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

Illinois Appellate Court Opens Door to Expanding List of Accepted Diseases in Medical Marijuana Program

by Wilson Elser on

On May 22, 2017, the Illinois First District Appellate Court upheld reversal of the Illinois Department of Public Health’s (IDPH’s) refusal to add chronic postoperative pain (CPOP) to the list of accepted diseases in the...more

Health Update - May 2017

Mapping the Healthcare M&A Landscape Under the New Administration - Editor’s Note: The healthcare M&A market continues to be among the most active sectors. In a recent webinar, Manatt examined how the policies and goals of...more

Manatt on Health Reform: Weekly Highlights - May 2017 #4

The President's budget proposes over $600 billion in Medicaid cuts on top of major reductions anticipated in repeal and replace legislation; the Trump Administration asks the Court for more time to decide on cost-sharing...more

Union Adherent’s Antics Not Protected By Act, NLRB Rules

The NLRB recently issued a rare decision completely dismissing all allegations against an employer; rarer still because it was unanimous. In Brooke Glen Behavioral Hospital, 365 NLRB No. 79 (May 15, 2017) the NLRB was...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

How Will the Appointment of a Special Counsel Affect the Administration's Regulatory Agenda?

by Mark Mansour on

The news of the the appointment of Robert Mueller as special counsel to be investigate the Russia-Trump connection rocked Washington. The immediate concern was how the White House would surmount the distraction and where all...more

Manatt on Health Reform: Weekly Highlights - May 2017 #3

Governors pen bipartisan letter to Congress urging five-year extension of funding for the Children's Health Insurance Program (CHIP); new analyses find Medicaid funding cuts under the AHCA would disproportionately affect...more

China FDA Calls for Comments on Key Policy Proposals

by Ropes & Gray LLP on

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the...more

Senate Confirms New FDA Commissioner

by Snell & Wilmer on

Dr. Scott Gottlieb was confirmed today as the new FDA Commissioner. Dr. Gottlieb has promised to put public health first and not do anything “that shakes the public’s confidence in the agency.” He is a former hospitalist who...more

NIST Releases Draft Guidance On Securing Wireless Infusion Pumps In The Healthcare Industry

by Dentons on

On May 8, 2017, the National Institute of Standards and Technology (NIST), through its National Cybersecurity Center of Excellence (NCCoE), released a new draft NIST Cybersecurity Practice Guide (SP 1800-8) entitled “Securing...more

House Approves the American Health Care Act to Repeal and Replace the Affordable Care Act

by King & Spalding on

Yesterday, by a vote of 217 to 213, the U.S. House of Representatives approved H.R. 1628, the American Health Care Act (AHCA), to repeal and replace the Patient Protection and Affordable Care Act (ACA). The House action...more

How Washington Can Help Biotechs

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

Third Circuit Weighs in on Materiality for First Time Since Escobar

by Pepper Hamilton LLP on

A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

The Trump Administration's First 100 Days

by Littler on

On April 29, 2017, the first 100 days of the Trump administration came to an end. A government shutdown was averted after the White House and Congress reached a spending deal, and the U.S. Supreme Court seat left vacant by...more

2017-2018 Legislative Session: Employer Updates

As the 2017-2018 legislative session continues to unfold on Beacon Hill, Massachusetts lawmakers are considering several policy proposals that have significant implications for employers across the Commonwealth. The FY2018...more

FY2018 Massachusetts Budget Update: House Ways and Means Budget

On Monday, April 10th, the House Ways and Means Committee proposed a $40.3 billion budget for FY2018 that calls for increasing spending by 3.8 percent, or about $1.47 billion, above FY2017 levels. The spending increase is...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Updates to Pennsylvania’s Medical Marijuana Program

by Tucker Arensberg, P.C. on

On April 26, Pennsylvania’s Secretary of Health Dr. Karen Murphy provided an update on the application review process for contending grower/processors and dispensaries. The Department of Health (DOH) has received over 500...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

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

Pennsylvania Releases Temporary Regulations for Physicians

by Tucker Arensberg, P.C. on

On April 11, the Pennsylvania Department of Health (DOH) released Practitioner Temporary Regulations for physicians and practitioners (those physicians, pharmacists, physician assistants and certified registered nurse...more

FDA authorizes first direct-to-consumer genetic test panel for predisposition to Alzheimer's disease and other serious disorders

by DLA Piper on

The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company's direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk ("GHR") tests. The GHR test panel currently...more

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