Healthcare

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WEBINAR: Preparing for the HITECH September Deadline - Tips for Negotiating Effective Business Associate Agreements under HIPAA

Business Associate Agreements (BAAs), in the current regulatory and technological environment, require careful review and negotiation of the implementation of the regulatory requirements. In meeting the September 23, 2014...more

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

ERISA (8th Circuit): Over-The-Counter Vitamin Supplements Trigger Pre-Existing Condition Exclusion

What sort of “medical treatment” triggers the pre-existing condition exclusion in an ERISA-governed disability policy?...more

For-Profit Companies Find Religion – What’s a Transactional Lawyer to Do?

Last month, the United States Supreme Court ruled in the Hobby Lobby case that closely held for-profit corporations can have “free exercise rights” as “persons” under The Religious Freedom Restoration Act of 1993 (“RFRA”),...more

Does housing count as health care?

Rocking ChairNPR aired a story Monday morning reporting that New York has allocated $260 million in State Medicaid funds for supportive housing and exploring the question of whether housing counts as health care. Right now,...more

Telemedicine: Many Opportunities, Many Legal Issues, Many Risks

Telemedicine touches on multiple practice areas for health care lawyers, such as payment and reimbursement, fraud and abuse, credentialing and privileging, peer review, privacy, consent, licensing, and regulatory compliance....more

Hell Hath No Fury Like a CFO Scorned (But His Whistleblower Suit Fails Anyway)

Medicare and Medicaid providers lie awake at night worrying about disgruntled—or worse yet, fired—finance officers filing whistleblower suits. After all, Medicare and Medicaid regulations are notoriously complicated, and...more

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

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

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