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 “justification” for drug price increases that exceed certain thresholds.
  • Mandate that manufacturers of drug, biologicals, devices, and medical supplies publicly report on the Open Payments database the value and quantity of free samples given to providers.
  • Extend to manufacturers without a Medicaid rebate agreement the requirement to report average sales price for drugs covered under Medicare Part B, and authorize civil money penalties for failure to report such information or for reporting false information.
  • Direct the Secretary of Health and Human Services to publicly disclose certain rebates, discounts, and other price concessions achieved by pharmaceutical benefits managers (PBMs) and to report on drugs furnished in the inpatient hospital setting.

Earlier this month the House Energy and Commerce Committee approved 12 bills aimed at reducing prescription drug and other health care costs, including legislation intended to:  bolster generic drug competition; support Affordable Care Act insurance enrollment programs and state-based insurance marketplaces; reverse Trump Administration policies on short-term, limited duration health insurance and State Relief and Empowerment Waivers; and establish an “Improve Health Insurance Affordability Fund” to help states lower premiums in the individual health insurance market.

In addition to these markups, Congressional panels have held hearings various health policy issues, including the following:
Continue Reading Congressional Committees Continue Focus on Prescription Drugs, Insurance Coverage Policy

This month, Congressional committees held a number of hearings that focused on health policy issues, including the following:

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

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

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

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

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 those efforts, including sections intended to strengthen, promote, and expand access to information, care, and coverage with respect to behavioral health care across communities and for individuals, families, and the nation’s health care workforce. The Act also includes $1 billion in block grant funding to target the “epidemic of death” associated with the opioid abuse crisis.

Mental Health and Substance Abuse Disorder Provisions

In one of the most noteworthy behavioral health provisions, the Act strengthens leadership within the Substance Abuse and Mental Health Services Administration (SAMHSA) by creating a new Assistant Secretary position. The new role will oversee mental health and substance abuse research, funding, and evidence-based health care practices, and will drive and coordinate federal policy in this area.  To do so, the Assistant Secretary will consult with stakeholders to improve community-based and other mental health services, including care for adults and children with serious mental illness, as well as collaborate with other federal departments, including the Departments of Defense, Veterans Affairs, Housing and Urban Development, and Labor, to improve care for veterans and service members and support programs to address chronic homelessness.  The Assistant Secretary is also tasked with working with stakeholders to improve the recruitment and retention of mental health and substance use disorder professionals.
Continue Reading Major Mental Illness, Substance Use Disorder Reforms, Opioid Abuse Treatment Funding Included in 21st Century Cures Act

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

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 newly-approved bills are as follows:
Continue Reading Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

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

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 Clears Bipartisan Biomedical Innovation, Health IT 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

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

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 and approval, clinical trial design, research funding, interoperability of health technology, and other issues. This blog post focuses on the bill’s proposed Sunshine Act (aka Open Payments) changes, which would broaden exclusions related to the provision of education-related payments or transfers of value.
Continue Reading 21st Century Cures Bill Includes Proposal to Broaden Sunshine Act Exclusions Related to Education

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