Alston & Bird Healthcare Week in Review, September 1, 2017

I. Regulations, Notices, & Guidance

• On August 28, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2018. The notice announces the FY 2018 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).
• On August 28, 2017, the FDA issued a notice entitled, Generic Drug User Fee Rates for Fiscal Year 2018. The notice announces the FY 2018 rates for Generic Drug User Fee Agreement fees.
• On August 28, 2017, the FDA issued a notice entitled, Medical Device User Fee Rates for Fiscal Year 2018. The notice establishes the fee rates for FY 2018, which apply from October 1, 2017, through September 30, 2018.
• On August 29, 2017, the FDA issued a guidance entitled, FY 2018 Medical Device User Fee Small Business Qualification and Certification. The guidance describes the process for how a business may request qualification and certification as a small business. Comments may be submitted at any time.
• On August 29, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; KENGREAL. The notice announces that the FDA has determined the regulatory review period for KENGREAL and is publishing this notice of that determination as required by law. According to the FDA, the FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. Comments are due by October 30, 2017.
• On August 29, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; XTORO. The notice announces that the FDA has determined the regulatory review period for XTORO and is publishing this notice of that determination as required by law. According to the FDA, the FDA has made the determination because of the submission of an application to the Director of the USPTO, Department of Commerce, for the extension of a patent which claims that human drug product. Comments are due by October 30, 2017.
• On August 29, 2017, the FDA issued a notice entitled, Determination That CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 Milligrams, and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 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 these products, if all other legal and regulatory requirements are met.
• On August 29, 2017, the FDA issued a revised draft guidance entitled, Product-Specific Guidance for Digoxin. The guidance, once finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support ANDAs for digoxin tablets. Comments are due by October 30, 2017.
• On August 29, 2017, the FDA issued a notice entitled, Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for PROPRANOLOL HYDROCHLORIDE. The notice announces that the FDA is withdrawing approval of an ANDA for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, held by Upsher-Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
• On August 30, 2017, the FDA issued a draft chapter of a multi chapter guidance entitled, Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry. The multi chapter draft guidance is intended to explain the FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under the FDA’s rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is entitled "Chapter Six--Use of Heat Treatments as a Process Control." Comments are due by February 27, 2018.
• On August 30, 2017, the FDA issued a notice entitled, Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities. The notice announces that the FDA is announcing support for the most current version of Medical Dictionary for Regulatory Activities (MedDRA), end of support for earlier versions of MedDRA, and an update to the FDA Data Standards Catalog (Catalog) for study data provided in new drug applications (NDAs), ANDAs, biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Comments may be submitted at any time.
• On August 30, 2017, the FDA issued a draft guidance entitled, Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices. The draft guidance when final, will clarify the FDA’s policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. The draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. This draft guidance is not final nor is it in effect at this time. Comments are due by October 30, 2017.
• On August 30, 2017, the FDA issued a guidance entitled, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. According to the FDA, the guidance is being issued to clarify how the FDA evaluates real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in the FDA regulatory decision-making for medical devices. The guidance describes the circumstances when real-world evidence can be used, and the scientific criteria that must be fulfilled in order to have confidence in the data. Finally, the guidance describes some examples of actual uses of real-world evidence that have already led to FDA decisions.
• On August 31, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Recognition of Revised NAIC Model Standards for Regulation of Medicare Supplemental Insurance. The notice announces the changes made by the Medicare Access and CHIP Reauthorization of 2015 (MACRA) to section 1882 of the Social Security Act (the Act), which governs Medicare supplemental insurance. The notice also recognizes that the Model Regulation adopted by the National Association of Insurance Commissioners (NAIC) on August 29, 2016, is considered to be the applicable NAIC Model Regulation for purposes of section 1882 of the Act, subject to our clarifications that are set forth in this notice.
• On August 31, 2017, the FDA issued a notice entitled, Determination that NIZORAL (Ketoconazole) Tablets, 200 Milligrams, were Not Withdrawn from Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that NIZORAL (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. According to the FDA, this determination means that the FDA will not begin procedures to withdraw approval of ANDAs that refer to NIZORAL, and it will allow the FDA to continue to approve ANDAs that reference NIZORAL as long as they meet relevant legal and regulatory requirements.
• On August 31, 2017, the FDA issued a notice entitled, Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1. The notice announces that CBER and CDER are announcing the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. The FDA will continue its support of the newer SDTM Version 1.3 and Version 1.4, which have been listed in the FDA Data Standards Catalog since December 2012 and August 2015, respectively. The FDA support for SDTM Version 1.2 will end for studies that start 12 months after March 15, 2018.
• On August 31, 2017, the FDA issued a guidance entitled, Procedures for Meetings of the Medical Devices Advisory Committee. The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel (DRP). The guidance describes the general circumstances in which the CDRH consults with a panel, the process for exchange of information among CDRH, the members of the panel, industry, and the public, and the conduct of panel meetings. The guidance supplements existing FDA Agency wide guidance on the conduct of Advisory Committee meetings. Comments may be submitted at any time.
• On August 31, 2017, The Health Resources and Service Administration (HRSA) issued a notice entitled, National Vaccine Injury Compensation Program; List of Petitions Received. The notice announces petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended.
• On September 1, 2017, the FDA issued a notice entitled, Determination That ENJUVIA (estrogens, conjugated synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 milligrams (mg) and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, if all other legal and regulatory requirements are met.
• On September 1, 2017, the FDA issued a draft guidance entitled, Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling. The draft guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on electronic format for submissions. The draft guidance describes how the FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications, and biologics license applications, beginning no earlier than 24 months after issuance of the final guidance. Comments are due by March 5, 2017.
• On September 1, 2017, the FDA issued a notice entitled, Pediatric Post-Marketing Pharmacovigilance and Drug Utilization Reviews. The notice announces that the FDA is establishing a public docket to collect comments related to the pediatric post-marketing pharmacovigilance and drug utilization reviews of products posted between March 11, 2017, and September 12, 2017, on the FDA’s website but not presented at the September 12, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public. Comments are due by October 20, 2017.
• On September 1, 2017, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of an Exclusive Patent License: Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors. The notice announces that the National Cancer Institute is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Nanobernetics, LLC (“Nanobernetics”) located in Maryland. Comments are due by September 20, 2017.
• On September 1, 2017, the NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The notice announces the availability for licensing of a Hybrid Computed Tomography Scanning System.

• September 7 – 8: The Medicare Payment Advisory Commission (MedPAC) announced its next public hearing. The agenda can be accessed here.
• September 25, 2017: The NIH announced a meeting of the Center for Scientific Review Advisory Council. The agenda includes advice to the Director, Center for Scientific Review (CSR), on matters related to planning, execution, conduct, support, review, evaluation, and receipt of referral of grant applications to CSR.
• October 23 – 25, 2017: The NIH announced that the National Toxicology Program (NTP) announced an expert panel meeting and is obtaining comment on a proposed approach to genomic dose-response modeling. Prior to the expert panel meeting, NTP will host four webinars that present other approaches to genomic dose-response modeling. The expert panel meeting and four webinar presentations leading up to the meeting are open to the public.
• October 25 – 26, 2017: HRSA announced a meeting of the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. During the October 25 to 26, 2017, meeting, the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will discuss strategies to link, retain, and re-engage people living with HIV into the Ryan White HIV/AIDS Program system of care; HAB’s benchmarking and risk adjustment initiatives; HRSA and CDC initiatives regarding congenital syphilis; and committee workgroup reports. Agenda items are subject to change as priorities dictate.

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 28, 2017, the Office of Inspector General (OIG) released a memorandum entitled, Early Alert: The Centers for Medicare & Medicaid Services Has Inadequate Procedures To Ensure That Incidents of Potential Abuse or Neglect at Skilled Nursing Facilities Are Identified and Reported in Accordance With Applicable Requirements. The memorandum alters CMS to the preliminary results of the OIG’s ongoing review of potential abuse or neglect of Medicare beneficiaries in skilled nursing facilities (SNFs). The audit is part of the ongoing efforts of the OIG to detect and combat elder abuse. The OIG identified 134 Medicare beneficiaries whose injuries may have been the result of potential abuse or neglect that occurred from January 1, 2015, through December 31, 2016. The OIG also found that a significant percentage of these incidents may not have been reported to law enforcement. As a result, the OIG determined that CMS has inadequate procedures to ensure that incidents of potential abuse or neglect of Medicare beneficiaries residing in SNFs are identified and reported. Accordingly, this Early Alert contains suggestions for immediate actions that CMS can take to ensure better protection of vulnerable beneficiaries.
• On August 29, 2017, the OIG issued a report entitled, Medicare Shared Savings Program Accountable Care Organizations Have Shown Potential for Reducing Spending and Improving Quality. The report found that over the first 3 years of the program, 428 participating Shared Savings Program Accountable Care Organizations (ACOs) served 9.7 million beneficiaries. During that time, most of these ACOs reduced Medicare spending compared to their benchmarks, achieving a net spending reduction of nearly $1 billion. At the same time, ACOs generally improved the quality of care they provided, based on CMS data on quality measures. In the first 3 years, ACOs improved their performance on most (82 percent) of the individual quality measures. ACOs also outperformed fee-for-service providers on most (81 percent) of the quality measures. Further, a small subset of ACOs showed substantial reductions in Medicare spending while providing high-quality care. These high-performing ACOs reduced spending by an average of $673 per beneficiary for key Medicare services during the review period. In contrast, other Shared Savings Program ACOs and the national average for fee-for-service providers showed an increase in per beneficiary spending for key Medicare services.
• On August 30, 2017, the Congressional Budget Office (CBO) released a cost estimate of H.R. 3168, the Special Needs Plans Reauthorization Act of 2017. The CBO estimates that enacting H.R. 3168 would increase direct spending by $119 million over the 2017-2027 period. Pay-as-you-go procedures apply because enacting the legislation would affect direct spending. H.R. 3168 would not affect revenues. The CBO also estimates that enacting the legislation would not increase net direct spending or on-budget deficits by more than $5 billion in any of the four consecutive 10-year periods beginning in 2028.

IV. Other Health Policy News

• On August 30, 2017, CMS posted an n 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 30, 2017. According to CMS, participation is expected to fluctuate and does not represent actual Exchange application submissions.
• On August 31, 2017, the OIG issued an advisory opinion regarding the use of a “preferred hospital” network as part of Medicare Supplemental Health Insurance (“Medigap”) policies, whereby insurance companies indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for their policyholders and, in turn, provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay (the “Arrangement”). The OIG concluded that, although the 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 will not impose administrative sanctions on the entities named on the attached distribution list under sections 1128(b)(7) or 1128A(a)(7) of the Act (as those sections relate to the commission of acts described in section 1128B(b) of the Act) in connection with the Arrangement.
• On August 31, 2017, CMS announced that they plan to spend $10 million on promotional activities in order to meet the needs of new or returning Affordable Care Act (ACA) enrollees – consistent with promotional spending on Medicare Advantage and Medicare Part D. CMS will target its advertising and outreach activities to educate consumers on the new dates of the Open Enrollment Period through digital media, email, and text messages.
• On August 31, 2017, CMS issued a bulletin that outlines policies related to the Patient Protection and Affordable Care Act (PPACA) Navigator program and enrollment education for the upcoming open enrollment period. The bulletin can be accessed here.

V. ACA Repeal News

• N/A.