CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback Statute

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory Sprint to Coordinated Care.” The Regulatory Sprint to Coordinated Care “aims to remove potential regulatory barriers to care coordination and value-based care created by four key Federal health care laws and associated regulations: (1) the physician self-referral law [(“Stark Law”)]; (2) the anti-kickback statute [(“AKS”)]; the Health Insurance Portability and Accountability Act of 1996 [(“HIPAA”)]; and (4) the rules… related to opioid and substance use disorder treatment.” Continue Reading

California Expands Medicaid Telehealth Policy

The California Department of Health Care Services (“DHCS”) recently revised its Medi-Cal telehealth policy to allow providers increased flexibility in their use of telehealth as a modality for delivering medically necessary services to their patients. The policy is retroactively effective as of July 1, 2019, and fee-for-service providers must submit claims for services provided via telehealth according to the new policy. Updates to the telehealth policy include the following: Continue Reading

OIG to Audit Provision of Behavioral Health Services Through Tele-Health Under Medicaid Managed Care

In its recently updated Work Plan, the Office of the Inspector General (“OIG”) at the Department of Health & Human Services (HHS) announced that it will conduct an audit focusing on how selected state Medicaid agencies and Medicaid managed care organizations (“MCOs”) leverage telehealth to provide behavioral healthcare. Continue Reading

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to inform their regulatory strategies. Continue Reading

Bipartisan Push To Repeal ACA’s Cadillac Tax

One of the most controversial taxes of the Affordable Care Act (ACA) is in danger of repeal. The tax colloquially known as the “Cadillac Tax” was supposed to take effect in 2018, but Congress has delayed it twice. With the tax now slated to take effect in 2022, opponents of the tax have taken the opportunity to attempt to repeal it for good. On July 17, 2019, the House of Representatives overwhelming voted, 419-6, to approve the Middle Class Health Benefits Tax Repeal Act of 2019, which would abolish the Cadillac Tax. A Senate companion bill with 61 co-sponsors, including 32 Republicans and 28 Democrats, shows that the bill is unlikely to encounter much resistance if it is brought to a vote. Continue Reading

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway. Continue Reading

D.C. District Court Vacates CMS Final Rule, Finds that CMS’ Lesser Reimbursement of Services Provided at Grandfathered Off-Campus Provider-Based Departments Was Improper

On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for certain outpatient hospital services provided at certain off-campus provider-based departments (“PBDs”). Continue Reading

California Department of Managed Health Care Opposes AB 1249

On Monday, August 8th, the Deputy Director of Legislative Affairs of the Department of Managed Health Care (the “Department”) released a letter of opposition (the “Letter”) to Assembly Bill 1249 (“AB 1249”). The Letter was addressed to Brian Maienschein of the California State Assembly, who is the lead author of AB 1249. Continue Reading

The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle for Proving Falsity

In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for the purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of their conclusion, with no other evidence to prove the falsity of the assessment.” U.S. v. AseraCare, Inc., No. 16-13004, at *3 (Sept. 9, 2019 11th Cir.) (“Op.”). Although the Court remanded the case to the district court to consider any such “other evidence” the Government might identify in the record, it also made clear that such evidence would need to “link” to specific claims submitted for payment, creating a substantial practical impediment to the Government’s ability to prove falsity in this and similar cases. See Op. at 56. Continue Reading

CMS Finalizes Rule Expanding its Authority to Deny and Revoke Medicare Program Enrollment, Among Other Changes

On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule with comment period entitled, “Program Integrity Enhancements to the Provider Enrollment Process” (the “Final Rule”). The Final Rule, aiming to “address various program integrity issues and vulnerabilities by enabling CMS to take action against unqualified and potentially fraudulent entities and individuals,” significantly expands CMS’ ability to deny or revoke the Medicare enrollment of providers (e.g., hospitals, skilled nursing facilities, home health agencies, hospices, etc.) and suppliers (e.g., physicians, therapists, ambulance services, durable medical equipment suppliers, etc.) in ways that may create concerns even for providers and suppliers who are fully qualified and have not engaged in any fraudulent conduct. Continue Reading

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