Tag Archives: Cures Act

CMS Retroactively Revises DMEPOS Fee Schedule to Implement Cures Act

CMS has announced revised Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule amounts for the period of July through December 2016, as required by the 21st Century Cures Act. By way of background, the Affordable Care Act mandated that CMS use pricing information from competitive bidding to adjust certain DMEPOS fee schedule … Continue Reading

CMS Guidance on Off-Campus Provider-Based Department Policy Changes

CMS recently released guidance on how hospitals can request from their CMS Regional Office a relocation exception from site-neutral payment rates for an excepted off-campus department of a provider due to an extraordinary circumstance, in conformance with the 2017 Medicare Outpatient Prospective Payment System Final Rule. A separate CMS document discusses implementation of 21st Century … 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

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

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

Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act.  Together with the bills cleared by the HELP committee in February and March 2016, the panel has now passed 19 bipartisan medical innovation bills.  The five … Continue Reading

March Congressional Health Policy Hearings

Congressional committees have held hearings recently on various health policy issues, including: Energy and Commerce Committee hearings on CMS implementation of the Medicare physician fee schedule reform provisions included in the Medicare Access and CHIP Reauthorization Act (MACRA), financing and delivery of long-term care, and the public health response to the Zika virus. A Ways … Continue Reading

Senate HELP Committee Approves Additional Biomedical Innovation Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee approved seven bills this month that are intended to promote biomedical innovation, building on legislation approved by the panel in February.  Specifically, on March 9, the Committee approved: S. 1878, the Advancing Hope Act of 2015 — to extend and expand an FDA priority review voucher … Continue Reading

Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the “House 21st Century Cures” initiative. Specifically, on February 9, 2016, the Committee approved:… Continue Reading

Senate HELP Committee Outlines Plans for Action on Biomedical Innovation Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee has announced its plans to consider companion legislation to the House-approved “21st Century Cures Act,” which is intended to improve the drug and device development processes and expedite patient access to medical treatments.  The Senate currently plans three sessions to consider components of its biomedical innovation … Continue Reading

House Approves 21st Century Cures Act

On July 10, 2015, the House of Representatives passed on a 344-77 vote the 21st Century Cures Act, H.R. 6, legislation intended to improve the drug and device development processes and expedite patient access to medical treatments. A blog post highlighting key drug and device development provisions of the bill is available on our Life … Continue Reading

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act.  Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes.  Notably changes in the newest version include: A provision excluding authorized generics … Continue Reading

21st Century Cures Bill Includes Proposal to Broaden Sunshine Act Exclusions Related to Education

As we reported last week, on May 21, 2015, the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development … Continue Reading

House Energy and Commerce Committee Unanimously Approves 21st Century Cures Bill

Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability … Continue Reading

Action Continues on 21st Century Cures Act; Hearings on Medicare Competition, ACA Implementation, Opioid Abuse

Later today, the full House Energy and Commerce Committee is scheduled to begin markup of the 21st Century Cures Act, following Health Subcommittee approval on May 14. Votes are expected tomorrow (markup was subsequently delayed until May 21).  Also today, the House Ways and Means Subcommittee on Health is holding a hearing on “Improving Competition in Medicare: … Continue Reading

Upcoming 21st Century Cures Markup, Hearings on Medicare Chronic Care, Competition

Tomorrow the House Energy & Commerce Health Subcommittee is scheduled to mark up the 21st Century Cures Act; the Subcommittee has posted a substitute amendment that will be considered by the panel.  Also tomorrow, the Senate Finance Committee is holding a hearing on improving care for Medicare patients with chronic conditions. Looking ahead to next … Continue Reading

Congressional Health Policy Hearings

Congressional committees have held a number of hearings recently on health policy issues, include the following A House Energy and Commerce Health Subcommittee hearing on “Medicare Post-Acute Care Delivery and Options to Improve It.”  A Senate Commerce Committee hearing on “Advancing Telehealth Through Connectivity.” A Senate Finance Committee hearing on the impact of the ACA … Continue Reading

Congressional Panels Take Steps to Speed Patient Access to Medical Innovation

On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the … Continue Reading
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