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President Trump Signs Bipartisan Opioid Legislation into Law; Includes Open Payments Reporting Expansion

President Trump has just signed into law HR 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.  The bipartisan legislation includes almost 200 provisions intended to strengthen opioid prevention and treatment efforts and bolster law enforcement tools. Among many other things, the new law:  Seeks to encourage … Continue Reading

Congress Approves Bills to Bar Restrictions on Pharmacies Sharing Certain Drug Pricing Information with Consumers

The House of Representatives approved two “gag clause” bills on September 25, 2018 that would prevent insurers from restricting pharmacies from informing consumers about lower cost, out-of-pocket prices for their prescriptions.  The bills were approved by the Senate earlier this month, and are now cleared for the President’s signature. Specifically, S 2553, the Know the … Continue Reading

House and Senate Hearings Focus on Health Costs and Policy Issues

Congressional panels continue to focus on federal health care policy topics, including cost, quality, and program integrity issues. Recent hearings have included the following: The Senate Health, Education, Labor and Pensions (HELP) Committee held hearings entitled “Reducing Health Care Costs: Examining How Transparency Can Lower Spending and Empower Patients”; “Prioritizing Cures: Science and Stewardship at … Continue Reading

Congress Continues Focus on Health Policy; More Hearings on the Congressional Agenda

The House Energy and Commerce Committee has scheduled three hearings this week on health topics: A July 24 hearing on advertising and marketing practices within the substance use treatment industry; A July 25 hearing on FDA and NIH implementation of the 21st Century Cures Act; and A July 26 hearing on the Medicare Merit-based Incentive … Continue Reading

Ways and Means Committee to Examine Ways to Modernize Stark Law to Promote Value-Based Reforms

The House Ways and Means Health Subcommittee has scheduled a July 17, 2018 hearing on “Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program.”  In announcing the hearing, Subcommittee Chairman Peter Roskam stated that “the lack of Stark modernization is a clear barrier to reforms that reward better … Continue Reading

Congressional Hearings Focus on 340B Program, Health Workforce, Other Health Policy Issues

In addition to the numerous hearings and markups on the opioid crisis discussed in a separate post, Congressional committees are examining the following health policy topics: The Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing to review HHS Office of Inspector General and Government Accountability Office oversight reports regarding the 340B … Continue Reading

Congressional Committees Approve Legislation to Address Opioid Crisis

Congress is considering a wide range of legislative proposals that seek to address the continuing opioid crisis. The following committees have tackled this topic recently: Senate Committee on Health, Education, Labor and Pensions (HELP) approved S. 2680, the Opioid Crisis Response Act of 2018, comprised of 40 proposals to address the opioid crisis through such … Continue Reading

Congress Approves Novel Use of Congressional Review Act to Invalidate Agency Guidance Document; Potential New Avenue of Relief for Health Industry?

As we reported on April 20, 2018, the Senate recently approved a joint resolution of disapproval under the Congressional Review Act (CRA) invalidating a five-year-old guidance document issued by the Consumer Financial Protection Bureau. It marked the first time in which a House of Congress invoked the CRA to invalidate something other than a formal … Continue Reading

Congressional Hearings Focus on Health Care Innovation, Medicaid Fraud, Health Policy Legislation – But Spotlight Remains on Opioids

Congressional committees with jurisdiction over health care legislation continue to focus on the opioid crisis: The Energy and Commerce held a hearing on “Combating the Opioid Crisis: Improving the Ability of Medicare and Medicaid to Provide Care for Patients” and a roundtable discussion on “Personal Stories from the Opioid Crisis.” The House Oversight Healthcare Subcommittee … Continue Reading

Congress Poised to Invalidate Agency Guidance Document in Unprecedented Use of the Congressional Review Act – Could it Provide a Roadmap for Relief for the Health Industry?

The Congressional Review Act (CRA) was long viewed as something of a paper tiger, and for good reason. The CRA requires agencies to submit certain rules to Congress before they go into effect. The CRA also creates a streamlined process for Congress to rescind such rules through the passage of a “joint resolution of disapproval” … Continue Reading

Congressional Hearings Spotlight Opioid Crisis, 340B Program, Medicare Physician Payments & More

The opioid crisis continues to be a focus for Congressional committees. The House Energy and Commerce Committee held hearings on prevention and public health solutions to the opioid crisis, along with the Drug Enforcement Administration’s role in combating the opioid epidemic. The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing focusing on … Continue Reading

Congressional Hearings on Federal Health Policies

A number of recent Congressional hearings focused on federal health policies, including the following: House Energy and Commerce Committee hearings on the impact of health care consolidation, oversight of the Department of Health and Human Services (including the Trump Administration’s HHS budget request), and drug compounding. Ways and Means Committee hearings on President Trump’s HHS … Continue Reading

Bipartisan Budget Act: Focus on Medicare, Medicaid, and Other Health Policy Provisions

The new Bipartisan Budget Act of 2018 (the Act), recently signed into law by President Trump, includes extensive Medicare, Medicaid, and other health policy and payment provisions.  Policy changes that will be welcome to health care providers and manufacturers include:  repeal of the Independent Payment Advisory Board (IPAB); elimination of the Medicare outpatient therapy caps; … Continue Reading

Stopgap Government Funding Law Includes Reprieve from ACA Medical Device, Insurance Taxes, Extends CHIP Funding

In addition to keeping the federal government operating through February 8, 2018, the newly-enacted Continuing Appropriations Act provides temporary relief from three health-related taxes imposed by the Affordable Care Act (ACA) and funds the Children’s Health Insurance Program (CHIP) through fiscal year 2023. With regard to the ACA taxes, the Continuing Appropriations Act: Imposes a … Continue Reading

House Panel Approves Off-Label Communication, OTC Monograph User Fee, Good Samaritan Health Professionals Bills

The House Energy and Commerce Health Subcommittee voted to approve the following health policy bills on January 18, 2017: H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act. This bill would create a safe harbor that would allow drug and medical device companies to share certain health care economic or scientific information with payers, formularies, and … Continue Reading

Congress Holds More Hearings on Opioid Crisis and Public Health Threats

A number of recent Congressional hearings focused on the opioid crisis, including the following: A House Ways and Means Oversight Subcommittee hearing on the current landscape of the crisis and CMS efforts to prevent opioid misuse. A Senate Homeland Security and Governmental Affairs Committee hearing examining the ways Medicaid may have unexpectedly contributed to development … Continue Reading

GOP Tax Bill Eliminates ACA Individual Insurance Mandate Penalty

While previous broad Republican efforts to dismantle the Affordable Care Act (ACA) have failed, the GOP tax bill cleared by Congress today has succeeded in effectively repealing the ACA’s individual health insurance mandate.  By way of background, the ACA established a penalty for failure to maintain health insurance coverage that provides at least minimum essential … Continue Reading

Year-End Congressional Hearings Examine Health Policies

This month, Congressional committees held a number of hearings that focused on health policy issues, including the following: House Energy & Commerce Committee hearings on the drug supply chain and patient brokering/addiction treatment fraud. Senate Health, Education, Labor, and Pensions (HELP) Committee hearings on the cost of prescription drugs and implementation of the 21st Century … Continue Reading

Congressional Hearings Focus on Health Policy Issues

A number of Congressional panels have scheduled or held recent hearings on health policy issues, including the following: On November 30, 2017, the House Energy & Commerce Committee is holding a hearing on implementation of the 21st Century Cures Act (Cures Act), featuring testimony by National Institutes of Health Director Francis Collins, M.D. and Food … Continue Reading

House Approves IPAB Repeal Legislation

The House of Representatives has voted 307 – 111 to approve HR 849, Protecting Seniors’ Access to Medicare Act, to repeal the Independent Payment Advisory Board (IPAB).  Under the ACA, the IPAB must submit Medicare spending plans to Congress if projected spending growth exceeds specified targets.  IPAB proposals go into effect automatically unless Congress enacts … Continue Reading
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