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Health Updates

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

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

Additional Opportunity for Increased Extension of Building Permits and Development Orders: Interested parties must notify issuing...

Due to Governor Scott's recent expansion of the State of Emergency issued for the Zika Virus, holders of permits and development orders have another opportunity to toll the period remaining to exercise rights under the permit...more

Efforts to Revive American Health Care Act (AHCA) Stall Before Recess

by King & Spalding on

Last week, prior to departing Washington, D.C. for a two week congressional recess, House Republicans and the Trump Administration worked to come to an agreement on the American Health Care Act (AHCA), legislation to repeal...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

by Foley & Lardner LLP on

The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Patient Check-Ups Before Checking Out: Partnering to Bring Health Care into the “One-Stop Shopping” Sector

Retail clinics—the popular term for walk-in clinics located in pharmacies, supermarkets, and “big-box” stores—are playing an expanding role in the health care market....more

Business Tax Reform – the Current State of Play

by Ballard Spahr LLP on

President Donald J. Trump campaigned on a platform of large tax cuts for businesses. With President Trump in the White House and Republicans controlling both the House of Representatives and Senate, does it mean businesses...more

DOJ vs. OIG: Analysis of Recently Issued Federal Compliance Documents

by Polsinelli on

Within just weeks of each other, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued separate documents that health care organizations may use to...more

Market Stabilization: To Be or Not to Be?

by BakerHostetler on

The Centers for Medicare and Medicaid Services (CMS) published a Final Rule intended to stabilize the individual and small group insurance markets on April 18, 2017. Reflecting the urgent need to address the uncertainty...more

Small Healthcare Provider Pays $31,000 for Failing to Have a Business Associate Agreement With File Storage Vendor

by Jackson Lewis P.C. on

Disclosing protected health information (PHI) to a business associate without a compliant business associate agreement (BAA) is an improper disclosure under the HIPAA privacy and security regulations. According to the HHS...more

Update #7: ACA Market Stabilization Rules Finalized; Cost-Sharing Next Hurdle

by Davis Wright Tremaine LLP on

The Trump Administration has issued final market stabilization rules designed to keep insurers in the individual health insurance Marketplaces. The rules are virtually the same as the proposed rules described in our Update...more

Isn’t a Power of Attorney Just for Old People, Right? Wrong!

by Jaburg Wilk on

Why Young Adults Need Power of Attorneys - When children turn 18, they legally become adults. If there was a catastrophic life event which rendered them unable to make their own life decisions, their parents no longer...more

Tort Reform Bill to Narrow Definition of Employee in Medical Negligence Actions

by Lathrop & Gage LLP on

SB 237 is a bill designed to limit the liability of hospitals and other healthcare providers for the actions or omissions of those who are not within a narrow definition of “employee.” SB 237 is designed as a legislative fix...more

D.C. District Court Allows Part C Plan to Continue with Challenge of Overpayment Rule

by King & Spalding on

On March 31, 2017, Judge Rosemary Collyer of the United States District Court for the District of Columbia held that plaintiffs UnitedHealthcare Insurance Company et al. (“United”) had standing to challenge CMS’s overpayment...more

Health Care Perspectives

With deep experience in the health care industry and a comprehensive understanding of its diverse participants, Katten attorneys serve as conference moderators and panelists, host accredited events, and produce webinars to...more

Home Health Agencies May Get More Time to Prepare for New Rules

The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule that would delay the effective date of the revised Conditions of Participation (CoP) for home health agencies (HHAs) from July 13, 2017 until...more

ML Strategies Alert - FY2018 Massachusetts Budget Update: House Ways and Means Budget

On Monday, April 10th, the House Ways and Means Committee proposed a $40.3 billion budget for FY2018 that calls for increasing spending by 3.8 percent, or about $1.47 billion, above FY2017 levels. The spending increase is...more

Suggested Questions for the Compliance Officer

by Ruder Ware on

In a previous blog post, I promised to release a list of questions a Board of Directors (Board) might ask its compliance officer. This post is intended to fulfill that promise. My intent is to help Board members exercise...more

Affordable Care Act’s Link to the Administration’s Plans for Tax Reform

by McNair Law Firm, P.A. on

On March 24, 2017 the vote to repeal the Affordable Care Act (‘Obamacare’) was cancelled when it became clear there were not enough Republican votes to move it past the House of Representatives....more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

The Fate of the ACA’s Cost-Sharing Reduction Subsidies

by Perkins Coie on

As deliberations over a replacement of the Affordable Care Act (ACA) continue in the U.S. House of Representatives, the fate of the ACA’s Cost-Sharing Reduction subsidies (CSRs) may be at stake. Under the ACA, Marketplace...more

HHS Finalizes Health Insurance Market Stabilization Rules

by Ballard Spahr LLP on

The U.S. Department of Health and Human Services (HHS) has finalized regulations designed to help stabilize the individual and small group health insurance markets and, in particular, the health insurance exchanges...more

Alabama CON Report

I. Certificate of Need Program - A. AL2017-012, Crowne Health Care of Springhill, LLC, Mobile, AL: Proposes to relocate twenty-six (26) nursing home beds from Crowne Health Care of Mobile, LLC, a 174-bed nursing home....more

Exercising Board Oversight of the Compliance Function

by Ruder Ware on

The Board of Directors (Board) of an organization has oversight responsibilities over the compliance program. Board members are often unsure of the nature and scope of their responsibilities over compliance. The roll of many...more

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