Ways and Means Advances Two Medicare Bills

The House Ways and Means Committee advanced two pieces of legislation dealing with the Medicare program last week. H.R. 3178, introduced by Chairman Kevin Brady (R-Texas) and Ranking Member Richard Neal (D-Mass.), is a package of changes to the Medicare Part B home infusion and dialysis benefits. It would create a transitional payment for providers of home infusion services before 2021, and would extend a demonstration project that pays for in-home administration of intravenous immunoglobulin (IVIG). The Medicare Part B Improvement Act would also allow dialysis centers to use telehealth for home patient monitoring. H.R. 3168, sponsored by Health Subcommittee Chairman Pat Tiberi (R-Ohio) and Ranking Member Sander Levin (D-Mich.), would make permanent Medicare Advantage special needs plans (SNPs) for institutionalized beneficiaries, and would reauthorize for five years SNPs for those with chronic conditions and for those that are dually eligible for Medicare and Medicaid. Additionally, it would narrow the conditions that individuals must meet in order to enroll in a chronic SNP. SNP authorization expires at the end of 2018. H.R. 3168 would also create a grievance and appeals process for SNP beneficiaries. The Centers for Medicare and Medicaid Services (CMS) would begin assessing quality data at the plan level, rather than the contract level, so that SNP beneficiaries can better assess a plan’s

House of Representatives Passes FDARA

The House of Representatives passed legislation (H.R. 2430) to reauthorize the Food and Drug Administration’s (FDA) user fee programs for five years by voice vote last week. Since advancing out of the Energy and Commerce Committee, several revisions were made to the legislation. A provision regarding pediatric drugs and devices was added, which will give the FDA authority to require that cancer drugs be studied in children. The agency will also be able to conduct earlier meetings with product sponsors about pediatric trials. The bill was amended to require that the FDA act within eight months on any generic drug application for a product on the FDA’s drug shortage list, for a product that has no more than three equivalents on the market, or for a product for which there are no patents blocking its ability to come to market. The House-passed bill also includes a provision requiring manufacturers seeking approval of a drug that has the same active ingredient as a drug already on the market to demonstrate clinical superiority in order to gain the orphan drug designation.

The Senate does not plan to vote on reauthorization until it completes work on health care reform. Sen. Ron Johnson (R-Wis.) announced that he would use procedural hurdles to delay reauthorization if his right to try bill is not included in the user fee package or given a floor vote. S. 204, the Trickett Wendler Right to Try Act, would increase access to experimental drugs for terminally ill patients.

Chairman on the Senate Health, Education, Labor, and Pensions (HELP) Committee Lamar Alexander (R-Tenn.) has said that he hopes a vote on reauthorization will take place before August recess, set to begin the week of August 14. The user fees are scheduled to expire on September 30, but if Congress does not pass legislation by August 1, the FDA will be forced to begin the process of sending out notices of potential layoffs to thousands of employees.

The White House continues to express concerns about the reauthorization bill, noting in a statement of administration policy (SAP) that the legislation would require significant taxpayer investment in FDA’s medical product review programs.

2017 Trustees Report Released; IPAB Not Triggered

The 2017 Medicare Trustees Report, which projects the long-term finances of the Medicare program, was released last week. The Board of Trustees finds that Medicare spending will not trigger the Independent Payment Advisory Board (IPAB) until 2021. The Board had previously forecast that the cost-cutting panel would be triggered this year. The 2017 report also indicates that the Medicare trust fund will remain solvent until 2029, a year later than previously predicted, though the reason for the slowdown is unclear.

Upcoming Congressional Meetings and Hearings

House Energy and Commerce Oversight and Investigations Subcommittee hearing on “Examining HRSA’s Oversight of the 340B Pricing Program;” 10:15 a.m., 2322 Rayburn Bldg.; July 18

House Ways and Means Oversight Subcommittee hearing on “Efforts to Combat Waste, Fraud, and Abuse in the Medicare Program;” 10:00 a.m., 1100 Longworth Bldg.; July 19

House Appropriations Committee markup of the FY18 Labor, Health and Human Services, and Education
Appropriations Bill; 10:00 a.m., 2359 Rayburn Bldg.; July 19

House Energy and Commerce Health Subcommittee hearing “Examining Bipartisan Legislation to Improve the Medicare Program;” 10:00 a.m., 2123 Rayburn Bldg.; July 20

Recently Introduced Health Legislation

H.R.3163 (introduced by Rep. Patrick J. Tiberi): To amend title XVIII of the Social Security Act to provide for a home infusion therapy services temporary transitional payment under the Medicare program; Energy and Commerce, Ways and Means

H.R.3164 (introduced by Rep. Diane Black): To amend title XVIII of the Social Security Act to expand access to home dialysis therapy; Energy and Commerce, Ways and Means

H.R.3166 (introduced by Rep. Lynn Jenkins): To amend title XVIII of the Social Security Act to provide under the Medicare program for independent accreditation for dialysis facilities and assurance of high quality surveys with respect to such facilities; Energy and Commerce, Ways and Means

H.R.3168 (introduced by Rep. Patrick J. Tiberi): To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; Ways and Means, Energy and Commerce

H.R.3171 (introduced by Rep. Mike Bishop): To amend title XVIII of the Social Security Act to provide that certain orthotist’s and prosthetist’s clinical notes under Medicare be treated as part of the patient’s medical record; Energy and Commerce, Ways and Means

H.R.3172 (introduced by Rep. Kevin Brady): To amend the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 to extend the Medicare Patient IVIG Access Demonstration Project; Energy and Commerce; Ways and Means

H.R.3173 (introduced by Rep. Kenny Marchant): To amend title XVIII of the Social Security Act to create alternative sanctions for technical noncompliance with the Stark rule under Medicare, and for other purposes; Energy and Commerce, Ways and Means

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