The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”) Accelerated Approval Program. The committee’s Democratic chairman, Frank Pallone, Jr. (D-NJ) and Republican ranking member, Cathy McMorris Rodgers (R-WA) have proposed competing bills that were featured prominently in the Health Subcommittee’s legislative hearing on March 17, … Continue Reading
On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684. The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021. The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the … Continue Reading
Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1] In the past year or … Continue Reading
On April 19th, 2021 Governor Andrew Cuomo (D) signed the state’s Budget for Health and Mental Hygiene (A3007C/S2507C), which includes several significant changes impacting the state’s nursing home operators and investors. Most notably, the legislation’s principal provisions require reinvestment of revenue into each nursing home facility and a cap on the profit the facility can … Continue Reading
During a press conference on Monday, March 29, 2021, Florida Governor Ron DeSantis signed Senate Bill 72, which grants civil immunity to corporations, hospitals, nursing homes, government entities, schools, and churches from COVID-19-related lawsuits, except in cases of gross negligence or intentional misconduct. Plaintiffs who file suit in Florida alleging coronavirus-related injuries will face robust … Continue Reading
The U.S. Senate recently voted unanimously to approve the Competitive Health Insurance Reform Act (Act), which the House of Representatives had already passed earlier in the fall. Currently, health insurers have federal antitrust immunity under the McCarran-Ferguson Act for state-regulated activity that constitutes the business of insurance. Should President Trump opt to sign CHIRA into … Continue Reading
In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133. The sprawling, 5,593-page legislation includes the most significant health care-related provisions to be passed since the CARES Act. The President is expected to sign the legislation shortly. Of note, in the course of appropriating billions of … Continue Reading
With only one day left before the final rule scaling back nondiscrimination regulations took effect, the U.S. District Court for the Eastern District of New York (EDNY) issued an order staying the repeal of certain parts of the former regulations. On June 19, 2020, the Department of Health and Human Services’ (HHS) Office for Civil … Continue Reading
On June 30, 2020, United States Senators Elizabeth Warren (D-Mass.) and Marco Rubio (R-Fla.) introduced legislation proposing the Committee on Foreign Investment in the United States (CFIUS), an interagency committee authorized to review certain transactions involving foreign investment in the United States for national security concerns, assist the Federal Trade Commission (FTC) in “conduct[ing] a … Continue Reading
The recently passed “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) is sweeping legislation that will have widespread impact on companies in the health care and life sciences space. In addition to expanding coverage of COVID-19 testing and preventive services, the Act includes provisions to address health care workforce needs, eases restrictions surrounding telehealth … Continue Reading
The Department of Health and Human Services (HHS) is ahead of schedule to reduce its Medicare Administrative Law Judge (ALJ) appeals backlog, as required by court order, but lawmakers are still looking for ways to improve the efficiency of the Medicare appeals process. Following a November 1, 2018 federal district court order in American Hospital … Continue Reading
Congress has completed action on federal fiscal year (FY) 2020 spending, and President Trump has signed the two domestic and national security funding packages into law. The major health care policy provisions included in the domestic spending package, HR 1865, the “‘Further Consolidated Appropriations Act, 2020” (the “Act”), are summarized below. Repeal of ACA Device, … Continue Reading
The House Energy and Commerce Committee held hearings December 10, 2019 to examine nine legislative proposals intended to expand health insurance coverage and reduce health care costs, including Medicare buy-in bills. The Committee also recently held hearings on FDA oversight of the US drug supply chain and regulation of cosmetics, along with public health preparedness … Continue Reading
President Trump has signed into law a short-term continuing resolution that funds the federal government and extends certain expiring health care programs through December 20, 2019. With regard to health care programs, the measure (HR 3055) delays a scheduled $4 billion reduction in Medicaid disproportionate share hospital allotments until December 21, 2019 and extends the … Continue Reading
The House of Representatives has approved — without objection — a series of bills intended to promote prescription drug pricing transparency and invest in the health care workforce. With regard to drug pricing transparency, the House approved HR 2115, the Public Disclosure of Drug Discounts Act, as amended to include HR 3415, the Real-Time Beneficiary … Continue Reading
Three House committees have approved drug pricing legislation that is a high priority of the House Democratic leadership. Specifically, HR 3, the Lower Drug Costs Now Act of 2019, has been approved by the Energy and Commerce Committee, the Ways and Means Committee, and the Education and Labor Committee. While the details of the committee-approved … Continue Reading
October Congressional hearings have focused on the following health policy topics: A House Ways and Means Committee hearing addressed “Investing in the U.S. Health System by Lowering Drug Prices, Reducing Out-of-Pocket Costs, and Improving Medicare Benefits.” A House Energy and Commerce Committee hearing, “Sabotage: The Trump Administration’s Attack on Health Care,” featured testimony from CMS … Continue Reading
On September 26, 2019 the Senate approved H.R. 4378, the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019, which would fund the federal government through November 21, 2019. The House has already approved the legislation, and President Trump is expected to sign the bill. The legislation includes a number of health program funding … Continue Reading
On September 25, 2019, the House Energy and Commerce Committee is holding a hearing entitled “Making Prescription Drugs More Affordable: Legislation to Negotiate a Better Deal for Americans.” A background memo and text of the bills are available here. Likewise, a second House panel – the Education and Labor Health, Employment, Labor, and Pensions Subcommittee … Continue Reading
While the latest federal budget agreement signed into law earlier this month provides a reprieve from statutory budget caps for certain defense and domestic programs, it extends Medicare sequestration cuts for an additional two years. Specifically, section 402 of the Bipartisan Budget Act of 2019 (P.L. 116-37) extends the 2% across-the-board reduction to Medicare provider … Continue Reading
Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including: surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others. The following are highlights of recent action. Note that none of the bills … Continue Reading
The House of Representatives has overwhelmingly approved H.R. 3253, the Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act, which would finance extension of various Medicaid-related health programs by increasing manufacturer Medicaid drug rebate obligations. In terms of health programs, the legislation also would, among other things: Extend the “Money Follows The Person Rebalancing Demonstration” and … Continue Reading
On June 12, 2019, three Congressional committees have scheduled hearings on health care policy topics: The House Ways and Means Committee will hold a hearing entitled “Pathways to Universal Health Coverage.” The House Energy and Commerce Health Subcommittee will hold a hearing entitled “No More Surprises: Protecting Patients from Surprise Medical Bills.” The Senate Judiciary … Continue Reading
The House of Representatives has approved H.R. 987, the “Strengthening Health Care and Lowering Prescription Drug Costs Act,” which packages seven prescription drug and insurance-related bills recently approved by the House Energy and Commerce Committee. The legislation is intended to: increase generic drug competition; fund Affordable Care Act “Navigator” outreach and enrollment programs and state-based … Continue Reading
