Archives: Legislative Developments

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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

President Signs “Expanding Capacity for Health Outcomes Act” into Law

President Obama has signed into law S. 2873, the Expanding Capacity for Health Outcomes Act (ECHO Act), which is intended to use “distance health education” to improve health care, particularly in medically-underserved areas.  Specifically, this program will test “technology-enabled collaborative learning and capacity building models” – or the use of simultaneous interactive videoconferencing to connect … 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

Public Health Bills Advance

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: HR 954, the “CO-OP Consumer … 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

House of Representatives Approves Bill to Delay LTCH 25% Rule Implementation, Make Other LTCH Reforms, and Tighten Medicare Enrollment Moratorium Authority

On September 21, 2016, the House Ways and Means Committee approved H.R. 5713, the “Sustaining Healthcare Integrity and Fair Treatment Act of 2016” or “SHIFT Act.”  The primary focus of the SHIFT Act is to provide an additional delay in full implementation of the “25 Percent Rule” for long-term acute care hospitals (LTCHs).  The legislation … Continue Reading

House Approves Medicare ESRD Coverage, Rural Hospital Supervision Bills

On September 21, 2016, the House of Representatives approved HR 5659, the Expanding Seniors Receiving Dialysis Choice Act of 2016, which would allow Medicare beneficiaries with end stage renal disease (ESRD) to enroll in Medicare Advantage plans beginning in 2020. The House also approved HR 5613, to prevent CMS from enforcing a Medicare requirement for … Continue Reading

Energy and Commerce Committee Clears Public Health Bills

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 … Continue Reading

Congressional Hearings Focus on Health Policy Issues

A number of recent Congressional hearings have focused on health policy issues, including:  Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and the safety of cosmetics. A House Judiciary Committee hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.” … Continue Reading

Congressional Health Policy Hearings, Markups Resume After Summer Break

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, … Continue Reading

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number … Continue Reading

House of Representatives Approves Mental Health System Reform Bill

The House of Representative has overwhelmingly approved a bipartisan bill (H.R. 2646, the Helping Families in Mental Health Crisis Act) to reform the nation’s mental health care system. Key provisions of the legislation would: provide grants to increase access to treatment for children with mental disorders and individuals with serious mental illness and fund various … Continue Reading

Committees Approve Rural Hospital Relief, ESRD Benefits, Medical Countermeasures Bills

On July 13, 2016, the Ways and Means Committee approved HR 5659, which would enable Medicare beneficiaries with end stage renal disease (ESRD) to enroll in Medicare Advantage plans. Earlier this month, the Committee approved HR 5613, to prevent CMS from enforcing a Medicare requirement for direct physician supervision of certain outpatient therapeutic services furnished … Continue Reading

Ways and Means Approves Bill to Delay LTCH 25% Rule Implementation, Make Other LTCH Reforms

On July 13, 2016, the House Ways and Means Committee approved an amended version of H.R. 5713, the “Sustaining Healthcare Integrity and Fair Treatment Act of 2016” or “SHIFT Act.” The primary focus of the SHIFT Act is to delay further the full implementation of the “25 Percent Rule” for long-term acute care hospitals (“LTCHs”). … Continue Reading

Senate Passes Legislation to Delay Pending Medicare DMEPOS Fee Schedule Cuts Based on Competitive Bidding Prices

As previously reported, the Affordable Care Act mandates that CMS use pricing information from the durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program (CBP) to adjust Medicare fee schedule amounts for items furnished in areas where the CBP is not implemented.  CMS is phasing in these adjustments.  Specifically, effective January 1, … Continue Reading

Energy & Commerce Committee Approves Mental Health System Reform Bill

The House Energy & Commerce Committee has unanimously approved an amended version of H.R. 2646, the Helping Families in Mental Health Crisis Act, which is intended to reform the nation’s mental health care system. Among other things, the bill would: provide grants to increase access to treatment for children with mental disorders and individuals with … Continue Reading

Recent Congressional Health Policy Hearings and Markups

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 … Continue Reading

House Approves “Helping Hospitals Improve Patient Care Act of 2016”

The House of Representatives has approved H.R. 5273, the “Helping Hospitals Improve Patient Care Act of 2016,” as amended by the Ways and Means Committee in May. As previously reported, while the bill focuses on Medicare payment policies pertaining to hospitals (including long term care hospitals and hospital outpatient departments), it also addresses Medicare Advantage … Continue Reading

Ways and Means Committee Approves Bill to Make Reforms to Medicare Hospital and Other Payment Policies

The House Ways and Means Committee has approved an amended version of H.R. 5273, the “Helping Hospitals Improve Patient Care Act of 2016.”  While most of the provisions address Medicare payment policies pertaining to hospitals (including long term care hospitals (LTCHs) and hospital outpatient departments), certain other reimbursement policies, including Medicare Advantage and physician payment … Continue Reading

Recent Congressional Health Policy Hearings

Recent Congressional hearings focusing on health policy topics include the following: House Energy and Commerce Committee hearings on HHS cybersecurity responsibilities, Medicare and Medicaid program integrity, the Administration’s proposed Medicare Part B drug payment model, and patient-focused health insurance reforms. House Ways and Means Committee hearings on implementation of the Medicare Access & CHIP Reauthorization … Continue Reading
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