Healthcare

News & Analysis as of

Upcoming Health and Welfare Plan Requirements Checklist for Employers

As the mid-way point of 2014 approaches, employers should actively turn their attention to several upcoming compliance obligations for the health and welfare benefit plans they sponsor. Below is a checklist of upcoming...more

New Federal Fire Safety Regulations Could Mean Changes for Health Care Facilities

On April 16, 2014, the Centers for Medicare & Medicaid Services (CMS) published proposed rules that would amend the fire safety standards for hospitals, long-term care facilities, ambulatory surgery centers, hospice inpatient...more

Digital Health Investments Top $2.6B* in the First Six Months of 2014

Thanks to an impressive showing in April, digital health investment in the first half of 2014 totaled $2.676 billion. There were a total of 38 deals for $20 million or more from January through June, with more than two-thirds...more

Employee Benefits Developments - July 2014

In May 2014, the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury issued Frequently Asked Questions (FAQs) Part XIX, addressing, among other subjects, the following: The newly revised DOL model...more

Audit Trails: Pitfalls of Electronic Medical Records, Part III

I do not profess to be an expert in the complexities of metadata in an electronic medical record (EMR). In simple terms, it is analogous to leaving footprints in the sand; although these do not wash away with high tide. In...more

Health Headlines: Also in the News - July 2014 #4

CMS Announces Quality Innovation Network QIO Contracts – On July 18, CMS announced the award of contracts to fourteen Quality Innovation Network Quality Improvement Organizations (QIN-QIOs) for work on data-driven quality...more

No delay of game – Affordable Care Act (ACA) compliance efforts should continue, despite court rulings

Perhaps you have put your compliance efforts on the back burner, hoping the ACA will just go away. We have heard many reasons for this procrastination, including the constitutional challenge to the individual mandate, the...more

NLRB Issues Mixed Decisions When Applying Specialty Healthcare to Retail Industry

In two separate decisions, the National Labor Relations Board (NLRB) has extended to the retail industry the standard for recognizing what is an “appropriate” bargaining unit that it established in Specialty Healthcare and...more

New Clarifications Affect Physician and Hospital Medicare Part B Billing for Services Provided by Nursing and Other Staff...

CMS recently released rules changing the requirements for Medicare coverage of services furnished incident to a physician’s, NP’s, or PA’s services. Howard Sollins, Donna Senft and Susan Turner explain the effect of the...more

OIG Reports that Two MACs are Responsible for $4 Million in Overpayments for Outpatient Drugs

According to two reports issued by OIG on July 25, the Medicare Administrative Contractors (MACs) for Jurisdictions 13 and 14 made overpayments of approximately $2.7 million and approximately $1.3 million, respectively, for...more

California Legislative Update: July 2014

Governor Jerry Brown recently signed into law a number of bills that will impact the employer community. A brief summary of these new laws, along with links to the bills, can be found below....more

New ACA Rules Could Require Broader Provider Networks

"If you like your doctor, you can keep your doctor." President Obama repeated this assurance to the American public numerous times, and the statement was prominently featured on the White House web site prior to and after...more

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

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