Alston & Bird Healthcare Week in Review, October 27, 2017

I. Regulations, Notices, & Guidance

• On October 23, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Watson Laboratories, In., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications. The FDA is withdrawing approval of 54 abbreviated new drug applications from the two applications. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
• On October 24, 2017, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of An Exclusive Patent License: Computer-Aided Diagnosis of Prostate Cancer in Multi-parametric MRI. The National Cancer Institute and Clinical Center, institutes of the National institutes of Health, Department of Health and Human Services (HHS), are contemplating the grant of an exclusive Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the notice to ScanMed, LLC located in Omaha, NE.
• On October 24, 2017, the HHS issued an announcement entitled, Notice of Interest Rate on Overdue Debts. Section 30.18 of HHS’ claims collection regulations (45 CFR part 30) provides that the Secretary shall charge an annual rate of interest, which is determined and fixed by the Secretary of the Treasury after considering private consumer rates of interest on the date that the HHS becomes entitled to recovery. The notice says the current rate of 9.75 percent is certified for the quarter that ended September 30, 2017.
• On October 24, 2017, the HHS issued a request for information entitled, Removing Barriers for Religious and Faith-Based Organizations to Participate in HHS Programs and Receive Public Funding. The HHS seeks comment from faith-based organizations and other interested parties to inform HHS on how it may best identify and remove regulatory or other barriers in order for these institutions to participate in HHS-funded or regulated programs, strengthen partnerships with faith-based organizations to improve service delivery, and ensure faith-based organizations are affirmatively accommodated and not excluded from publicly funded or conducted programs or activities because of HHS requirements that burden or interfere with their religious character or exercise.
• On October 24, 2017, the FDA issued a guidance entitled, Breakthrough Devices Program; Draft Guidance for Industry and FDA staff. This guidance describes policies that the FDA intends to use to implement the new Breakthrough Devices Program, established by the 21^st Century Cures Act (Cures). The Breakthrough Devices Program supersedes and combines elements from FDA’s Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications and applied those criteria to other types of premarket submissions for medical devices. This guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program. This guidance is neither final nor in effect.
• On October 25, 2017, the Drug Enforcement Agency (DEA) issued a scheduling order entitled, Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl into Schedule I. This action is based on a finding by the DEA Administrator that the placement of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into schedule I of the Controlled Substances Act is necessary to avoid imminent hazard to public safety. This temporary scheduling is effective until October 28, 2019. If the order is extended or made permanent, the DEA will publish a document in the Federal Register.
• On October 25, 2017, the FDA issued a notice entitled, In Vitro Diagnostic Devices for Detection of Zika Virus. The FDA is announcing the issuance of two Emergency Use Authorizations (EUAs) for vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. The EUAs contain, among other things, conditions on the emergency use of authorized in vitro diagnostic devices. The EUAs follow the February 26, 2016, determination by the Secretary of HHS that there is a significant potential for a public health emergency that has significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of those determinations, the Secretary declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika infection, subject to federal law.
• On October 26, 2017 the FDA issued a notice entitled, Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice. The FDA is announcing an opportunity for the public to comment on the proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and allow 60 days for public comment. This notice solicits comments on the information collection in the guidance on “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.” Comments due December 27, 2017.
• On October 27, 2017, the Health Resources and Services Administration (HRSA) issued a notice entitled, Revised Amount of Average Cost of Health Insurance Policy. HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP). Section 100.2 of the VICP’s implementing regulations (42 CFR Part 100) states that the revised amount of an average cost of a health insurance policy , as determined by the Secretary, is effective upon its delivery by the Secretary to the United States Court of Federal Claims and will be published periodically in a notice in the Federal Register. The Secretary announces that the revised average cost of a health policy under the VICP is $528.76 per month. The notice was delivered to the Court on October 24, 2017.
• On October 27, 2017, the FDA issued a notice entitled, Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period. The FDA is reopening the comment period on the public work shop held October 10, 2017.
• On October 27, 2017, the FDA issued a guidance entitled, Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request. The FDA developed the guidance to clarify FDA’s position regarding manufacturers appropriately and responsibly sharing patient-specific information. The guidance provides information and recommendations to industry, health care providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with individual patients when they request it.
• On October 27, 2017, the HHS issued a proposed rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit Payment Parameters for 2019. This proposed rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It proposes changes that would enhance the role of States as related to essential health benefits (EHB) and qualified health plan (QHP) certification; and would provide states with additional flexibility in the operation and establishment of exchanges. It includes proposed changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions and other related topics.
• On October 27, 2017, CMS issued a final rule entitled, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program. This rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year 2018. It also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program (QIP), including for payments years 2017 through 2021.

• October 27, 2017: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). During the October meeting, the Advisory Council will welcome its new members and invite them to share their experiences and where they see the Council going over the length of their terms. The Advisory Council will also spend some time discussing the process of developing recommendations and how those recommendations relate to the National Plan. The Council will then spend much of the meeting discussing the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, held on October 16-17.
• October 30, 2017: The NIH announced a meeting of the Frederick National laboratory Advisory Committee to the National Cancer Institute. The agenda includes a discussion of ongoing and new activities at the Frederick National Laboratory for Cancer Research.
• October 31, 2017: The FDA announced a public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss NDA 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.
• November 1, 2017: HHS announced that the Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session entitled, Partnering to Prevent Hypoglycemia. The purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications.
• November 2-3, 2017: the NIH announced the Center for Scientific Review Special Emphasis Panel will hold a closed meeting to review and evaluate grant applications.
• November 3, 2017: HHS announced that the Agency for Healthcare Research and Quality (AHRQ) will hold a public meeting in accordance with section 10(a) of the Federal Advisory Committee Act. The purpose on the meeting is to advise the HHS Secretary and the Director of AHRQ to conduct its mission including providing guidance on priorities for health care research, the field of health care research including training needs and information dissemination on health care quality.
• November 6 – 7, 2017: The FDA announced a public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). On November 6, 2017, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. On November 7, 2017, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Tobacco Products, Center for Veterinary Medicine, and the Office of Regulatory Affairs will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.
• November 12-14: The National Institute of Environmental Health Sciences issued a notice of meeting. The meeting will cover AHRQ’s current research, programs, and initiatives and also include an update on work in learning health care systems and an update on AHRQ’s data platform.
• November 16, 2017: The FDA announced a public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.
• December 4-5, 2017: The NIH announced meetings of the Eunice Kennedy Shriver National Institute of Child Health and Human Development committee of the National Advisory Board on Medical Rehabilitation Research. The meetings will cover a variety updates and reports conducted regarding rehabilitation research.
• December 5, 2017: The NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. The purpose of the meeting is to bring together the Committee members to update one another on progress relevant to the Action Plan for the Muscular Dystrophies.
• December 11, 2017: The CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). The agenda will include discussion on 1) update on preliminary tuberculosis funding formula; 2) update on whole genome sequencing data sharing plan; and 3) an update on the three-month Isoniazid/Rifapentine regime guidelines.
• December 18, 2017: The FDA announced a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA may be used to inform regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21^st Century Cures Act.

II. Congressional Legislation & Committee Action

• On October 25, 2017, the Special Committee on Aging held a hearing entitled, Working and Aging with Disabilities: From School to Retirement. The witnesses included David Mank, Ph. D. Professor Emeritus at Indiana University; Tamar Heller, Ph.D. Professor at University of Illinois-Chicago; Jeff Smith; Eric Meyer, President and CEO of Spurwink.

• On October 24, 2017, the House Veterans Affairs Committee held a legislative hearing entitled, Draft Legislation to establish permanent Veterans Choice Program; Draft legislation to modify VA’s authority to enter into agreements with the State homes to provide nursing home care to veterans, to direct the Secretary to carry out a program to increase the number of graduate medical education residency positions, and for other purposes; Draft legislation, to direct VA to conduct a study of the Veterans Crisis Line; Draft legislation, to direct VA to furnish mental health carte to veterans at community or non-profit mental health providers p[participating in the Veterans Choice Program; the Department of Veterans’ (VA’s) legislative proposal, the Veteran Coordinated Access and Rewarding Experiences (CARE) Act; H.R. 1133; H.R. 2123; H.R. 2601; and H.R. 3642. The Committee considered legislation to permanently extend programs that allow veterans to use health care systems outside the Department of Veterans Affairs.
• On October 24, 2017, the House Committee on Energy and Commerce held a hearing entitled, Examining HHS’s Public Health Preparedness for and Response to the 2017 Hurricane Season. The hearing considered public health response to the recent natural disasters. Witnesses include Mc. Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare and Medicaid Services; Scott Gottlieb, MD Commissioner, U.S. Food and Drug Administration; Robert Kadlec, MD Assistant Secretary for Preparedness and Response, Department of Health and Human Services; Rear Admiral Upper Half Stephen C. Redd, MD Director of the Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention.
• On October 24, 2017, the House Appropriations Subcommittee for Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, The Role of Facilities and Administrative Costs in Supporting NIH-Funded Research. Witnesses were Dr. Kelvin Droegemeier, Vice President of Research, University of Oklahoma; Dr. Gary Gilliland, President and Director, Fred Hutchinson Cancer Research Center; Dr. Bruce Liang, MD, FACC, Dean at University of Connecticut School of Medicine; Dr. Keith Yamamoto, Vice Chancellor for Science Policy and Strategy at the University of California.
• On October 25, 2017, the House Committee on Energy and Commerce held a hearing entitled, Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives. The witnesses included Neil Doherty, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration; Dr. Scott Gottlieb, Commissioner, Food and Drug Administration (FDA); Dr. Elinore McCance-Katz, Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMSHA); Dr. Anne Schuchat, Principal Deputy Director, Center for Disease Control and Prevention (CDC); Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).

• On October 25, 2017 the Congressional Budget Office (CBO) released its report on the Bipartisan Health Care Stabilization Act of 2017, which is Senators Lamar Alexander and Patty Murray’s legislation to fund the cost-sharing reduction (CSR) payments. Overall, the CBO and the Joint Committee on Taxation estimate that the legislation would reduce the deficit by $3.8 billion from 2018 to 2027 and that it would not result in substantial changes to the number of individuals with insurance.

IV. Other Health Policy News

• The Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) held their October meetings in Washington, DC. MACPAC’s meeting agenda can be accessed here.