House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following: A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay,” the first of three planned hearings on prescription drug costs. A … Continue Reading
On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September. … Continue Reading
Although President Trump and House Republican leaders held a White House Rose Garden ceremony to celebrate House passage of legislation to partially repeal the Affordable Care Act (ACA), the prospects for actual enactment of the bill into law are highly uncertain. The American Health Care Act of 2017 (HR 1628), approved by the House May … Continue Reading
On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. The legislation also includes various policy changes, including provisions intended to improve the medical device inspection process and … Continue Reading
The Senate voted May 9, 2017 to approve the nomination of Scott Gottlieb, MD, to serve as Commissioner of Food and Drugs, by a vote of a 57-42. Dr. Gottlieb was sworn in on May 11.… Continue Reading
A number of Congressional committees have recently held hearings on health policy issues, including the following: House Energy and Commerce Committee hearings on “Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships” and Food and Drug Administration (FDA) medical device user fees. A House Oversight and Government Reform Committee hearing on “Federally Funded Cancer Research: … Continue Reading
The House of Representatives has adjourned for a two-week recess without a full House vote on the Republican party’s signature legislation — the American Health Care Act (AHCA) — to repeal and replace the Affordable Care Act (ACA). Since Republican leaders pulled the AHCA from House consideration on March 24, 2017 due to insufficient support, … Continue Reading
The House of Representatives has approved HR 372, the Competitive Health Insurance Reform Act of 2017, which would repeal the antitrust exemption for health insurance companies provided under the McCarran-Ferguson Act (although the antitrust exemption for certain collaborative activities between health insurance businesses would be retained). HR 372 was approved by a vote of 416-7, … Continue Reading
The House of Representatives is moving ahead on the Republican plan -– the American Health Care Act (AHCA) – that would repeal and replace major provisions of the Affordable Care Act (ACA). On March 16, 2017, the House Budget Committee approved sending the bill to the full House as part of fiscal year 2017 budget … Continue Reading
Two Congressional committees are holding hearings this week on FDA user fees: a March 21 Senate Health, Education, Labor, and Pensions Committee hearing and a March 22 Energy and Commerce Subcommittee on Health hearing. In addition, on March 22, 2017, the House Oversight Subcommittee on Health Care is holding a hearing on “Examining the Impact … Continue Reading
The House Judiciary Committee has approved HR 1215, the “Protecting Access to Care Act of 2017.” The bill includes a variety of medical liability reforms, including a $250,000 cap on noneconomic damages, limits on contingency fees, and allocation of damages in direct proportion to fault. The provisions would apply only to claims concerning the provision … Continue Reading
The Senate voted early on February 10, 2017 to confirm Thomas Price to be Secretary of Health and Human Services, on a party-line vote of 52 to 47. The Senate will now turn to the nomination of Seema Verma to be CMS Administrator, with a February 16 Senate Finance hearing scheduled to consider the nomination.… Continue Reading
The House Energy and Commerce Subcommittee on Health has approved two bills that would modify Medicaid eligibility rules to consider additional sources of income. First, HR 829 would establish standards for states to consider lottery winnings and other lump sum payments for purposes of determining Modified Adjusted Gross Income (MAGI) for Medicaid and CHIP eligibility. … Continue Reading
The House and Senate have approved a budget resolution (S.Con.Res. 3) providing instructions to Congressional committees on the federal spending framework for fiscal years 2017 through 2026. Notably, the resolution would enable the Senate to repeal provisions of the ACA pertaining to spending and revenues on a simple majority vote, without opportunity for filibuster. Such … Continue Reading
On January 31, 2017, the Senate Finance Committee is set to vote on the nomination of Rep. Thomas Price to be Secretary of Health and Human Services.… Continue Reading
Early in the new Congress, the House of Representatives has approved, without objection, the following bipartisan public health bills: H.R. 309, the National Clinical Care Commission Act, to establish a National Clinical Care Commission to improve coordination of federal programs that support care for people with metabolic syndromes and related autoimmune disorders. H.R. 315, the … Continue Reading
The House Energy & Commerce Committee has scheduled two hearings this week on Medicaid policy: a January 31 hearing on “Medicaid Oversight: Existing Problems and Ways to Strengthen the Program,” and a February 1 hearing on “Strengthening Medicaid and Prioritizing the Most Vulnerable.” … Continue Reading
As previously reported, President Obama has signed into law the 21st Century Cures Act (PL 114-255), which is intended to spur the discovery and availability of new medical treatments. Reed Smith has prepared a client alert summarizing the major drug, device, and biologic development and approval provisions contained in the Cures Act. The alert is … Continue Reading
President Obama has signed into law S. 2873, the Expanding Capacity for Health Outcomes Act (ECHO Act), which is intended to use “distance health education” to improve health care, particularly in medically-underserved areas. Specifically, this program will test “technology-enabled collaborative learning and capacity building models” – or the use of simultaneous interactive videoconferencing to connect … Continue Reading
Included in the 21st Century Cures Act are numerous changes to Medicare and Medicaid policies, including provisions with significant reimbursement impacts for certain types of Medicare providers and suppliers, along with changes intended to reduce the regulatory and administrative burdens associated with the use of electronic health records. Furthermore, the law once again expands the … Continue Reading
Advocates have been pushing hard over the past couple of years for the reform and expansion of mental illness and substance use disorder (i.e., behavioral health) treatment in the U.S. The 21st Century Cures Act — which has cleared Congress and is awaiting the President’s signature — includes a number of important provisions that reflect … Continue Reading
On September 30, 2016, President Obama signed into law S 1878, the Advancing Hope Act, which modifies the FDA’s priority review voucher program for rare pediatric diseases and extends the program through December 31, 2016. In addition, the House has approved a number of health policy bills, including the following: HR 954, the “CO-OP Consumer … Continue Reading
On September 29, 2016, President Obama signed into law HR 5325, which averts a government shutdown by continuing funding for the federal government through December 9, 2016. The legislation also includes $1.1 billion in supplemental funding to combat the Zika virus (including vaccine and diagnostic test development, public health, and other functions), along with $37 … Continue Reading
On September 21, 2016, the House Ways and Means Committee approved H.R. 5713, the “Sustaining Healthcare Integrity and Fair Treatment Act of 2016” or “SHIFT Act.” The primary focus of the SHIFT Act is to provide an additional delay in full implementation of the “25 Percent Rule” for long-term acute care hospitals (LTCHs). The legislation … Continue Reading
