The Department of Justice (DOJ) lost its third jury trial in its mission to secure criminal convictions against companies and executives accused of labor-side antitrust violations on March 22, 2023, when a jury in Maine acquitted four home healthcare staffing executives of violating Section 1 of the Sherman Act. In United States v. Manahe, the DOJ charged Faysal Kalayaf Manahe, Yaser Aali, Ammar Alkinani, and Quasim Saesah with entering into an approximately two-month conspiracy between April and May 2020 not to hire each other’s caretakers and to fix caretaker wages.[1] After the district court declined to dismiss the indictment, holding
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DOJ Revises Guidance on Evaluation of Corporate Compliance Programs Concerning Compensation and Employee Use of Personal Devices and Personal Messaging Applications
Following remarks made on March 2 and March 3, 2023 at the American Bar Association’s 38th Annual National Institute on White Collar Crime, the U.S. Department of Justice (“DOJ”) issued revisions to its Evaluation of Corporate Compliance Programs (“ECCP”). The newly revised ECCP guidance contains two important changes: (1) the DOJ has directed prosecutors to “consider more closely compensation structures and consequence management when evaluating compliance programs”, and (2) the DOJ will consider corporate practices surrounding the use of personal devices, communications platforms, and messaging applications, including ephemeral messaging applications, and the company’s ability to access and produce underlying data.
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Payor-Led Initiatives to Strengthen Mental Health Resources
In light of the increasing demand for mental health treatment and simultaneous provider shortages, the private insurance industry is rolling out targeted initiatives to increase mental health support for members by mitigating many of the barriers to entry facing the mental health industry today.
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CMS Releases First Set of Part B Rebatable Drugs for Coinsurance Adjustment Under IRA
The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the guidance documents issued by the Centers for Medicare and Medicaid Services (“CMS”) detailing the proposed implementation of the Medicare Part B and Medicare Part D Prescription Drug Inflation Rebate Programs.
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PBM Practices Receive Increased Federal Scrutiny
Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers and agencies.
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Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency
According to the White House, the end of the COVID-19 national emergency and public health emergency (PHE) declarations is now barely two months away, as they are scheduled to end on May 11, 2023. These declarations provided the federal government with flexibility to waive or modify certain regulatory requirements applicable to the healthcare industry. Once the declarations end, so will the vast majority of these flexibilities and waivers. Accordingly, a relatively short and closing window remains for the healthcare industry – including but not limited to health plans, hospitals, home health agencies, clinics, and entities that offer telehealth services – to…
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California Office of Health Care Affordability: Another Regulatory Hurdle for California Healthcare M&A Transactions?
California has a new regulatory review process that could have implications for healthcare mergers and acquisitions and similar transactions in the state. By way of background, after nearly two years of negotiations with state legislators, Governor Gavin Newsom signed into law healthcare omnibus bill SB 184 on June 30, 2022, which created the new Office of Health Care Affordability (OHCA). With this new law and state agency, California joins several other states, including Massachusetts, New Jersey, Oregon, Washington and Nevada in implementing oversight and funding measures geared towards healthcare cost growth targets and containment. While the goal of the law…
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OIG Advisory Opinion Alert: Medical Flights for Patient Access
On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug manufacturer to provide financial assistance for transportation, lodging, meals, and other out-of-pocket expenses to eligible patients receiving the manufacturer’s drug (the “Arrangement”). Overall, OIG concluded that: (1) the risk of fraud and abuse presented by the manufacturer’s Arrangement was sufficiently low under the Federal anti-kickback statute; and (2) the remuneration offered under the Arrangement was not likely to influence a beneficiary to…
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ChatGPT And Healthcare Privacy Risks
Since its launch in November 2022, ChatGPT (“GPT” stands for Generative Pre-trained Transformer), a type of artificial intelligence model, has gained over a million users. ChatGPT is used by entities in a wide variety of industries. On March 1, 2023, OpenAI, the developer of ChatGPT, updated its data usage policies[1] noting that (i) OpenAI will not use data submitted by customers to train or improve its models unless customers expressly opt-in to share such data, and (ii) OpenAI also will enter into business associate agreements in support of applicable customers’ compliance with the Health Insurance Portability and Accountability Act (“HIPAA”).
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CMS’s Administrative Simplification Rule Aims to Increase Efficiency and Standardization for Health Care Attachments
The Centers for Medicare & Medicaid Services (“CMS”), on behalf of the U.S. Department of Health and Human Services (“HHS”), recently issued a proposed rule to adopt standards under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) for “health care attachment” transactions (the “Proposed Rule”). The Proposed Rule would implement requirements of HIPAA’s administrative simplification regulations, which are intended to support healthcare claims and prior authorization transactions while also introducing a standard format for electronic signatures to be used in conjunction with health care attachments.
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DEA Proposes Rule for Post-PHE Telemedicine
This blog is the third installment of our Digital Health Trends Series, see previous blog posts here and here.
On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008 (“RHA”) after the COVID-19 Public Health Emergency (“PHE”) terminates on May 11, 2023. The proposed rule extends certain flexibilities beyond the PHE and proposes to make permanent certain scenarios, in which a practitioner may prescribe controlled substances without a prior in-person medical evaluation.
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Telehealth in a Post-PHE World
The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid Services in its response to the public health emergency (“PHE”) declared in March of 2020 and which was repeatedly renewed until now. On January 30, 2023, President Joe Biden announced that the PHE would end on May 11, 2023. As the curtains are drawn on the PHE, there can be no doubt that telehealth is here to stay. In light of that reality, it is…
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CMS Streamlines Stark Law Self-Referral Disclosure Protocol (SRDP)
Effective March 1st, certain providers choosing to self-disclose Stark Law violations must use forms updated by the Centers for Medicare & Medicaid Services (“CMS”).
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CMS Updates List of Telehealth Services for CY 2023
On February 13, 2023, the Centers for Medicare and Medicaid Services (CMS) published the revised List of Telehealth Services for Calendar Year (CY) 2023 (List). The List includes the services that are payable under the Medicare Physician Fee Schedule when furnished via telehealth.
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CMS Issues Proposed Rule Requiring Nursing Homes to Disclose Additional Ownership Information, Including Ties to Private Equity and REITS
On February 15, 2023, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require nursing homes enrolled in Medicare and Medicaid to disclose new information about their ownership and management structures. If finalized, the rule would require nursing homes to disclose any ties to private equity companies or real estate investment trusts (REITs) (defined below), as well as the names and information of individuals and entities that provide certain administrative, management or consulting services.
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Navigating Permissive State Laws in Light of the Federal Information Blocking Rules
Under the 21st Century Cures Act information blocking requirements and the regulations promulgated thereunder by the Office of the National Coordinator for Health IT (ONC) (the Information Blocking Rules), certain actors, such as healthcare providers and certain electronic health record developers (Actors), are prohibited from engaging in information blocking of electronic health information (EHI). Information blocking is defined, in part, as a practice that “[e]xcept as required by law or covered by an exception [to the information blocking regulations], is likely to interfere with access, exchange, or use of electronic health information.”[1] Put simply, the Information Blocking Rules generally…
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