Alston & Bird Healthcare Week in Review, May 20, 2017

Regulations, Notices, & Guidance

• On May 15, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Request for Comments on Food and Drug Administration Accreditation Scheme for Conformity Assessment Pilot Program. The notice announces that the FDA is establishing a public docket to request comments related to the FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. According to the FDA, the purpose of creating the public docket is to gain insight regarding the development and overall design/approach of the ASCA pilot program including program goals, pilot standards, design concepts, and overall program approach. Comments are due by June 30, 2017.

• On May 15, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation of Nominations for Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The notice announces that HHS is soliciting nominations of individuals who are interested in being considered for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria as a non-voting liaison representative member from an organization and/or interest group. Nominations must be received by June 30, 2017.
• On May 15, 2017, the National Institutes of Health (NIH) issued a notice entitled, National Cancer Institute Notice of Charter Renewal. The notice announces that the Committee to the National Cancer Institute (FNLAC) was renewed for an additional two year period on March 30, 2017.
• On May 15, 2017, the NIH issued a notice entitled, Request for Comments on National Institute of Dental and Craniofacial Research’s 2030 Strategic Visioning Initiative. The notice announces a request for comments. The NIH is seeking input on how best to ensure that dental, oral, and craniofacial health and disease are understood in the context of the whole body, and that research transforms how we promote health, treat disease, and overcome health disparities. Comments are due by May 19, 2017. All votes must be entered by June 2, 2017.
• On May 16, 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 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 July 17, 2017.
• On May 16, 2017, the FDA issued a notice entitled, Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter was 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 FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
• On May 17, 2017, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Noninvasive, Nonpharmacological Treatment for Chronic Pain. The notice announces that the AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Noninvasive, Nonpharmacological Treatment for Chronic Pain, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Comments are due by June 19, 2017.
• On May 17, 2017, the AHRQ issued a notice entitled, Common Formats for Reporting on Health Care Quality and Patient Safety. The notice announces the release of the Common Formats for Event Reporting - Hospital Version 2.0. The remaining Common Formats can be accessed electronically here.
• On May 18, 2017, the Health Resources and Services Administration (HRSA) issued a final rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. The HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.
• On May 18, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR); Delay of Effective Date. The final rule finalizes May 20, 2017 as the effective date of the final rule titled "Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the CJR" originally published in the January 3, 2017 Federal Register. The final rule also finalizes a delay of the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to January 1, 2018 and delays the effective date of the specific CJR regulations listed in the DATES section from July 1, 2017 to January 1, 2018.
• On May 18, 2017, CMS issued a proposed notice entitled, Medicare and Medicaid Programs: Application from the Joint Commission for Continued CMS-approval of its Critical Access Hospital Accreditation Program. The proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs. Comments are due by June 19, 2017.
• On May 18, 2017, the NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The notice announces that products for treatment and prevention of Ebola Zaire disease are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
• On May 18, 2017, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines. The notice announces that the NIH is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of the notice to PathoVax, LLC located in Baltimore, MD. Comments are due by June 5, 2017.
• On May 18, 2017, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers. The notice announces that the NIH is contemplating the grant of an Exclusive Patent License to AbPro, located in Woburn, Massachusetts, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of the notice. Comments are due by June 5, 2017.
• On May 18, 2017, the NIH issued a notice entitled, Prospective Grant of an Exclusive Patent License: Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors expressing Poliovirus Receptor CD155. The notice announces that the NIH 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 Istari Oncology Incorporated located in North Carolina, U.S.A Comments are due by June 5, 2017.

• May 24, 2017: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP). The meeting will include the initial review, discussion, and evaluation of applications received in response to “Conducting Public Health Research in China”, GH17- 005.
• June 1, 2017: HHS announced a meeting of the Advisory Committee on Minority Health (ACMH). The topics to be discussed during the teleconference include creating a work plan for developing recommendations related to opioid usage and health disparities. The recommendations will be given to the Deputy Assistant Secretary for Minority Health.
• June 1, 2017: The NIH announced a meeting of the Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee. Invited speakers will present and discuss research recommendations developed for the Draft Federal Pain Research Strategy.
• June 20, 2017: FDA announced a meeting of Endocrinologic and Metabolic Drugs Advisory Committee. The committee will discuss a supplemental new drug application for VICTOZA (liraglutide) injection (sNDA 022341), sponsored by Novo Nordisk, for the proposed additional indication of: as an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk.
• June 21 – 22, 2017: HHS announced a meeting of the National Committee on Vital and Health Statistics. The Committee will hear presentations, hold discussions on several health data policy topics, and receive updates from HHS, the Office of the National Coordinator for Health IT, the CDC National Center for Health Statistics, the National Library of Medicine, and CMS.
• June 23, 2017: The CDC announced a meeting of the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR). The subcommittee will discuss strategies and options on ways to prioritize NCEH/ATSDR's activities, improve health outcomes, and address health disparities as it relates to lead exposures. The subcommittee will deliberate on ways to evaluate lead exposure and how to best conduct health evaluations through exposure and epidemiologic studies. Subcommittee proposals on lead prevention practices and national lead poisoning prevention efforts will be provided to the Board of Scientific Counselors for deliberation and possible adoption as formal recommendations to NCEH/ATSDR.
• June 27, 2017: The CDC announced a meeting of the Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH). The agenda for the Subcommittee meeting includes the following dose reconstruction program quality management and assurance activities: dose reconstruction cases under review from Sets 14 - 23, including the Oak Ridge sites (Y-12, K-25, Oak Ridge National Laboratory), Hanford, Feed Materials Production Center (“Fernald”), Mound Plant, Rocky Flats Plant, Nevada Test Site, Idaho National Laboratory, Savannah River Site, and other Department of Energy and “Atomic Weapons Employer” facilities.

II. Congressional Legislation & Committee Action

• On May 16, 2017, the Senate Finance Committee held a hearing entitled, Examining Bipartisan Medicare Policies that Improve Care for Patients with Chronic Conditions. The witnesses were Katherine Hayes, Director of Health Policy at the Bipartisan Policy Center; Lee Schwamm, Professor of Neurology at Harvard Medical School and Director of Acute Stroke Services and Director of Partners TeleStroke Center at Massachusetts General Hospital; John Lovelace, President of Government Programs and Individual Advantage for UPMC Insurance Services Division and President of UPMC for You; and Stephen Rosenthal, Senior Vice President for Population Health Management at the Montefiore Health System.
• On May 17, 2017, the Senate Special Aging Committee held a hearing entitled, Aging With Community: Building Connections that Last a Lifetime. The witnesses were Lindsay Goldman, Director of Healthy Aging at the Center for Health Policy and Programs of The New York Academy of Medicine; Meg Callaway, Project Director of The Piscataquis Thriving in Place Collaborative; Cathy Bollinger, Managing Director of Embracing Aging in the York County Community Foundation; and Isabel Rovira, Manager and Director of Operations & Management with the Miami-Dade Age-Friendly Initiative and Urban Health.
• On May 17, 2017, the Senate Veterans Affairs Committee held a hearing on pending veterans' health care and benefits legislation, including on S.23, the "Biological Implant Tracking and Veteran Safety Act of 2017"; S.112, the "Creating a Reliable Environment for Veterans' Dependents Act"; S.324, the "State Veterans Home Adult Day Health Care Improvement Act of 2017" S.543, the "Performance Accountability and Contractor Transparency Act of 2017"; S.591, the "Military and Veteran Caregiver Services Improvement Act of 2017"; S.609, the "Chiropractic Care Available to All Veterans Act of 2017"; S.681, the "Deborah Sampson Act"; S.764, the "Veterans Education Priority Enrollment Act of 2017"; S.784, the "Veterans' Compensation Cost-of-Living Adjustment Act of 2017": S.804, the "Women Veterans Access to Quality Care Act"; S.899, the "Department of Veterans Affairs Veteran Transition Improvement Act"; S.1024, the "Veterans Appeals Improvement and Modernization Act of 2017"; the "Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017"; the "Serving our Rural Veterans Act"; and the "Veteran Partners' Efforts to Enhance Reintegration Act."
• On May 18, 2017, the Senate Finance Committee held a markup of S. 870, the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act.” S. 870 was reported favorably out of the Senate Finance Committee by a roll call vote of 26-0.

• On May 17, 2017, the House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held a hearing entitled, Advances in Biomedical Research. The witnesses were Francis Collins, Director, NIH; Anthony Fauci, Director of NIH’s National Institute of Allergy and Infectious Diseases; Gary Gibbons, Director of NIH’s National Heart, Lung and Blood Institute; Joshua Gordon, Director of NIH’s National Institute of Mental Health; Doug Lowy, Acting Director of NIH’s National Cancer Institute; and Nora Volkow, Director of NIH’s National Institute of Drug Abuse.
• On May 17, 2017, the House Energy & Commerce Health Subcommittee held a hearing on examining initiatives to advance public health, including: H.R.767, the "SOAR to Health and Wellness Act of 2017"; H.R.931, the "Firefighter Cancer 5 Registry Act of 2017"; and H.R.1876, the "Good Samaritan 5 Health Professionals Act of 2017." The witnesses are Kevin O’Connor, Assistant to the General President of the International Association of Fire Fighters; Cheryl Watson-Lowry of the American Dental Association; Martin Levine, Interim Clinical Dean and Professor of Family and Community Medicine at the Touro College of Osteopathic Medicine; and Jordan Greenbaum, Director of the Global Child Health and Well Being Initiative, International Centre for Missing and Exploited Children, Clinical Assistant Professor in the Emory School of Medicine’s Department of Pediatrics and Staff Physician at the Stephanie V. Blank Center for Safe and Healthy Children.
• On May 18, 2017, the House Ways & Means Health Subcommittee held a hearing entitled, The Current Status of the Medicare Program, Payment Systems, and Extenders. Dr. Mark Miller, Executive Director, Medicare Payment Advisory Commission (MedPAC) was the only witness at the hearing.
• On May 18, 2017, the House Energy & Commerce Health Subcommittee held a markup of H.R. 1222, the “Congenital Heart Futures Reauthorization Act of 2017”; H.R. 2410, the “Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017”; and H.R. 2430, the “FDA Reauthorization Act of 2017.” All pieces of legislation were reported favorably by voice vote.

• On May 15, 2017, the Office of Inspector General (OIG) released a report entitled, Kentucky Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries. The report found that Kentucky did not always determine Medicaid eligibility in accordance with Federal and State requirements. Of the OIG’s sample of 120 beneficiaries, Kentucky correctly determined eligibility for 111 beneficiaries, but it did not determine eligibility for the remaining 9 beneficiaries in accordance with Federal and State requirements. Specifically, Kentucky did not always electronically or manually verify income and citizenship. In addition, although it did not violate an eligibility requirement, Kentucky did not perform, or maintain documentation of, identity-proofing for 40 beneficiaries in accordance with Federal requirements. The Federal identity-proofing requirements are intended to reduce the potential for identity theft.
• On May 15, 2017, the OIG released a report entitled, Iowa Did Not Invoice Rebates to Manufacturers for Physician-Administered Drugs of Medicaid Managed-Care Organizations. The report found that the Iowa Department of Human Services, Iowa Medicaid Enterprise (State agency), did not invoice rebate-eligible physician-administered drugs dispensed to enrollees of Medicaid managed-care organizations (MCOs) in the State. Specifically, the State agency did not invoice drug manufacturers for rebates totaling $709,000 ($401,000 Federal share). These errors occurred because the State agency was still in the process of developing policies and procedures to ensure that it accurately invoiced manufacturers to collect rebates for physician-administered drugs dispensed to enrollees of MCOs.
• On May 16, 2017, the Congressional Budget Office (CBO) released a cost estimate of S. 870, the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017.” The CBO score provides an estimate of S. 870, increases or decreases in direct spending.
• On May 16, 2017, the OIG released a report entitled, S. Department of Health and Human Services Met Many Requirements of the Improper Payments Information Act of 2002 but Did Not Fully Comply for Fiscal Year 2016. Ernst & Young (EY), under its contract with HHS found that HHS did not comply with several Improper Payments Information Act of 2002 requirements. EY found HHS did not report an improper payment estimate for the Temporary Assistance for Needy Families program. EY also determined HHS did not achieve an improper payment rate of less than 10 percent for the Medicare Fee-for-Service and Medicaid programs; did not meet improper-payment-rate reduction targets for the Medicare Advantage program, the Children's Health Insurance Program, and the Foster Care program; and did not conduct recovery audits for the Medicare Advantage program.
• On May 18, 2017, the OIG released a report entitled, HHS Did Not Identify and Report Antideficiency Act Violations. The report found that the Program Support Center (PSC) obligated and expended funds for 17 of the 30 contracts the OIG reviewed in accordance with appropriations law and Federal acquisition requirements; however, for the remaining 13 contracts, the PSC did not always obligate and expend funds for its contracts in compliance with applicable law and requirements, resulting in unreported Antideficiency Act obligation violations totaling $20.3 million and expenditure violations totaling $29.2 million. Also, for 4 of the 30 contracts reviewed, the PSC incorrectly extended the period of performance and the fiscal year funding beyond its 12 month period of availability. In addition, the PSC did not always submit contracts to the Office of Grants and Acquisition Policy and Accountability and Office of General Counsel for appropriations funding reviews before awarding the contracts. These conditions occurred because the PSC: (1) funded nonseverable service contracts incrementally; (2) expended funds on a first-in, first-out basis instead of on the basis of a fund's period of availability; and (3) did not use correct product/service codes. Further, the Unified Financial Management System did not validate that expenditures were matched to obligations with an appropriate period of availability.

IV. Other Health Policy News

• On May 15, 2017, CMS announced that they intend to allow small businesses in Small Business Health Options Programs (SHOP) to use healthcare.gov more flexibly when enrolling gin healthcare coverage.
• On May 16, 2017, CMS released a Section 1332 state innovation waiver checklist. According to CMS, the new tool is intended to help states complete waiver applications that allow them to establish high-risk pools/ state-operated reinsurance programs. Section 1332 waivers, generally can be used by states to opt-out of some mandated provisions under the Affordable Care Act (ACA).
• On May 17, 2017, CMS issued an informational bulletin entitled, Basic Health Program; Federal Funding Methodology for Program Year 2018. The bulletin specifies the final values for the factors needed to calculate the federal Basic Health Program (BHP) payment rates for 2018 that were not included in the 2017 and 2018 BHP Payment Notice. It does not alter the payment methodology or definitions of any of the factors. In addition, the bulletin reminds states operating a BHP for 2018 of the need to make two decisions: (1) whether or not to develop a retrospective population health factor (PHF) adjustment methodology; and (2) whether to use the 2017 or 2018 qualified health plan (QHP) premiums as the basis for calculating the 2018 BHP federal payments.
• On May 17, 2017, CMS announced that in order to reduce undue regulatory burden on direct enrollment (DE) entities, and in the interest of expanding direct enrollment for Open Enrollment 5 for plan year 2018, CMS will no longer require the consumer-facing redirect with Security Assertion Markup Language (SAML)2 for all individual market enrollment transactions for coverage offered through the Federally-facilitated Exchanges (FFEs) and State-Based Exchanges on the Federal Platform (SBE-FPs) that rely on HealthCare.gov for individual market eligibility and enrollment functions, and will permit DE entities to use a “proxy direct enrollment” pathway, under which DE entities may collect consumer information on its website and input that information into HealthCare.gov.
• On May 17, 2017, CMS announced the Comprehensive Primary Care Plus (CPC+) Round 2 Region. The following four regions were selected for CPC+ Round 2: (1) Louisiana: Statewide; (2) Nebraska: Statewide; (3) North Dakota: Statewide; and (4) New York: Greater Buffalo Region (Erie and Niagara Counties).

V. ACA Repeal News

• On May 19, 2017, the CBO announced it will release a cost estimate for the House-passed American Health Care Act on May 24, 2017.