Alston & Bird Healthcare Week in Review, September 9, 2017

I. Regulations, Notices, & Guidance

• On September 5, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices. The FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. The document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. Comments may be submitted at any time.
• On September 5, 2017, the FDA issued a guidance entitled, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption." Comments may be submitted at any time.
• On September 5, 2017, the FDA issued a notice entitled, Determination that GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams, were Not Withdrawn from Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that GYNOREST (dydrogesterone) oral tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. According to the FDA, this determination will allow the FDA to approve abbreviated new drug applications (ANDAs) for GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, if all other legal and regulatory requirements are met.
• On September 5, 2017, the FDA issued a notice entitled, Determination That RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. According to the FDA, this determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride extended-release capsules, 60 mg, if all other legal and regulatory requirements are met.
• On September 6, 2017, the FDA issued  a guidance entitled, Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products. The guidance provides establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. Comments may be submitted at any time.
• On September 6, 2017, the National Institutes of Health (NIH) issued a notice entitled, Notice of Listing of Members of the National Institutes of Health’s Senior Executive Service 2017 Performance Review Board (PRB). The notice announces the persons who will serve on the National Institutes of Health’s Senior Executive Service 2017 Performance Review Board.
• On September 7, 2017, the FDA issued a request for comments and information entitled, Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements. The FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Biologics Evaluation and Research (CBER). Comments are due by December 7, 2017.
• On September 7, 2017, the FDA issued a request for comments and information entitled, Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements. The FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Devices and Radiological Health (CDRH). Comments are due by December 7, 2017.
• On September 7, 2017, the FDA issued a request for comments and information entitled, Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements. The FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Drug Evaluation and Research (CDER). Comments are due by December 7, 2017.
• On September 7, 2017, the FDA issued a request for comments and information entitled, Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements. The FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Food Safety and Applied Nutrition (CFSAN). Comments are due by December 7, 2017.
• On September 7, 2017, the FDA issued a request for comments and information entitled, Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements. The FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Tobacco Products (CTP). Comments are due by December 7, 2017.
• On September 7, 2017, the FDA issued a request for comments and information entitled, Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration. The FDA is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to general regulatory and information collection requirements that affect multiple FDA Centers and/or Offices. Comments are due by December 7, 2017.
• On September 8, 2017, the FDA issued a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product. The notice announces the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The FDA has determined that KYMRIAH (tisagenlecleucel), manufactured by Novartis Pharmaceuticals Corporation, meets the criteria for a priority review voucher.

• September 27, 2017: The Office of National Drug Control Policy (ONDCP) announced a meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis (Commission). The meeting will consist of statements to the Commission from invited government, nonprofit, and business organizations regarding Innovative Pain Management and Prevention Measures for Diversion followed by discussion of the issues raised.
• October 3, 2017: The FDA announced meeting entitled, Development of a List of Pre-DSHEA Dietary Ingredients. The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA’s future development of such a list.
• October 4, 2017: The FDA announced an advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). On October 4, 2017, the VRBPAC will meet in an open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern hemisphere influenza season. The FDA intends to make background material available to the public no later than 2 business days before the meeting. If the FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on the FDA's website after the meeting.
• October 6, 2017: The NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. During the open portion of the hearing, the agenda includes a report from the Institute Director and other staff.
• October 18 – 19, 2017: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Community Preventive Services Task Force (Task Force). The matters proposed for discussion include: Cardiovascular Disease Prevention (Mobile Health Interventions for Cardiovascular Disease Prevention); Diabetes Prevention and Control (Lifestyle Interventions to Reduce Risk of Gestational Diabetes); Nutrition (Gardening-Based Interventions to Increase Fruit and Vegetable Intake); Obesity Prevention and Control (School-based Diet and Physical Activity Interventions); and Women’s Health (Primary Prevention of Intimate Partner Violence and Sexual Violence Among Youth).
• October 30, 2017: The FDA’s CDER, is sponsoring a public workshop entitled, CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development. According to the FDA, the public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what the FDA needs to enhance drug development. The effort is consistent with FDA’s efforts to support the integration of patient experience in drug development programs, including through implementation of the “Patient-Focused Drug Development” provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.
• January 11, 2018: The FDA announced a public workshop entitled, Self-Collection Devices for Pap Test. The purpose of the public workshop is to obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and least burdensome validation approaches for self-collection devices for cervical samples for the purpose of cervical cancer screening by Pap testing. Comments and suggestions generated through this workshop will guide the development of an appropriate least burdensome regulatory framework for the evaluation of cervical sample self-collection devices to be used for cervical cancer screening of patients.

II. Congressional Legislation & Committee Action

• On September 6, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Stabilizing Premiums and Helping Individuals in the Individual Insurance Market for 2018: State Insurance Commissioners. The witnesses included: Mike Kreidler (WA), Julie Mix McPeak (TN), Theresa Miller (PA), Lori Wing-Heier (AK), and John Doak (OK).
• On September 6, 2017, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled, The History and Current Reality of the U.S. Health Care System. The witnesses included: Melissa Thomasson, Professor and Director of Graduate Studies in Miami University's Department of Economics; Katherine Baicker, Dean of the University of Chicago's Harris School of Public Policy; and Sabrina Corlette, research professor in Georgetown University Health Policy Institute's Center on Health Insurance Reforms.
• On September 6, 2017, the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held a markup of the Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2018. The bill was approved and sent to the full Senate Appropriations Committee.
• On September 6, 2017, the Senate Finance Committee held a markup to vote on the nominations of Gilbert Kaplan to be Commerce Undersecretary for International Trade; Matthew Bassett to be an Assistant HHS Secretary; and Robert Charrow to be HHS General Counsel. The Senate Finance Committee unanimously forwarded the nominations to the Senate floor.
• On September 7, 2017, the Senate HELP Committee held a hearing entitled, Stabilizing Premiums and Helping Individuals in the Individual Insurance Market for 2018: Governors. The governors who testified included: John Kickenlooper (D-CO), Charlie Baker (R-MA), Steve Bullock (D-MT), Bill Haslam (R-TN), and Gary Herbert (R-UT).
• On September 7, 2017, the Senate Finance Committee held a hearing entitled, The Children's Health Insurance Program (CHIP): The Path Forward. The witnesses included: Mr. Avik Roy, Co-Founder and President, Foundation for Research on Equal Opportunity; Mr. Edmund F. Haislmaier, Preston A. Wells, Jr. Senior Research Fellow, The Heritage Foundation; Mr. Andrew M. Slavitt, Former Acting Administrator, CMS; and Ms. Aviva Aron-Dine, Senior Fellow and Senior Counselor, Center on Budget and Policy Priorities.
• On September 7, 2017, the Senate Appropriations Committee held a full Committee markup of the Labor, Health and Human Services, Education and Related Agencies Appropriations Act, 2018. The Committee approved the spending bill by a vote of 29-2.

• There were no health care-related hearings scheduled in the House.

• On September 5, 2017, the Government Accountability Office (GAO) released a report entitled, VA Health Care: Opportunities Exist for Improving Implementation and Oversight of Enrollment Processes for Veterans. The report found that how the Department of Veterans Affairs (VA) reviews applications and enrolls veterans can lead to delays and errors. Enrollment staff—spread across the VA's central enrollment center and network of 170 medical centers—frequently missed the VA's 5-day timeliness standard, and sometimes incorrectly rejected veterans for health care benefits. Some applications we reviewed had been pending for more than 3 months.
• On September 5, 2017, the Office of Inspector General (OIG) released a report entitled, Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2014 Average Sales Prices. The report found that (1) CMS lowered Part B reimbursement for 14 drugs on the basis of data from 2014; (2) CMS's price-substitution policy saved Medicare and its beneficiaries $24 million over 1 year based on 2014 data; and (3) Medicare and its beneficiaries could have saved up to an additional $9 million over 1 year by expanding the price-substitution criteria to include drugs that exceeded the 5 percent threshold in a single quarter.
• On September 5, 2017, the OIG released a report entitled, Calculation of Potential Inflation-Indexed Rebates For Medicare Part B Drugs 2017. The report found that an average sales price (ASP)-based rebate program for Medicare Part B drugs could have resulted in $1.4 billion in inflation-indexed rebates in 2015 for 64 high expenditure drugs. An AMP-based rebate program for the same 64 drugs could have resulted in $1.8 billion in inflation indexed rebates that same year. Several implementation issues related to claims and data would need to be addressed should Congress decide to establish a rebate program under Part B.
• On September 7, 2017, the GAO released a report entitled, State Health-Insurance Marketplaces: Three States Used Varied Data Sources for Eligibility and Had Few Indications of Potentially Improper Enrollments. The report found that for plan year 2015, the GAO reviewed three selected state-based marketplaces' key processes to verify applicant eligibility for subsidized coverage and found that they used various data sources. Under the Patient Protection and Affordable Care Act (PPACA), marketplaces are required to verify applicant eligibility using data sources and methods approved by the Department of Health and Human Services (HHS). Applicant information that must be verified or validated to receive subsidized coverage includes Social Security number (SSN), citizenship or lawful presence, and income. To accomplish this verification, the selected state-based marketplaces relied on various federal data sources, including sources accessed via the federal data services hub (data hub). They also used state data sources, some of which may have been more current than the data hub sources. For example, all three selected state-based marketplaces supplemented federal tax income information accessed through the data hub, which can be up to 2 years old, with more-current state wage information to verify income. The Centers for Medicare & Medicaid Services (CMS) oversaw the state-based marketplaces' verification procedures by conducting annual reviews, collecting enrollment metrics, and engaging in regular communication in plan year 2015. For the three selected states, the GAO found few indications of potentially improper or fraudulent enrollments for plan year 2015 in the verification processes reviewed, but did identify data-quality issues, such as data-entry errors or name changes.
• On September 8, 2017, the GAO released a report entitled, Medicaid: States Fund Services for Adults in Institutions for Mental Disease Using a Variety of Strategies. The report Federal and state Medicaid spending on behavioral health services—mental health and substance use treatments—is projected to be $71 billion in 2017. However, the report found that some adults on Medicaid may have limited access to inpatient or residential behavioral health care because Medicaid generally doesn't cover services for adults in institutions for mental disease.
• On September 8, 2017, the OIG released a report entitled, Challenges Appear to Limit States' Use of Medicaid Payment Suspensions. The report found most Medicaid agencies (41 of 56) reported imposing 10 or fewer payment suspensions during FY 2014. Medicaid agencies reported significant challenges associated with imposing payment suspensions. These include: (1) demonstrating sufficient evidence to support payment suspensions when providers appealed, (2) not jeopardizing law enforcement investigations when providers appealed, and (3) sustaining payment suspensions through lengthy fraud investigations without unintentionally driving innocent providers out of business. Medicaid agencies often applied "good cause exceptions," during which payment suspensions are not suspended, while law enforcement investigated a credible allegation of fraud against a provider. Additionally, Medicaid agencies reported taking actions that improved their processes for payment suspensions, including how they handle fraud allegations and collaborate with law enforcement.
• On September 8, 2017, the Drug Enforcement Agency (DEA) issued a proposed amendment; notice of intent entitled, Schedules of Controlled Substances: Temporary Placement of FUB-AMB into Schedule I. The DEA is issuing the notice of intent to publish a temporary order to schedule the synthetic cannabinoid, Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [FUBAMB, MMB-FUBINACA, AMB-FUBINACA], into Schedule I. According to the DEA, the action is based on a finding by the DEA Administrator that the placement of this synthetic cannabinoid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of this synthetic cannabinoid.

IV. Other Health Policy News

• On September 6, 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 September 6, 2017. According to CMS, participation is expected to fluctuate and does not represent actual Exchange application submissions.
• On September 7, 2017, CMS issued a State Medicaid Letter entitled, Implications of the ABLE Act for State Medicaid Programs. The purpose of the letter is to provide guidance to states on the implications of the ABLE Act for state Medicaid programs.
• On September 7, 2017, the OIG issued an advisory opinion on regarding a retail pharmacy chain’s proposal to allow Federal health care program beneficiaries to participate in a paid membership program that includes discounts on certain prescriptions and clinic services (the Proposed Arrangement). The OIG conclude that: (1) the Proposed Arrangement would not constitute grounds for the imposition of civil monetary penalties under section 1128A(a)(5) of the Act; and (ii) although the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of Federal health care program business were present, the OIG would not impose administrative sanctions on [name redacted] under sections 1128(b)(7) or 1128A(a)(7) of the Social Security Act (as those sections relate to the commission of acts described in section 1128B(b) of the Act) in connection with the Proposed Arrangement.