Gottlieb Confirmation Hearing Set for April 5
On Wednesday, April 5, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee for Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb held a number of senior positions at the FDA during the George W. Bush Administration. He served as deputy commissioner for medical and scientific affairs and helped coordinate with the White House and the Department of Health and Human Services (HHS). He also worked for the Centers for Medicare and Medicaid Services (CMS) where he aided with the implementation of the Medicare Part D program. In addition to his previous roles at the FDA, Dr. Gottlieb worked as an advisor to various investment firms and as a fellow at the American Enterprise Institute (AEI). He is an advocate for lowering the cost of prescription drugs by modernizing the agency’s approval process and expediting generic competitors to market. Dr. Gottlieb is focused on easing burdensome regulations and supports policies that benefit patients. Members of the Senate HELP Committee are likely to ask Dr. Gottlieb how he would implement the 21st Century Cures Act, legislation spearheaded by the Senate HELP Committee and the House Committee on Energy and Commerce in the 114th Congress and signed by President Obama on December 13, 2016. Dr. Gottlieb may also receive questions regarding the reauthorization of the FDA user fee agreements and the rising price of prescription drugs.
This Week’s Hearings:
- Monday, April 3: The House Committee on Rules will meet to formulate a rule on H.R. 1343, Encouraging Employee Ownership Act of 2017; H.R. 1219, Supporting America’s Innovators Act of 2017; and H.R. 1304, Self-Insurance Protection Act.
- Tuesday, April 4: The Senate HELP Committee will hold a hearing titled “FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients Part II.”
- Tuesday, April 4: The House Committee on the Judiciary Subcommittee on Crime, Terrorism, Homeland Security, and Investigations will hold a hearing titled “Oversight of the Drug Enforcement Administration (DEA) and Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF).”
- Tuesday, April 4: The House Committee on Veterans’ Affairs will hold a hearing titled “An Assessment of Ongoing Concerns at the Veterans Crisis Line.”
- Tuesday, April 4: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “Cybersecurity in the Health Care Sector: Strengthening Public-Private Partnerships.”
- Wednesday, April 5: The Senate HELP Committee will hold a hearing on the nomination of Scott Gottlieb to be Commissioner of the FDA.
- Wednesday, April 5: The House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will hold a hearing titled “Federal Response to the Opioid Abuse Crisis.”
- Wednesday, April 5: The House Committee on Veterans’ Affairs Subcommittee on Disability Assistance and Memorial Affairs will hold a hearing on a number of pieces of legislation including H.R. 1564, A bill to amend section 504 of the Veterans’ Benefits improvements Act of 1996 to specify the funding source for travel related to examinations by physicians not employed by the Department of Veterans Affairs regarding medical disabilities of applicants for benefits under title 38, United States Code, to codify section 504 of the Veterans Benefits Improvements Act of 1996, and for other purposes; and draft legislation titled Quicker Veterans Benefits Delivery Act of 2017.
CMS Issues Final Rule on Medicaid DSH Payments
On Thursday, March 30, CMS issued a final rule titled “Medicaid Program; Disproportionate Share Hospital (DSH) Payments- Treatment of Third Party Payers in Calculating Uncompensated Care Costs.” The final rule addresses the hospital-specific limitation on Medicaid DSH payments and the application of the limitation in the annual DSH audits under the Social Security Act by clarifying the hospital-specific DSH limit is based only on uncompensated care costs. It explicitly states that uncompensated care costs include only those costs for Medicaid eligible individuals, including Medicare and other third party payments that compensate hospitals for care. The result is a hospital-specific limit calculation that only reflects the costs for Medicaid eligible individuals for which the hospital has not received payment from any source. The final rule will be published in the Federal Register on April 3, 2017, and is effective 60 days after publication.
Home Health CoPs Delayed
On Friday, March 31, CMS issued a proposed rule to delay implementation the new Conditions of Participation (CoPs) for Home Health Agencies (HHAs) which was published in the Federal Register on January 13, 2017. The proposed rule delays the effective date of the rule by six months to January 13, 2018, and is subject to a 60 day comment period. It will be published in the Federal Register on April 3, 2017.
MedPAC Meetings This Week
On Thursday, April 6, and Friday, April 7, the Medicare Payment Advisory Commission (MedPAC) will hold meetings to discuss Medicare policy issues and questions, as well as develop recommendations for Congress. The agenda includes the following topics:
- Part B drug payment policy issues;
- Using premium support in Medicare;
- Implementing a unified payment system for post-acute care;
- An overview of the medical device industry;
- Regional variation in Medicare Part A, Part B, and Part D spending and service use;
- Measuring low-value care in Medicare;
- Payment and plan incentives in Part D; and
- Provider consolidation: The role of Medicare policy