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Health Updates

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

Spring Cleaning Comes Early: The Affordable Care Act and the Importance of Updating ERISA Plan Documents

The year 1974 was a watershed for employee benefits. For the first time, the federal government undertook the complicated task of providing a statutory and regulatory framework for employee benefit plans and employee pension...more

Responding To Mental Health Parity Model Disclosure Request Form

by Fox Rothschild LLP on

In June 2017, the Departments of Labor, Health and Human Services and Treasury released a draft model form that participants may use to request mental health/substance use disorder (MH/SUD) limitation information from their...more

AGG Food and Drug Newsletter - September 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

CMS Provides Waivers in States Affected by Hurricanes Harvey and Irma

by McGuireWoods LLP on

September 20, 2017 The Centers for Medicare & Medicaid Services (CMS) recently modified and waived certain Medicare enrollment and billing requirements to ensure the availability of adequate medical care for Medicare...more

Referral Sources Can Be A Protectable Interest Under Florida Law

by Jackson Lewis P.C. on

In Florida, non-competition and other restrictive covenant agreements are enforceable to the extent they are tailored to protect a legitimate business interest. On September 14, 2017, the Florida Supreme Court held that a...more

Healthcare & Life Sciences Private Equity Deal Tracker: Bain Capital-Backed Navicure Merges With ZirMed

by McGuireWoods LLP on

Navicure and ZirMed have announced the two companies are merging. Navicure, based Duluth, Ga., is a provider of cloud-based medical claims management and patient payment solutions. Bain Capital Private Equity acquired a...more

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are...

by Arnall Golden Gregory LLP on

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more

United States ex rel Campie v. Gilead Sciences: Ninth Circuit Revives FCA Suit Despite Escobar’s “Demanding and Rigorous”...

The United States Court of Appeals for the Ninth Circuit unanimously reversed dismissal of a False Claims Act Complaint in United States ex rel. Campie v. Gilead Sciences. The most notable aspect of the case is that the panel...more

Health Care Weekly Preview from ML Strategies – September 2017 #2

Welcome back everybody. The House is out this week and the Senate is out Thursday and Friday with a lot to sort out before they skip town. Graham-Cassidy has people on edge because, if nothing else, it is still alive. The...more

A Category 5 Compliance Problem: Hurricane Irma Gives Providers a Stark Reminder of Emergency Preparedness Realities

by Carlton Fields on

The havoc that Hurricane Irma caused in the Caribbean and most of Florida reminds us of the Centers for Medicare and Medicaid Services (CMS) requirements for emergency preparedness, which take effect November 15....more

Emergency Rules Requiring Generators in Florida ALFs and Nursing Homes

by Holland & Knight LLP on

As a result of Hurricane Irma, eight nursing home residents died after a power failure in a Hollywood, Florida nursing home. In the wake of that tragedy, on Sept. 18, 2017, Florida regulators published emergency rules...more

FL Medical Marijuana Treatment Center License Application Released

The Department of Health has finally released the new Medical Marijuana Treatment Center (“MMTC”) license application and proposed rules, all of which can be found at...more

FDA Approves First-Ever Mobile App for Addiction Treatment

by Knobbe Martens on

The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD)....more

Court Cases Challenge English-Only COBRA Election Procedures

by McDermott Will & Emery on

Two pending federal cases could reveal situations in which employers with a significant multi-lingual workforce should provide translated versions of their COBRA election materials....more

OIG Study Finds States Are Not Using Medicaid Payment Suspensions

by King & Spalding on

A recent HHS OIG review of 2014 data on fraud allegations found that significant challenges were limiting the States’ use of payment suspensions, even in the face of what CMS determined were credible allegations of provider...more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

Maybe the Yacht Was the Tip-Off

by Faegre Baker Daniels on

If you’re a surgical device distributor and you want to reward a surgeon for using your products on Medicare and Medicaid patients, you may want to choose a reward that’s less conspicuous than a yacht. That’s one lesson in...more

As Medical Food Industry Grows, So May FDA Scrutiny

by Baker Donelson on

On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The...more

False Claims Act Relators Be Warned: Rule 54’s Taxable Costs Award Lies Ahead for the Overeager Relator

by Liskow & Lewis on

In a published opinion last week, the Fifth Circuit sent a reminder to would-be False Claims Act (“FCA”) relators that they better think carefully before filing suit because while they may be seeking treble damages, they may...more

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

by Arnall Golden Gregory LLP on

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and...more

Does the NAD’s Capillus Decision Baldly Contradict the FDA?

by Kelley Drye & Warren LLP on

On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case #6107). This case is unusual in that it addressed a challenge to a prescription-only medical device, and related closely...more

The Rise of Managed Care Audits and Reimbursement Demands in the Wake of the ACA

If the summer of 2017 demonstrated anything, it is that health care remains a complex and contentious industry. One of its many complications stems from the natural tension between health care providers and health care...more

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

by Arnall Golden Gregory LLP on

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

The Graham-Cassidy Bill: Evaluating the Latest ACA Repeal Measure

by Faegre Baker Daniels on

Last week, the Senate unveiled the Graham-Cassidy Bill, Republican legislators’ latest attempt to repeal the Affordable Care Act (ACA). Crafted by Sens. Bill Cassidy, R-LA, Lindsey Graham, R-SC, Dean Heller, R-NV, and Ron...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

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