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

I. Regulations, Notices, & Guidance

• On June 26, 2017, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, National Advisory Council For Healthcare Research and Quality: Request for Nominations for Public Members. The notice announces the AHRQ is seeks nominations for the National Advisory Council for Healthcare Research and Quality. Nominations are due by August 28, 2017.
• On June 27, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation for Written Comments on the Development of Healthy People 2030. The notices announces that HHS is soliciting written comments on the Healthy People 2030 proposed framework, including the vision, mission, overarching goals, plan of action, and foundational principles. Comments are due by September 29, 2017.
• On June 28, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II. The FDA is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original biologics license applications (BLAs) (351(k)s) submitted under the Public Health Service Act (hereafter referred to as 351(k) applications). Comments are due July 31, 2017.
• On June 28, 2017, the FDA issued a draft guidance entitled, Current Good Manufacturing Practice for Medical Gases. The draft guidance is intended to assist manufacturers of medical gases in complying with applicable current good manufacturing practice (CGMP) regulations. Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are not manufactured, produced, processed, packed, or held according to applicable CGMP requirements can cause serious injury or death. According to the FDA, the draft guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions. Comments are due by August 28, 2017.
• On June 29, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicaid Program: Zika Health Care Services Program--Round 2. The notice announces the April 7, 2017 posting of a funding opportunity for Round Two of the Zika Health Care Services Program which provides up to $6.45 million to support prevention activities and treatment services for health conditions related to the Zika virus for entities that meet the eligibility requirements of the Zika Health Care Services Program, but that did not receive an award under the Round One Funding Opportunity. The Round Two Funding Opportunity provides two application due dates, May 8, 2017 and July 10, 2017. Entities eligible to apply for this funding opportunity are states, territories, tribes or tribal organizations, with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention (CDC).
• On June 29, 2017, the FDA issued a notice entitled, Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus. The notice announces that the FDA revoked the Emergency Use Authorization (EUA) issued to Roche Molecular Systems, Inc. for the LightMix® Zika rRT-PCR Test. FDA revoked this Authorization on March 13, 2017.
• On June 29, 2017, the FDA issued a notice entitled, Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus. The notice announces that the FDA issued two EUAs for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas.
• On June 29, 2017, the FDA issued a notice entitled, Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning. The notice announces that the FDA issued a EUA for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning.
• On June 29, 2017, CMS issued a final rule entitled, Medicaid/CHIP Program; Medicaid Program and Children’s Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act. The final rule updates the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and CHIP eligibility under the Patient Protection and Affordable Care Act. The final rule also implements various other improvements to the PERM program.
• On June 29, 2017, CMS issued a proposed rule entitled, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program. The rule proposes to update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2018, as well as to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). The rule also proposes to set forth requirements for the ESRD Quality Incentive Program (QIP), including for payment years (PYs) 2019 through 2021. Comments are due by August 28, 2017.
• On June 30, 2017, the FDA issued a final rule entitled, Listing of Color Additives Exempt from Certification; Spirulina Extract. The final rule amends the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hardboiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick). DATES: The final rule is effective August 3, 2017 and objections and requests for a hearing on the final rule are due by August 2, 2017.
• On June 30, 2017, the FDA issued a draft guidance entitled, Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy. The draft guidance describes the FDA’s intention with regard to enforcement of requirements related to product identifiers under the Drug Supply Chain Security Act (DSCSA). Specifically, the draft guidance addresses manufacturers’ product identifier and verification requirements, which begin November 27, 2017. The draft guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products. Comments are due by September 1, 2017.
• On June 30, 2017, the FDA issued a notice entitled, Advisory Committee; Medical Imaging Drugs Advisory Committee, Renewal. The notice announces the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 18, 2019.

• July 26, 2017: AHRQ announced a meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an update on AHRQ’s current research, programs, and initiatives. The agenda will also include an update on AHRQ’s work in learning health care systems and AHRQ’s EvidenceNOW initiative, and will focus on the use of AHRQ data and analytics to answer emerging policy questions.
• July 26, 2017: The FDA announced a public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 209653, for oxycodone hydrochloride extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.
• August 11, 2017: The CDC announced a meeting of the Advisory Committee to the Director (ACD), CDC – State, Tribal, Local and Territorial (STLT) Subcommittee. At the meeting, the Subcommittee will provide advice to the ACD on strategies, future needs, and challenges faced by State, Tribal, Local and Territorial health agencies, and will provide guidance on opportunities for CDC through the ACD. Specifically, the STLT Subcommittee members will discuss progress on implementation of ACD-adopted recommendations related to the health department of the future, other emerging challenges and how CDC can best support STLT health departments in the transforming health system.
• August 30, 2017: CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). During the meeting, the MEDCAC will discuss recommendations regarding the appraisal of the state of evidence for health outcomes in the Medicare population for surgical and endoscopic procedures for weight loss.
• September 13, 2017: The FDA announced a public workshop entitled, Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices. The purpose of the workshop is to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies, and to provide an overview of relevant provisions of the 21st Century Cures Act that may impact the development of such devices.

II. Congressional Legislation & Committee Action

• There were no health care-related hearings this week.

• On June 28, 2017, the House Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee advanced the fiscal year 2018 FDA spending bill to the full House Appropriations Committee.

• On June 26, 2017, the Congressional Budget Office (CBO) released a cost estimate of H.R. 1628, the Better Care Reconciliation Act of 2017. The report found that  enacting the Better Care Reconciliation Act of 2017 would reduce federal deficits by $321 billion over the coming decade and increase the number of people who are uninsured by 22 million in 2026 relative to current law.
• On June 27, 2017, the Office of Inspector General (OIG) released a report entitled, T-MSIS Data Not Yet Available for Overseeing Medicaid. The report found that states and CMS report that early implementation challenges have resulted in delays with The Transformed Medicaid Statistical Information System (T-MSIS). These delays were caused by technological problems during data testing and by competing priorities for States' IT resources. As a result, the goal for when T-MSIS will contain data from all State Medicaid programs has been repeatedly postponed. Most recently, CMS indicated that it expects that all States will be reporting to T-MSIS by the end of 2017. As of December 2016, 21 of 53 State programs were submitting data to T-MSIS. As States and CMS continue to work together to submit data into T-MSIS, they continue to raise concerns about the completeness and reliability of the data; the OIG raised these same concerns in our 2013 review of the T-MSIS pilot. Specifically, States indicate that they are unable to report data for all the T-MSIS data elements. Additionally, even with a revised data dictionary that provides definitions for each data element, States and CMS report concerns about States' varying interpretations of data elements. If States do not have uniform interpretations of data elements, the data they submit for these elements will not be consistent across States, making any analysis of national trends or patterns inherently unreliable.
• On June 27, 2017, the Government Accountability Office (GAO) released a report entitled, Generic Drug User Fees: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees. The report found that nearly 90 percent of the prescription drugs dispensed in the United States are generics. The FDA must approve these drugs before they are marketed. The GAO found that the FDA's reliance on user fees increased and that it surpassed many of its performance goals. However, the GAO recommends that the FDA make a plan for the fees it doesn't spend in the same year they're collected.
• On June 27, 2017, the GAO released a report entitled, Physician Workforce: Locations and Types of Graduate Training Were Largely Unchanged, and Federal Efforts May Not Be Sufficient to Meet Needs. The report found that from 005-15, residents were concentrated in the Northeast and in urban areas. And, while many trained in primary care, primary care residents often subspecialize in other fields. Federal efforts to increase graduate medical education (GME) in rural areas and primary care were limited. In 2015, the GAO recommends that HHS develop a plan for its health care workforce programs—it has yet to do so.
• On June 29, 2017, the CBO released a report entitled, Longer-Term Effects of the Better Care Reconciliation Act of 2017 on Medicaid Spending. The report found that Medicaid spending under the Better Care Reconciliation Act of 2017 would be about 35 percent lower in 2036 compared with the CBO’s extended baseline. Such spending under the bill would increase each year throughout the next two decades.
• On June 30, 2017, the GAO released a report entitled, Hospital Value-Based Purchasing: CMS Should Take Steps to Ensure Lower Quality Hospitals Do Not Qualify for Bonuses. The report found that some hospitals with low quality scores received bonuses because they had relatively high efficiency scores. To ensure that lower quality hospitals do not receive these bonuses, the GAO recommends that CMS revise the methodology this program uses to calculate total performance scores.

IV. Other Health Policy News

• On June 27, 2017, CMS released an updated county-level mapof projected issuer participation on the Health Insurance Exchanges in 2018 based on the known issuer public announcements through June 27, 2017. This updated map shows that coverage choices on the Exchanges continue to disappear week to week. Plan options are projected to be down from last year and, and in the last two weeks Americans in four additional counties are projected to have no coverage options available to them on the Exchanges.
• On June 29, 2017, the FDA unveiled a strategic plan to eliminate the FDA’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The plan can be accessed here.

V. ACA Repeal News

• On June 27, 2017, Senate Majority Leader, Mitch McConnell (R-KY) agreed to delay a vote on the Better Care Reconciliation Act until after the July 4 recess.