Healthcare

News & Analysis as of

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - On Monday, July 28, the House Committee on Energy and Commerce, Subcommittee on Health will hold a markup to consider two bills: H.R. ____, a bill to require the Secretary of Health and Human...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more

Draft Forms Released for the Affordable Care Act's Health Coverage Reporting Requirements

The Affordable Care Act (ACA) imposes new reporting requirements on employers and insurance companies offering health coverage. Last week, the IRS released drafts of the four forms that will be used by employers and insurers...more

Finally, Some Good News for Halifax–And All Other–Hospitals

It’s been a long time since Orlando’s Halifax Hospital got any good news from the federal court hearing the whistleblower case brought by employee Elin Baklid-Kunz. Earlier this year the hospital had to agree to an $85...more

USCIS Issues Policy Memorandum Regarding H-1B Petitions for Nursing Occupations

As a general matter, most registered nurse (RN) positions do not qualify as H-1B specialty occupation positions because they do not normally require a U.S. bachelor’s or higher degree in nursing or its equivalent as the...more

It’s No Surprise: Health Care Data Breaches Are on the Rise and So Is Government Enforcement

In This Issue: - The Take-Aways for Covered Entities and Business Associates - For More Information - Excerpt from The Take-Aways for Covered Entities and Business Associates: As a majority of the...more

Circuit Courts Split on ACA Subsidies

On July 22, 2014, United States Circuit Courts of Appeals from two different circuits issued opposing rulings on the legality of the Federal government providing subsidies to eligible buyers of health insurance products from...more

U.S. Department of Labor Issues Proposed Regulations and New Model COBRA Notices

The U.S. Department of Labor (DOL) recently issued new proposed COBRA regulations. The regulations include an updated model general notice and model election notice under the federal COBRA law. Use of the model notices is not...more

Rhode Island Hospital Reaches Settlement with Massachusetts AG to Resolve Data Security Allegations

Last week, Women & Infants Hospital of Rhode Island (“W&I”) reached a settlement with the Massachusetts Attorney General to resolve allegations that W&I failed to adequately protect personal data stored on unencrypted backup...more

Favorable Ruling: Taxability of HMOs Under New York City General Corporation Tax

A New York City Tax Appeals Tribunal Administrative Law Judge (ALJ) recently ruled in favor of Aetna, Inc. (Aetna) on whether a health maintenance organization (HMO) was “doing an insurance business” in New York State,...more

Lessons From Omnicare Settlement In 'Swapping' Cases

On June 25, the U.S. Department of Justice announced that it had settled with Omnicare Inc. in two matters alleging that kickbacks resulted from below-cost discounts offered to skilled nursing homes as an inducement to select...more

Health Care Update - July 2014 #4

In This Issue: - Congressional Negotiators Reach Deal on Veteran Affairs Bill - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

Ohio Physician Assistants and Advance Practice Nurses Now Permitted to Admit Patients to Hospitals

As the prevalence of physician extenders continues to grow to meet patient demand, so does their scope of practice. Effective May 20, 2014, Ohio law now permits physician assistants, certified nurse practitioners,...more

Conflicting Rulings on Health Insurance Subsidies Raise Concerns Among Insurers and Providers

On Tuesday, July 23rd 2014, separate federal circuit court panels issued conflicting rulings regarding whether the government could subsidize health insurance premiums for Americans enrolled in federally-run health exchanges....more

Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

News from the Health Law Gurus™

Former Walmart Exec to Help Manage HHS — Leslie Dach, former Executive Vice President of Corporate Affairs for Walmart, will assume the role of Senior Counsel of the HHS, according to a press release on Wednesday. ...more

OIG Determines $4.3 Million Improperly Paid to LTCHs for Interrupted Stays in 2010 and 2011

The OIG issued a report on June 3, 2014 summarizing its findings concerning the vulnerabilities and enforcement of Medicare’s interrupted-stay policy for long-term care hospitals (LTCHs). Beneficiaries in LTCHs tend to have...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Stay Tuned: Impact of Supreme Court Decision on ACA's Contraceptive Mandate Uncertain

It’s too soon to know the impact on the workplace of the U.S. Supreme Court’s recent decision that certain businesses may opt out of the Affordable Care Act’s (ACA) requirement to pay for birth control in their healthcare...more

Shorts on Long Term Care - Summer 2014

In this issue: - Nursing Facility Survey Trends: Directed Plans of Correction, Privacy Violations and FTag 520 Quality Assurance Committee Citations - COBRA Meets ACA – Time to Update COBRA Notices -...more

Medicare Part C Update: Co-Insurance Payments

Prior to the implementation of NC Tracks, the North Carolina Medicaid program would pay co-insurance for correctly filed claims for dual eligible residents (Medicare and Medicaid) who were covered primarily by Medicare Part C...more

CMS Publishes Proposed 2015 OPPS and ASC Payment Rule

On July 3, 2014, CMS posted the proposed CY 2015 outpatient perspective payment system (OPPS) and Ambulatory Surgical Center (ASC) payment rule, which was subsequently published in the Federal Register on July 14, 2014 [PDF]....more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Of Mice and Elephants: Halbig and King and The Struggle of Two Federal Appeals Courts to Find Meaning in Words That May or May Not...

At issue in Halbig v. Burwell and King v. Burwell is whether or not subsidies to buy insurance on an exchange are available in both state and federal exchanges. On its face the Affordable Care Act (“ACA”) provides for...more

What patients misunderstand about their right of informed consent [Video]

Many patients misunderstand what "informed consent" is all about. They often believe it's about signing a form ahead of surgery that acts as a waiver against any rights they may have for legal recourse if the surgery goes...more

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