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CMS Announces Drug List for Inflation Reduction Act Price Negotiations
August 29, 2023 | Alert | By Theresa Carnegie, Lauren Moldawer
OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers
August 23, 2023 | Blog | By Rachel Yount, Karen Lovitch
On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider of intraoperative neuromonitoring (IONM) services. In reaching its determination, the OIG stated that Newco and its arrangements with the IONM Company would present a significant risk under the federal Anti-Kickback Statute (AKS) primarily because it exhibits many indicia of a suspect contractual joint venture.
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California Publishes Proposed Regulations for the Pre-Closing Review of Health Care Transactions: What You Need To Know Before January 1, 2024
August 7, 2023 | Blog | By Lara Compton, Daniel Cody, Kathryn Edgerton
January 1, 2024 is rapidly approaching, which is when California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care mergers, acquisitions, affiliations, and other arrangements that result in material changes of assets, control, or governance. The law establishing OHCA left many details regarding the types of transactions that would be subject to review to be established by emergency regulations, which have been proposed and are available here. A public workshop will be held on August 15, 2023 (more information here), allowing for public comment and the written comment period will be open until August 31, 2023. The final emergency rulemaking package is expected to be submitted in October 2023.
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CMS Announces GUIDE – a New Dementia Care Model Designed for Participation by a Range of Providers
August 2, 2023 | Blog | By Rachel Yount
Health care providers furnishing dementia care should take note of a new payment model announced by the Centers for Medicare & Medicaid Services on July 31, 2023, called Guiding an Improved Dementia Experience (GUIDE). GUIDE is designed to improve dementia care, reduce strain on unpaid caregivers, and help people with dementia remain in their homes and communities. Providers participating in GUIDE receive monthly per-beneficiary per-month payments, can bill for respite care services, and are eligible for one-time payments to support infrastructure.
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OIG, HHS Publish Information Blocking CMP Final Rule, Enforcement Priorities
July 13, 2023 | Blog | By Pat Ouellette
Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun enforcing statutory penalties associated with violations of the Information Blocking Rules. On July 3, 2023, OIG and Department of Health and Human Services (HHS) took a significant step toward enforcement of these penalties when they published long-awaited civil monetary penalty (CMP) final rule (CMP Final Rule) for certain Information Blocking Actors in the Federal Register.
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Recent Developments Signal Headwinds for Homeopathic Drug Products
June 26, 2023 | Blog | By Joanne Hawana
Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes articles recognized in the official Homoeopathic Pharmacopoeia of the United States (a historical perspective can be found in this ScienceInsider article from 2015, when government scrutiny was beginning to increase). But on the other hand, there is growing consensus that the effectiveness of such products is not supported by scientific evidence and that they are, in many cases, mere placebos that do not actually treat the patient’s medical conditions; in the worst cases, they contain harmful ingredients that may cause serious injury.
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New California Mental Health and Addiction Treatment Laws
May 4, 2023 | Blog | By Lara Compton, Kathryn Edgerton, Ryan Rasdall
Governor Gavin Newsom signed multiple pieces of mental health treatment-related legislation into law in 2022 that have or will begin to go into effect this year. These laws address mental health commitment timing and hearing rights, involuntary mental health treatment, the CARE program, and substance use disorder treatment client rights. This is a good time for relevant facilities and groups to audit the effectiveness of updated policies and evaluate and address any operational issues that may have cropped up during implementation.
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Supreme Court Justices Agree to Hear Second FCA Issue This Term
January 19, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s authority to dismiss an FCA whistleblower case after declining to intervene, the Court has now granted certiorari to hear two cases addressing what constitutes a “knowing” violation of the FCA. Hanging in the balance is the fate of two lower court decisions that endorsed a powerful defense to FCA liability.
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CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard
January 17, 2023 | Blog | By Laurence Freedman, Jane Haviland
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims Act (FCA) and the Civil Monetary Penalties Law. Though this proposal purportedly ensures that a lack of “reasonable diligence” cannot create civil liability, it would create significant confusion as to how CMS expects providers and Medicare Advantage organizations (MAOs) to “identify” and quantify potential overpayments before triggering the 60-day period to refund them. The proposed rule, if adopted, would likely become part of the framework for the Department of Justice and Department of Health & Human Services’ Office of Inspector General when evaluating potential liability for the alleged failure to return overpayments.
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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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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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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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Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations
August 18, 2022 | Blog | By Kevin McGinty, Rachel Yount
In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth Circuit adopted a stricter but-for causation standard for FCA claims based on AKS violations, holding that, in order to prevail on these claims, the government must prove that FCA defendants would not have submitted claims for particular items or services to Medicare or Medicaid absent the illegal kickbacks.
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Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation
July 19, 2022 | Blog | By Karen Lovitch , Lauren Moldawer, Jane Haviland
Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation” (the Policy Guidance). Since then, the industry has been watching to see how DOJ implements this Policy Guidance.
Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases. Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.
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Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases. Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.
OIG Issues Favorable Opinion on Federally Qualified Health Center’s Smartphone Loan Program
May 6, 2022 | Blog | By Rachel Yount, Jean D. Mancheno
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).
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OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09
May 5, 2022 | Blog | By Karen Lovitch
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a network of laboratories (the Requestor) would compensate hospitals for certain specimen collection services related to testing performed by Requestor (the Proposed Arrangement). The OIG ultimately concluded that the Proposed Arrangement poses a risk of fraud of abuse under the federal Anti-Kickback Statute (AKS). In this post, we will cover the OIG’s rationale for this decision, as well as some of the history of the OIG’s scrutiny of specimen collection arrangements.
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DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action
April 28, 2022 | Blog | By Samantha Kingsbury
Last week, the Department of Justice (DOJ) announced another significant takedown that it described as “build[ing] on the success of the May 2021 COVID-19 Enforcement Action.” As part of this enforcement effort, criminal charges were announced against 21 defendants across the country for their alleged involvement in various COVID-19 related fraud schemes that resulted in over $149 million in “COVID-19 related false billings to federal programs and theft from federally-funded pandemic assistance programs.”
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OIG Approves Manufacturer’s Offer of Free Genetic Testing
April 14, 2022 | Blog | By Karen Lovitch , Theresa Carnegie, Pat Ouellette
The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a pharmaceutical manufacturer would not result in the imposition of sanctions under the federal Anti-Kickback Statute (AKS) and the beneficiary inducements civil monetary penalty provision (Beneficiary Inducements CMP). This Advisory Opinion is the first to address this type of arrangement and thus provides useful insight for the health care and life sciences industries.
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HRSA Demands Repayment from Providers that Failed to Comply with Provider Relief Fund Reporting Requirements
April 11, 2022 | Blog | By Jean D. Mancheno
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.
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