Alston & Bird Healthcare Week in Review, October 20, 2017

I. Regulations, Notices, & Guidance

• On October 16, 2017, the Centers for Disease Control (CDC) issued a notice entitled, Application of Biological Monitoring Methods for Chemical Exposures in Occupational Health. The National Institute for Occupational Safety and Health announced the availability of a draft chapter to be published in the NIOSH Manual of Analytical Methods that is now available for public comment. Comments are due by December 15, 2017.
• On October 16, 2017, the CDC issued a notice entitled, Request for Nominations of Potential Reviewers to serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP). The CDC is seeking nominations for possible membership on the Injury Prevention and Control Special Emphasis Panel (SEP) in the National Institute for Occupational Safety and Health (NIOSH), World Trade Center Health Program (WTCHP). The SEP provides advice and guidance to the Secretary of the Department of Health and Human Services; the Director for CDC, and the Administrator for the Toxic Substances and Disease Registry (ATSDR) regarding the concept review, scientific and technical merit of grant and cooperative agreement assistance applications, and control of diseases, disabilities, injuries, and impairments of public health significance; exposure to hazardous substances in the environment; health promotion and education; and other related activities that promote health and well-being. Nominations for membership on the WTCHP SEPs are due by December 15, 2017.
• On October 16, 2017, President Trump’s Executive Order (EO) was made available for public inspection. The EO is intended to expand choices and alternatives to the ACA individual and small group market insurance plans and to increase competition to bring down costs for consumers. The EO directs the Departments of Treasury, Labor, and Health and Human Services to review and revise existing guidance in three areas: association health plans (AHP), short term limited duration insurance (STDLI), and health reimbursement arrangements (HRAs). The EO is intended to facilitate the purchase of insurance across state lines and the development and operation of a high-quality and affordable healthcare system. The EO states that government rules and guidelines affecting the United States healthcare system should expand the availability of and access to AHP, STDLI, and HRAs, re-inject competition into healthcare markets by lowering barriers to entry, limit excessive provider consolidation, prevent abuses of market power, and improve access to and the quality of information that Americans need to make informed healthcare decisions, including data about healthcare prices and outcomes, while minimizing reporting burdens on affected plans, providers, or payers. The EO did not direct the agencies to adopt any particular rules but asks the agencies to consider access to AHPs, STDLI, and HRAs to the extent consistent with law and comments received from the public.
• On October 16, 2017, the Drug Enforcement Agency (DEA) issued a final rule, which places N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexymethyl-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl) methanone (THJ-2201), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This rule continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle AB-CHMINACA, AB-PINACA and THJ-2201.
• On October 17, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Agency Information Collection Activities: Proposed Collection. CMS is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public related to the New Technology Payments for APCs Under the Outpatient Prospective Payment System (CMS-10054) and the Medicare Authorization to Disclose Personal Health Information (CMS-10106). Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow sixty days for public comment on the proposed action. Interested persons are invited to send comments regarding CMS’ burden estimates or any other aspect of this collection information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
• On October 17, 2017, the Food and Drug Administration (FDA) issued a final order entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. The FDA is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organosphate that test system’s classification. FDA is taking the action because the FDA has determined that classifying the device into call II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On October 17, 2017, the FDA issued a notice of availability entitled, Center for Devices and Radiological Health: Experiential Learning Program. The FDA Center for Devices and Radiological Health (CDHR) is announcing the 2018 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/input, and challenges that impact the medical device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding ELP.
• On October 17, 2017, CMS issued a transmittal concerning Fiscal Year (FY) 2018 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes. Transmittal 3858, dated September 8, 2017, is being rescinded and replaced by Transmittal 3885 dated, October 17, 2017 to update factor 3 denominator for hospitals treated as new, the fixed-loss amount for LTCH standard Federal payment rate cases, reference to the Grouper software version, applicable tables and files available on the CMS website, and to clarify the list of ICD-10 codes eligible for the GORE IBE device system new technology add-on payment. In addition, it updates the assignment of the wage index for Indian Health Service or Tribal Hospitals of the Pricier in the attachment. All other information remains the same.
• On October 18, 2017, the FDA issued a notice of availability entitled, Product-Specific Guidances; Draft and Revised Guidances for Industry; Availability. The guidances provide product specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications. In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled Bioequivalence Recommendations for Specific Products that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using process described in that guidance.
• On October 18, 2017, CMS issued a proposed notice regarding an application by Community Health Accreditation Partner (CHAP) for Continued CMS Approval of its Home Health Agency Accreditation Program. The proposed notice acknowledges the receipt of an application from CHAP for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Comments are due November 20, 2017.
• On October 19, 2017, CMS issued a final rule entitled, Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing. The final rule amends the CLIA regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
• On October 20, 2017, the CDC issued a notice regarding Evaluation of the National Tobacco Prevention and Control Public Education Campaign. The CDC published a document in the Federal Register on October 13, 2017, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act Review. The document provided the incorrect proposed project title, number of annual reporting responses for each respondent and average burden per response estimate.
• On October 20, 2017, the FDA issued a notice entitled, Product-specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance for Industry; Availability. The FDA is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled Draft Guidance on Methylphenidate Hydrochloride. The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications for methylphenidate hydrochloride oral extended-release tablets.
• On October 20, 2017, the FDA issued a notice entitled, Determination That ELAVIL (amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. The FDA has determined that ELAVIL oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications for the above tablets if all other legal and regulatory requirements are met.

• October 16, 2017: HHS announced the next federal advisory committee meeting regarding the development of national health promotion and disease prevention objectives for 2030. The Committee will discuss the nation’s health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure. The Committee will provide advice regarding criteria for identifying a more focused set of measurable, nationally representative objectives.
• October 17 – 18, 2017: HHS announced a meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The SACHRP meeting will open to the public at 8:30 a.m., on Tuesday, October 17, 2017, followed by opening remarks from Dr. Jerry Menikoff, Director, Office for Human Research Protections (OHRP) and Dr. Stephen Rosenfeld, SACHRP Chair. The Wednesday, October 18, meeting will begin at 8:30 a.m. with a presentation and discussion led by FDA staff on a recent FDA experience with IRB review under 21 CFR 50.54, and the lessons learned. Time is allotted for review of the previous day’s recommendations. The meeting will adjourn at approximately 4:00 p.m., October 18, 2017.
• October 17 – 20, 2017: HHS announced a meeting of the 2018 Physical Activity Guidelines Advisory Committee. The meeting will include subcommittee reports on the remainder of their literature review questions, discussion of overarching issues, and discussion of plans for finalizing the Committee’s report to the Secretary.
• October 18, 2017: The FDA announced a public advisory committee meeting of the Endocrinology and Metabolic Drugs Advisory Committee. The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• October 19, 2017: The FDA announced a regional public meeting entitled, Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Geneva.
• October 20, 2017: The National Institutes of Health (NIH) announced a meeting of the NIH Clinical Center Research Hospital Board. The agenda includes discussion on the Patient Safety Racking and Reporting System; quality improvement assessment results, and IRB consolidation.
• October 20, 2017: The FDA announced a public workshop entitled, Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access. The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.
• October 25, 2017: The NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). The October 25, 2017 DMICC meeting will focus on Enhancing Opportunities in Addressing Obesity and Type 2 Diabetes Disparities.
• 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) 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. Pursuant to section 10(d) of the Federal Advisory Committee Act notice given for a meeting of the Board of Scientific Counselors.
• 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.

II. Congressional Legislation & Committee Action

• On October 17, 2017, the Senate Committee on Health, Education Labor and Pensions held a hearing entitled, The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay, Part II. The witnesses scheduled to testify are Lori Reilly, Executive Vice President, Pharmaceutical Research and Manufacturers of America; Chester “Chip: Davis, Jr., President and Chief executive Officer, Association for Accessible Medicines; Elizabeth A. Gallenagh, Senior Vice President Government Affairs and General Counsel, Healthcare Distribution Alliance; Mark Merritt President and Chief Executive Officer, Pharmaceutical Care Management Association; and Thomas E. Menighan, BSPharm, MBA, ScD(Hon.), FAPhA, Executive Director and Chief Executive Officer, American Pharmacists Association.
• On October 19, 2017, the Senate Committee on Health, Education Labor and Pensions held a hearing entitled, Examining How Healthy Choices Can Improve Health Outcomes and Reduce Costs. The witnesses scheduled to testify are Steve Burd, Founder and CEO of Burd Health; Michael F. Roizen, MD, Chief Wellness Officer, Roizen Family Chair The Wellness Institute of the Cleveland Clinic; David A. Asch, MD, MBA, John Morgan Professor, Perelman School of Medicine and the Wharton School Executive Director, Center for Health Care Innovation at University of Pennsylvania.
• On October 19, 2017, the Senate passed Con.Res.71, FY18 Budget by a 51-49 vote.

• In recess for the week of October 16, 2017

• On October 16, 2017 the American Hospital Association released a report entitled, Estimates of the federal revenue forgone due to the tax exemption of non-profit hospitals compared to the community benefit they provide, 2013. The report said the benefits that non-profit hospitals provide to communities outweigh forgone federal tax revenue.
• On October 19, 2017 the Kaiser Family Foundation (KFF) and the National Association of Medicaid Directors held a briefing entitled, Medicaid in Uncertain times: Results from a 50-State Medicaid Budget Survey. The briefing discussed the findings of the 50-state survey. Diane Rowland, the Executive Vice President of the Foundation, moderated the briefing. There were two panels. The first panel reported on key findings from the survey including Medicaid enrollment and spending. The panelists were co-authors Robin Rudowitz, Associate Director of the Foundation’s Program on Medicaid & the Uninsured and Kathy Gifford, Principal at Health Management Associates (HMA). The second panel covered state perspectives in relation to the report. The panelists were Kate McEvoy, Vice President of the Board of Directors of NAMD and Director of the Division of Health Services, Connecticut Department of Social Services (CT) and Michael Heifetz, Medicaid Director, Wisconsin Department of Health Services (WI). The KFF used the survey to create three new reports: (1) Medicaid Enrollment & Spending Growth: FY2017 and 2018; (2) Medicaid Moving Ahead in Uncertain Times: Results from a 50-state Medicaid Budget Survey for State Fiscal Years 2017 and 2018; and (3) Putting Medicaid in the Larger Budget Context, An In-Depth look at Three States in FY 2017 and FY 2018.

IV. Other Health Policy News

• On October 16, 2016 the CDC issued a notice entitled, Application of Biological Monitoring Methods for Chemical Exposures in Occupational Health. The National Institute for Occupational Safety and Health announced the availability of a draft chapter to be published in the NIOSH Manual of Analytical Methods that is not available for public comment. Comments are due by December 15, 2017.
• On October 17, 2017 CMS issued a Matters Special Edition (SE) Article intended for pharmacies billing Durable Medical Equipment Medicare Administrative Contractors (DME MACs) for immunosuppressive drugs provided to Medicare beneficiaries who received an organ transplant that was paid for by Medicare.
• On October 19, CMS approved Oregon’s reinsurance waiver. Oregon’s Sec. 1332 waiver request allows pass-through federal funding to support a state reinsurance program starting in 2018. Also, the comment period for Iowa’s Sec.1332 waiver request is awaiting CMS approval.