section 749B(i) Public Health Service Act for fiscal years 2010-2013, but never appropriated for the Rural Physician Training Grant Program, and the program was not implemented. Therefore, this regulation is no longer relevant, and HRSA suggested the regulations defining underserved rural communities for the Rural Physician Training Grant Program be removed.
- On June 28, 2018, the National Institutes of Health (NIH) issued a request for information (RFI) entitled, Request for Information on the HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis. This RFI is intended to gather broad public input on the conduct of a multi-site national research effort to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and Opioid Use Disorders (OUD). The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (e.g. Hepatitis C and HIV), increase the number of individuals receiving medication-assisted treatment, increase the proportion retained in treatment beyond 6 months, and increase the number of individuals receiving needed recovery support services.
- On June 28, 2018, the Food and Drug Administration (FDA) issued a notice entitled, Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program. The FDA Center for Drug Evaluation and Research (CDER) is announcing two new efforts to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation based on stakeholder feedback. These efforts include Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests, and a pilot study to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply (e.g., active pharmaceutical ingredients (API) establishments, contract manufacturing organizations, over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments). Participation in either of these efforts is voluntary and the programs are intended to foster the joint efforts of FDA and stakeholders to further develop an FDA Quality Metrics Program. The FDA Quality Metrics Program aims to evaluate a new approach for regulatory oversight of pharmaceutical products through the collection of certain quality information developed and maintained in the course of manufacturing drugs under current good manufacturing practices. FDA intends to use quality metrics data to further develop the Agency’s risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments) to improve the efficiency and effectiveness of establishment inspections, improve FDA’s evaluation of drug manufacturing and control operations, and identify situations in which there may be a risk for drug supply disruption.
- On June 28, 2018, the FDA issued a guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. This guidance concerns FDA’s implementation of the Biosimilar User Fee Amendments of 2017 and certain changes in policies and procedures surrounding its application.
- On June 29, 2018, HRSA issued a notice entitled, Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas. This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2018. The lists are available on HRSA’s HPSAFind website.
Event Notices
- July 9, 2018: The FDA announced a public meeting on “Patient-Focused Drug Development for Chronic Pain.” The meeting will provide patients with an opportunity to present FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
- July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
- August 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
- August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
- August 21, 2018: The FDA announced a public work shop entitled, Development of Non-Traditional Therapies for Bacterial Infections. The purpose of the workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
- September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.
II. Congressional Legislation & Committee Action
U.S. Senate
- On June 26, 2018, the Senate Finance Committee held a hearing entitled, Prescription Drug Affordability and Innovation: Addressing Challenges in Today’s Market. HHS Secretary Alex Azar was the only witness present.
- On June 27, 2018, the Senate Health, Education, Labor, and Pensions Committee held a hearing entitled, How to Reduce Health Care Costs: Understanding the Cost of Health Care in America. The witnesses were Melinda Buntin, PhD, Department of Health Policy, Vanderbilt University School of Medicine; Ashish Jha, MD, Director, Harvard Global Health Institute, Harvard Medical School; Niall Brennan, President and Executive Director, Health Care Cost Institute; David Hyman, MD, Professor, Georgetown University Law Center.
- On June 27, 2018, the Senate Homeland Security & Governmental Affairs Committee held a hearing entitled, Medicaid Fraud and Overpayments: Problems and Solutions. Witnesses included the Honorable Eugene Dodaro, Comptroller General of the United States, Government Accountability Office; and Brian Ritchie, Assistance Inspector General for Audit Services, U.S. Department of Health and Human Services.
- On June 27, 2018, the Senate Veterans Affairs Committee held a hearing entitled, Pending Nomination – Robert Wilkie to be Secretary of Veterans Affairs. The Committee considered the nomination of Robert Wilkie to be the next Secretary of Veterans Affairs. Mr. Wilkie was the only witness present.
- On June 28, 2018, the Senate Appropriations Committee held a markup of the FY 2018 Labor, HHS, & Education Appropriations bill. The measure was advanced by a 30-1 vote.
House of Representatives
- On June 26, 2018, the House Veterans Affairs Committee held a hearing entitled, VA Electronic Health Record Modernization: The Beginning of the Beginning. Witnesses present included Peter O’Rourke, Acting Secretary, Department of Veterans Affairs; Vice Admiral Raquel Bono, Director, Defense Health Agency, Department of Defense; John Windom, Program Executive Officer, Electronic Health Record Modernization Program; and David Powner, Director of IT Management Issues, Government Accountability Office.
III. Reports, Studies, & Analyses
- On June 28, 2018, the Government Accountability Office (GAO) issued a report entitled, Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement. The GAO was asked to provide information on the use of contract pharmacies within the 340B Program. The GAO makes seven recommendations, including that HRSA’s audits assess for duplicate discounts in Medicaid managed care, and HRSA require information on how entities determined the scope of noncompliance and evidence of corrective action prior to closing audits.
IV. Other Health Policy News
- On June 28, 2018, the HHS Office of Inspector General (OIG) announced that, throughout June, the OIG participated in one of the largest health care fraud takedowns in history. According to the OIG, more than 600 defendants in 58 federal districts were charged with participating in fraud schemes involving about $2 billion in losses to Medicare and Medicaid. Additional information is available here.