Elections & Politics Health

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Bipartisan Budget Act of 2015 Repeals ACA Automatic Enrollment Provision

Despite a marked lack of success for efforts in Congress and through the courts to repeal the Patient Protection and Affordable Care Act of 2010 (ACA) completely, or substantially interrupt its implementation, the Bipartisan...more

Health Care Update - November 2015 #3

Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

The Impact of the Bipartisan Budget Act of 2015 on Off-Campus Hospital Outpatient Departments

On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 (“Act”) into law significantly impacting how Medicare pays certain off-campus hospital departments. Specifically, Section 603 of the Act provides...more

Congress Clears Controlled Substances Act Scheduling Legislation

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances...more

OMB Releases Fall 2015 Regulatory Agenda

Earlier today, the White House Office of Management and Budget released its semi-annual Unified Regulatory Agenda and Regulatory Plan for Fall 2015, covering 59 Federal departments, agencies, and commissions. Entries are...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

Single-Payer Health Care Plan Makes Ballot, Beer and Wine Initiatives Filed

On Nov. 9, 2015, the Colorado Secretary of State announced that the proponents of a ballot measure to create a single-payer state health care system had submitted a sufficient number of signatures for the measure to appear on...more

Manatt on Health Reform: Weekly Highlights - November 2015 #3

Kansas legislators supportive of Medicaid expansion are pulled from committee; Montana’s Medicaid expansion is off to a strong start; and New Mexico sees declines in uncompensated care since ACA implementation....more

Health Care Update - November 2015 #2

FDA Hosts Genome Scientists For Next-Generation Sequencing Conference - Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public...more

Energy and Commerce Health Subcommittee Advances Mental Health, Medicaid, Synthetic Drug Legislation

On November 4, 2015, the House Energy and Commerce Health Subcommittee approved the following health policy bills: ..HR 2646, the Helping Families in Mental Health Crisis Act – includes a series of reforms intended to...more

Washington Healthcare Update

This Week: Repealing Obamacare becomes problematic in the Senate... More focus on drug prices and reimbursement... FDA asks, should we regulate “natural” and if so, how? ...more

NC Legislative Update: 2015 Session in Review

2015 Session in Review - The North Carolina General Assembly adjourned just after 4:00 in the morning on Wednesday September 30th, 2015. Barring the Governor calling legislators to return for a special session, the...more

Upcoming Health Policy Hearings - November 2015

Several Congressional hearings are scheduled next week and into December on health policy issues, including...more

Life Sciences Alert: House hearing on in vitro clinical tests will focus on proposed regulatory framework – key features

On November 17, 2015, the US House of Representatives Committee on Energy and Commerce, Subcommittee on Health will hold a hearing entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” The focus...more

Washington, D.C. Update – November 2015

In the final week of October, congressional leaders and the White House reached an agreement on a wide variety of measures to "clean the barn" for Speaker John Boehner's (R-OH) successor. The Bipartisan Budget Act of 2015...more

Africa Update - November 2015 #2

Leading the News: Egypt - On November 5th, U.S. President Barack Obama expressed his belief it was possible there was a bomb on board the Russian passenger jet that went down in Egypt’s Sinai Peninsula last week....more

President Obama Signs Bill to Encourage PACE Program Innovation

On November 5, 2015, President Obama signed into law S. 1362, the Program of All-Inclusive Care for the Elderly (PACE) Innovation Act. The PACE Innovation Act authorizes the Secretary of Health and Human Services (HHS) to...more

Bipartisan Budget Law Extends Medicare Sequestration, Includes Medicaid Drug Rebate, Off-Campus Hospital Outpatient Department,...

On November 2, 2015, President Obama signed into law H.R. 1314, the “Bipartisan Budget Act of 2015” (BBA). The two-year, $80 billion budget/debt-ceiling deal is funded in part by several significant Medicare and Medicaid...more

Bipartisan Budget Act Jacks Up Civil Monetary Penalties Under the Social Security Act and False Claims Act Penalties

The Bipartisan Budget Act of 2015 (H.R. 1314), signed into law by President Obama November 2, 2015, will increase the civil monetary penalties (CMPs) imposed under the Social Security Act (SSA) in addition to False Claims Act...more

California Medical Marijuana Regulation and Safety Act: What you need to know

After being the first state to legalize medical marijuana almost 20 years ago, California is implementing regulations across the industry. Commentators have focused on the effective and efficient processes called for in the...more

Budget Law Moves Towards Site-Neutral Medicare Payments; Join Foley for a Discussion on November 13

The recently enacted Bipartisan Budget Act (P. L. 114-74) included a provision that will significantly alter the future of hospital-based outpatient care. The provision, Section 603, will exclude from Medicare’s...more

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