Alston & Bird Healthcare Week in Review, September 23, 2017

I. Regulations, Notices, & Guidance

• On September 18, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. The guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to the FDA. Comments may be submitted at any time.
• On September 18, 2017, the FDA issued a notice entitled, Flavor Developer and Manufacturer Site Tours Program. The FDA’s Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Flavor Developer and Manufacturer Site Tours Program. The program is intended to give CTP staff an opportunity to visit companies that develop and/or manufacture flavors (including flavor mixtures) that are sold to tobacco product manufacturers in order to gain a better understanding of the development, testing, and production of flavors and flavor mixtures used in the manufacturing of tobacco products. The site tours in the program are not intended as regulatory inspections. The purpose of the notice is to invite parties interested in participating in the Flavor Developer and Manufacturer Site Tours Program to submit requests to CTP.
• On September 19, 2017, the Health Resources and Services Administration (HRSA) issued a notice announcing the availability of a final policy document entitled, Health Center Program Compliance Manual. According to HRSA, the Manual has been developed as a comprehensive, significantly streamlined, and web-based guidance document to assist health centers in understanding and demonstrating compliance with Health Center Program requirements. As such, the guidance document will reduce burden for current and prospective health centers and look-alikes and further strengthen HRSA’s oversight of the Health Center and Health Center Federal Tort Claims Act (FTCA) Programs. The guidance document also responds to recommendations contained within the Government Accountability Office report, Health Center Program: Improved Oversight Needed to Ensure Grantee Compliance with Requirements, GAO-12-546, for increased transparency, clarity, and consistency in Health Center Program oversight.
• On September 20, 2017, the FDA issued a notice entitled, Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications. The notice announces that the FDA is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the FDA in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
• On September 20, 2017, the FDA issued a notification; petition for rulemaking entitled, Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use). The notice announces that Akzo Nobel Surface Chemistry AB has filed a petition proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. Comments are due by October 23, 2017.
• On September 21, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final notice entitled, Medicare and Medicaid Programs; Continued Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program’s (AOA/HFAP’s) Ambulatory Surgical Center Accreditation Program. The notice announces CMS’ decision to approve the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
• On September 21, 2017, the FDA issued a draft guidance entitled, Statistical Approaches to Evaluate Analytical Similarity. The draft guidance, when finalized, will provide advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products. Specifically, the draft guidance describes the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity. Comments are due by November 21, 2017.
• On September 21, 2017, the National Institutes of Health (NIH) issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The notice announces the research material: a potent, broadly-neutralizing, anti-HIV antibody (35O22) that binds a novel epitope is government owned an available for licensing.
• On September 22, 2017, the FDA issued a notice entitled, Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. The notice announces that the FDA is publishing a list of premarket approval applications (PMAs) that have been approved. The list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
• On September 22, 2017, the FDA issued a guidance entitled, Compliance Policy for Required Warning Statements on Small-Packaged Cigars. The guidance is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in the FDA's regulations deeming other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance describes the FDA’s compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The guidance explains that the FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package. Comments may be submitted at any time.
• On September 22, 2017, the FDA issued a guidance entitled, Minutes of Institutional Review Board Meetings; Guidance for Institutions and Institutional Review Boards. The guidance is intended for institutions and Institutional Review Boards (IRBs) that are responsible for the review and oversight of human subject research conducted or supported by the U.S. Department of Health and Human Services (HHS) or regulated by the FDA. The purpose of the guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guidance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The guidance also provides general recommendations on the type and amount of information to be included in the minutes. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2015.

• October 13, 2017: The FDA announced a public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The committee will discuss the safety and efficacy of new drug application (NDA) 208254, for netarsudil ophthalmic solution 0.02%, submitted by Aerie Pharmaceuticals Inc., for the proposed indication to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
• October 24 – 25, 2017: The FDA announced public meeting entitled, 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System. The purpose of the public meeting is to discuss the current status of the National Antimicrobial Resistance Monitoring System (NARMS) and directions for the future.
• October 27, 2017: The FDA announced a public workshop entitled, FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints. The purpose of the public workshop is to address challenges related to the evaluation of products in pediatric heart failure including population to study, endpoints, and extrapolation of adult efficacy data. The workshop will also provide a forum for discussion on the use of registry data, as well as alternative trial designs and statistical methods.
• October 30 – 31, 2017: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). The agenda for day one of the meeting will include discussions that will cover briefings and BSC deliberation on the following topics: interval updates from OPHPR Divisions and Offices; updates from the Biological Agent Containment working group; overview of OPHPR division roles and responsibilities during complex emergencies; and Preparedness Updates from Liaison Representatives. Day two of the meeting will cover briefings and BSC deliberation on the following topics: OPHPR Office of Policy, Planning and Evaluation Stories Project; Public Health Preparedness and Response Social Media and Communications Metrics; Incident 4 Management Training Development Program updates, OPHPR Practice-based Research Agenda and Synthesis and Translation of Public Health Preparedness and Response Research. Agenda items are subject to change as priorities dictate.
• November 7, 2017: The FDA announced a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). On November 7, 2017, the CRBPAC will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations.
• November 7 – 8, 2017: HRSA announced a meeting of the National Advisory Council on Migrant Health (NACMH/Council). The agenda for the NACMH meeting can be obtained by contacting the Designated Federal Officer (DFO) or accessing the Council website, which can be accessed here.
• November 15 – 16, 2017: The FDA announced an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The public workshop on the FDA’s clinical trial requirements is designed to aid the clinical research professional’s understanding of the mission and authority of the FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among the FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; and inspections of clinical investigators, IRBs, and research sponsors.

II. Congressional Legislation & Committee Action

• There were no scheduled health care-related hearings for the week of September 18, 2017.

• The House has adjourned and will reconvene on September 25, 2017.

• On September 19, 2017, the Office of Inspector General (OIG) released a report entitled, Wisconsin Did Not Always Comply With Maternal, Infant, and Early Childhood Home Visiting Program Requirements. The report found that the Wisconsin Department of Children and Families (DCF) did not always comply with Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program requirements and the terms and conditions of the program's grants, resulting in unallowable expenditures totaling $275,175. Specifically, for the five sub-recipients reviewed, the DCF did not ensure that one sub-recipient used grant funding for allowable purposes. The OIG also found that for three of the five sub-recipients, the DCF did not ensure that sub-recipients' time-and-effort reporting systems complied with Federal requirements. In addition, the DCF did not have adequate procedures to monitor sub-recipients, could not provide an approved budget for one of its sub-recipient agreements, and did not comply with Federal Funding Accountability and Transparency Act of 2006 (FFATA) reporting requirements. The OIG did not identify any unallowable expenditures at the State level.
• On September 19, 2017, the OIG released a report entitled, Nevada Did Not Bill Manufacturers for Some Rebates for Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. The report found that when Nevada billed manufacturers for rebates for physician-administered and pharmacy drugs, it did so correctly. However, Nevada estimated that it did not bill for rebates of $520,137 ($327,624 Federal share) for physician-administered and pharmacy drugs that were eligible for rebates. In addition, Nevada did not bill for rebates for 19,650 claim lines for other physician-administered and pharmacy drugs that may have been eligible for rebates. Because there was insufficient information to determine the amount of any rebates that may have been due, the OIG set aside these claim lines for resolution by CMS. Nevada's internal controls did not ensure that it billed for and collected rebates for all drugs dispensed to enrollees of Medicaid managed-care organizations (MCOs).
• On September 21, 2017, the OIG released a report entitled, Medicare Inappropriately Paid Acute-Care Hospitals for Outpatient Services They Provided to Beneficiaries Who Were Inpatients of Other Facilities. The report found that Medicare did not appropriately pay acute-care hospitals any of the $51.6 million for outpatient services that we reviewed. In addition, beneficiaries were held responsible for unnecessary deductibles and coinsurance of $14.4 million paid to the acute-care hospitals for outpatient services. Generally, Medicare should not pay an acute-care hospital for outpatient services provided to an inpatient of another facility, such as a long-term-care hospital. Instead, the services should be provided under arrangements between the two facilities, and Medicare should pay the inpatient facility for all services provided to a beneficiary (as part of the facility's inpatient payment rate). The report found that Medicare overpaid the acute-care hospitals because the system edits that should have prevented or detected the overpayments were not working properly. If the system edits had been working properly since 2006, Medicare could have saved almost $100 million, and beneficiaries could have saved $28.9 million in deductibles and coinsurance that may have been incorrectly collected from them or someone on their behalf.
• On September 21, 2017, the OIG released a report entitled, Alabama Did Not Adequately Secure Its Medicaid Data and Information Systems. The report found that Alabama did not adequately secure its Medicaid data and information systems in accordance with Federal requirements. Although Alabama had adopted a security program for its Medicaid Management Information System (MMIS), numerous significant system vulnerabilities remained. These vulnerabilities remained because Alabama neither implemented sufficient controls over its MMIS data and information systems nor provided sufficient oversight to ensure that HP, Alabama's Medicaid fiscal agent, implemented contract security requirements. Although we did not identify evidence that anyone had exploited these vulnerabilities, exploitation could have resulted in unauthorized access to and disclosure of Medicaid data, as well as the disruption of critical Medicaid operations. These vulnerabilities were collectively and, in some cases, individually significant and could have compromised the integrity of Alabama's Medicaid program.

Iv. Other Health Policy News

• Per Politico, the Senate will vote next week on the latest bill to repeal the Affordable Care Act, a spokeswoman for Senate Majority Leader Mitch McConnell (R-Ky.) said Wednesday. "It is the Leader's intention to consider Graham/Cassidy on the floor next week," the spokesperson said. The latest proposal, written by Sens. Lindsey Graham (R-S.C.) and Bill Cassidy (R-La.), would turn federal health insurance funding into block grants for states.
• On September 20, 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 20, 2017. According to CMS, participation is expected to fluctuate and does not represent actual Exchange application submissions.
• On September 22, 2017, Senator John McCain (R-AZ) has announced that he will vote “no” on the Graham-Cassidy-Heller-Johnson (GCHJ) Legislation.