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Showing 11 posts from 2019.

CMS Revises Requirements for PACE

Over on the Hinshaw & Culbertson LLP website, we review revisions by the Centers for Medicare & Medicaid Services (CMS) to the regulations for the Programs of All-Inclusive Care for the Elderly (PACE), which make significant changes to ownership restrictions, compliance program monitoring and oversight requirements, staffing requirements, marketing, and participants' rights. The changes will provide greater administrative and operational flexibility for PACE organizations and includes multiple incentives for the growth and development of PACE Programs, making PACE program development a tremendous business opportunity for any health care provider organization that serves a large Medicare patient population. More ›

Why Electronic Health Records are a Game Changer in Medical Malpractice Cases

I recently had opportunity to publish an article in the DRI Medlaw Update regarding the challenges posed by Electronic Health Records (EHRs) technology within the context of medical malpractice cases. In the article, I address how EHRs operate and how they differ from the more familiar paper medical chart. 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 ›

Spot the Legal Issues and Prepare Your Telemedicine Compliance Program

I recently published an article in the Journal of Health Care Compliance that provides on overview of the many legal issues raised by the practice of telemedicine services by federally qualified health centers (FQHCs) and rural health centers (RHCs). Because of the many benefits conferred by this health care service modality, FQHCs and RHCs are rapidly adopting telemedicine measures. However, there are many legal risks and compliance issues associated with the use of telemedicine, and in the article I discuss a series of compliance best practices that can help reduce the associated fraud and abuse risks. 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 ›

New Cost Containment Strategies Allow Payors to Reduce In-Network Reimbursements

A Managed Care Organization (MCO) contracts with providers to create provider networks that deliver health care services at discounted rates. The plan accessing the provider network may offer a Coverage Agreement issued by the MCO. In the alternative, the plan accessing the provider network may be a self-funded plan offered by an employer that contracts with the MCO to access the MCO's network to apply its discounted rates to the self-funded plan's Coverage Agreement. Providers are either reimbursed by the MCO's plans or by the self-funded plans accessing the network and offering benefit plans to employees. 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 ›

Health Care Organizations Should Take Heed of New HHS Cybersecurity Guidance

Cybersecurity is a significant and growing compliance risk for health care organizations. If your organization fails to protect patients from cybersecurity risks, the result could be serious fines and penalties for non-compliance with federal and state cybersecurity and data breach laws. The good news is that the U.S. Department of Health & Human Services ("HHS") recently released voluntary cybersecurity guidance for health care organizations. More ›

OIG Issues Advisory Opinion Allowing a Federally Qualified Health Center to Routinely Waive Co-Payments and/or Deductibles for Medicare and TRICARE Patients

On January 14, 2019, the U.S. Department of Health and Human Services Office of the Inspector General (the "OIG") issued Advisory Opinion 19-01, which was favorable to a federally qualified health center's ("FQHC's") proposal to routinely waive co-payments and/or deductibles for Medicare and TRICARE patients (the "Proposed Arrangement"). The particular FQHC that made the request is a pediatric clinic that provides medical, psychiatric, and dental care to children who reside in an area that contains disproportionately large numbers of children living in poverty. More ›

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