Weekly Washington Healthcare Update - April 6, 2015

1. Congress

   House

   District Work Period - No Legislative Activity

   The House was not in session this week. Congress will return from a two-week recess on April 13. The House of Representatives calendar for 2015 can be found here.

   Senate

   State Work Period - No Legislative Activity

   The Senate was not in session this week. Congress will return from a two-week recess on April 13. The Senate calendar for 2015 can be found here.

   Bipartisan Letter to Preserve Community Health Center Funding

   On March 30, Senators Debbie Stabenow (D-MI) and Roger Wicker (R-MS), along with 58 other senators, sent a letter to Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Chairman Roy Blunt (R-MO) and Ranking Member Patty Murray (D-WA), urging them to continue national financial support for community health centers. In the letter, the bipartisan senators requested continued funding from the appropriators, explaining that the potential mandatory cuts at the end of this fiscal year could result in site closures and prevent millions of people in high-need communities from accessing cost-effective, primary care services. “As Congress works to improve access to care and reduce health-care expenditures, we urge the Subcommittee to support Health Centers, allowing them to continue to provide cost-effective primary care,” the letter said. The discretionary account for community health center funding amounts to $1.5 million this year; this fund is separate from the $7 billion in mandatory two-year funding for community health centers that is included in the SGR bill the Senate is expected to pass later this month. As it stands, community health centers could have their funding cut by nearly 70 percent at the end of the fiscal year in September. Health Centers are the health-care home for more than 23 million patients, including nearly seven million children and more than 268,000 veterans. These centers employ more than 156,000 Americans, and generate an economic impact and overall cost savings of over $24 billion.

2. Administration

   DOL, HHS and Treasury Delay Implementation of New Summary of Benefits and Coverage Templates Until 2017

   The Department of Health and Human Services (HHS), the Treasury Department and the Department of Labor (DOL) released a frequently asked questions document (FAQ) March 30 noting of their intention to delay implementation of a revised summary of benefits and coverage (SBC) templates until the beginning of the 2017 plan year; the revised SBC templates would include details on plans sold in open enrollment periods in the fall of that coverage year. As is currently proposed, the revised template requires group health plans and health insurers to provide summaries of benefits and coverage that “accurately [describe] the benefits and coverage under the applicable plan or coverage” during open enrollment periods. A notice of proposed rule-making issued in December would have required new summary regulations, templates and associated documents to begin being used as of Sept. 1, 2015. Moreover, the FAQ document says the agencies expect plan summary templates to be finalized by the agencies as early as January 2016. “The Departments are fully committed to updating the template and associated documents (including the uniform glossary) to better meet consumers' needs as quickly as possible,” the FAQ says. Moreover, the FAQ notes that agencies plan to use consumer testing and give members of the public an opportunity to provide additional input before finalizing the template.

   CMS Seeks Comments on QHP Requirements for Provider Networks and Prescription Drug Formularies

   The Centers for Medicare and Medicaid Service (CMS) released a collections notice seeking comments on the requirement that qualified health plans (QHPs) publish machine-readable data on provider networks and prescription drug formularies, a function that aids consumers in comparing qualified health plans in the federal marketplace. In a notice published in January, CMS commanded insurers who sell plans through the federal exchange that beginning in the 2016 plan year, QHPs must publish information regarding their formulary drug lists and provider directories on their websites in a format and at times to be announced by the Department of Health and Human Services (HHS). Moreover, the published notice also solicits feedback on guidelines for exchange navigator grant programs, specifically feedback on the progress reports required of exchange navigator programs. A program developed under the Affordable Care Act (ACA), CMS awards navigator grants to individuals and groups that assist customers in selecting plans in the state and federal exchanges.

   CMS Releases Bulletin on Retirement of Transitional Medical Assistance (TMA) and Qualifying Individuals (QI) Programs

   The Centers for Medicare and Medicaid Services (CMS) released an informational bulletin April 1 to provide information to state Medicaid agencies on the impact of the sunset of Transitional Medical Assistance (TMA) and the Qualifying Individuals (QI) programs, which became effective on April 1, 2015. The six- to 12-month TMA program is covered under Section 1925 and Section 1902(e)(1)(B) of the Social Security Act and requires states to provide certain families with continued Medicaid coverage for a designated six- to 12-month period after the family becomes income ineligible. Originally authorized under the Family Support Act of TMA and extended numerous times, the six- to 12-month program expired on April 1. The bulletin clarifies that the sunset does not disrupt coverage for families already receiving support under Section 1925 TMA and does discontinue future eligibility for Section 1925 TMA if in the future the sunset is lifted by subsequent legislation. The four-month extension under Section 1902(e)(1)(A) remains available and does not have a sunset date. Like the TMA program, the Qualifying Individuals program (QI) has been extended numerous times. In the absence of an extension, states will not be required to discontinue their payment of Part B premiums for QI beneficiaries; however these payments will no longer be eligible for federal reimbursement from CMS unless and until the program is reauthorized.

   FDA Releases Long-awaited Final Abuse Deterrent Opioid Guidance

   The Food and Drug Administration (FDA) released its final guidance April 1 on evaluation and labeling of abuse-deterrent opioids, ahead of a June 1 deadline set by Congress. While drugs with abuse-deterrent properties are not “abuse-proof,” FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse. The document, entitled “Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling,” lays out three premarket studies that should generally be performed to demonstrate the abuse deterrence properties of a new opioid drug and the general characteristics of post-market studies to show whether a product actually leads to meaningful reductions in abuse and misuse of the medication. The guidance described what is required for labeling language that allows manufacturers to claim the opioid is indeed abuse-deterrent. The final guidance does not address generic versions of abuse-deterrent opioids, but the agency plans to release draft guidance for generic products later this year. Abuse-deterrent opioids are designed to make it harder to manipulate the drugs — such as being crushed and swallowed, crushed and smoked, crushed and snorted or dissolved and injected — to make abuse of the medications more difficult, or “make abuse of the manipulated product less attractive or rewarding.” FDA is also clear in the guidance that these products make the drugs more difficult to abuse only in specific ways, thereby meaningfully deterring abuse, rather than preventing abuse all together.

   NIH Team Announced for POTUS's Precision Medicine Initiative

   On March 30, the National Institutes of Health (NIH) announced the formation of a Working Group of the Advisory Committee to the NIH Director (ACD) that will deliver a preliminary report in September 2015 to develop the President's Precision Medicine Initiative. The Precision Medicine Initiative is a research consortium that will create a cohort of 1 million people who would share information about their lifestyles and health to help researchers understand how...