Alston & Bird Healthcare Week in Review, July 15, 2017

Regulations, Notices, & Guidance

• On July 11, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies. The notice announces that the FDA is requesting comment on the draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of PQ/CMC data. The establishment of standardized pharmaceutical quality data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As a result, these established data elements and terminologies will improve the efficiency and quality of the drug review process. The Agency is seeking comment on the accuracy, suitability, and appropriateness of these data elements and terminologies for submission of PQ/CMC data. FDA is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document. Comments are due by September 11, 2017.
• On July 11, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; INTERCEPT BLOOD SYSTEM FOR PLASMA. The notice announces that the FDA has determined the regulatory review period for INTERCEPT BLOOD SYSTEM FOR PLASMA and is publishing this notice of that determination as required by law. 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 medical device. Comments are due by September 11, 2017.
• On July 11, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; INTERCEPT BLOOD SYSTEM FOR PLATELETS. The notice announces that the FDA has determined the regulatory review period for INTERCEPT BLOOD SYSTEM FOR PLATELETS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the USPTO, Department of Commerce, for the extension of a patent which claims that medical device. Comments are due by September 11, 2017.
• On July 11, 2017, the FDA issued a notice entitled, Medical Devices; Exemptions From Premarket Notification: Class II Devices. The notice announces a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. The FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. The notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. According to the FDA, the exemptions in the notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.
• On July 11, 2017, the Drug Enforcement Agency (DEA) issued a notice of proposed rulemaking entitled, Schedules of Controlled Substances: Removal of Naldemedine from Control. The notice announces the DEA’s proposal to remove naldemedine (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12- methanobenzofuro[3,2-e]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act (CSA). Naldemedine is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine. Comments are due by August 11, 2017.
• On July 12, 2017, the Health Resources and Service Administration (HRSA) issued a notice of charter amendment entitled, Advisory Committee on Training in Primary Care Medicine and Dentistry. The notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has been amended. The effective date of the renewed charter is May 31, 2017.
• On July 12, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, World Trade Center Health Program; Petitions 016 and 017— Parkinson’s Disease and Parkinsonism, Including Manganese-Induced Parkinsonism; Finding of Insufficient Evidence. The notice announces that on February 22, 2017, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 016) to add Parkinson’s disease and Parkinsonism, including manganese-induced Parkinsonism, to the List of WTC-Related Health Conditions (List). On May 10, 2017, the Administrator received a second petition (Petition 017) to add the same health conditions to the List. Upon reviewing the scientific and medical literature, including information provided by the two petitioners, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add Parkinson’s disease and/or Parkinsonism, including manganese-induced Parkinsonism, to the List.
• On July 12, 2017, the Agency for Healthcare Research and Quality (AHRQ) issued a request for supplemental evidence and data submissions entitled, Supplemental Evidence and Data Request on Stroke Prevention in Atrial Fibrillation Patients: A Systematic Review Update. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Stroke Prevention in Atrial Fibrillation Patients: A Systematic Review Update, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Submissions are due by August 14, 2017.
• On July 13, 2017, the National Institutes of Health (NIH) issued a notice announces that the charter for the Sickle Cell Disease Advisory Council (SCDAC) was renewed for an additional two-year period on June 30, 2017.
• On July 13, 2017, the FDA issued a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry. The notice announces the availability of additional draft and revised draft product-specific guidances. The guidances, when finalized, provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Comments are due by September 12, 2017.
• On July 13, 2017, the DEA issued a temporary scheduling order entitled, Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl into Schedule I. The DEA is issuing the temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4- yl)-N-phenylacrylamide (acryl fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I. This action is based on a finding by the Administrator that the placement of acryl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, acryl fentanyl. The temporary scheduling order is effective July 14, 2017, until July 15, 2019.
• On July 13, 2017, the DEA issued a final rule entitled, Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical. The DEA is finalizing the designation of the chemical alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act (CSA). The DEA proposed control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine. The final rule finalizes, without change, the control of APAAN as a list I chemical. According to the FDA, this action does not establish a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, shall be regulated.
• On July 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. The proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems and certain provisions under the 21st Century Cures Act (Pub. L. 114-255). In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Comments are due by September 11, 2017.
• On July 13, 2017, CMS issued a proposed rule entitled, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program. The proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies. Comments are due by September 11, 2017.
• On July 14, 2017, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers. 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 U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to NantBioScience, Inc., located in, California, USA. Comments are due by August 1, 2017.
• On July 14, 2017, the NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The NIH is announcing the availability for licensing of compounds that treat Malaria and prevent Malaria transmission.

• July 31, 2017: The Office of National Drug Control Policy (ONDCP) announced a public teleconference of the President’s Commission on Combating Drug Addiction and the Opioid Crisis (Commission). The purpose of the meeting is to review a draft interim report that will be posted on ONDCP’s Commission website listed below before the teleconference.

II. Congressional Legislation & Committee Action

• On July 12, 2017, the Senate Special Aging Committee held a hearing entitled, Nourishing our Golden Years: How Proper and Adequate Nutrition Promotes Healthy Aging and Positive Outcomes. The witnesses included Connie Bales PhD, RD, Professor, Senior Fellow, Associate Director Division of Geriatrics, Center for the Study of Aging, Duke University School of Medicine; Geriatrics Center at the Durham VA Medical Center; Seth Berkowitz, MD, MPH, General Internist, Assistant Professor Of Medicine; Massachusetts General Hospital, Harvard Medical School; Elizabeth Pratt, MPH, SNAP-Ed Program Manager; University Of New England; and Pat Taylor, Retiree.

• On July 12, 2017, the House Energy & Commerce Oversight and Investigations Subcommittee held a hearing entitled, Combating the Opioid Crisis: Battles in the States. The witnesses included The Honorable Rebecca Boss Director, Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, State of Rhode Island; The Honorable Brian J. Moran, Secretary of Public Safety and Homeland Security, State of Virginia; The Honorable Boyd K. Rutherford, Lieutenant Governor, State of Maryland; and The Honorable John Tilley Secretary of the Justice and Public Safety Cabinet, State of Kentucky.
• On July 12, 2017, the House Energy & Commerce Health Subcommittee held a hearing entitled, Examining Medical Product Manufacturer Communications. The witnesses included The witnesses present at the hearing were Coleen Klasmeier, Partner, Sidley Austin LLP, speaking on behalf of the Medical Information Working Group (MIWG); R. Alta Charo, Warren P. Knowles Professor of Law, University of Wisconsin (UW); Dr. George F. Van Hare, Division Chief, Pediatric Cardiology, Louis Larrick Ward Professor of Pediatrics, Washington University School of Pediatrics, Co-Director, St. Louis Children’s and Washington University Heart Center (WU); Dr. Aaron Kesselheim, JD, MPH, Associate Professor of Medicine, Harvard Medical School, Director, Program on Regulation, Therapeutics and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital (Harvard); Linda House, President, Cancer Support Community (CSC); and Dr. Kat Wolf Khachatourian, PharmD, Vice President, Delegation Oversight, Pharmacy Services & Strategy, Qualchoice Health Plan Services (Qualchoice).
• On July 12, 2017, the House Appropriations Committee held a markup of FY2018 Agriculture Appropriations Bill and FY2018 Energy and Water Development Appropriations Bill. Both bills were reported favorably.
• On July 12, 2017, the House passed H.R. 2430, the FDA Reauthorization Act of 2017 by a voice vote.
• On July 13, 2017, the House Veterans’ Affairs Health Subcommittee held a hearing entitled, Maximizing Access and Resources: An Examination of VA Productivity and Efficiency. The witnesses included C. Sharif Ambrose, Principal, Grant Thornton LLP; Randall B. Williamson, Director, Health Care, GAO; Jonathan B. Perlin MD, PhD, President, Clinical Services Group, Chief Medical Officer, HCA Healthcare, Inc.; and Carolyn Clancy M.D., Deputy Under Secretary for Organizational Excellence, Veterans Health Administration, VA.
• On July 13, 2017, the House Ways & Means Committee held a markup of H.R. 3178, the Medicare Part B Improvement Act of 2017 and H.R. 3168, to amend title XVIII of the Social Security to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes. Both bills were reported favorably by a voice vote.

• On July 11, 2017, the Government Accountability Office (GAO) released a report entitled, Investigational New Drugs: FDA Has Taken Steps to Improve the Expanded Acce https://veterans.house.gov/calendar/eventsingle.aspx?EventID=1803ss Program but Should Further Clarify How Adverse Events Data Are Used. The report found that the FDA’s expanded access program allows patients with serious or life threatening illnesses access to certain drugs before it has approved them. The FDA also requires that manufacturers submit data about adverse reactions to these drugs. While the FDA has provided some guidance to manufacturers, the FDA does not fully explain the few instances when it would use these data on adverse reactions. This may influence manufacturers' decisions to give these drugs to patients due to concerns that adverse reactions will result in the FDA placing a hold on their drug.
• On July 11, 2017, the Congressional Budget Office (CBO) released a cost estimate of H.R. 2430, the FDA Reauthorization Act of 2017. The table providing the estimated direct spending and revenue effects for H.R. 2430 can be found here.
• On July 13, 2017, the Office of Inspector General (OIG) released a report entitled, Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing. The report found the following: one in three Medicare Part D beneficiaries received a prescription opioid in 2016; about 500,000 beneficiaries received high amounts of opioids; almost 90,000 beneficiaries are at serious risk, some received extreme amounts of opioids, while others appeared to be doctor shopping; and about 400 prescribers had questionable opioid prescribing patters for beneficiaries at serious risk.
• On July 13, 2017, the GAO released a report entitled, Improper Payments: Improvements Needed in CMS and IRS Controls over Health Insurance Premium Tax Credit. The report found that in fiscal year 2016, HHS and CMS assessed its advance premium tax credit (PTC) program as susceptible to significant improper payments. CMS instituted a qualitative method for assessing the susceptibility of its program that was consistent with requirements, including assessing each of the nine required qualitative risk factors. However, CMS stated that it may not report improper payment estimates for the PTC program as required until at least fiscal year 2022 because of the complexity and timing of the process for developing such estimates. As a result, HHS' overall improper payments estimate will continue to be understated, and Congress and others will continue to lack key payment integrity information for monitoring HHS' improper payments. The fiscal year 2016 Internal Revenue Service (IRS) assessment for its PTC program was not consistent with requirements nor did it demonstrate whether the program met applicable thresholds for susceptibility to significant improper payments. Until IRS conducts an appropriate assessment, it will remain uncertain whether IRS should estimate the amount of improper payments for its PTC program. Although CMS properly designed and implemented control activities related to the accuracy of advance PTC payments, it did not properly design control activities related to preventing and detecting improper payments of advance PTC, such as verifying individuals' eligibility. As a result, CMS is at increased risk of making improper payments of advance PTC to issuers on behalf of individuals.
• On July 13, 2017, the GAO released a report entitled, VA Health Care: Improvements Needed in Data and Monitoring of Clinical Productivity and Efficiency. The report found that to help manage and optimize its resources, the Department of Veterans Affairs collects data on the productivity and efficiency of its health care providers and medical centers. However, the data VA collects does not account for all providers or clinical services, and may not accurately reflect clinical workload or staffing levels. The report also found that the VA lacks a robust process to oversee medical centers' efforts to identify drivers of low productivity and efficiency and implement solutions.

IV. Other Health Policy News

• On July 10, 2017, CMS announced that 141 individual market qualified health plan (QHP) issuers submitted initial applications to offer coverage using the Federally-facilitated Exchange eligibility and enrollment platform in 2018.
• On July 11, 2017, CMS and the United States Department of the Treasury announced the approval of Alaska’s 1332 State Innovation Waiver application. According to CMS, Alaska sought a 1332 waiver to implement the Alaska Reinsurance Program (ARP) for 2018 and future years in an effort to stabilize the individual healthcare market.
• On July 12, 2017, CMS posted an update to the Health Insurance Exchanges Issuer County Map. This map is of projected issuer participation on the Health Insurance Exchanges in 2018 based on the known issuer public announcements through July 12, 2017. According to CMS, participation is expected to fluctuate and does not represent actual Exchange application submissions.
• On July 13, 2017, CMS issued a guidance document entitled, Annual Eligibility Redetermination and Re-enrollment for Exchange Coverage for 2018. The document provides guidance for the annual eligibility redetermination and re-enrollment for exchange coverage for the year 2018.

V. ACA Repeal News

• On July 13, 2017, the Senate released an updated version of the Better Care Reconciliation Act. The updated text can be found here.