President Trump has signed into law a bill (P.L. 115-63) that extends the Medicare Intravenous Immune Globulin (IVIG) Demonstration through December 31, 2020. The law also extends through the first quarter of FY2018 (1) the Teaching Health Center Graduate Medical Education Program, and (2) the Special Diabetes Program for Indians.

The President also

House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following:

  • A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay,” the first of three planned hearings on prescription drug costs.
  •  A House Ways and Means Committee hearing on Medicare Advantage and coordinated care models such as the Program for All-Inclusive Care.
  • Senate Finance Committee and House Ways and Means Committee hearings examining the Trump Administration’s proposed FY 2018 HHS budget request.
  • House Energy and Commerce Committee hearings on the HHS response to cybersecurity vulnerabilities and the U.S. public health response to the Zika Virus. A planned June 14 hearing on extension of safety net health programs (the Children’s Health Insurance Program, Federally Qualified Health Centers, and the Community Health Center Fund) has been postponed.

Continue Reading Congressional Hearings, Markups Focus on Chronic Care, Drug Pricing, HHS Budget, Other Health Programs

On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September. 

On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. The legislation also includes various policy changes, including provisions intended to improve the medical device inspection process and modify the regulation of hearing aids, among other things.  The bill now moves to the full Senate.  Previously, the HELP Committee approved:  S 652, to reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children; S 849, to support programs for mosquito-borne and other vector-borne disease surveillance and control; S 916, to amend the Controlled Substances Act with regard to the provision of emergency medical services; and S 920, to establish a National Clinical Care Commission.

The House Energy and Commerce Committee also held a hearing regarding improving the regulation of medical technologies. The hearing focused on the following bipartisan bills:  HR 1652, the Over-the-Counter Hearing Aid Act of 2017; HR 2009, the Fostering Innovation in Medical Imaging Act; HR 2118, the Medical Device Servicing and Accountability Act, and HR 1736, to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device.  The panel held a separate hearing on “Combating Waste Fraud and Abuse in Medicaid Personal Care Services Program.”

In addition, the following hearings and markups are scheduled next week:
Continue Reading Congressional Panels Tackle FDA Reauthorization Act and Other Health Policy Issues

A number of Congressional committees have recently held hearings on health policy issues, including the following:

  • House Energy and Commerce Committee hearings on “Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships” and Food and Drug Administration (FDA) medical device user fees.
  • A House Oversight and Government Reform Committee hearing on “Federally Funded Cancer Research:

The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget blueprint,” dubbed “America First: A Budget Blueprint to Make America Great Again.”  The blueprint

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

The Centers for Disease Control and Prevention (CDC) has issued a final rule to strengthen the federal government’s ability to prevent the introduction, transmission, and spread of communicable diseases into the United States and interstate. The regulation is intended to both aid public health responses to outbreaks of new or re-emerging communicable diseases and provide 

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:

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

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, the “CO-OP Consumer Protection Act of 2016,” which would provide an exemption from the requirement to maintain minimum essential coverage if an individual’s Consumer Operated and Oriented Plan (CO-OP) coverage is terminated.
  • The Ways and Means Health Subcommittee held a hearing on “the Evolution of Quality in Medicare Part A.”
  • The House Budget Committee examined the CMS Center for Medicare & Medicaid Innovation: Scoring Assumptions, and Real World Implications.
  • The House Energy and Commerce Health Subcommittee held a legislative hearing on bipartisan bills intended to improve public health, including: H.R. 1192, the National Diabetes Clinical Care Commission Act; H.R. 1807, the Sickle Cell Disease Research Surveillance, Prevention and Treatment Act; H.R. 3119, the Palliative Care and Hospice Education and Training Act; and H.R. 3952, the Congenital Heart Futures Reauthorization Act.

Continue Reading Congressional Health Policy Hearings, Markups Resume After Summer Break

A number of Congressional committees have recently considered legislation and/or held hearings on various health policy proposals.

  •  The Ways and Means Committee approved seven bills related to health care coverage and tax policy, including various bills to: expand access to health reimbursement arrangements and health savings accounts; ease employer insurance coverage mandates for students and certain tribally-owned businesses; and modify an Affordable Care Act provision related to deduction of medical expenses. The Committee also held a hearing on various legislative proposals “to improve and sustain the Medicare program.”
  • The Energy & Commerce Health Subcommittee approved H.R. 921, the Sports Medicine Licensure Clarity Act of 2015, to clarify medical liability rules for athletic trainers and medical professionals. The panel also approved H.R. 3299, the Strengthening Public Health Emergency Response Act of 2015, to incentivize the development of medical countermeasures for public health emergencies and biochemical attacks. Furthermore, the Committee held hearings focusing on legislation to modernize the health insurance market and the public health responses to antibiotic resistance.

Continue Reading Recent Congressional Health Policy Hearings and Markups

On May 18, 2016, the House of Representatives approved H.R. 5243, the Zika Response Appropriations Act, by a vote of 241-184.  The bill would provide $622.1 million to the federal agencies to fight the Zika virus, offset by rescissions of existing funds (including unobligated resources left over from the 2014 Ebola outbreak).  According to the