Health Updates

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CMS Issues Guidance on Privacy Concerns at Nursing Homes

Earlier this month, CMS issued guidance regarding privacy concerns in nursing homes. In a letter entitled “Protecting Resident Privacy and Prohibiting Mental Abuse Related to Photographs and Audio/Video Recordings by Nursing...more

Check Your Neutral Policies: The EEOC Joins the ACLU’s Challenge to Dignity Health’s Exclusion of All Care Related to Sex...

The ACLU filed a complaint against Dignity Health, claiming that the total exclusion of care related to “sex transformation surgery” in Dignity’s employee health insurance plan is unlawful sex discrimination. Now the EEOC...more

IRS Addresses Health Coverage Opt-Out Payments Under the Affordable Care Act

As the cost of providing health coverage increased over the past fifteen years, many employers began to offer employees cash payments if they “opted out” of coverage. Some expected that the Affordable Care Act (ACA) would...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On...more

Drug Costs Study Argues for Increased Funding for Biosimilar Review

A recent meta-analysis investigated several factors impacting prescription drug costs in the United States. Doctors associated with the Brigham and Women’s Hospital and Harvard Medical School authored the report. Funding...more

No HIPAA Hall Pass for Business Associates and Small Breaches

Phase 2 Audits of Business Associates: The Department of Health and Human Services, Office for Civil Rights (OCR) is in the process of conducting its phase 2 audits of Covered Entities and Business Associates. “Covered...more

Where to Draw the Line: Who Gets to be Exempt?

Legal challenges to controversial provisions in the Affordable Care Act (ACA) continue to work their way though the courts. In a follow-on to the Supreme Court’s decisions in Burwell v. Hobby Lobby and Zubik v. Burwell...more

BREAKING NEWS: FDA Approves Sandoz’s Erelzi, biosimilar to Enbrel (etanercept)

The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar etanercept approved by FDA, and the third...more

The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new...

The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and...more

Healthcare Compliance: Juggling Risk Mitigation Strategies

Healthcare organizations – ranging from physician practice groups to large, multi-state hospital systems – face a variety of risks, including fraud and abuse, as well as HIPAA privacy issues. Starting from a baseline risk...more

Health Care Legislation Maryland 2016 First Interim Report

The bills cited and reviewed in this Report are not an exhaustive presentation of all healthcare legislation. Rather, they represent either proposed or adopted legislation that we believe are among the most beneficial,...more

FDA Reaches Agreement with Industry for Reauthorization of Medical Device User Fees

The Food and Drug Administration has issued a statement announcing that the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations...more

60-Day Overpayment FCA Enforcement Action Results in $2.95 Million Settlement

On August 23, 2016, a New York hospital system settled False Claims Act (FCA) allegations that it violated the 60-day overpayment rule by improperly retaining Medicaid overpayments. The whistleblower alleged that three of the...more

When and Where Can the "Line" Be Drawn? NLRB Considers When Off-Duty Employees May Picket a Hospital Employer

The National Labor Relations Board (the “Board”) recently addressed hospital employers’ ability to prohibit picketing by off-duty employees on their own premises. Although the Board concluded that a hospital employer may...more

New OkPOLST form designed to improve end-of-life and crisis care

Beginning Friday, August 26, 2016, Oklahomans have another tool available to them for use in planning end-of-life care and treatment. It’s called an OkPOLST, which stands for Oklahoma Physician Orders for Life-Sustaining...more

New 340B Dispute Resolution Process: Will It Level the Playing Field?

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

Eighth Circuit Determines that Compliance with Reasonable Interpretation of Government Regulation Sufficient to Avoid FCA...

The Centers for Medicare and Medicaid Services (“CMS”) establishes requirements for how medical procedures must be performed for a medical provider to seek payment for those procedures. Seeking payment without properly...more

Corporate E-Note - August 2016

In a “Table of Experts” series published on July 15, 2016 by the Birmingham Business Journal, Ed Christian provides his insight into a series of questions related to mergers and acquisitions. Please see full E-note below...more

Biosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products –...more

US Supreme Court False Claims Act Decision in Escobar Has Significant Implications for Contractors

On June 16, 2016, the U.S. Supreme Court ruled in the matter of Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016), changing the legal landscape for False Claims Act qui tam claims...more

OCR to Increase Investigations Of Smaller PHI Breaches

Healthcare providers and other covered entities must report breaches of unsecured protected health information (“PHI”) to the Secretary of Health and Human Services in accordance with the Breach Notification Rule of the...more

Short-Sellers Partnering with Hackers: Exploiting Cybersecurity Fears for Short-Term Profit

A research report released last week on the supposed cyber vulnerabilities of St. Jude Medical’s devices not only jeopardizes a pending $25 billion acquisition of the company by Abbott Laboratories, it opens a worrisome new...more

Ninth Circuit Uproots Department of Justice Prosecution of Medical Marijuana Cases

On August 16, 2016, the United States Court of Appeals for the Ninth Circuit rebuked the Department of Justice (“DOJ”) in United States v. McIntosh, a case that involves the tension between federal and state laws involving...more

OIG Releases Revised Guidance on Independent Review Organization Independence and Objectivity

On August 22, 2016, the Office of Inspector General of the Department of Health and Human Services (OIG) released updated guidance on Independent Review Organization (IRO) independence and objectivity (the “Guidance”). The...more

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