A&B Healthcare Week in Review, June 17, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On June 13, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care.” This proposed rule would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposals are intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
• On June 17, 2016, CMS issued a final rule entitled, “Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System.” This final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), requiring laboratories performing clinical diagnostic laboratory tests to report the amounts paid by private insurers for laboratory tests. Medicare will use these private insurer rates to calculate Medicare payment rates for laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) beginning January 1, 2018. The final rule includes provisions to ease administrative burdens for physician office laboratories and smaller independent laboratories. In response to public comments, CMS moved implementation of the new payment system from January 1, 2017 to January 1, 2018 to allow laboratories sufficient time to develop the information systems necessary to collect, review, and verify data before reporting applicable information to CMS. This will also allow time for CMS to perform independent validation and testing of the CMS system through which laboratories will report applicable information, and allow laboratories to perform end-to-end testing of their systems with CMS’ system.
• On June 10, 2016, the CMS Center for Medicaid and CHIP Services (CMCS) issued an informational bulletin entitled, “Federal Financial Participation for Managed Care External Quality Review.” The Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Final Rule published on May 6, 2016, extends annual external quality review (EQR) requirements currently applied to Managed Care Organizations (MCOs) and Prepaid Inpatient Health Plans (PIHPs) to Prepaid Ambulatory Health Plans (PAHPs) and certain Primary Care Case Management entities (PCCM entities). This informational bulletin discusses: (1) The application of external quality review to PAHPs and certain PCCM entities; (2) Federal financial participation for EQR of MCOs; (3) Federal financial participation for EQR of PIHPs, PAHPs, and PCCM entities; (4) Effective dates for federal financial participation (FFP) for EQR; (5) State Expenditure Reporting for Medicaid EQR; and (6) Application of external quality review to managed care entities in CHIP.
• On June 13, 2016, the Department of Health and Human Services (HHS) issued a notice entitled, “Health IT Policy Committee Advisory Meeting; Notice of Meeting.” This notice announces updated dates for meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). These meeting will be open to the public.
• On June 13, 2016, the Food and Drug Administration (FDA) issued a draft guidance entitled, “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry; Availability.” This draft guidance provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. This guidance also discusses the nonclinical development of biopharmaceuticals (e.g., recombinant proteins and monoclonal antibodies). Public comments are due by August 13, 2016.
• On June 13, 2016, CMCS issued an informational bulletin entitled, “Strategies to Enroll and Retain Eligible Children in Medicaid and CHIP.” According to CMS, the availability of new coverage, efforts to streamline Medicaid and CHIP enrollment and renewal processes and robust outreach activities have brought the number of uninsured children in the United States to the lowest levels on record: in 2015, just 4.5 percent of children remained uninsured. To continue this rate of progress and cover the remaining 4.5 million children, the majority of whom are eligible for Medicaid and CHIP but not yet enrolled, CMS announced it will award $32 million in funding for cooperative agreements that will be distributed to 38 awardees across 27 states. These awards will support innovative community-based outreach and enrollment efforts targeted at enrolling vulnerable populations of uninsured children.
• On June 14, 2016, HHS issued a proposed rule entitled, “Freedom of Information Regulations.” HHS is proposing to revise and republish its regulations implementing the Freedom of Information Act (FOIA). The regulations are being revised in order to incorporate changes made to the FOIA by the Openness Promotes Effectiveness in the National Government Act of 2007 (OPEN Government Act) and the Electronic FOIA Act of 1996 (E-FOIA Act). Additionally, the regulations are being updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS’s fee schedule, and to make provisions clearer. Because of the numerous changes to the organization and to the headings, the regulations are being republished in their entirety. Public comments are due August 14, 2016.
• On June 14, 2016, FDA issued a final rule entitled, “Use of Symbols in Labeling.” FDA is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices. Public comments are due by September 14, 2016.
• On June 10, 2016, CMS issued a transmittal entitled, “Medicare Fee-For-Service Change Request Correction and Rescind Process.” CMS is developing the requirements to automate the correction and rescind process in the Electronic Change Information Management Portal (ECHIMP) for the Fee-or-Service Change Requests (CRs). This CR provides the instructions, requirements and steps the contractors will take when this automation goes into production.
• On June 10, 2016, CMS issued a transmittal entitled, “Revisions to the State Operations Manual (SOM) – Chapter 2.” This instruction revises the instructions to surveyors in Chapter 2 to clarify guidance to surveyors regarding the procedures for conducting the Exit Conference in the review of compliance with Medicare or Medicaid Conditions of Participation, Conditions for Coverage, and Requirements for Participation.
• On June 10, 2016, CMS issued a transmittal entitled, “Revisions to the State Operations Manual (SOM) –Chapter 5.” This instruction revises the instructions to surveyors in Chapter 5 to clarify guidance to surveyors regarding the procedures for conducting the exit conference in the review of compliance with Medicare or Medicaid Conditions of Participation, Conditions for Coverage, and Requirements for Participation.
• On June 10, 2016, CMS issued a transmittal entitled, “Revisions to the State Operations Manual (SOM) - Appendix P – Survey Protocol for Long Term Care Facilities.” This instruction revises the instructions to surveyors in section IV, subsection E of Appendix P, Psychosocial Outcome Severity Guide, in order to provide additional information to surveyors about assessing for psychosocial harm.
• On June 10, 2016, CMS issued a transmittal entitled, “Revisions to the State Operations Manual (SOM) - Appendix PP – Guidance to Surveyors for Long Term Care Facilities.” This instruction revises interpretive guidance for the sections listed below to provide additional information to surveyors about consideration of psychosocial harm when assessing compliance with specific regulations.
• On June 10, 2016, CMS issued a transmittal entitled, “Billing of Vaccine Services on Hospice Claims.” The transmittal makes changes to Original Medicare systems and provides billing instructions to allow hospices to submit institutional claims for vaccine services. Transmittal 3503, dated April 28, 2016, is being rescinded and replaced by Transmittal 3540, to remove chapter 1, section 190, which was revised via CR 9623. All other information remains the same.
• On June 14, 2016, FDA issued a notice entitled, “Food and Drug Administration Modernization Act: Modifications to the List of Recognized Standards, Recognition List Number: 042.” FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
• On June 14, 2016, the National Institutes of Health (NIH) issued a notice entitled, “Women’s Health Initiative.” This proposal is to extend the Women’s Health Initiative (WHI), which comprises a group of research studies that will address critical issues about the most common causes of frailty, disability, and death among postmenopausal women aged 50 to 79 years. This Initiative is comprised of two main investigational approaches: 1) A large clinical trial (CT) to evaluate the clinical efficacy of promising, but unproven preventive approaches for specific diseases common among older women; and 2) a companion observational study (OS) comprised of women 3 ineligible or unwilling to participate in the CT, to evaluate risk factors for chronic diseases by following this large cohort of women and relating subsequent disease development to baseline assessments of historical, physical, and physiologic characteristics. Public comments are due by July 14, 2016.
• On June 16, 2016, CMS issued a notice entitled, “Student Health Insurance Coverage; Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers; Minimum Essential Coverage; Transcatheter Valve Therapy Registry and KCCQ-10; Rate Increase Disclosure and Review Reporting Requirements.” Public comments are due July 16, 2016.
• On June 16, 2016, CMS issued a notice entitled, “Clearance for Evaluation of Stakeholder Training - Health Insurance Marketplace and Market Stabilization Programs; the Health Insurance Enforcement and Consumer Protections Grant Program Cycle I.” CMS is strongly committed to providing appropriate education and technical outreach to States, issuers, self-insured group health plans and third-party administrators (TPA) participating in the Marketplace and/or market stabilization programs mandated by the Affordable Care Act (ACA). CMS continues to engage with stakeholders in the Marketplace to obtain input through Satisfaction Surveys following Stakeholder Training events. Public comments are due by August 16, 2016.
• On June 16, 2016, NIH issued a notice entitled, “Request for Public Comments on the Development of the IACC Strategic Plan for Autism Spectrum Disorder (ASD).” Interagency Autism Coordinating Committee (IACC) (is seeking public comments to assist the IACC in identifying priorities for the 2016 update of the IACC Strategic Plan for Autism Spectrum Disorder (ASD). Public comments are due by July 29, 2016.
• On June 16, 2016, FDA issued a notice entitled, “Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus.” FDA is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for two in vitro diagnostic devices for detection of Zika virus in response to the Zika virus outbreak in the Americas. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices.
• On June 16, 2016, FDA issued a notice of availability entitled, “Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability.” FDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs).
• On June 16, 2016, FDA issued a draft guidance entitled, “Quality Attribute Considerations for Chewable Tablets; Draft Guidance for Industry.” This draft guidance describes the Agency's thinking on the critical quality attributes that should be assessed when developing a chewable tablet dosage form and recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product. Public comments are due by August 16, 2016.
• On June 16, 2016, FDA issued a draft guidance entitled, “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process.” FDA has developed this draft guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. Public comments may be submitted at any time.
• On June 16, 2016, FDA issued a notice entitled, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” This draft guidance, when finalized, is intended to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. Public comments are due by September 16, 2016.
• On June 14, 2016, the Office of Management and Budget (OMB) received a proposed rule for review entitled, “FY 2017 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update (CMS-1650-N).” The proposed rule announces the prospective payment rates for inpatient psychiatric facilities with discharges beginning on October 1, 2016.
• On June 15, 2016, OMB received a proposed rule for review entitled, “Advancing Care Coordination (CMS-5519-P).” The proposed rule would encourage care coordination among providers furnishing services to Medicare beneficiaries, which CMS expects will lead to higher quality health care.
• On June 15, 2016, OMB received a proposed rule for review entitled, “340B Drug Pricing Program; Administrative Dispute Resolution Process.” This proposed rule is required under the ACA and would implement an enhancement to the 340B Program by establishing a required and binding administrative dispute resolution process to resolve claims raised by covered entities that they have been overcharged for drugs purchased under the 340B Program. This administrative dispute resolution process also is available to drug manufacturers.
• On June 16, 2016, CMS issued a transmittal entitled, “Medical Review of Skilled Nursing Facility Prospective Payment System (SNF PPS) Bills.” The purpose of this CR is to update chapter 6.1, Medical Review of Skilled Nursing Facility Prospective Payment System (SNF PPS) Bills.
• On June 17, 2016, FDA issued a draft guidance entitled, “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.” The purpose of this document is to outline FDA’s proposed recommendations and expectations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. Public comments are due by September 17, 2016.
• On June 17, 2016, FDA issued a notice entitled, “Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format.” FDA is republishing to correct an inadvertent error in the Docket Number and to announce a revised comment period. FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Public comments are due by July 17, 2016.

Event Notices

• June 28, 2016, FDA announced a public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
• July 12, 2016, FDA announced a public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
• September 12 &13, 2016, FDA announced a 2-day public workshop entitled “Pediatric Clinical Investigator Training.” The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling.
• October 19, 2016, FDA announced a public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On June 15, 2016, the Senate Homeland Security and Governmental Affairs Committee convened a hearing entitled, “America's Insatiable Demand for Drugs: Examining Potential Approaches.” The witnesses included D. Scott MacDonald, Physician Lead at the Providence Crosstown Clinic; Ethan Nadelmann, Executive Director of the Drug Policy Alliance; David Murray, Senior Fellow at the Hudson Institute; and Frederick Ryan, Chief of Police in Arlington, Mass.
• On June 16, 2016, Senator Rob Portman (R-OH) sent a letter to CMS, regarding the next steps for Ohioans who received coverage from a failed ACA Consumer Operated and Oriented Plans (CO-OP). “The consumers were encouraged by the Administration to enroll in the Obamacare marketplace in the first place. Now they have to find new insurance or risk paying a penalty to the IRS. Worse, many of them have already paid high deductibles for their CO-OP coverage, yet they are about to lose credit for those payments and incur more out-of-pocket costs if they chose a new insurance plan mid-year,” Sen. Portman wrote.

House of Representatives

• On June 14, 2016, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing entitled, “Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance.” The witnesses included Beth Bell, Director of the Centers for Disease Control's National Center for Emerging and Zoonotic Infectious Disease; Janet Woodcock, Director of the Food and Drug Administration's Center for Drug Evaluation and Research; Richard Hatchett, Acting director of the Biomedical Advanced Research and Development Authority (BARDA); and Dennis Dixon of the Division of Microbiology and Infectious Diseases in the NIH's National Institute of Allergy and Infectious Diseases.
• On June 15, 2016, the House Energy and Commerce Committee convened a markup of H.R.2646, the “Helping Families in Mental Health Crisis Act.” The bill, as amended, was favorably reported to the House floor by a unanimous voice vote.
• On June 15, 2016, the House Ways and Means Committee convened a markup of H.R.5456, the “Family First Prevention Services Act of 2016”; H.R.5447, the “Small Business Health Care Relief Act”; H.R.5458, the “Veterans TRICARE Choice Act”; H.R.5452, to amend the Internal Revenue Code of 1986 to permit individuals eligible for Indian Health Service assistance to qualify for health savings accounts; H.R.5445, to amend the Internal Revenue Code of 1986 to improve the rules with respect to health savings accounts; H.R.3080, the “Tribal Employment and Jobs Protection Act”; H.R.210, the “Student Worker Exemption Act of 2015”; and H.R.3590, the “Halt Tax Increases on the Middle Class and Seniors Act.”

III. REPORTS, STUDIES, & ANALYSES

• On June 15, 2016, the Medicare Payment Advisory Commission (MedPAC) releases its June 2016 Report to the Congress: Medicare and the Health Care Delivery System. Three chapters in this report examine policy issues related to prescription drugs. The Commission remains concerned about rapid growth in drug prices, which can affect beneficiary access to needed medications, as well as the financial sustainability of the Medicare program. MedPAC presents its analysis of telehealth services and raises issues for policymakers to consider in addressing how telehealth services will fit into the Medicare program in the future. The report also provides initial payment framework options for the implementation of a consolidated Post-Acute Care Prospective Payment System (“PAC PPS”) for post-acute care services, as required under the Improving Medicare Post-Acute Care Transformation (“IMPACT”) Act of 2014.
• On June 15, 2016, the Medicaid and CHIP Payment and Access Commission (MACPAC) issued their June 2016 Report to Congress on Medicaid and CHIP, which focuses on Medicaid spending and financing. According to the Commission, the focus of the report reflects concerns among some policymakers, including the chairs of congressional committees with an interest in Medicaid, about the growth and sustainability of the program as it becomes a larger share of both federal and state budgets. Also available is the Commission’s Access in Brief: Children’s Access to Health Care.
• On June 15, 2016, the Government Accountability Office (GAO) released a report entitled, “Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers.” FDA developed a strategic integrated management plan (SIMP) for its three centers that oversee medical products (biologics, drugs, and medical devices); however, GAO found that the plan does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers. GAO recommended that the Secretary of HHS direct FDA to engage in a strategic planning process to identify challenges that cut across the medical product centers, and document how it will achieve measurable goals and objectives in these areas. HHS agreed with the recommendation.
• On June 15, 2016, GAO released a report entitled, “Medical Product Oversight: FDA Needs More Strategic Planning to Guide Its Scientific Initiatives.” GAO found that FDA lacks measurable goals to assess its progress in advancing regulatory science—the science supporting its effort to assess the products it regulates. GAO recommended that to improve strategic planning for regulatory science efforts, FDA should (1) develop and document measurable goals, including targets and time frames, and (2) systematically track funding across its regulatory science priority areas. HHS agreed with GAO's recommendations.
• On June 16, 2016, HHS Office of the Inspector General (OIG) released a report entitled, “CMS Is Taking Steps To Improve Oversight of Provider-Based Facilities, But Vulnerabilities Remain.” OIG found that CMS cannot identify all on- and off-campus provider-based billing in its aggregate claims data, a capability that is critical to ensuring appropriate payments. OIG recommended that CMS (1) implement systems and methods to monitor billing by all provider-based facilities, (2) require hospitals to submit attestations for all of their provider-based facilities, (3) ensure that regional offices and Medicare Administrative Contractors (MACs) apply provider-based requirements appropriately when conducting attestation reviews, and (4) take appropriate action against hospitals and their off-campus provider-based facilities that were identified as not meeting requirements. CMS partially concurred with the first new recommendation, did not concur with the second, and concurred with the third and fourth.

IV. OTHER HEALTH POLICY NEWS

• On June 16, 2016, CMS hosted a conference entitled, “CMS 2016 Medicare Advantage and Prescription Drug Plan Audit & Enforcement Conference & Webcast.” The conference provided insight into how Medicare Advantage and Part D organizations can best prepare for a CMS performance audit. CMS experts examined best practices of high performing organizations, common findings from audits, and enforcement consequences.
• On June 17, 2016, the Better Medicare Alliance (BMA) convened a session entitled, “The Value of Medicare Advantage: Pioneering Community Partnerships to Improve Health Outcomes for Seniors.” BMA hosted the panel discussion with Medicare experts to examine community partnerships in Medicare Advantage that are reducing disease progression and improving health outcomes. The speakers for the panel included Allyson Y. Schwartz, President/CEO of Better Medicare Alliance; Lisa Doncsecz, RN, BSN, Senior Clinical Lead, Health Quality Partners; Erika Kelly, Chief Advocacy/Government Affairs Officer, Meals on Wheels; Dr. Matt Longjohn, National Health Officer, YMCA; and Dr. Anand Parekh, Senior Advisor, Bipartisan Policy Center.
• On June 15, 2016, CMS announced the availability of $22 million in funding to state insurance regulators to use for issuer compliance with ACA key consumer protections. This award opportunity enables states to seek funding for activities related to planning and implementing select federal market reforms and consumer protections including: essential health benefits, preventive services, parity in mental health and substance use disorder benefits, appeals processes, and bringing down the cost of health care coverage (also known as medical loss ratio provision).