Alston & Bird Healthcare Week in Review, August 18, 2017

I. Regulations, Notices, & Guidance

• On August 14, 2017, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Mobile Health Technology for Diabetes. The notice announces that AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Mobile Health Technology for Diabetes, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Comments are due by September 14, 2017.
• On August 15, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Determination that CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams, Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that CORDARONE (amiodarone hydrochloride) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow the FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
• On August 15, 2017, the FDA issued a notice entitled, Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON. The notice announces that the FDA is withdrawing approval of an ANDA for ZALEPLON Capsules, 5 milligrams (mg) and 10 mg, 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 Upsher-Smith has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.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 15, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Funding Availability: Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities. The notice announces that the Indian Health Service (IHS) Office of Public Health Support, Division of Epidemiology and Disease Prevention (DEDP), is accepting applications for a cooperative agreement for competitive supplemental funds to enhance activities in the This document is scheduled to be published in the Federal Register on 08/16/2017 and available online at https://federalregister.gov/d/2017-17311, and on FDsys.gov 2 Epidemiology Program for American Indian/Alaska Native (AI/AN) Tribes and Urban Indian communities. Applications are due by September 19, 2017.
• On August 15, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Cancellation of Advancing Care Coordination through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model. The proposed rule proposes to cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and to rescind the regulations governing these models. It also proposes to revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track. Comments are due by October 16, 2017.
• On August 16, 2017, AHRQ issued a notice entitled, Patient Safety Organizations: Voluntary Relinquishment from the Specialty Benchmarks PSO. The notice announces that the AHRQ has accepted a notification of voluntary relinquishment from the Specialty Benchmarks Patient Safety Organization (PSO) of its status as a PSO, and has delisted the PSO accordingly.
• On August 17, 2017, the FDA issued a notice entitled, Bayer Healthcare Pharmaceuticals; Withdrawal of Approval of a New Drug Application for BAYCOL (cerivastatin sodium) Tablets, 0.05 Milligrams, 0.1 Milligrams, 0.2 Milligrams, 0.3 Milligrams, 0.4 Milligrams, and 0.8 Milligrams. The notice announces that the FDA is withdrawing approval of new drug application (NDA) 020740 for BAYCOL (cerivastatin sodium) tablets, 0.05 milligrams (mg), 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8 mg, held by Bayer Healthcare Pharmaceuticals (Bayer). Bayer requested withdrawal of this application, and has waived its opportunity for a hearing.
• On August 17, 2017, the National Institutes of Health (NIH) issued a notice entitled, Government-Owned Inventions; Availability for Licensing: Development of a Transferrable Norwalk Virus Epitope and Detector Monoclonal Antibody. The notice announces that development of a transferrable Norwalk virus epitope and detector monoclonal antibody is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
• On August 18, 2017, the Health Resources and Services Administration (HRSA) issued a Notice of proposed rulemaking; further delay of effective date entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. The notice announces that HHS is soliciting comments on delaying the effective date of the January 5, 2017 final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to delay the effective date of the final rule published in the Federal Register (82 FR 1210, January 5, 2017) to July 1, 2018. According to HHS, HHS proposes this action in order to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking, as set forth below. Comments are due by September 20, 2017.
• On August 18, 2017, the FDA issued a final rule; technical amendment entitled, Medical Device Classification Procedures; Change of Address. The final rule amends the Medical Device Classification Procedures regulation to reflect a change in address for the Center for Devices and Radiological Health (CDRH). According to the FDA, this action is editorial in nature and is intended to improve the accuracy of the Agency’s regulations.
• On August 18, 2017, the FDA issued a notice entitled, Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements.  The notice announces that the FDA is establishing a public docket to assist with its development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics. Comments are due by November 20, 2017.
• On August 18, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA. The notice announces that the FDA has determined the regulatory review period for RECUVYRA 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 animal drug product.
• On August 18, 2017, the FDA issued a notice entitled, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047. The notice announces that the FDA is making a publication containing modifications the Agency is making to the list of standards the FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 047" (Recognition List Number: 047), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Comments may be submitted at any time.
• On August 18, 2017, the FDA issued a notice entitled, Electronic Study Data Submission; Data Standards; Support for Standard for Exchange of Nonclinical Data Implementation Guide Version 3.1. The notice announces that the FDA’s Center for Drug Evaluation and Research (CDER) is announcing support for the 3.1 version of Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of support for the 3.0 version of SEND IG, and an update to the FDA Data Standards Catalog.

• August 31, 2017: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced the inaugural meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will include information on federal advances related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss workgroups, future meetings, and the Report to Congress.
• September 13 – 14, 2017: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The first day of the public meeting, September 13, 2017, will be dedicated to the topic of Stewardship of Antibiotic Prescription and Use. The three working groups on Incentives for Diagnostics, Therapeutics/Anti-Infectives, and Vaccines, will report their final findings to the full Advisory Council for deliberation on the second day of the public meeting, September 14, 2017, and the Advisory Council will deliberate and vote on the final report presented. Additionally, federal agencies will provide updates on their achievements as stipulated in the goals with corresponding objectives and milestones of the National Action Plan on Combating Antibiotic Resistant Bacteria.
• September 14, 2017: The FDA announced a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss supplemental new drug application (sNDA) 021306, for BUTRANS (buprenorphine) transdermal system submitted by Purdue Pharma L.P., evaluating BUTRANS in pediatric patients ages 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the findings of the clinical study of BUTRANS conducted in pediatric patients, and whether they support additional labeling.

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 15, 2017, the Congressional Budget Office (CBO) released a report entitled, The Effects of Terminating Payments for Cost-Sharing Reductions. The CBO and Joint Committee on Taxation (JCT) expect that insurers in some states would withdraw from or not enter the nongroup market because of substantial uncertainty about the effects of the policy on average health care costs for people purchasing plans. In the agencies’ estimation, under the policy, about 5 percent of people live in areas that would have no insurers in the nongroup market in 2018. By 2020, though, insurers would have observed the operation of markets in many areas under the policy and the CBO and the JCT expect that more insurers would participate, so people in almost all areas would be able to buy nongroup insurance (as is projected to be the case throughout the next decade under the CBO’s baseline projection).
• On August 16, 2017, the Office of Inspector General (OIG) released a report entitled, Texas Improperly Received Medicaid Reimbursement for School-Based Health Services. The report found that not all of the direct medical service costs that the Texas Health and Human Services Commission (State agency) claimed for Medicaid School Health and Related Services (SHARS) were reasonable, adequately supported, and otherwise allowable in accordance with applicable Federal and State requirements. Specifically, Fairbanks, LLC (the Contractor), coded random moments incorrectly. Of the 3,161 random moments coded as an Individualized Education Plan-covered direct medical service, 274 were coded incorrectly. As a result of these errors, the State agency received $18.9 million in unallowable Federal reimbursement for the Medicaid SHARS program during the period October 1, 2010, through September 30, 2011.
• On August 18, 2017, the OIG released a summary report entitled, Information Technology Control Weaknesses Found in the New Mexico Human Services Department's Medicaid Eligibility Systems. The summary report provides an overview of the results of the OIG’s audit of the information system general controls over the New Mexico Medicaid eligibility systems. It does not include specific details of the vulnerabilities that we identified because of the sensitive nature of the information. The OIG has provided more detailed information and recommendations to New Mexico so that it can address the issues the OIG identified. The findings listed in the summary report reflect a point in time regarding system security and may have changed since the OIG reviewed these systems.
• On August 18, 2017, the OIG released a report entitled, The Ministry of Health and Social Welfare National AIDS Control Program Did Not Always Manage and Expend PEPFAR Funds in Accordance With Award Requirements. The report found that of the 52 transactions totaling $1 million that the OIG reviewed, the OIG found 27 unallowable transactions totaling $495,379. These transactions were unallowable because the Ministry did not provide adequate supporting documentation for the expenditures. Additionally, the Ministry could not support $1.5 million in funded personnel costs, did not always record financial transactions correctly, filed an inaccurate Federal Financial Report (FFR) for budget years 1 and 2, filed one of its FFRs more than 15 months late, did not maintain a United States dollar (USD) bank account, and paid unallowable value-added taxes (VAT).

IV. Other Health Policy News

• On August 16, 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 August 16, 2017. According to CMS, participation is expected to fluctuate and does not represent actual Exchange application submissions.
• On August 16, 2017, CMS unveiled the Hospice Compare website. The site displays information in a ready-to­­-use format and provides a snapshot of the quality of care each hospice facility offers to its patients. According to CMS, the Hospice Compare website will reflect current industry best practices for consumer-facing websites and will be optimized for mobile use. The website can be accessed here.

V. ACA Repeal News

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