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Read need-to-know updates, commentary, and analysis on Elections & Politics issues written by leading professionals.

GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies....more

Medical Device Excise Tax Remains in Limbo

President Trump and Paul Ryan (R-Wis) have not yet successfully replaced the Affordable Care Act with the American Health Care Act (“AHCA”). The medical device industry had been paying particular attention to the proposed...more

Canada expands protection of individual rights with new legislation on genetic testing and privacy

by DLA Piper on

Significant legislative changes are on the horizon in the field of genetic testing with Parliament’s recent passage of Bill S-201: An Act to Prohibit and Prevent Genetic Discrimination (“Act”). The Act will implement broad...more

California Advances PBM Licensing and “Transparency” Law

Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more

Health Care Weekly Preview from ML Strategies – April 2017

Welcome back everybody. While the momentum around an American Health Care Act (AHCA) comeback is unclear, there’s no discounting that efforts are ongoing to reach a consensus among House Republicans with significant pressure...more

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

How Will the Trump Administration Impact Healthcare Litigation?

Editor's Note: In a dramatic conclusion to the heated debate surrounding the American Health Care Act (AHCA), the bill was withdrawn after it became clear that House leadership did not have enough votes to pass it. There is...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 4

by Clark Hill PLC on

Budget Battles: Amid a recess, lawmakers will miss the April 15 target date for adopting a federal budget outline for the second year in a row. While there are no penalties for missing the April 15 date, a slow start for...more

President Trump Proposes Dr. Scott Gottlieb as FDA Commissioner

by Jones Day on

According to a White House statement, President Trump intends to nominate Scott Gottlieb, M.D., as FDA Commissioner. Dr. Gottlieb has previously served in government in various capacities, including as deputy commissioner for...more

Trump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know

by Epstein Becker & Green on

The 21st Century Cures Act (“Cures Act”), signed into law by former President Obama on December 13, 2016, sets out a bold agenda for the Food and Drug Administration (“FDA”). Among other things, the Cures Act strives to...more

New Jersey Telemedicine Law Update

The majority of states have already enacted legislation governing telemedicine. New Jersey lawmakers are considering a bipartisan Bill (S291) which would address the growth of telemedicine in New Jersey. On November 3, 2016,...more

Legislation Tracker: Improving Access to Affordable Prescription Drugs Act

by Goodwin on

On March 29, Senator Al Franken and fifteen co-sponsoring Senate Democrats introduced a bill called the “Improving Access to Affordable Prescription Drugs Act” (S. 771). A companion bill (H. 1776) with the same title was...more

Politics, Medicine and Progress

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

DEA awards Schedule II classification to synthetic THC drug

by Thompson Coburn LLP on

On March 23, 2017, the DEA announced it has scheduled the newly approved synthetic THC-containing drug, Syndros, as a Class II substance. This announcement comes as a surprise to some for a number of reasons, including that...more

States Continue Trend to Reduce Telemedicine Barriers

In 2016 and now in early 2017, state legislatures and regulatory boards continue to enact laws and rules setting telemedicine practice standards. Such standards generally include clarifying the definition of telemedicine as...more

C-THRU’s Proposed Changes to Negotiated Prices – A Demonstration of the Part D Program’s Complexities and Misunderstandings

As described in last week’s post, Senator Wyden has introduced the C-THRU Act that seeks to require public disclosure of PBM rebate amounts, establish a minimum rebate percentage that PBMs must pass on to Part D and Exchange...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Health-Related Programs Face Deep Cuts In President Trump’s “Budget Blueprint to Make America Great Again”

On March 16, 2017, President Trump Administration released his first budget outline for the 2018 fiscal year (FY 2018). In an effort to “shrink the role of government,” the $1.1 trillion budget proposal calls for a $54...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

FDA User Fee Hearings Picking Up Steam on Capitol Hill

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more

GAO, states jump into battles to rein in Big Pharma’s sky-high prices

Big Pharma’s skyrocketing prices are finally in for some real scrutiny by the U.S. Government Accountability Office (GAO), as well as new initiatives in the Maryland and New York statehouses....more

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