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CMS Issues Additional Flexibilities to the ACO REACH Model’s Benefit Enhancements
December 16, 2022 | Blog | By Rachel Yount
As Accountable Care Organizations (ACOs) and providers gear up for the start of the new ACO REACH Model in 2023, CMS recently issued helpful policy updates to the model’s benefit enhancements (BEs). Under BEs, CMS waives certain Medicare payment requirements for services provided to REACH beneficiaries through the REACH ACO’s participant providers and preferred providers. REACH ACOs can opt to use one or more of the BEs, which are designed to create flexibility in managing REACH beneficiaries’ care. REACH ACOs have full control over which providers participate in any BE. As discussed below, CMS recently announced updates to two of the model’s BEs – the 3-Day Skilled Nursing Facility (SNF) Rule Waiver and the Nurse Practitioner (NP) Services.
Is Your Website Collecting PHI Under OCR's New Tracking Technologies Bulletin?
December 7, 2022 | Blog | By Dianne Bourque, Lara Compton, Kathryn Edgerton, Cassandra Paolillo, Kate Stewart
Covered Entities and Business Associates should promptly and carefully review their use of online tracking technologies on their websites and mobile apps following a bulletin (Bulletin) published by the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) last week. The Bulletin addresses multiple facets of compliance with HIPAA when using online third-party tracking technologies (Tracking Technologies). In doing so, OCR significantly expands its interpretation of the definition of Protected Health Information (PHI) to include, in some instances, identifiable information gathered by Tracking Technologies where a user visits a website and does not interact with the entity in any other way. In its Bulletin, OCR interprets the act of an individual visiting a website as evidence of a relationship or anticipated future relationship between the visitor and the entity.
New Year, New Laws: Changes to New York Health Care Provider Staffing Laws Taking Effect in January 2023
November 30, 2022 | Blog | By Cody Keetch, Jean D. Mancheno
In this post, we summarize the reforms under Article 28 of the New York Public Health Law and changes to general hospital and nursing home staffing laws and discuss what these changes mean for both.
DOJ Charges 10 Defendants for Allegedly Defrauding Public and Private Health Insurers Out of $11.1 Million Through Business Email Compromise Schemes
November 28, 2022 | Blog | By Kathryn Edgerton
This post provides insights and recommendations surrounding the DOJ's charges against 10 defendants involved in business email compromise schemes.
Health Care Workforce Shortages Persist in Massachusetts and the United States
November 22, 2022 | Blog | By Ryan Rasdall
The Massachusetts Health and Hospital Association (MHA) also recently released a survey raising similar alarm bells about health care workforce shortages in Massachusetts. The survey, An Acute Crisis: How Workforce Shortages are Affecting Access and Costs, provided a stark overview of the challenges facing Massachusetts, including health care workforce shortages, labor costs, and capacity constraints.
CMS Announces Changes to the MSSP Designed to Increase MSSP Participation and Promote Equity within the MSSP
November 17, 2022 | Blog | By Rachel Yount
The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Shared Savings Program (MSSP) designed to improve equity within the MSSP and increase the percentage of Medicare beneficiaries in accountable care arrangements. The changes are included in the Calendar Year 2023 Physician Fee Schedule final rule (Final Rule), which is scheduled for publication on November 18, 2022.
PBM Regulatory Roundup (Fall 2022): State Medicaid Enforcement Efforts Continue As Legislative Activity Slows Down
November 14, 2022 | Blog | By Bridgette Keller, Hassan Shaikh
Though the flurry of state PBM-focused legislation slowed down with the summer recess, there has still been plenty of noteworthy PBM news. This roundup focuses on state Medicaid enforcement activities involving Centene and provides a brief overview of recent legislative activity.
California Legislative Update Part I: New Requirements for Licensed Health Care Professionals
November 11, 2022 | Blog | By Kathryn Edgerton, Lara Compton
As of the close of the 2021-22 legislative session, Governor Gavin Newsom signed into law health care related legislation tackling issues from management of health care costs to reproductive rights. In Part I of our legislative update, we summarize many of the laws relevant to licensed health care professionals.
Advance Regulatory Review of California Health Care Transactions by the New Office of Health Care Affordability to Begin in 2024
November 9, 2022 | Blog | By Lara Compton, Kathryn Edgerton, Daria Niewenhous
The health omnibus trailer SB-184, which created the Office of Health Care Affordability (OHCA), is set to usher in a significant change in California’s health care regulatory landscape. In this post, we provide a preliminary review of the material changes that are set to begin in 2024.
Connecticut Joins the Interstate Medical Licensure Compact and the Psychology Interjurisdictional Compact
November 3, 2022 | Blog | By Jean D. Mancheno, Cody Keetch
Effective October 1, 2022, Connecticut adopted the Interstate Medical Licensure Compact (IMLC) and the Psychology Interjurisdictional Compact (PSYPACT). As of the date of this post, Connecticut joins 38 other states who have adopted the IMLC and 34 other states that have adopted the PSYPACT. This blog post provides an overview of the IMLC and PSYPACT and analyzes its impact in Connecticut.
Serial Relator Brings Multiple Lawsuits Alleging False Claims Act Violations Premised on Paycheck Protection Program Fraud
November 2, 2022 | Blog | By Laurence Freedman, Jane Haviland
This blog highlights a recently unsealed qui tam case brought by relator GNGH2, Inc against 15 entities that allegedly operated nursing homes in the Bronx, New York and in Florida and various health care staffing agencies.
Supreme Court Declines to Weigh in on False Claims Act Pleading Requirements
October 25, 2022 | Blog | By Brian Dunphy, Laurence Freedman, Ashley Markson
The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act (FCA).
California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database
October 11, 2022 | Blog | By Lara Compton, Rachel Yount
A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase patients’ awareness of the Open Payments database so they can make informed decisions about drugs and devices prescribed by their physician. This blog post provides an overview of the Open Payments Program, what exactly California's AB 1278 entails, and the implications of the law come January 2023 and January 2024.
Regulatory Roundup: Important FDA Developments at the End of September 2022
October 10, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary roundup for our readers!
Recent Federal and State Legislative Action Targeting Health Care Staffing Agencies
October 5, 2022 | Blog | By Stephnie John
Nurse and health care professional staffing shortages during the COVID-19 pandemic resulted in a significant increase in the use of temporary health care professional staffing. Shortages have also lead to the increase in the use of travel nurses, causing state lawmakers to prioritize regulation of health care staffing agencies. This post provides an overview of recently enacted and proposed state legislation requiring licensure or registration of health care staffing companies and/or nursing pools..
MintzRx — Digital Health Update: Federal Government Shows Growing Enforcement Interest in Online Prescribing of Controlled Substances
October 3, 2022 | Blog
Health care stakeholders across the industry are keeping close tabs on whether the current COVID-19 public health emergency declaration will be extended past October 13, 2022 and whether the various non-permanent flexibilities around telehealth services will correspondingly be extended. However, earlier this summer, increased oversight of medications prescribed via telehealth visits came to the surface as a consideration against the numerous benefits of the increased availability of telehealth services during the COVID-19 public health emergency.
MintzRx — The 340B Drama Continues
October 3, 2022 | Blog
It is no secret that the 340B program is fraught with controversy and is facing many challenges. The saga continued this summer with a unanimous Supreme Court decision finding that the Centers for Medicare & Medicaid Services’ (CMS) payment cuts to 340B hospitals under the 2018 Outpatient Prospective Payment System (OPPS) were illegal. Simultaneously, the fight between manufacturers, contract pharmacies, and the Health Resources and Services Administration (HRSA) continued. Currently, 18 pharmaceutical manufacturers now either refuse or restrict contract pharmacies’ access to 340B drugs and multiple cases on this issue are working through the courts.
MintzRx — Drug Pricing Update: The Inflation Reduction Act
October 3, 2022 | Blog
While the IRA is expansive, it does not include all current drug pricing reform proposals. We will continue to monitor lawmakers’ efforts to curb drug costs and the response from the pharmaceutical industry.
MintzRx — Summer 2022 Enforcement Round-Up: Key Trends in Pharmacy Enforcement Actions
October 3, 2022 | Blog
Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with DOJ and OIG bringing a number of fraud cases against pharmacies and pharmacists. Although many enforcement actions under the False Claims Act (FCA) continue to focus on illegal kickback arrangements, this summer we observed substantial developments in the enforcement landscape concerning Controlled Substances Act (CSA) prosecutions. We also saw enforcement actions brought against pharmacies for allegedly falsifying prior authorization information and providing more insulin than the pharmacy billed to payors.
MintzRx — Medicaid Best Price Value Based Purchasing Rules Took Effect July 1, 2022
October 3, 2022 | Blog
Medicaid Best Price Value Based Purchasing Rules Took Effect July 1, 2022
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