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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

Public Health Bills Advance

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

With Short-Term Government Funding Bill in Place, Congress Adjourns until after Elections

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

House of Representatives Approves Bill to Delay LTCH 25% Rule Implementation, Make Other LTCH Reforms, and Tighten Medicare Enrollment Moratorium Authority

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

House Approves Medicare ESRD Coverage, Rural Hospital Supervision Bills

On September 21, 2016, the House of Representatives approved HR 5659, the Expanding Seniors Receiving Dialysis Choice Act of 2016, which would allow Medicare beneficiaries with end stage renal disease (ESRD) to enroll in Medicare Advantage plans beginning in 2020. The House also approved HR 5613, to prevent CMS from enforcing a Medicare requirement for … Continue Reading

Energy and Commerce Committee Clears Public Health Bills

On September 21, 2016, the House Energy and Commerce Committee unanimously approved the following public health bills: H.R. 4365, Protecting Patient Access to Emergency Medications Act – to amend the Controlled Substances Act (CSA) to enable paramedics and other emergency medical services (EMS) professionals to continue to administer controlled substances to patients under standing orders … Continue Reading

Congressional Hearings Focus on Health Policy Issues

A number of recent Congressional hearings have focused on health policy issues, including:  Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and the safety of cosmetics. A House Judiciary Committee hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.” … Continue Reading

Congressional Health Policy Hearings, Markups Resume After Summer Break

Congress has returned from recess, and health care policy continues to be on the agenda. The following health-related hearings and markups were held this week: The House Ways and Means Committee approved H.R. 5942, a bill to establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and H.R. 954, … Continue Reading

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number … Continue Reading

House of Representatives Approves Mental Health System Reform Bill

The House of Representative has overwhelmingly approved a bipartisan bill (H.R. 2646, the Helping Families in Mental Health Crisis Act) to reform the nation’s mental health care system. Key provisions of the legislation would: provide grants to increase access to treatment for children with mental disorders and individuals with serious mental illness and fund various … Continue Reading
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