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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

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

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

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

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

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

MA Health Policy Updates – Moves to Strengthen HPC and Expand Telemedicine

In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission...more

Blog: Implications of the Cybersecurity Bill for the Health Care Industry

On Tuesday the Senate passed the Cybersecurity Information Sharing Act (CISA). The House had passed a similar bill, the Protecting Cyber Networks Act, in April of this year. The Act comes in the wake of many large scale data...more

Proposed Budget Deal Would Add Medicaid Inflation Rebates for Generic Drugs

As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes...more

House Energy & Commerce Panel Releases Draft Bill to Regulate Diagnostic Lab Tests, Schedules November 17 Hearing

The House Energy and Commerce Health Subcommittee has scheduled a November 17, 2015 hearing on the regulation of diagnostic tests and laboratory operations. The hearing will feature FDA and CMS officials who will testify on...more

Six Ways to Take Advantage of New Hampshire’s New Telemedicine Law

A physician in New Hampshire can now establish a valid doctor-patient relationship without needing a prior in-person exam. This is among several recent changes in New Hampshire’s telemedicine laws that offer new opportunities...more

Changes to New York Telehealth Coverage Coming Soon

After New York became the 22nd state to enact a telemedicine commercial coverage statute, Governor Andrew Cuomo signed an amendment changing the statute. The amendment makes sweeping changes to telehealth coverage under New...more

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

House Passes Bill to Help Prevent Prescription Drug Abuse

On September 8, 2015, the House of Representatives passed a bill intended to combat prescription drug abuse through the reauthorization of a program that provides federal grants to states for prescription drug monitoring...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

A&B Healthcare Week In Review, September 2015

On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

Blog: Joining the Debate, Hillary Clinton Releases Plan to Curb Drug Prices

In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs,...more

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

Washington Healthcare Update

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

Summer is (Almost) Over & Congress is Back!

While summer isn’t officially over until September 22, for most here in the nation’s capital the vacations are nearly completed and it is back to work as Congress returns from the long August recess and Labor Day...more

Update: The 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act, which modifies Food and Drug Administration (FDA) processes, provides funding for the FDA and the National Institutes of Health (NIH), includes...more

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

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