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.

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.

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.

Many of our nation’s 18 million veterans experience significant day-to-day challenges related to their time in the military. Through our pro bono legal counsel and the firm’s community services, including a holiday gift drive for veterans, we assist many nonprofit and advocacy organizations working to improve veterans’ lives.

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.

Throughout 2021, former Governor Andrew Cuomo introduced sweeping legislation to initiate reform in nursing homes licensed under Article 28 of the New York Public Health Law. While many of these laws took effect this past year, some are set to take effect in the New Year and beyond. Below we provide a brief overview of three that are taking effect in January 2022.

On November 8, 2021, Governor Hochul signed legislation to permanently amend the New York Business Corporation Law and New York Not-for-Profit Corporation Law. Under the new law, for profit and not-for-profit corporations are permitted to hold their shareholder or member meetings solely through virtual means, unless such virtual meetings are prohibited by a corporation’s articles of organization or bylaws.

On Friday, August 6, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA), the preeminent trade association representing pharmacies companies, announced revisions to its Code on Interactions with Health Care Professionals (PhRMA Code) that will become effective January 1, 2022. The PhRMA Code is a voluntary code for pharmaceutical companies, but its standards are considered to be best practices and are commonly adhered to by pharmaceutical and medical device companies. Moreover, some states (e.g. California, Massachusetts, Nevada, and the District of Columbia) require pharmaceutical companies to adopt a code consistent with the PhRMA Code.

The changes to the PhRMA Code are undoubtedly in response to a November 16, 2020, Special Fraud Alert from the Department of Health and Human Services’ Office of the Inspector General (OIG), on “fraud and abuse risks associated … speaker programs.” (For additional information on the OIG’s Special Fraud Alert, please see our November 25, 2020 blog post.) Speaker programs are a common practice in the industry and generally entail pharmaceutical and medical device companies retaining health care professionals (HCPs) to speak or present to educate their peers on the companies’ drugs or devices.

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance, which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for determining whether an act done to an original equipment manufacturer’s (OEM’s) legally marketed finished device is considered remanufacturing (the “Draft Remanufacturing Guidance”).