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Health Updates

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

Law Review Article on Off-label is On Target

by Reed Smith on

More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective...more

North Dakota Medicaid Recipients Data Found in Dumpster

The North Dakota Department of Human Services (NDDHS) is notifying 2,452 Medicaid recipients that their protected health information has been compromised when their records were discovered in a dumpster....more

Health Care E-Note - June 2017

by Burr & Forman on

When a physician leaves a medical practice, especially if the physician stays in the area to compete against his/her former employer, the situation can become stressful and acrimonious. Please see full E-Note below for...more

United States ex rel. Phalp

by Bass, Berry & Sims PLC on

A unanimous panel of the U.S. Court of Appeals for the Eleventh Circuit (Eleventh Circuit) recently affirmed two grants of summary judgment in favor of defendant Lincare, Inc. d/b/a Diabetic Experts of America (collectively,...more

Electronic Drug Product Listing Errors Can Result in FDA Warning Letter

by Morgan Lewis on

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements,...more

Cancer Moonshot: USPTO Extends Cancer Immunotherapy Pilot Program Initiative

by Morrison & Foerster LLP on

The United States Patent and Trademark Office (PTO) issued a Notice today extending the Cancer Immunotherapy Pilot Program (Pilot Program), also known as “Patents 4 Patients.” The Pilot Program, which accelerates the...more

Why do drug prices soar? Blame PBJs, PBMs, weak regulators, and CME

What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into...more

Numerous Provisions Affecting Employers in Senate's Draft Better Care Reconciliation Act of 2017

by Holland & Knight LLP on

U.S. Senate Republicans on June 22, 2017, released a discussion draft of the Better Care Reconciliation Act of 2017 (BCRA), its bill to repeal and replace the Affordable Care Act (ACA). The BCRA follows on the heels of the...more

Manatt on Medicaid: The Senate’s New Per Capita Cap Redistribution Policy

On June 22, Senate leadership released its proposed substitute for the House-passed American Health Care Act (AHCA), the Better Care Reconciliation Act of 2017 (BCRA), as a discussion draft. Like the House-passed AHCA, the...more

Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

by Smart & Biggar on

As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations...more

Senate Republicans Unveil ACA Repeal Bill

by McDermott Will & Emery on

On June 22, 2017, Senate Republicans unveiled draft legislation to move toward repealing portions of the Affordable Care Act (ACA). The draft health care bill, known as the Better Care Reconciliation Act, was hatched behind...more

USPTO Extends Cancer Immunotherapy Pilot Program

by Foley & Lardner LLP on

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO...more

"Locum Tenens" Physical Therapist – Does the Change Provide Sufficient Relief?

by Baker Ober Health Law on

CMS recently published guidance to implement Section 16006 of the 21st Century Cures Act, effective June 13, 2017, which allows physical therapists providing services to Medicare beneficiaries to utilize "locum tenens"...more

Senate Republican Health Care Working Group Releases Health Care Reform Bill Text

by Baker Donelson on

On June 22, Senate Republicans released a discussion draft of the Better Care Reconciliation Act (BCRA), their companion bill to the House-passed American Health Care Act (AHCA). The legislation, which reforms the Affordable...more

CoPilot Provider Support Services Settles with NYAG for $130,000 for Late Breach Notification

CoPilot Provider Support Services, Inc. (CoPilot), which provides health care companies with billing and insurance support services, has settled allegations by the New York Attorney General of failing to notify individuals of...more

Senate Finance Committee Advances Bipartisan CHRONIC Care Act

by Baker Donelson on

On May 18, the Senate Finance Committee unanimously approved the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S. 870). The bipartisan bill aims to modernize care...more

Here Comes the Rain: Employers Offering Mental Health Benefits Should Prepare for More Scrutiny

Employers can expect some challenging information requests about the mental health and substance abuse benefits offered to employees and their dependents through group health plans, if a draft form released by federal...more

After Escobar, Lower Courts Build On The “Materiality” Analysis for False Claims Act Lawsuits

by Saul Ewing LLP on

It’s been just over a year since the Supreme Court’s seminal False Claims Act (“FCA”) decision Universal Health Servs., Inc. v. United States ex rel. Escobar. In the wake of Escobar, the lower courts are confronted with...more

Highlights of Better Care Reconciliation Act

by Holland & Knight LLP on

U.S. Senate Republicans on June 22, 2017, unveiled a "discussion draft" of their healthcare plan, the Better Care Reconciliation Act. This memorandum provides highlights of key provisions. The Congressional Budget Office...more

Florida Governor Signs Medical Marijuana Law

by Jackson Lewis P.C. on

Last November, Florida voters overwhelmingly voted to amend the Florida Constitution to permit the use of medical marijuana. The constitutional amendment went into effect on January 3, 2017, and required regulations to be...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...more

The Better Care Reconciliation Act of 2017 vs. The American Health Care Act: Summary of Key Differences

On June 22, 2017, Senate Republicans released a discussion draft of their proposal to repeal and replace the Affordable Care Act (ACA), titled the “Better Care Reconciliation Act of 2017” (BCRA). Beyond the title change,...more

CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more

Slow but Steady: CMS Proposes to Simplify and Slow Down the Quality Payment Program Rollout

by Hogan Lovells on

On Tuesday, June 20, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to continue the rollout of the Quality Payment Program (QPP), an initiative to adjust Medicare payments to eligible clinicians...more

Supreme Court Says “No” to “Litigation Tourism”

There has been a lot said already about the effect on product liability (especially drug) cases and “mass actions” as a result of the United States Supreme Court’s June 17, 2017 decision in Bristol-Myers Squibb Co. v....more

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