Read about the key revisions to Illinois’ amended Mental Health and Developmental Disabilities Confidentiality Act (MHDDCA), which removes the longstanding requirement for a witness signature on consent and revocation forms.

Read our alert examining a federal action challenging Illinois’ nonprofit demographic reporting law and its implications for organizations required to disclose leadership data.

Learn how the HHS reclassification of the Health Center Program as a "Federal public benefit" impacts access, compliance, and funding for health centers, and read our urgent guide on the critical steps your organization should take now.

Learn how OIG Advisory Opinion 25-03 safeguards and compliance best practices can help providers expand their telehealth services while minimizing regulatory risk.

Discover how OIG Advisory Opinion 25-02 empowers community health centers to integrate social services with primary care.

Discover the key compliance challenges and legal risks in the rapidly growing medical spa industry, with a focus on California regulations and practical guidance for ensuring patient safety and business success.

Read our latest legal update about why healthcare professionals need to "Stop, Look, and Listen" before they enter into Medicare Advantage Plan Marketing arrangements.

Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about changes in ownership, corporate structure, staffing, and the scope of services provided. Reportable changes can be grouped into the following three areas:

The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred to as "Covered Entities" [42 United States Code (USC) §256b]. 

Pharmacy employees at some CVS and Walgreens stores, including pharmacists, technicians, and support staff, recently walked off of their jobs to protest insufficient staffing and dangerous workloads that they claim jeopardize patient safety.

Federally Qualified Health Centers (FQHCs) are required to provide all required primary, preventive, and enabling health services as well as additional health services as appropriate and necessary – either directly or through established written arrangements and referrals.[1]FQHCs may provide services "either through the staff and supporting resources of the center or through contracts or cooperative arrangements." All required and applicable additional Health Center services must be provided through one or more service delivery methods: directly, or through written contracts and/or cooperative arrangements (which may include formal referrals).[2]

In OIG Advisory Opinion 22-17, the U.S. Department of Health and Human Services (H.H.S.) Office of Inspector General (OIG) analyzed a proposal whereby a regional non-profit health system would forgive debt owed by a federally qualified health center look-alike clinic (FQHC Look-Alike) with regard to the restructuring of a loan credit line, medical office lease, and master services agreement (collectively referred to as the Collaborative  Arrangement) between the parties. The OIG concluded that a proposed restructuring of the Collaboration Arrangement would not be subject to an enforcement action under the Anti-Kickback Statute (A.K.S.). 

On July 20, 2022, the United States Department of Justice (the DOJ) announced charges against multiple defendants alleging fraudulent schemes (including telemedicine arrangements) totaling more than $1.2 billion. That same day, the OIG issued a Special Fraud Alert describing suspect characteristics (Suspect Characteristics) of fraudulent telemedicine arrangements between telemedicine companies (Telemedicine Companies) with practitioners (Practitioners) and providers (Providers). The continuing focus on telemedicine health care fraud schemes signals heightened enforcement scrutiny of such arrangements.

Telehealth—the provision and coordination of healthcare remotely by means of telecommunications technology—is now an essential tool in the delivery of health care services. The COVID-19 pandemic created an incentive for federally qualified health centers (FQHCs) to quickly adopt telemedicine, eVisits, Virtual Check-Ins, remote patient monitoring, and other forms of virtual care. Medicare Advantage Plans and State Medicaid Managed Care Plans have recently added benefits that address social isolation//loneliness to combat feelings of isolation that can create emotional distress that exacerbates health conditions and may result in early mortality.

On January 13, 2021, the United States Supreme Court (the court), in a 5-4 per curiam decision, issued stays on injunctions issued by the Western District of Louisiana and the Eastern District of Missouri against enforcement of the Centers for Medicare & Medicaid Services’ (CMS) interim final rule (the Rule) requiring that providers participating in the Medicare and Medicaid programs ensure that their covered staff are vaccinated against COVID-19. The court reasoned that Congress has authorized the Secretary of Health and Human Services (the Secretary), in the interest of the health and safety of patients, to impose conditions on participation in the Medicaid and Medicare programs and receipt of funds for services rendered in the programs. The court held that the Secretary’s finding that the Rule’s vaccine mandate is “necessary to promote and protect patient health and safety” because the COVID-19 vaccination “substantially reduce[s] the likelihood that healthcare workers will contract the virus and transmit it to their patients,” fit well within CMS’ purpose and authorization.

The role of community pharmacies in health care has evolved and expanded in recent years. Many community pharmacies now offer health and wellness services related to identifying, preventing, and monitoring acute and chronic health care conditions. New developments in point of care testing technology have significantly broadened the number of available CLIA waived tests, and therefore have increased opportunities for community pharmacies to provide patient care services including point of care laboratory testing that takes place at or near the site where the patient is located. Pharmacies can collect specimens, conduct laboratory tests, interpret results, and make recommendations based on the results of screenings and diagnostic tests.

On Monday, November 29, 2021, a court in the Eastern District of Missouri issued an order granting a motion for a preliminary injunction of the Centers for Medicare and Medicaid Services' (CMS) interim final rule (the Rule), issued earlier this month on November 5, 2021. The Rule requires employees and contractors of certain healthcare facilities to be vaccinated fully by January 5, 2022. The challenge to the Rule was brought principally by the Attorneys General for ten states. Pending further court action, this order effectively blocks CMS from implementing and enforcing the Rule in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming (collectively, the States).

On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an emergency regulation, requiring the workforce of Medicare- and Medicaid- certified providers and suppliers to be fully vaccinated against COVID-19 in order for Medicare and Medicaid facilities to continue participation in those programs. Noncompliance with the emergency regulation may result in the termination of Medicare and Medicaid provider status and could also subject providers and suppliers to civil monetary penalties and denial of payment.

Last year, The New York Times published an article titled "How Chaos At Chain Pharmacies Is Putting Patients At Risk." The article described how many pharmacists in large chain pharmacies "struggle to fill prescriptions, give flu shots, tend the drive-through, answer phones, work the register, counsel patients and call doctors and insurance companies … all the while racing to meet corporate performance metrics that they characterized as unreasonable and unsafe in an industry squeezed to do more with less." Recent documents and data obtained by investigative reporters for an NBC News article entitled "Overworked, Understaffed: Pharmacists Say Industry In Crisis Puts Patient Safety At Risk" also alleges that large, publicly-traded pharmacy chains impose performance quotas on licensed pharmacists and pharmacy technicians that place at risk the health and well-being of patients. For itself, the California Pharmacy Association has stated  that "benchmarks and quotas are not conducive to the clinical practice of pharmacy and may actually inhibit a pharmacist's care for their patients."

Family Health Centers of San Diego (Health Center) operates a federally qualified health center (FQHC) that has 49 locations throughout San Diego County, California, and provides a comprehensive range of primary and preventive services, as well as pharmacy, dental, behavioral, and vision services to its patients, most of whom are Medi-Cal beneficiaries. FQHCs qualify for special payments for health care services covered by Medi-Cal. State Medicaid programs generally reimburse FQHCs based on service costs. The Consolidated Appropriations Act of 2001 (P.L. 106-554) established a prospective payment methodology based on service costs in a base year and trended forward using the Medicare Economic Index (MEI). In California, FQHC Medi-Cal reimbursement is 100 percent of reasonable and allowable costs for Medi-Cal services rendered to Medi-Cal beneficiaries.