Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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HIPAA for HR - Some Good News for Employers

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...more

Health Care E-Note - Februaury 2017

Ransomware: A Reportable Breach? In the past several years, a huge increase has occurred in the number of electronic attacks in the United States using ransomware, a form of malware that targets and encrypts critical...more

The Future of the Affordable Care Act Week 6: Focus on the Individual Health Insurance Market

A recent report from the nation’s top actuaries takes a sobering look at the challenges policy makers face in creating a viable individual (i.e., non-group) health insurance market—a critical component of any plan to replace...more

Focus on the FMLA – Part II

Last week, we wrote about some of the Family and Medical Leave Act (FMLA) requirements that can be particularly challenging for employers. This week, we’re going to focus on an aspect of FMLA entitlement that causes employers...more

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

HHS Expresses Interest in Pre-Existing Condition Exclusions

In proposed regulations published on February 17, 2017, the U.S. Department of Health and Human Services (HHS) has suggested several adjustments designed to help stabilize the individual health insurance market – particularly...more

HHS Finalizes Appeals Backlog Rule in Wake of Judicial Order

The U.S. Department of Health and Human Services (HHS) released a Final Rule aimed at reducing and eventually eliminating the backlog of more than 650,000 claims currently awaiting adjudication by an administrative law judge...more

HHS Makes Its First Move to Stabilize the Individual Health Insurance Market

Wednesday, the Trump Administration released its first proposed regulation seeking to stabilize the individual insurance market – in particular, the Affordable Care Act (ACA) insurance exchange market (or marketplace). Amidst...more

HHS Proposed Rule Signals Future of Obamacare May be Repair not Repeal

On Wednesday, February 15, 2017, the Health and Human Services Department (HHS) announced a proposed rule designed to help stabilize the Affordable Insurance Exchanges for the 2018 benefit year. The rule proposes several...more

DOJ Settles with Nursing Home for Allegations of Worthless Services

On February 1, 2017, an Iowa nursing facility and residential care facility operator entered into a settlement agreement (the Agreement) with DOJ and the State of Iowa for alleged violations of the False Claims Act for the...more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

Technical Noncompliance with HIPAA Can Lead to Big Penalties

As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance initiatives in recent months and is poised to continue its enforcement...more

AGG Food and Drug Newsletter - February 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

The Critical Role of Telemedicine in the Addiction Crisis

Telemedicine is now mainstream. Surprisingly, however, one area in which telemedicine has not been used to its fullest capability is drug addiction treatment. As you are aware, the country is in the midst of an addiction...more

Trump Administration Proposes Insurer-Friendly Rule Modifying Exchanges under the ACA

Less than three weeks after our last article involving healthcare under the Trump Administration, the Centers for Medicare and Medicaid Services Department of Health and Human Services (“HHS”) has released its first proposed...more

Medicaid Outlook: Policy and Regulatory Change in 2017

Perspectives on Health Care and Life Sciences - Medicaid has been a vital part of the American health care safety net for more than 50 years. Today, Medicaid, along with the State Children’s Health Insurance Program...more

FSMB and ATA Documents Shed Light on States’ Views on Telemedicine

Over the past year, the Federation of State Medical Boards (FSMB) and the American Telemedicine Association (ATA) have published documents regarding telemedicine that shed some new light on how state regulatory bodies view...more

FDA Hits “Pause” on Regulation of LDTs

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

What’s New in Washington: 10 Things You Need to Know

The first four weeks of the Trump administration have brought a flurry of policy and regulatory activity through Executive Orders (EO), proposed new legislation and review of existing regulation. After eight years of the...more

TCPA Violations Claimed Against Rady Children’s Hospital in San Diego

Rady Children’s Hospital-San Diego (Rady) was hit with a proposed class action in California federal court this week for alleged violations of the Telephone Consumer Protection Act (TCPA) for autodialed debt-collection calls...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

New Bundled Payments Are a Go…For Now

CMS issued a final rule on January 3, 2017, implementing three new episode payment models (EPMs) and a Cardiac Rehabilitation (CR) incentive payment model under the authority of the Center for Medicare & Medicaid Innovation...more

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