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Showing 20 posts in Health Care.

Tips on How to Pass Your State Board of Pharmacy Inspection

I recently published an article in the Journal of Health Care Compliance that provides compliance tips on how to pass State Board of Pharmacy inspections. Passing these inspections is important because any compliance deficiencies identified during the process can result in suspension or revocation of a pharmacy license and PBM contract terminations. More ›

Florida Law Voiding Noncompete Contracts Between Doctors and Their Employers Clears Legal Hurdle

Hospitals operating in Florida need to be aware of a new Florida law that voids noncompete agreements between doctors and their employers. Specifically, Section 542.336 of the Florida statutes voids noncompete agreements between physicians and specialty physician groups where the group employs all the specialty physicians in a given Florida county. An oncology service provider had sued in federal court, arguing the law amounted to special interest legislation and did not serve a legitimate public purpose, as required by the U.S. Constitution's Contracts Clause. More ›

OCR Provides Guidance on Direct Liability for Business Associates Under HIPAA

A HIPAA Business Associate ("Business Associate") is an individual or entity who performs or furnishes activity or service for or on behalf of a HIPAA Covered Entity ("Covered Entity") involving the use or disclosure of protected health information ("PHI"). The HITECH Act and OCR's HIPAA Security final rule provides the U.S. Department of Health & Human Services Office for Civil Rights ("OCR") with authority to take enforcement action against Business Associates only for those requirements and prohibitions of the HIPAA Rules outlined below.

Based on recent guidance provide by OCR, Business Associates should implement a HIPAA compliance program and document compliance with the HIPAA Privacy and Security rules in order to minimize potential HIPAA enforcement actions. Covered Entities should also perform due diligence on potential Business Associates and monitor and audit Business Associate compliance. More ›

Attention Health Care Providers: California Adopts Restricted Knox-Keene Licensure/Exemption Requirements

The California Department of Managed Health Care (the "DMHC"), which regulates Health Care Service Plans, recently adopted a regulation regarding general licensure requirements for health care providers ("Entities") that accept global risk, as defined by the Knox-Keene Health Care Service Plan Act of 1975 ("Knox-Keene Act"). Taking effect this week (July 1, 2019), the regulation is codified in California Code of Regulations, title 28, section 1300.49.

The new law will require most Entities to file their health plan contracts and request an exemption any time they enter into or renew a health plan contract during the next 12 months, and will eventually require a significant minority of the approximately 300 Entities in California to obtain licensure as a Knox-Keene Plan. Below, we take a closer look at these requirements and how they will impact the Entities. More ›

Responding to State Board of Pharmacy Licensing and Regulatory Proceedings

State Boards of Pharmacy are responsible for protecting the health, safety and welfare of the public by regulating the legal distribution of prescription drugs in their respective states, and ensuring the quality of all drugs administered, prescribed, distributed, or dispensed by prescription. That responsibility includes regulating the practice of pharmacy; administering and enforcing pharmacy practice acts and regulations in their respective states; and licensing, regulating, monitoring, investigating, and disciplining pharmacists and pharmacies.

A State Board of Pharmacy may reprimand, cancel, suspend, or revoke the license of a pharmacist or pharmacy that is found to have violated applicable pharmacy laws or regulations. State Board of Pharmacy disciplinary action on a pharmacist or pharmacy license based on disciplinary action by another State Board of Pharmacy is common and can present a multitude of problems for pharmacists and pharmacies that operate on a national basis.

It takes years of dedication and hard work to develop the skills necessary to secure a pharmacist license or operate a pharmacy. If confronted with State Board of Pharmacy disciplinary actions, it is critical for pharmacists and pharmacies alike to know how to respond. More ›

Health Care Providers and Pharmaceutical Distributors Should Heed These Warnings to Reduce the Risk of an Opioid-Related Lawsuit

The national opioid crisis has triggered an avalanche of lawsuits around the country. Pharmaceutical manufacturers and distributors are often among the named defendants, but other entities are also at risk. The wide variety of claims that figure in these lawsuits means that all health care industry participants should evaluate their risk of being subjected to an opiate-related claim. Many of these suits are being consolidated into multidistrict litigation (MDL), while others are being handled as individual claims. More ›

Employer Wellness Programs Operating Under a Cloud of Uncertainty

Wellness programs have quickly found favor with many employers: studies indicate that nearly half of employers who sponsor a health plan offer a wellness program. However, wellness programs have been operating under cloud ever since a federal court decision invalidated guidance issued by the EEOC that an incentive to participants equal to 30% of the cost of coverage under the group health plan was permissible. In December 2018, the EEOC revoked its guidance and the agency is expected to offer new guidance later in 2019. More ›

What Health Care Providers Need to Know About the Illinois Gender Violence Act

Years before the rise of the "#MeToo" movement, the Illinois Gender Violence Act (IGVA) was enacted to give victims of criminal "gender violence" a civil remedy. The IGVA creates a civil cause of action for persons who have been subjected to gender-related violence, which is defined in part as, "a physical intrusion or physical invasion of a sexual nature under coercive conditions satisfying the elements of battery under the laws of Illinois." A cause of action under the IGVA exists regardless of whether the alleged act of sexual aggression resulted in criminal charges, prosecution, or conviction. Essentially, any claim involving sexual harassment and physical touching could arguably fall within the scope of the statute. More ›

Sixth Circuit Applies Escobar Ruling in Decision to Resuscitate False Claims Act Case

The United States Court of Appeals for the Sixth Circuit recently resuscitated a qui tam action under the False Claims Act (FCA), and, in so doing, held that the relator had properly alleged materiality under the U.S. Supreme Court's decision in Universal Health Services Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989, 2002 (2016). The Sixth Circuit's decision, U.S. ex rel. Prather v. Brookdale Senior Living Communities, Inc., 892 F.3d 22 (6th Cir. June 11, 2018) addressed a relator's claims under the FCA. The FCA imposes civil liability on those who defraud the federal government by levying fines and penalties, including up to three times the government's damages. Private persons called relators file lawsuits or qui tam actions for violations of the FCA on behalf of the government. More ›

More than 600 Healthcare Professionals Hit by DOJ with Medicare Fraud Charges

The number of criminal charges filed annually by the Department of Justice (DOJ) against health care providers and professionals continues to escalate. On June 28, 2018, the DOJ announced that the Medicare Fraud Strike Force had charged 601 individuals across the United States, including more than 150 physicians, nurses, and other licensed medical professionals for participating in health care fraud schemes involving more than $2 billion in false billings this summer. At the same time, the U.S. Department of Health and Human Services initiated suspension actions against numerous providers, including doctors, nurses, and pharmacists. More ›

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