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Health Updates

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

Second CAR-T Cell Therapy Approved by FDA

by Holland & Knight LLP on

Less than two months after approving the first gene therapy for use in the U.S., that of Novartis's Kymriah for treatment of pediatric patients with acute lymphoblastic leukemia (ALL), the FDA has approved a second...more

The Citation of Immediate Jeopardy Deficiencies Against Nursing Facilities: Unforeseen Consequences

by Poyner Spruill LLP on

There are no words more feared by a skilled nursing facility Administrator during an annual recertification survey or complaint survey than these from a surveyor—“we’re citing you for an Immediate Jeopardy.” Those words set...more

Staying The Course In A Mississippi Drug Case

by Reed Smith on

Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense...more

Shame and blame in a lame nomination for drug policy chief

Some powerful political players deserve a big dose of public condemnation for bungling and stalling the nation’s desperately needed war on the epidemic abuse of opioid drugs....more

CFDA Issues New Classification Catalogue for Medical Devices In China

by Morgan Lewis on

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more

To Disclose or Not to Disclose, That is the Question

by Poyner Spruill LLP on

The use of criminal background checks is becoming more prevalent as a form of credentialing for both individual and institutional health care providers seeking licensure, certification or the benefits of other government...more

Washington Paid Sick Leave Update: Top 10 Things Every Washington Employer Needs to Know Now

by Lane Powell PC on

The Washington State Department of Labor and Industries has now published final regulations implementing Initiative 1433 — the new statewide paid sick leave law passed by the voters in November 2016. These regulations have...more

The intersection of Federal Civil Enforcement: claims and health care restructurings

by DLA Piper on

It is well known that the healthcare industry as a whole has undergone significant changes, challenges and uncertainties in recent years. Many hospitals, senior living facilities, pharmaceutical companies, laboratories and...more

Kickback Arrangements – Cause for Alarm Beyond Federal Healthcare Programs

by Farrell Fritz, P.C. on

Few, if any, in the medical industry are unfamiliar with the federal Anti-Kickback Statute (“AKS”). Under AKS, those giving or receiving compensation for referrals for items or services reimbursed by the federal healthcare...more

Healthcare Cyber: House Inquiry Targets Medical Software

In its latest inquiry into cybersecurity risks in the healthcare sector, the House Energy and Commerce Committee last week requested a “formal briefing” from medical transcription vendor Nuance Communications, Inc. concerning...more

President Trump Signs New Executive Order To Loosen Insurance Regulations

by King & Spalding on

Following multiple failed attempts by the Republican-led Congress to repeal the Affordable Care Act (ACA), on October 12, 2017, President Trump took unilateral action signing an executive order aimed at expanding choices and...more

The UK Care Sector | Problem or Opportunity for Investors?

by McDermott Will & Emery on

For investors considering the UK care sector, the Care Quality Commission (CQC) State of Care report released 10 October 2017 again raises alarm bells. Beds in nursing homes declined meaningfully, and funding pressures are...more

CMS Clarifies Streamlined Submission to Self-Referral Disclosure Protocol for Physician Organizations

by Baker Ober Health Law on

In an apparent effort to reduce redundancy, CMS issued an FAQ clarifying a simplified process for submissions to the CMS Voluntary Self-Referral Disclosure Protocol (SRDP) involving financial relationships with physicians who...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

CMS Advisory Opinion 2017-01 Approves Pop-up Alerts to Physicians Through Online Laboratory Portal

by Baker Ober Health Law on

A clinical laboratory has received a green light from CMS to offer pop-up notifications alerting physicians of various potential issues (Laboratory Alerts) through its web-based portal for ordering and reporting results of...more

CMS Requests Industry Feedback on "New Direction" for the Innovation Center

by Baker Ober Health Law on

CMS is seeking comments through a Request for Information (RFI) on a "new direction" for the CMS Innovation Center. The RFI includes focus areas identified by CMS, but the RFI welcomes all stakeholder input on "additional...more

Children's Products and the "Internet of Things": Data Privacy Beyond COPPA

by Stinson Leonard Street on

In this internet age, "smart" children’s products—those that collect, transmit or store electronic data—are on the rise. By some estimates, the smart toy market will reach $11.3 billion in sales by 2020. Manufacturers of...more

Alexander, Murray Announce Bipartisan Proposal on Market Stabilization

by Baker Donelson on

On October 17, the Senate Health, Education, Labor and Pensions Committee Chair Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) announced they had agreed on a proposal for a narrow, short-term individual market...more

Window On Washington - This Week in the Nation's Capital - Vol. 1, Issue 31

by Clark Hill PLC on

Senate Adopts Budget Resolution Making Way for Tax Reform: The Senate on a party-line vote of 51-49 adopted its FY18 budget resolution that includes $5.1 trillion in spending reductions and instruction for reconciliation for...more

Yes, Virginia, There Is a Reverse False Claim

by Faegre Baker Daniels on

The False Claims Act has a scienter requirement: it makes it illegal to knowingly present a false claim to the government. So if a company innocently presents a false claim, it can’t be guilty of violating the Act, right?...more

Health Alert (Australia) 16 October 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales (NSW) 6 October 2017 - City of Ryde Council v Principal Healthcare Finance Pty Ltd (No 2) [2017] NSWLEC 134 -...more

Recent Merger Reflects Enhanced Need for Revenue Cycle Management Platforms

Two of the nation’s most noteworthy companies in the Revenue Cycle Management (“RCM”) technology space, Navicure Inc., and ZirMed Inc., announced a merger on September 14, 2017....more

Emergency Regulation Confirming the 13-Hour Payment Rule for Live-In Home Care Aides Working 24-Hour Shifts to be Followed by...

by Bond Schoeneck & King PLLC on

On Friday, October 6, 2017 the New York State Department of Labor (NYDOL) used its “emergency” regulatory power to amend its Minimum Wage Order for Miscellaneous Industries and Occupations, relating to home care workers...more

Repayment Delay Fuels Whistleblower Settlement

On October 13, 2017, the United States Department of Justice (DOJ) revealed that First Coast Cardiovascular Institute, P.A. (FCCI) entered into a Settlement Agreement with the federal government and the State of Florida...more

News from Second & State

Weekly Wrap - Beyond the budget, there was some significant legislative activity. First, on Monday the House Education Committee reported out two noteworthy bills; H.B. 1386 (Hill, R-York), which would update teacher...more

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