Among the plethora of different contractors used by the Centers for Medicare & Medicaid Services (CMS) to administer the Medicare program is the Supplemental Medical Review Contractor, or SMRC. Like the Medicare Administrative Contractors (MACs), Recovery Audit Contractors (RACs), Unified Program Integrity Contractors (UPICs), and others, the SMRC – of…
The integration of Artificial Intelligence (AI) into healthcare represents a frontier of innovation, offering transformative potential for patient care, diagnostic accuracy, and operational efficiency. However, as healthcare providers and technology companies rapidly adopt AI solutions, navigating the complex landscape of regulatory compliance becomes increasingly crucial. This landscape is defined by…
When structuring healthcare arrangements, three major compliance challenges frequently emerge: the Stark Law (officially the Physician Self-Referral Law), the Anti-Kickback Statute (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA). These laws govern referrals to or from a healthcare provider or supplier and carry the risk of severe, sometimes criminal,…
Nearly 4 years after the beginning of the COVID-19 pandemic, healthcare providers continue to see payor audits and demands for repayment for services provided during the pandemic, primarily COVID-19 testing and vaccinations. While these services were an essential public function during the pandemic, constantly changing and often unclear rules and…
Both the Centers for Medicare & Medicaid Services (CMS) and its plethora of contractors rely on the mail to notify providers and suppliers of document requests, audit findings, disciplinary actions, and many other important items. Providers should be careful that their mailing addresses on file with Medicare are current and…
Medicare providers who use skin substitutes, allografts, and similar products for wound care are seeing a sharp increase in audits by Medicare contractors. These products often carry high reimbursement rates and require frequent reapplication. Therefore, they are seen by the Medicare program as high risk for improper payments or outright…
The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently released a joint statement suggesting that the FDA is about to end its decades-long policy of declining to regulate lab-developed tests (LDTs). The statement casts the policy as outdated and suggests that the FDA…
The Michigan Medicaid program recently sent a program-wide email to healthcare providers and suppliers reminding them of certain duties under the Michigan Medicaid program. Specifically, the Michigan Department of Health and Human Services (“MDHHS”), which oversees the Michigan Medicaid program, emailed providers that: “As a reminder, all Medicaid-reimbursed services are…
Earlier this month, the Department of Health and Human Services (HHS) released a concept paper that outlines the Department’s cybersecurity strategy for the healthcare sector. The concept paper builds on the Biden Administration’s National Cybersecurity Strategy, specifically focusing on strengthening resilience for hospitals, patients, and communities threatened by cyber-attacks. The…
Recently, the Centers for Medicare & Medicaid Services (CMS) published the calendar year (CY) 2024 physician fee schedule (PFS) final rule, which solidified certain proposed changes to Medicare provider enrollment requirements. The changes discussed below go into effect January 1, 2024. The final rule expands CMS’s current revocation and denial…