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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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). The heightened pleading requirements of Federal Rule of Civil Procedure 9(b) require that, for allegations of fraud (which include FCA claims), “a party must state with particularity the circumstances constituting fraud or mistake.” Among other things, a cause of action for “false claims” must allege the defendants submitted false claims, or caused false claims to be submitted, to the government. The crux of the issue petitioners asked the Court to address is whether, to meet Rule 9(b)’s requirements for FCA causes of action, relators must allege in the complaint specific details of false claims allegedly submitted to the government for payment. This issue typically arises in qui tam cases under the FCA after the government declines to intervene.
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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.
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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!
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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.
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MintzRx — The 340B Drama Continues
October 3, 2022 | Blog
MintzRx — Drug Pricing Update: The Inflation Reduction Act
October 3, 2022 | Blog
MintzRx — Summer 2022 Enforcement Round-Up: Key Trends in Pharmacy Enforcement Actions
October 3, 2022 | Blog
MintzRx — Medicaid Best Price Value Based Purchasing Rules Took Effect July 1, 2022
October 3, 2022 | Blog
HHS, Treasury and Labor Issue More Guidance on the No Surprises Act
October 3, 2022 | Blog | By Marc Aspis
On August 19, 2022, the Departments of Health and Human Services, Treasury and Labor (the "Departments") issued final rules (the “Final Rules”) incorporating comments received on the interim rules issued in July and October 2021, clarifying some of the requirements set forth in Title I of Division BB of the Consolidated Appropriations Act, 2021 (the "Act") and the interim rules and accounting for relevant federal court rulings. In particular, the Final Rules primarily address three distinct but related topics: (1) eliminating the “rebuttable presumption standard,” (2) adding new rules regarding “downcoding,” and (3) reminding the arbitrators of their written requirements. In this post Mintz attorneys Mark Aspis and Alden Bianchi discuss the implication of the Final rules which will be effective on October 25, 2022.
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MintzRx — Tension Over Copay Assistance and Maximizer Programs Continues
October 3, 2022 | Blog
MintzRx — OCR Provides Post-Dobbs Guidance on Non-Discrimination to Pharmacies
October 3, 2022 | Blog
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