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Health Updates

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

American Indian Law and Policy: 10 Things You Need to Know - December 2017

Congress returned from the Thanksgiving holiday with an intense workload that must be completed by the end of the year. Tax reform remains a focus, and the Republican-controlled Congress is still committed to getting a final...more

Through a Glass Darkly: The Latest Health Care Deals Signal a Further Shift in Control and the Locus of Care

by Epstein Becker & Green on

Two merger announcements this week—one concerning CVS’s intention to acquire Aetna and the other concerning United/Optum’s intention to acquire DaVita’s physician group—have health investors and strategists peering over the...more

IRS Updates Employer Shared Responsibility Payment Information

by Ropes & Gray LLP on

Last month, the IRS provided guidance regarding the procedures it will use to propose and assess employer shared responsibility payments under the Affordable Care Act (“ACA”). More recently, the IRS issued sample Forms 14764,...more

“Tap Here For A Doctor” – The Proliferation of Telemedicine In The Gig Economy

by Fisher Phillips on

Several years ago, many people were leery of the thought of ordering personal drivers through a mobile app and getting into a car of a complete stranger. However, over time, the idea of ride-sharing through Uber or Lyft has...more

The FCC to Propose Major Changes to Its Rural Health Care Funding Programs

The Federal Communications Commission (FCC) is launching a major revision to its Rural Health Care (“RHC”) subsidy programs. These revisions would address two main issues, the level of funding and ways to make the programs...more

Final Senate Tax Bill Targets Health Care, Hospitals

by King & Spalding on

In the early hours of Saturday, December 2, 2017, the Senate approved its version of tax reform legislation, S. 1, the Tax Cuts and Jobs Act, by a vote of 51-49. All Republican Senators except Senator Bob Corker (R-TN)...more

Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

by McDermott Will & Emery on

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to...more

Watch out for IRS letters: IRS Begins Enforcing Employer Mandate

by FordHarrison on

The IRS has recently begun enforcing the “employer shared responsibility” (ESR) provisions of the Affordable Care Act (the "Act"), which require employers having 50 or more full-time employees (or full-time equivalent...more

Americans For Medical Progress Premieres An Extraordinary Video That Describes The Incredible Need For And Contribution Of Animals...

by Fox Rothschild LLP on

Americans for Medical Progress (AMP) “supports research involving animals when it is necessary to advance our understanding of biological processes.” and provides tools for “public outreach that builds understanding and...more

‘Tis the Season for ACA Penalties

by Polsinelli on

After several years of uncertainty surrounding enforcement of the Patient Protection & Affordable Care Act of 2010’s so-called “employer mandate,” the Internal Revenue Service (IRS) has begun assessing penalty notices for the...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Chris Mattei Announces Campaign for Connecticut Attorney General- Democrat Chris Mattei announced his candidacy for Connecticut AG in 2018, switching statewide races and forgoing a previously...more

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

Telehealth Reaches Tipping Point – Now Included in OIG Audit Plan

by Tucker Arensberg, P.C. on

Telehealth has apparently reached the tipping point in its significance to the Medicare budget, because OIG has now announced that it will “review Medicare claims for telehealth services provided at distant sites that do not...more

Automated External Defibrillator Drones – Saving Lives One Flight at a Time

Drones have infiltrated almost all aspects of our lives. They have even infiltrated the medical world. One of the most useful ways drones have emerged in the medical world is as a vehicle for delivery of automated external...more

Self-Administered Versions of Orencia and Cimzia Were Included In Calculating Medicare Part B Payment Costs Which Significantly...

by King & Spalding on

A report issued by the OIG on November 21, 2017 found that inclusion of the more costly self-administered versions of Orencia and Cimzia when calculating Medicare Part B costs caused Medicare and its beneficiaries to pay an...more

Guest post – Observations on FDA 3D Printing Guidance

by Reed Smith on

A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was...more

A “House of Cards”: DOJ Drops Out of ManorCare FCA Case After Judge Excludes Expert Witness

by Arnall Golden Gregory LLP on

The Department of Justice (DOJ) filed a motion on November 17, 2017 to voluntarily dismiss its False Claims Act (FCA) case against HCR ManorCare, Inc. (ManorCare). Despite a years-long investigation, coupled with nearly three...more

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

by Reed Smith on

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration...more

Will DOJ Dismiss More Meritless Qui Tam Actions?

by Holland & Knight LLP on

Is the U.S. Department of Justice (DOJ) going to dismiss more meritless qui tam actions brought under the False Claims Act (FCA)? At a conference on Oct. 30, 2017, Michael Granston, the Director of DOJ's Civil Fraud Section,...more

Healthcare, Hospitals, and Immigration: The Need to Access the Global Medical Professional Workforce with Ease

Every healthcare organization has two essential requirements: (1) continuous access to qualified talent; and (2) continuous access to significant numbers of that talent. Hospitals clearly need a lot of employees. To meet...more

The Expanding False Claims Act Materiality Requirement

by Holland & Knight LLP on

There is a renewed focus on the government’s activities for purposes of the False Claims Act (FCA) materiality analysis and as demonstrated by a number of recently issued decisions, the roster of relevant government actors is...more

CVS Health to Acquire Aetna

On December 3, 2017, CVS Health, a giant in the retail pharmacy industry, announced plans to acquire Aetna. Aetna is one of the largest medical insurers in the nation, servicing approximately 46.7 million people. Under the...more

Lawsuit Seeks to Shut Down Pennsylvania’s Medical Marijuana Program Before It Even Sets Up Shop

by Cozen O'Connor on

A lawsuit accusing Pennsylvania’s fledgling medical marijuana program of running a faulty permitting process could stonewall patients looking for relief. Keystone ReLeaf (Keystone), a Bethlehem-based medical marijuana...more

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

by Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more

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