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Health Updates

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

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

by Hogan Lovells on

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more

FDA Seeks Comments On Potential Marijuana Reclassification Under International Drug Control Treaty

by Jackson Lewis P.C. on

The Food and Drug Administration requested comments in a notice published in the Federal Register on April 9, 2018 concerning the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling...more

CMS Announces New Initiatives For Innovating Patient Care

by Fox Rothschild LLP on

Last month, CMS Administrator Seema Verma announced several initiatives to innovate the delivery of patient care at the ground level. In collaboration with the Trump Administration and other federal agencies, CMS is taking...more

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

by Arnall Golden Gregory LLP on

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

by Reed Smith on

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also...more

Filing Review is About More Than Checking the Boxes; or Is It?

by Arnall Golden Gregory LLP on

Things sometimes change fast. Our original article described one company’s recent announcement that the Food and Drug Administration refused to file its new drug application as a reminder that the agency’s filing review may...more

FDA Announces “Unique” Restriction on Approved Medical Device

by Arnall Golden Gregory LLP on

On April 9, 2018, the Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and...more

The Shifting Landscape of Organ Allocation for Transplantation

by Jones Day on

Recent policy changes and the prospect of new organ sources have markedly altered the landscape for organ transplantation. In particular, new allocation policies for lung and liver transplants, and advances in gene-editing...more

Mylan Partners with Fujifilm Kyowa Kirin Biologics

by Goodwin on

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the...more

Scrutiny Increases on Healthcare Providers in Central Florida

In the past month, the U.S. Attorney's Office for the Middle District of Florida--the primary federal law enforcement authority in Central Florida--has announced a series of healthcare-fraud related developments. These...more

Blue Cross to Face Per Se Review in Multidistrict Antitrust Litigation

by King & Spalding on

On April 5, 2018, a Federal court held that Blue Cross health insurance plans’ “aggregation of a market allocation scheme” will be analyzed under the per se standard of antitrust review, which treats categories of restraints...more

We, the Jury

by Reed Smith on

Last week we served on a jury in a medical malpractice verdict. To put it mildly, we were surprised that we made it through the peremptory gauntlet. The verdict? It was an enlightening and edifying experience....more

Pennsylvania case reminds Ohio hospitals of the importance of adhering to provisions of peer review statute

by Bricker & Eckler LLP on

A recent Pennsylvania Supreme Court decision, Reginelli v. Boggs, 0 WAP 2016, 21 WAP 2016, 23 WAP 2016 (Pa. Mar. 27, 2018), has been raising a number of questions regarding the strength of a state peer review privilege based...more

K&L Gates Triage: Ride Sharing and Health Care Regulatory Considerations

by K&L Gates LLP on

Transportation is often cited as one of the top barriers to health care for individuals in the United States. To reduce this burden and increase access to care, many health care providers are now partnering with ride-sharing...more

Two Recent FCA Cases Reflect Courts’ Continued Skepticism of Statistical Sampling To Prove FCA Liability

by King & Spalding on

Courts are continuing to grapple with whether relators can use statistical sampling to prove liability in False Claims Act (FCA) cases. As demonstrated by two recent cases, courts remain skeptical that relators can meet...more

CMS to Use Enforcement Discretion to Help States Comply with the Medicaid Home Health Final Rule

by Arnall Golden Gregory LLP on

On April 5, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Informational Bulletin regarding compliance with the Medicaid Home Health Final Rule (the “Medicaid HH Final Rule”). The Medicaid HH Final Rule...more

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors

by Arnall Golden Gregory LLP on

In recent years, the Federal Trade Commission (FTC) has brought a series of cases involving drug manufacturers allegedly seeking to delay competition from generic drug companies. See, e.g., F.T.C. v. Actavis, Inc., 570 U.S....more

FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule

by Arnall Golden Gregory LLP on

The Food and Drug Administration issued a final rule setting forth postmarketing safety reporting (PMSR) requirements for combination products subject to premarket review by FDA on December 20, 2016. For some of these...more

Federal Telehealth Policies Summary

by Holland & Knight LLP on

On Feb. 9, 2018, Congress passed and President Donald Trump signed into law the Bipartisan Budget Act of 2018 (BBA). This wide-reaching legislation enacts major changes for telehealth policy in Medicare by incorporating...more

China Announces New Initiatives to Level the Playing Field for Innovative and Generic Drugs

by Ropes & Gray LLP on

China’s Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs. The State Council, China’s cabinet, has decided not to apply any tariff on imported drugs,...more

Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative...

The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending –...more

Employment Performance Review Excluded from Peer Review Confidentiality

by Tucker Arensberg, P.C. on

The Pennsylvania Supreme Court ruled, on March 27, 2018, in Regenelli v. Boggs, Monogahela Valley Hospital and UPMC/ERMI that physician performance reviews of an ER physician, who was provided by ERMI to Mon Valley Hospital,...more

Emerging Benefit Risks

by Winstead PC on

Watch All of the Company’s Mailboxes for a New Round of Tax Assessments - Another wave of Internal Revenue Service (“Service”) assessments of the employer shared responsibility tax (a/k/a pay or play) were recently released....more

CMS releases annual health insurance exchanges final rule

by Hogan Lovells on

On April 9, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Benefit and Payment Parameters final rule for 2019 (2019 Payment Notice) applicable to qualified health plans (QHPs) offered on health...more

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