On July 26, 2022, we published a blog post detailing part one of three of proposed regulations published by the New York State Office of Medicaid Inspector General (OMIG). The proposed regulations would repeal the current Part 521 - Provider Compliance Programs of Title 18 of the New York Codes, Rules and Regulations (NYCRR) in its entirety and establish new requirements for providers to detect and prevent fraud, waste, and abuse in the Medicaid Program under a new Part 521: Fraud, Waste, and Abuse Prevention (Part 521). In this post, we summarize the second subpart of Part 521 covering proposed regulations that would require MMCOs to develop and implement programs to detect and prevent fraud, waste, and abuse in the Medicaid program.

On an episode of Connected Nation, Lara Compton and Jean Krebs examined a report from the White House Office of National Drug Control Policy, which issued new guidance and recommendations for making some telehealth access measures permanent when treating substance use disorders. 

The New York State Office of Medicaid Inspector General (OMIG) published proposed regulations in the July 13, 2022 issue of the New York State Register.  The proposed regulations would repeal the current Part 521 - Provider Compliance Programs of Title 18 of the New York Codes, Rules and Regulations (NYCRR) in its entirety and establish new requirements for providers to detect and prevent fraud, waste and abuse in the Medicaid Program under a new Part 521: Fraud, Waste, and Abuse Prevention (Part 521). This blogpost highlights certain provisions from the first of Part 521’s three subparts, Subpart 521-1, that are relevant to New York Medicaid providers as they structure and update their compliance programs.

Bridgette Keller speaks with Kerlann Flowers, Legal Director and Senior Attorney for Hofstra University School of Law’s Medical-Legal Partnership (MLP), and Mintz Associate Jean Krebs about the MLP’s work and how collaboration between medical providers and lawyers can improve outcomes.

On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with substance use disorders (SUD). The guidance, titled Telehealth and Substance Use Disorder Services in the Era of Covid-19: Review and Recommendations (Guidance), made four recommendations geared at increasing telehealth access, utilization, and equity among individuals who have experienced an SUD. This blogpost with provide an analysis of the four recommendations and their implications. 

On May 11, 2022, New York Governor Kathy Hochul announced the creation of the Department of Financial Services’ Pharmacy Benefits Bureau. Governor Hochul noted that the Pharmacy Benefits Bureau is the first of its kind in the country. The Pharmacy Benefits Bureau will be tasked with implementing and overseeing new licensing and reporting requirements impacting Pharmacy Benefit Managers (PBMs) in New York.  This blog post provides an analysis of the intended purpose of the Pharmacy Benefits Bureau and an overview of the new PBM guidance from the Department of Financial Services.

On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health center (FQHC) (hereafter, Requestor) that loans limited-use smartphones to enable existing patients’ access to Requestor’s telehealth platform (the Arrangement).  The Arrangement’s purpose is described as increasing access to telehealth services and combating isolation by allowing patients to talk and text with others, including during the COVID-19 public health emergency (PHE).

Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its Provider Relief Fund (PRF) to certain providers. These providers can then use the funds to support COVID-19 prevention, preparedness, and response, or to alleviate loss of patient care revenue.  However, HRSA requires that providers receiving PRF funds comply with certain requirements, including post-payment reporting requirements.  HRSA is now notifying providers that failed to comply with the reporting requirements that they must return the PRF funds they received. 

On March 18, 2022, President Biden signed the Dr. Lorna Breen Health Care Provider Protection Act (Act) into law. The Act is named for Dr. Lorna Breen, who served as the Medical Director of New York-Presbyterian Allen Hospital. Dr. Breen died by suicide in April 2020, as the COVID-19 pandemic was taking hold of the nation and, in particular, New York City. Since Dr. Breen’s passing, her family has established the Dr. Lorna Breen Heroes’ Foundation (Heroes’ Foundation). The Heroes' Foundation’s mission is to reduce burnout, safeguard the well-being of health care providers (HCPs), and reduce the stigma surrounding HCPs seeking help or treatment. The Act is a crucial step in achieving this mission.

In an effort to counteract rising prescription drug costs and health insurance premiums, New York Governor Hochul signed S3762/A1396 (the Act) on December 31, 2021.  This legislation specifies the registration, licensure, and reporting requirements of pharmacy benefit managers (PBMs) operating in New York. The Superintendent of the Department of Financial Services (Superintendent) will oversee the implementation of this legislation and the ongoing registration and licensure of PBMs in New York. Notably, this legislation establishes a duty of accountability and transparency that PBMs owe in the performance of pharmacy benefit management services.