A&B Healthcare Week in Review, December 11, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• December 11, 2015, the Centers for Medicare & Medicaid Services (CMS) released a guidance document entitled “Waivers for State Innovation”. This guidance relates to Section 1332 of the Patient Protection and Affordable Care Act (ACA) and its implementing regulations. Section 1332 provides the Secretary of Health and Human Services and the Secretary of the Treasury with the discretion to approve a state’s proposal to waive specific provisions of the ACA (a State Innovation Waiver), provided the proposal meets certain requirements. In particular, the Secretaries can only exercise their discretion to approve a waiver if they find that the waiver would provide coverage to a comparable number of residents of the state as would be provided coverage absent the waiver, would provide coverage that is at least as comprehensive and affordable as would be provided absent the waiver, and would not increase the Federal deficit. If the waiver is approved, the state may receive funding equal to the amount of forgone Federal financial assistance that would have been provided to its residents pursuant to specified ACA programs, known as pass-through funding. State Innovation Waivers are available for effective dates beginning on or after January 1, 2017. They may be approved for periods up to 5 years and can be renewed. The Departments promulgated implementing regulations in 2012. This document provides additional information about the requirements that must be met, the Secretaries’ application review procedures, and the amount of pass-through funding, certain analytical requirements, and operational considerations. The document is expected to be published in the Federal Register on December 16th; a pre-publication version may be accessed here.
• On December 7, 2015, the Equal Employment Opportunity Commission announced the extension of the comment period for a proposed rule entitled “Genetic Information Nondiscrimination Act of 2008” published on October 30, 2015. The Commission is extending the comment period in response to a stakeholder request for an extension. Comments regarding this proposal must be received by the Commission on or before January 28, 2016. The comment period was originally scheduled to end on December 29, 2015. More information may be found here.
• CMS recently released the “Issuer Guidance for Handling 2015 Unaffiliated Issuer Enrollments and Clarification to Section V of Bulletin 16: Guidance for Issuers on 2016 Reenrollment in the Federally-Facilitated Marketplaces (FFMs)”. The purpose of this document is to provide guidance to Qualified Health Plan (QHP) issuers that offer plans through the Federally-facilitated Marketplaces (FFMs) and State-Based Marketplaces that rely on the federal platform for their eligibility and enrollment activities (SBM-FPs) on how to establish 2016 coverage for 2015 Unaffiliated Issuer Enrollments (also known as “Issuer Orphans”). This bulletin also clarifies the guidance in Section V of Bulletin 16: Guidance for Issuers on 2016 Reenrollment in the Federally-facilitated Marketplace (FFM).
• The CMS Center for Consumer Information & Insurance Oversight (CCIIO) released a notice entitled “Policy-Based Payments: Approach to 2016 Marketplace Payment Program Integrity, Withholding for Issuers Delayed on Policy-Based Payments Implementation, an Payment Adjustment for Issuers Deemed Policy-Based Payments Ready”. This bulletin provides guidance on the operational processes that CMS will use to evaluate issuers’ readiness for policy-based payment implementation. It also sets forth the approach to partially withholding advance payments of Marketplace financial assistance for issuers deemed non-compliant with the policy-based payment process and the policy and operational approach to transitioning issuers, when deemed ready, to policy-based payments in early 2016.
• On December 9, 2015, the Food and Drug Administration (FDA) released a draft guidance entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development”. The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This guidance describes:
  • FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between the review team and the sponsor
  • The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development
  • Expectations for appropriate methods, including the frequency, of such communications
• On December 9, 2015, FDA announced that it is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of September 9, 2015. In the notice of the public workshop, FDA requested comments on the workshop topics about the use of databases that contain information linking human genetic variations to disease, where such information has been curated by qualified professionals, to inform regulatory oversight of the clinical performance of genetic tests. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments. Submit either electronic or written comments by December 24, 2015.
• On December 10, the Department of Health and Human Services (HHS) released a notice entitled “Viral Hepatitis Action Plan-Community Stakeholder Activities Request for Information”. HHS is seeking public input from state and local governments, community based organizations, academic institutions, professional organizations, advocacy groups, private industry, and other non-federal stakeholders on activities undertaken in 2014-2015 in support of the goals of the national Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis. Input must be received by February 8, 2016.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On December 10, 2015, the Senate passed the Further Continuing Appropriations Act of 2016 (H.R. 2250). The bill passed the House on December 11th, and heads to the President for his signature. H.R. 2250 is a stopgap measure which funds the government through December 16th, staving off a government shutdown next week while budget negotiations continue.
• On Tuesday December 8th, the Senate Health, Education, Labor and Pensions Committee convened a hearing entitled “Opioid Abuse in America: Facing the Epidemic and Examining Solutions”. Witnesses for the hearing included: Leana Wen, Baltimore City Health Commissioner in Baltimore, MD; Robert Valuck, professor in the Skaggs School of Pharmacy and Pharmaceutical Science Clinical Pharmacy Department at the University of Colorado in Aurora, Colo.; and Eric Spofford, CEO of Granite House in Derry, N.H., and New Freedom Academy in Canterbury, N.H. More information on the hearing may be found here.
• On Wednesday December 9th, the Senate Special Aging Committee convened a hearing entitled “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines”. Witnesses for the hearing included Gerard Anderson, Ph.D., Professor, Health Policy and Management, Medicine, and International Health, Johns Hopkins University, Baltimore, MD; Erin R. Fox, Pharm.D., Director, Drug Information Service, University of Utah Health Care and Adjunct Associate Professor, University of Utah College of Pharmacy, Dept. of Pharmacotherapy, Salt Lake City, UT; David W. Kimberlin, M.D., Professor and Vice Chair for Clinical and Translational Research; Co-Director, Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL; and Mark Merritt, President & Chief Executive Officer, Pharmaceutical Care Management Association, Washington, D.C. More information on the hearing may be found here.

House of Representatives

• On Tuesday December 8th, the House Energy & Commerce Oversight and Investigations Subcommittee convened a hearing entitled “An Overdue Checkup Part II: Examining the ACA’s State Insurance Marketplaces”. The sole witness for the hearing was Andy Slavitt, Acting Administrator of the Centers for Medicare & Medicaid Services. More information on the hearing may be found here.
• On Wednesday December 9th, the House Energy & Commerce Health Subcommittee convened a hearing on H.R.921, the "Sports Medicine Licensure Act of 2015"; H.R.4152, the "Cardiac Arrest Survival Act of 2015"; H.R.3441, the "Accurate Education for Prenatal Screenings"; H.R.1209, the "Improving Access to Maternity Care"; H.R.2713, the "Title VII Nursing Workforce Reauthorization Act"; and H.R.4153, the "Educating to Prevent Eating Disorders Act of 2015.” More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On December 7, 2015, the Congressional Budget Office (CBO) released a working paper entitled “How CBO Estimates the Effects of the Affordable Care Act on the Labor Market: Working Paper 2015-09”. This working paper describes the methods and calculations CBO used in its August 2015 baseline projections to estimate the effects of the Affordable Care Act on the labor market.
• On December 11, 2015, Kaiser published the results of a survey of Kentucky residents on state health policy. Kentucky has received national attention as the only Southern state to fully embrace the ACA by creating its own state-based health insurance marketplace and by choosing to expand Medicaid to cover more low-income adults. Roughly 425,000 state residents have gained Medicaid coverage since the expansion, and among all states, Kentucky had the second-highest drop in its uninsured rate. On November 3, Republican Matt Bevin was elected as the state’s next governor after promising during his campaign to roll back the Medicaid expansion, end the state marketplace (known as Kynect), and switch Kentucky to the federal marketplace. In light of this, the Kaiser Family Foundation conducted a survey of Kentucky residents to gauge their views on health care policy in the state, including their preferences for the future of the Medicaid expansion and Kynect. The poll finds that Kentuckians are divided, leaning negative in their views of the ACA in general (41 percent favorable, 49 percent unfavorable), but they feel more positively about the two biggest ways the law has played out in their state.

IV. OTHER HEALTH POLICY NEWS

• On December 11, 2015, CMS announced that it has fully deployed a number of consumer decision support features on HealthCare.gov, which had been piloted earlier this season. These include the Out of Pocket Cost calculator, Doctor and Facility Lookup, and Prescription Drug Lookup features. CMS’ announcement may be found here.
• On December 10, 2015, the Medicaid and CHIP Payment and Access Commission (MACPAC) convened meetings in Washington, DC. An agenda, as well as presentations and transcripts as they become available, may be found here.
• On December 10, 2015, CMS announced that the agency has added new quality data to both the Physician Compare and Hospital Compare websites. According to CMS, “These websites are part of an Administration-wide effort to increase the availability and accessibility of information on quality to help consumers make informed health care decisions and encourage care improvements among health care professionals and hospitals.” A total of 14 group-level Physician Quality Reporting System (PQRS) measures reported via the Group Practice Reporting Option Web Interface and six individual eligible professional (EP)-level PQRS measures reported via claims are now available on Physician Compare. In addition, eight patient experience measures are publicly reported for group practices of 25 or more EPs who reported Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS summary survey measures. In addition, 14 measures for Shared Savings Program and Pioneer ACOs are now available on Physician Compare. In future years, CMS will add additional measures to Physician Compare, which may include data collected from EHR systems and qualified registries.
• On December 10-11, 2015, the Medicare Payment Advisory Commission (MedPAC) convened a series of meetings which primarily focused on developing draft Medicare provider payment update recommendations for the Congress. An agenda, presentations and transcripts may be accessed here. The draft recommendations will be revisited at the Commission’s next meeting in January 2016.
• On December 9, 2015, CMS announced that, heading into the final days before the December 15 deadline for January 1 coverage, more than 1 million new consumers signed-up for health coverage through the HealthCare.gov platform and about 1.8 million have returned to the Marketplace to renew their coverage for 2016. “I am pleased with the strong start to this year’s Open Enrollment,” Department of Health and Human Services Secretary Sylvia Burwell said. "While we have more work to do, more than 1 million new consumers have signed up for affordable quality coverage through HealthCare.gov. And the average returning Marketplace consumer who has shopped and chosen a new plan will pay less in premiums after their tax credits this year than they were paying last year. Time is running out to sign up for a health plan that begins on January 1. With less than a week remaining before the December 15th deadline, we urge consumers to visit Healthcare.gov and get enrolled.” The announcement may be found here.