A&B Healthcare Week In Review, September 4, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On September 1, 2015, the Center for Medicare & Medicaid Services (CMS) Center for Consumer Information & Insurance Oversight (CIIO) released a document entitled “Information on Essential Health Benefits (EHB) Benchmark Plans”. The Affordable Care Act requires non-grand fathered health plans in the individual and small group markets to cover essential health benefits (EHB). HHS regulations (45 CFR 156.100) define EHB based on state-specific EHB benchmark plans. The document contains information on the EHB benchmark plans for each of the 50 states and the District of Columbia (D.C.). For plan years 2014-2016, two documents are provided for each EHB benchmark plan in the 50 states and D.C.: (1) a summary of the plan's benefit coverage and limits, including a list of covered prescription drug categories and classes; and (2) a list of state-required benefits. For 2017, two documents are provided for each proposed EHB benchmark plan: (1) a summary of the plan’s coverage of certain benefits that appear on the Plans & Benefits Template, including a list of covered prescription drug categories and classes; and (2) supporting plan documents that provide detail regarding all plan coverage, limits, and exclusions. An updated list of state-required benefits will be posted at a later date.
• On September 1, 2015, the Internal Revenue Service (IRS) published a supplemental notice of proposed rulemaking entitled “Minimum Value of Eligible Employer-Sponsored Health Plans”. This document withdraws, in part, a notice of proposed rulemaking published on May 3, 2013, relating to the health insurance premium tax credit enacted by the Affordable Care Act (ACA) (including guidance on determining whether health coverage under an eligible employer-sponsored plan provides minimum value) and replaces the withdrawn portion with new proposed regulations providing guidance on determining whether health coverage under an eligible employer-sponsored plan provides minimum value. The proposed regulations affect participants in eligible employer-sponsored health plans and employers that sponsor these plans. Comments on the notice are due November 2, 2015.
• On August 31, 2015, the CMS Center for Medicaid & CHIP Services released a letter to State Medicaid Directors entitled “Policy Options for Using SNAP to Determine Medicaid Eligibility and an Update on Targeted Enrollment Strategies.” This letter is intended to clarify and expand upon the opportunities for facilitating Medicaid and the Children’s Health Insurance Program (CHIP) enrollment options described in our guidance to states (SHO #13-003; ACA #26) issued on May 17, 2013. In particular, CMS is offering states a new opportunity under Medicaid state plan authority to use Supplemental Nutrition Assistance Program (SNAP) gross income to support Medicaid income eligibility determinations at both initial application and renewals for certain populations. CMS is also clarifying the timeframes associated with the use of 1902(e)(14)(A) waivers described in the May 2013 guidance.
• On September 2, 2015, CCIIO released a guidance entitled “Adjustment of Risk Adjustment Transfers Due to Submission of Incorrect Data”. On June 30, 2015, CMS provided to issuers of risk adjustment covered plans in all markets in all states (other than Massachusetts, which operates its own risk adjustment program) and the District of Columbia reports stating their expected payments and charges under the Affordable Care Act’s reinsurance and risk adjustment programs This guidance sets forth CMS’s process for addressing instances of materially incorrect EDGE server data submissions for the 2014 benefit year calculations. CMS intends to propose and seek comment on this and other operational processes in the proposed HHS Notice of Benefit and Payment Parameters for 2017.
• On September 2, 2015, the sixteen federal Departments jointly released a proposed rule entitled “Federal Policy for the Protection of Human Subjects”. The departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The participating departments and agencies propose these revisions to the human subjects regulations because they believe these changes would strengthen protections for research subjects while facilitating important research. The rule is scheduled for publication in the Federal Register on September 8, 2015, and comments will be due 90 days after its publication.
• On September 3, 2015, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking entitled “Nondiscrimination in Health Programs and Activities”. HHS is issuing this proposed rule on Section 1557 of the Affordable Care Act (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the ACA authorizes the Secretary of the Department to promulgate regulations to implement the nondiscrimination requirements of Section 1557. In addition, the Secretary is authorized to prescribe regulations for the Department’s governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities. The rule is scheduled for publication in the Federal Register on September 8, 2015, and comments will be due 60 days after its publication.
• On September 4, 2015, the Food and Drug Administration (FDA) released an information collection activity entitled “Environmental Impact Considerations” for public comment. This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statues for which FDA is responsible must, in most instances, submit applications requesting approval. The rule is scheduled for publication in the Federal Register on September 8, 2015, and comments will be due 60 days after its publication.
• On September 4, 2015, FDA released a guidance document entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product– Responses to Frequently Asked Questions; Second Edition”. FDA is issuing the second edition to provide further information on demonstrating substantial equivalence (SE) of a new tobacco product, including demonstrating SE when the new tobacco product has: A modified label that renders it distinct from, but has identical characteristics to, a valid predicate product; or a change in product quantity from, but where the per weight composition is identical to, a valid predicate product.

Under Review at OMB

• On August 28, 2015, the Office of Management and Budget (OMB) received a rule entitled “Medicare Clinical Diagnostic Laboratory Test Payment System” (CMS-1621-P). This proposed rule would require Medicare payment for clinical laboratory tests to be based on private payor rates beginning January 1, 2017, as required by section 216(a) of the Protecting Access to Medicare Act of 2014.
• On September 3, 2015, OMB received the following rules:
  • 2015 Edition Health Information Technology (Health IT) Certification Criteria, Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications 
  • Electronic Health Record Incentive Program--Modifications to Meaningful Use in 2015 through 2017 (CMS-3311-F)
  • Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 through 2017 (CMS-3310-F)

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate is not in session. Both chambers of Congress are expected to resume regular legislative business on September 8th. The Senate calendar may be found here.

House of Representatives

• The House is not in session. Both chambers of Congress are expected to resume regular legislative business on September 8th. The House calendar may be found here.

III. REPORTS, STUDIES, & ANALYSES

• A study published this week in the journal of Arthritis and Rheumatology sought to address recent findings regarding the association between total knee arthroplasty (TKA) or total hip arthroplasty (THA) surgery and serious cardiovascular events among osteoarthritis patients in a UK general population. The findings provide the first general population-based evidence that TKA and THA among osteoarthritis patients are associated with a substantially increased risk of myocardial infarction during the immediate postoperative period. However, the authors conclude, its overall long-term impact was null, unlike the risk of venous thromboembolism that remained years after the procedure. The article may be accessed here.

IV. OTHER HEALTH POLICY NEWS

• On September 1, 2015, CMS announced the Medicare Advantage Value-Based Insurance Design (MA-VBID) model, an opportunity for Medicare Advantage plans (MA plans), including Medicare Advantage plans offering Part D benefits (MA-PD plans), to “…offer clinically-nuanced benefit packages aimed at improving quality of care while also reducing costs”. The MA-VBID model will begin January 1, 2017 and run for five years. CMS will test the model in 7 states: Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania, and Tennessee. According to CMS’ announcement, the MA-VBID model supports high-value clinical services, improved health outcomes, and health care cost savings or cost neutrality through the use of structured patient cost sharing and other health plan design elements that encourage enrollees to use high-value clinical services. The MA-VBID model will provide flexibility for Medicare Advantage plans accepted into the model to develop clinically-nuanced benefit designs for enrollee populations that fall within certain clinical categories. The conditions are:
  • Diabetes
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure (CHF)
  • Patient with Past Stroke
  • Hypertension
  • Coronary Artery Disease
  • Mood disorders

The MA-VBID model test is open to all qualifying Medicare Advantage and MA-PD plans in the test states that submit acceptable programmatic proposals to CMS. CMS will accept applications for the MA-VBID via a Request for Applications (RFA), to be released shortly. Once released, application materials will be available at: http://innovation.cms.gov/initiatives/VBID/.

• On September 1, 2015, the 19th Judicial District Court granted an Order of Rehabilitation and Injunctive Relief giving Louisiana Insurance Commissioner Jim Donelon possession and control of the Louisiana Health Cooperative, Inc. (LAHC, aka CO-OP). The CO-OP is a health maintenance organization (HMO) formed under the provisions of the Affordable Care Act as a non-profit health insurance company. It had previously announced it would wind down operations at the end of this year and not offer coverage in 2016. “Our on-site review and analysis of the Louisiana Health Cooperative’s operations led us to the decision that placing it in Rehabilitation is in the best interests of its policyholders and providers, as well as taxpayers,” said Commissioner Donelon. “We are convinced that the CO-OP, with the support of the Centers for Medicare and Medicaid Services (CMS), will have the ability to pay claims owed to health care providers and I am confident that we can more efficiently and successfully wind down affairs in a timely and equitable fashion.” More information on the rehabilitation process from the Louisiana Department of Insurance may be found here.
• On September 2, 2015, CMS announced grant awards totaling $67 million to support outreach efforts “designed to connect people with local help as they seek to understand the coverage options and financial assistance available at HealthCare.gov.” CMS awarded three year-long Marketplace Navigator grants to 100 organizations located in 34 states that operate Federally Facilitated and State Partnership Marketplaces. More information may be found here.
• On September 2, 2015, the Centers for Disease Control and Prevention (CDC) published an “Early Release of Selected Estimates Based on Data From the January-March 2015 National Health Interview Survey”. In this release, the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) updates estimates for 15 selected health measures based on data from the January–March 2015 National Health Interview Survey (NHIS) and presents estimates from 1997 through 2014 for comparison. According to the analysis, January–March 2015, the percentage uninsured at the time of interview was 9.2%, which was lower than the 2014 estimate of 11.5%.
• On September 2, 2015, , the US Court of Appeals for the Federal Circuit denied Amgen’s emergency motion to block Novartis’s drug Zarxio (a biosimilar copy of Amgen's cancer biologic Neupogen) from being marketed. On September 3rd, Sandoz (a Novartis subsidiary) announced that the drug was available in the United States, which represents the first biosimilar approved in the country. "While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general. Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies," said Dr. Ralph Boccia, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION).