Archives: Legislative Developments

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Federal Court stays repeal of “On the Basis of Sex” definition in recent nondiscrimination final rule one day before regulations take effect

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

Bipartisan bill proposes to leverage CFIUS in assessing pharmaceutical supply chain

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

Sweeping “CARES Act” Legislation Will Have Wide Impact on Health Care, Life Sciences Companies

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

HHS Continuing to Reduce Medicare ALJ Appeals Backlog under Court Order; Senators Reintroduce Legislation Striving to Improve Efficiency of Medicare Appeals Process

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

FY 2020 Government Funding Bill Repeals ACA Health-Related Taxes, Extends Expiring Health Provisions, Makes Other Health Policy Updates

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

Energy & Commerce Committee Focuses on Universal Health Coverage, Other Health Policies

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

Government Funding Bill Signed by President Trump Extends Expiring Federal Health Programs through December 20

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

House Clears Prescription Drug Price Transparency, Health Workforce Legislation

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 Panels Approve HR 3, the Lower Drug Costs Now Act

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

Wrap-Up of October Congressional Health Policy Hearings

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

Short-Term Government Funding Legislation includes Health Policy Extenders, Drug Rebate Definition Change, DSH Policies

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

Congressional Committees Renew Focus on Drug Pricing, Other Health Policy Topics

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

Medicare Sequestration Extended through FY 2029 under New Budget Law

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

Congressional Committees Advance Multiple Bills Addressing Surprise Medical Billing, Prescription Drug Policy, and Other Health Policy Issues

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

Legislation to Modify Medicaid Drug Rebate Policies, Extend Medicaid Health Provisions Advances in Congress

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

Upcoming Congressional Hearings to Focus on Health Coverage, Surprise Billing, and Vertical Integration

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

Congress Continues Focus on Health Care Costs

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

Surprise Medical Billing:  Bipartisan Consensus on the Problem, but Finding an Effective Fix May be Harder

In a rare display of unity, President Donald Trump and bipartisan Congressional leaders have highlighted their shared commitment to tackling “surprise” medical billing – when an insured patient is subject to unexpectedly high out-of-pocket costs for out-of-network care that is beyond their control.  Such surprise billing can occur when a patient receives emergency care from … Continue Reading

New Legislation Seeks to Narrow Stark Law Exceptions for Certain Complex Non-Ancillary Services

Representatives Jackie Speier (D-California) and Dina Titus (D-Nevada) have introduced HR 2143, the Promoting Integrity in Medicare Act of 2019 (PIMA), which – if enacted – would narrow the “Stark” law’s exceptions and have a direct impact on the services provided by physicians who self-refer for the performance of certain designated health services. The 2019 … Continue Reading

Congressional Committees Continue Focus on Prescription Drugs, Insurance Coverage Policy

Recent Congressional hearings and markups have concentrated on prescription drug pricing, insurance access, and other health topics.  For instance, last week the House Ways and Means Committee unanimously approved H.R. 2113, the Prescription Drug Sunshine, Transparency, Accountability and Reporting Act of 2019 (STAR Act).   The legislation would, among other things: Require drug manufacturers to report their … Continue Reading

Medicaid Legislation with Medicaid Rebate Misclassification Penalty Heads to President Trump

The House and Senate have both approved H.R. 1839, the Medicaid Services Investment and Accountability Act of 2019, clearing it for President Trump’s signature.  Notably, the legislation would: subject drug manufacturers to a new civil monetary penalty (CMP) for knowingly misclassifying or misreporting covered outpatient drugs under a Medicaid drug rebate agreement (such as by … Continue Reading

Senate Committee Calls for Sunshine Act/Open Payments Enforcement

The Senate Finance Committee recently called for federal agencies to begin investigating physician owned distributors’ (PODs) alleged noncompliance with the U.S. Physician Payment Sunshine Act (Sunshine Act, or Open Payments). The letter is addressed to the head of the Office of Inspector General (OIG) and the Administrator of the Centers for Medicare & Medicaid Services … Continue Reading

Congressional Hearings on Drug Pricing, Other Health Policy Topics  

As we have previously reported, prescription drug pricing is an early focus for Congressional hearings this year.  This week the Senate Finance Committee held its second hearing on drug pricing, and the following hearings are on the schedule next week: On March 7, 2019, the Ways and Means Health Subcommittee is holding a hearing entitled … Continue Reading

Congressional Committees Focus on ACA and Other Health Policy Issues

Federal health policy is an early focus for Congressional committees.  In addition to several hearings held in January, Congressional hearings in February have concentrated on the Affordable Care Act (ACA) and primary care, including the following: A House Energy and Commerce Committee hearing on the Texas v. United States court case challenging the constitutionality of … Continue Reading
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