Alston & Bird Healthcare Week in Review, August 11, 2017

Regulations, Notices, & Guidance

• On August 8, 2017, the Food and Drug Administration (FDA) issued a revised draft guidance entitled, Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products. The revised draft guidance describes the conditions under which the FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. According to the FDA, through the notice, the FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety. Comments are due by October 10, 2017.
• On August 8, 2017, the FDA issued a draft guidance entitled, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. The draft guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to be documented in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that the FDA generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report. Comments are due by October 10, 2017.
• On August 8, 2017, the Centers for Disease Control and Prevention (CDC) issued a request for comments entitled, Draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention. The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of the draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention Agenda for public comment. Comments are due by October 10, 2017.
• On August 9, 2017, the FDA issued a guidance entitled, Qualification of Medical Device Development Tools (MDDT). The guidance formalizes the MDDT program and provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. In addition, the guidance discusses the framework of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. Comments may be submitted at any time.
• On August 9, 2017, the FDA issued a guidance entitled, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. The guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations. Comments may be submitted at any time.
• On August 11, 2017, the FDA issued a notice entitled, International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances. The notice announces that the FDA is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. According to the FDA, the comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. The WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. Comments are due on September 13, 2017.

• September 7, 2017: The National Institutes of Health (NIH) announced a meeting of the National Center for Advancing Transitional Sciences. The agenda includes a report from the Institute Director and other staff.
• September 7 – 8, 2017: The Department of Health and Human Services (HHS) announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). The meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public.
• September 8, 2017: The FDA announced a meeting of the Medical Imaging Drugs Advisory Committee. The committee will discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures.
• September 12, 2017: The NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. The agenda includes a discussion of program policies and issues.
• September 12, 2017: The NIH announced a meeting of the National Cancer Institute. The agenda includes Acting Director’s and program reports and presentations and business of the Board.
• September 13, 2017: The Centers for Medicare & Medicaid Services (CMS) announced the next meeting of the Advisory Panel on Outreach and Education (APOE). The agenda includes a recap of the previous (March 22, 2017) meeting, review of CMS programs and initiatives, and a summary of the meeting and review of recommendations and next steps.
• September 14 – 15, 2017: The NIH announced a meeting of the National Institute of General Medical Sciences (NIGMS). The agenda includes a discussion of program policies and issues; opening remarks; report of the Director of NIGMS; and other business of the Council.
• September 18, 2017: The FDA announced a meeting to convene a discussion of topics related to the structured assessment of benefits and risks in drug regulatory decision-making. The meeting will focus on regulatory and industry experiences with approaches to structured benefit-risk assessments, approaches to incorporating patient perspectives into structured benefit-risk assessment, and exploration of methods to advance structured benefit-risk assessment. The format of the meeting will include a series of presentations on the above topics related to structured assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members.
• September 18 – 19, 2017: The NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). The meeting’s agenda will focus on the US strategic roadmap for implementation of new approaches to safety evaluation, which is under development, and the Interagency Coordinating Committee on the Validation of Alternative Methods agencies’ activities related to the development and implementation of alternative methods.
• September 26, 2017: The CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). The agenda for the meeting addresses occupational safety and health issues related to: stockpiled surgical gowns & respirators; the increased use and complexity of robots; NIOSH’s disaster science responder research; and fentanyl exposures to emergency responders.
• September 26 – 27, 2017: The CDC announced a meeting of the Board of Scientific Counselors BSC National Center for Injury Prevention, (NCIPC). The Board of Scientific Counselors agenda for the two-day meeting will be: September 26, 2017 - will discuss science matters to include research strategies needed to guide the Center’s focus, as well as updates on the NCIPC extramural research program, the National Intimate and Sexual Violence Workgroup, and the Pediatric Mild-Traumatic Injury Workgroup. September 27, 2017 - will discuss science matters to include the Essentials for Childhood Workgroup Portfolio Review, the Suicide Strategic Plan, and Opioid Overdose CDC Coordination/Strategic Directions.
• September 28, 2017: The CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), Subcommittee for Dose Reconstruction Reviews (SDRR), NIOSH. The agenda for the Subcommittee meeting includes the following dose reconstruction program quality management and assurance activities: dose reconstruction cases under review from Sets 14 - 23, including the Oak Ridge sites (Y-12, K-25, Oak Ridge National Laboratory), Hanford, Feed Materials Production Center (“Fernald”), Lawrence Livermore National Laboratory, Mound Plant, Rocky Flats Plant, Nevada Test Site, Idaho National Laboratory, Savannah River Site, Brookhaven National Laboratory, Westinghouse, W.R. Grace, Uranium Mill in Monticello, Ventron Corporation, Weldon Springs Plant, and other Department of Energy and “Atomic Weapons Employer” facilities.
• October 4, 2017: The NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). According to the NIH, the purpose of the meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.

II. Congressional Legislation & Committee Action

• The Senate has adjourned and will reconvene on September 5, 2017.

• The House of Representatives has adjourned and will reconvene on September 5, 2017.

• On August 9, 2017, the Congressional Budget Office (CBO) released a work paper entitled, Distribution of Lifetime Medicare Taxes and Spending by Sex and by Lifetime Household Earnings. The working paper projects the distribution of Medicare taxes and spending on the basis of administrative earnings data as well as demographic and economic projections from the CBO’s long-term microsimulation model.
• On August 10, 2017, the Office of Inspector General (OIG) released a report entitled, Maine Did Not Comply With Federal and State Requirements for Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities. The report found that the Maine Department of Health and Human Services (State agency) did not comply with Federal Medicaid waiver and State requirements for reporting and monitoring critical incidents involving Medicaid beneficiaries with developmental disabilities residing in community residences. The State agency did not fulfill many of the participant safeguard assurances it provided to CMS in its Medicaid waiver. Specifically, the State agency did not (1) ensure that community-based providers reported all critical incidents to the State agency; (2) ensure that community-based providers conducted administrative reviews of all critical incidents involving serious injuries, dangerous situations, or suicidal acts and submitted their findings within 30 days; (3) report appropriately all restraint usage and rights violations to Disability Rights Maine (DRM); (4) review and analyze data on all critical incidents; (5) investigate and report immediately to the appropriate district attorney's office or to law enforcement all critical incidents involving suspected abuse, neglect, or exploitation; and (6) ensure that community-based providers reported all beneficiary deaths to the State agency appropriately and that the State agency analyzed, investigated, and reported the deaths to law enforcement or Maine's Office of Chief Medical Examiner (OCME). The State agency failed to demonstrate that it has a system to ensure the health, welfare, and safety of the 2,640 Medicaid beneficiaries with developmental disabilities covered by the Medicaid waiver.

IV. Other Health Policy News

• On August 9, 2017, CMS posted an update to the Health Insurance Exchanges Issuer County Map. The map is of projected issuer participation on the Health Insurance Exchanges in 2018 based on the known issuer public announcements through August 9, 2017. According to CMS, participation is expected to fluctuate and does not represent actual Exchange application submissions.
• On August 9, 2017, CMS announced the second annual release of the Medicare Hospice Utilization and Payment Public Use File (Hospice PUF). The Hospice PUF is a comprehensive resource for information on hospice utilization, payments, submitted charges, diagnoses, and beneficiary demographics organized by hospice provider and state. The data can be accessed here.

V. ACA Repeal News

• N/A.