Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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Federal auditors assail $359 million in Medicare costs for chiropractic care

Federal auditors have found that 80 percent of Medicare spending in a recent year on chiropractic care-some $359 million-was medically unnecessary. The federal insurance program for senior citizens should not have thrown...more

Price fixing not justified to protect pharmacies in rural areas

On 19 October 2016, the Court of Justice of the European Union (CJEU) issued an important judgment concerning the German law on fixing prices of retail prescription drugs. In the case before the Higher Regional Court of...more

OSHA Issues Final Rule On Complaints Under Affordable Care Act's Anti-Retaliation Provision

The Affordable Care Act (ACA) added Section 18C to the Fair Labor Standards Act (FLSA) to prohibit retaliation against employees who engage in certain activities protected by the ACA. Responsibility for receiving and...more

Catalent Biosimilars Manufacturing Update

Yesterday, Catalent Pharma Solutions announced that it has broken ground for a 22,000 square foot extension of its biologics manufacturing facility in Madison, Wisconsin. According to the press release, following completion...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

ICU Medical Buys Hospira Infusion Systems From Pfizer

ICU Medical and Pfizer have reached an agreement to transfer ownership of Hospira Infusion Systems to ICU Medical, according to a joint press release on October 6....more

Washington, D.C. Update – October 2016

In a rush to leave Washington and head home to campaign for reelection, members of Congress passed a continuing resolution (CR) avoiding a shutdown and extending federal government operations through December 9. In an effort...more

Health Care System’s HIPAA Security Risk Results in $2.14 Million Fine

On October 18, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced that St. Joseph Health (SJH) agreed to settle allegations relating to the HIPAA Privacy and Security Rules,...more

MHRA Updates Guidance on Healthcare Apps as Medical Devices

Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United...more

Health Alert (Australia) October 24, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Victoria 19 October 2016 - Damir Redzepovic v Western Health [2016] VSCA 251 The applicant sought leave to appeal from...more

Colleges/Universities Granted Extended Relief for Premium Reductions in Connection with Student Health Insurance

The Departments of Labor, Health and Human Services and the Treasury (collectively, the “Departments”) on Friday extended enforcement relief, via publication of FAQs About Affordable Care Act Implementation Part 33 (“FAQs”),...more

NAIC Long-Term Care Innovation Subgroup Public Hearing

At the NAIC Summer 2016 National Meeting, the Long-Term Care Innovation (B) Subgroup held a public hearing as part of an initiative to address the challenges facing the private LTC market. With baby boomers retiring at a rate...more

Tennessee Health Services and Facilities Report: October 2016 Newsletter

The Tennessee Health Services and Development Agency (HSDA) is responsible for regulating the health care industry in Tennessee through the Certificate of Need Program. A Certificate of Need (CON) is a permit for the...more

Section 1557 of the Affordable Care Act: Implications for Health Care Providers and Health Insurers

Section 1557 of the Affordable Care Act (the “ACA”) prohibits discrimination on the basis of race, color, national origin, sex (including gender identity), age, or disability under any health program or activity that receives...more

Student Health Insurance Plans and the ACA: Agencies Provide Enforcement Relief that Allows Colleges and Universities to Continue...

Late last week, the Departments of Labor (“DOL”), Health and Human Services (“HHS”) and the Treasury (collectively, the “Agencies”) issued a very welcome FAQ that will allow higher education institutions to continue...more

NLRB Issues Numerous Decisions Against Employers as Hirozawa's Term Expires

In the midst of a heated presidential election cycle, employers are following recent decisions of the National Labor Relations Board closely. Before losing its three-member Democratic majority at the expiration of Board...more

Is Marriage a “Material Connection”? The FTC Challenges an “Independent” Expert Based on Marital Status

Medical endorsements can be powerful selling tools for health care products. But if a medical professional has a connection to the company marketing the products that would be material to consumers in evaluating the...more

Lessons Learned from FCA Settlement Involving Waiver of Medicare Coinsurance Amounts

The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry. Despite the near absence of clear legal...more

CMS Releases Much Anticipated MACRA Final Rule

On October 14, 2016, CMS issued its Final Rule for the new physician payment system under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA replaced the Medicare Sustainable Growth Rate (SGR) with a new...more

Temporary Relief for Certain Student Health Plans Extended Indefinitely

In recently issued guidance, the U.S. Departments of Treasury, Labor, and Health and Human Services indicated that they will indefinitely extend relief to colleges and universities that subsidize the cost of individual...more

Clouds, With A Nearly 100% Chance of a Business Associate Agreement

HHS recently posted guidance on its website addressing HIPAA’s approach to cloud computing. Basically, any time a cloud service provider has electronic protected health information (ePHI), it’s a business associate. This is...more

The MACRA Final Rule: Key Takeaways for Health IT Vendors

The Centers for Medicare and Medicaid Services (CMS) surprised everyone with its earlier than expected release on Friday, October 14, 2016 of the MACRA final rule. Given ongoing updates from CMS, the contents were not a...more

Catching Up With the Times: CMS Reforms Long-Term Care Facility Requirements Part III

On October 4, the Centers for Medicare and Medicaid Services (CMS) published the biggest overhaul to federal long-term care regulations since 1991, and impacted facilities can immediately take steps to ensure they’re prepared...more

Changing Liver Transplant Parameters: Threatening Patients and Health Care Providers in Georgia and Across the Southeast

On March 16, 2000, the U.S. Department of Health and Human Services (HHS) promulgated a Final Rule, in part instructing the federally contracted Organ Procurement and Transplantation Network/Unit Network for Organ Sharing...more

The 60-Day Rule: Failure to Return Overpayments Caused by Software Glitch Costs Hospital $2.95 Million

A software glitch can be just as risky for a healthcare provider as submitting a false claim. Or so it was declared on August 24, 2016 when the U.S. Attorney for the Southern District of New York announced that Continuum...more

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