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With All Eyes on Senate ACA-Repeal Debate, House Passes Bill to Tweak Stark Law and Other Medicare Part B Policies

While the Capitol Hill spotlight is focused on the Senate debate on legislation to repeal or revise the Affordable Care Act, the House of Representatives quietly approved by voice vote HR 3178, the Medicare Part B Improvement Act of 2017. The bipartisan bill would impact a number of Medicare policies, including the Stark physician self-referral … Continue Reading

House Committees Examine Health Care Policy Issues

Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following: Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug discount program; drug and device company communications, including clinical/economic data; state efforts to address the opioid crisis; and extension of safety net … Continue Reading

Congressional Hearings, Markups Focus on Chronic Care, Drug Pricing, HHS Budget, Other Health Programs

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

House Energy & Commerce Committee Unanimously Approves FDA Reauthorization, Public Health Bills

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

Rose Garden Ceremony Notwithstanding, Finish Line Not in Sight for ACA Repeal Legislation

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

Congressional Panels Tackle FDA Reauthorization Act and Other Health Policy Issues

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

Roundup of Recent Congressional Health Policy Hearings

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

House Republican Leaders Tout “Progress” on ACA Repeal/Replace Efforts Before Congressional Recess

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

House Overwhelmingly Approves Insurance Antitrust Reform Legislation

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

House GOP Moving Ahead on Controversial ACA Repeal & Replace Bill; First of Three Planned Phases of Health Reform

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

Congressional Panels Examining Pharmaceutical Distribution Systems, FDA Drug User Fees

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

House Judiciary Committee Advances Medical Liability, Insurance Antitrust Reform Bills

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

House Panel Votes to Tighten Medicaid Income Standards

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

Congressional Budget Resolution Provides Framework for ACA Repeal Legislation, Hearings Focusing on ACA Issues

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

House Takes Early Action on Noncontroversial Public Health Bills

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

21st Century Cures Act: Focus on Drug/Device Provisions

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 Signs “Expanding Capacity for Health Outcomes Act” into Law

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

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

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

Major Mental Illness, Substance Use Disorder Reforms, Opioid Abuse Treatment Funding Included in 21st Century Cures Act

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
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