Alston & Bird Healthcare Week in Review, April 22, 2017

I. Regulations, Notices, & Guidance

• On April 17, 2017, the Office of Management and Budget (OMB) received a proposed rule from the Centers for Medicare & Medicaid Services (CMS) entitled, CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B. The propose rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2018.

• On April 19, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF). The notice invites nominations of individuals qualified to serve as members of the USPSTF. Nominations are due by June 15, 2017.

• On April 19, 2017, HHS issued a notice entitled, Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received. The notice announces the petitions received under the National Vaccine Injury Compensation Program.

• On April 19, 2017, HHS issued a notice entitled, National Preparedness and Response Science Board; Call for Nominees. The notice announces that HHS is seeking application submissions from qualified individuals for consideration for membership on the National Preparedness and Response Science Board (NPRSB). According to HHS, terms of eight members expire December 31, 2017; therefore, the Secretary must appoint eight new voting members. Nominees shall represent the following categories: industry, academia, health care consumer organizations, and organizations representing other appropriate stakeholders. Applications are due by June 7, 2017.

• On April 20, 2017, HHS issued a notice entitled, Notice of Interest Rate on Overdue Debts. The notice states that the current rate of 10%, as fixed by the Secretary of the Treasury, is certified for the quarter ended March 31, 2017. The rate is based on the Interest Rates for Specific Legislation, “National Health Services Corps Scholarship Program (42 USC 254o(b)(1)(A))” and “National Research Service Award Program (42 USC 288(c)(4)(B)).” The interest rate will be applied to overdue debt until the HHS publishes a revision.

• On April 21, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Guerbet Group; Withdrawal of Approval of Two New Drug Applications. The notices announces that the FDA is withdrawing approval of two new drug applications (NDAs) held by Guerbet Group. Guerbet Group notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Withdrawal of approval is effective on May 24, 2017.

• On April 21, 2017, the FDA issued a draft guidance entitled, Draft Guidance on Naloxone Hydrochloride. According to the FDA, 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 (ANDAs) for naloxone hydrochloride nasal spray. Comments are due by June 23, 2017.

• On April 21, 2017, the FDA issued a notice entitled, Training Program for Regulatory Project Managers; Information Available to Industry. The notice announces that the FDA’s Center for Drug Evaluation and Research will continue the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). Furthermore, the purpose of the notice is to invite pharmaceutical companies interested in participating in this program to contact the Center for Drug Evaluation and Research. Pharmaceutical companies may send proposed agendas to the Agency by June 23, 2017.

• April 25, 2017: The FDA’s Center for Drug Evaluation and Research, in co-sponsorship with the Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium, announced a public workshop entitled, Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials. The purpose of the public workshop is to provide a forum for collaborative multidisciplinary discussion to identify opportunities and address challenges for clinical outcome assessments, particularly patient-reported outcome (PRO) assessments, in oncology drug development.
• May 5, 2017: HHS announced an informal stakeholder listening sessions related to the 70^th World Health Assembly. The stakeholder listening session will help the HHS Office of Global Affairs prepare the U.S. delegation for the World Health Assembly by taking full advantage of the knowledge, ideas, feedback, and suggestions from communities that are interested in and may be affected by agenda items to be discussed at the 70th World Health Assembly.
• May 9 – 10, 2017: The FDA announced a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. The public workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.
• May 9, 2017: The FDA announced a public advisory committee meeting of the Science Board to the FDA. The Science Board will provide recommendations on the Agency’s Innovation Funds work plan as prescribed in section 1002 of the 21st Century Cures Act.
• May 10, 2017: The FDA announced a public advisory committee meeting of the Medical Imaging Drugs Advisory Committee. The committee will discuss new drug application (NDA) 208-630 for 5- Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.
• May 17, 2017: The FDA announced a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The VRBPAC will meet in an open session to discuss considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.
• May 17, 2017: The FDA announced a public advisory committee meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TRANSMEDICS ORGAN CARE SYSTEM (OCS)--Lung System, by TransMedics, Inc. The proposed Indication for Use, as stated in the PMA, is as follows: The TRANSMEDICS ORGAN CARE SYSTEM (OCS) Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation.
• May 24, 2017: The FDA announced a public advisory committee meeting of the Oncologic Drugs Advisory Committee (ODAC). During the morning session, the committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication (use) for this product is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy. During the afternoon session, the 5 committee will discuss NDA 208587, for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication (use) for this product is for the treatment of sickle cell disease.
• May 25 – 26, 2017: HHS announced a meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The SACHRP meeting will be open to the public at 8:30 a.m., on Thursday, May 25, 2017, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Executive Secretary of SACHRP, and Dr. Stephen Rosenfeld, SACHRP Chair. Dr. Menikoff will then lead a discussion focusing on selected sections of the new Common Rule, which was published January 19, 2017, with an effective date of January 19, 2018. The Friday, May 26, meeting will begin at 8:30 a.m. with recommendations from the The Subcommittee on Harmonization (SOH) on the FDA Draft Guidance “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” issued July 27, 2016. SOH will also present recommendations on the return of incidental findings to research subjects. The Subpart A Subcommittee (SAS) will present recommendations surrounding the new Common Rule’s expedited review requirements.
• June 15, 2017: The FDA’s Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a 1-day public symposium entitled, Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting. The purpose of the symposium is to discuss sources of preventable harm from drugs in the outpatient setting and to stimulate the exchange of ideas among thought leaders on interventions to reduce preventable harms and how these interventions can be studied.
• September 12, 2017: The FDA’s Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is announcing a 1-day public workshop entitled, Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population. The purpose of the workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes; to reduce the risk of serious hypoglycemia; identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to the FDA, that are of direct relevance and importance to older patients living with the disease; discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients; and disseminate the results of this discussion to inform patients, patient advocates, and health care practitioners.

II. Congressional Legislation & Committee Action

• The Senate has adjourned and will reconvene on Monday, April 24, 2017.

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

• On April 17, 2017 the Government Accountability Office (GAO) released a report entitled, Medicaid Program Integrity: CMS Should Build on Current Oversight Efforts by Further Enhancing Collaboration with States. The report found that CMS has tailored its state program integrity reviews—in which the agency reviews states’ program integrity activities—to states’ managed care delivery systems and other areas at high risk for improper payments. From 2014 through 2016, CMS conducted on-site reviews in 31 states. The reviews usually addressed state oversight of managed care plans, and some reviews addressed other high-risk areas such as provider enrollment. CMS and states have found the reviews to be beneficial in identifying areas for improvement. To expand oversight to more states, CMS also began off-site desk reviews of certain state program integrity efforts.

• On April 20, 2017, the Office of Inspector General (OIG) released a report entitled, New Jersey Claimed Medicaid Reimbursement for Adult Partial Hospitalization Services That Did Not Comply With Federal and State Requirements. The report found that all 100 of the New Jersey Department of Human Services' (State agency) sampled claims for Federal Medicaid reimbursement for partial hospitalization services did not comply with Federal and State requirements, and 92 contained more than 1 deficiency. Partial hospitalization services are provided on a hospital-outpatient basis to adults with serious mental illnesses to prevent inpatient hospitalization and achieve community integration. On the basis of our sample results, we estimated that the State agency improperly claimed at least $30.7 million in Federal Medicaid reimbursement for partial hospitalization services that did not meet Federal and State requirements. The deficiencies occurred because the State agency did not (1) work with the State Department of Health to ensure that partial hospitalization services are provided by appropriately licensed hospitals, (2) adequately monitor the partial hospitalization program to ensure that providers complied with Federal and State requirements, and (3) have adequate controls to ensure that services were paid at the proper payment rate.

IV. Other Health Policy News

• On April 17, 2017, CMS announced that it is conducting the Rural Community Hospital Demonstration Program, which was originally authorized for a 5-year period by section 410A of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and extended for another 5-year period by sections 3123 and 10313 of the Affordable Care Act (ACA).

• A new survey by the actuarial firm Oliver Wyman conducted in early April finds the vast majority of respondents who are participating in the individual market intend to offer products in 2018, but the firm warns the results are preliminary and could change if cost-sharing subsidies aren't continued and data collected on 2017 consumers are negative. The report also found wide variations in potential rate increases. The report can be found here.

V. ACA Repeal News

• On April 20, 2017, House Speaker Paul Ryan (R-WI) told reporters that Congress is “very close” to a deal. Speaker Ryan told reporters that Congress is “in the midst of negotiating sort of finishing touches, because our members want to make sure that we lower premiums.”  Additionally, the office GOP moderate Tom MacArthur (R-NJ) confirmed reports that Rep. MacArthur is working on an amendment to the American Health Care Act (AHCA) that could come up for a vote as early as next week. A draft of the amendment language can be found here.