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Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog


HHS Proposes Anti-Kickback Statute and Stark Law Revisions Protecting Value-Based Arrangements and Care Coordination

On October 9, 2019, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) issued a Notice of Proposed Rulemaking to update the safe harbors to the federal Anti-Kickback Statute (“AKS”) and the Civil Monetary Penalties Law (“CMP Law”) related to the prohibition on beneficiary inducements. Read More ›

CMS Issues New Reporting Requirements for Providers and Suppliers

Authored by David Padalino

On September 10, 2019, the Center for Medicare & Medicaid Services (“CMS”) announced its Final Rule applying new reporting requirements for enrolled, and prospective, providers and suppliers. Medicare, Medicaid, and CHIP providers and suppliers will need to disclose their affiliations with organizations that have uncollected debts, are subject to a payment suspension under a federal health care program, have been excluded by the OIG, or had their Medicare, Medicaid, or CHIP billing privileges denied or revoked (“Disclosable Events”). Read More ›

Eleventh Circuit Rejects Expert Challenge to Clinical Judgment Decision in Hospice False Claims Act Litigation

On September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision for health care providers, especially those in the hospice industry. In U.S. v. AseraCare, Inc., No.16-13004, Slip. Op. (11th Cir. September 9, 2019), the Court held that a “reasonable disagreement between medical experts” about prognosis for a terminally ill patient, without more, cannot establish falsity. Slip. Op. at 3. The case began in 2008 as a qui tam action when former AseraCare company employees filed a False Claims Act lawsuit alleging that AseraCare submitted documents that falsely certified some Medicare patients were “terminally ill” and eligible for hospice care. The Government intervened. While the Eleventh Circuit remanded to the District Court to review its ruling in favor of AseraCare, the Eleventh Circuit upheld the lower court’s ruling that differing medical opinions do not qualify as “objective” evidence of falsity required by the False Claims Act.

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DHHS Issues Proposed Rule Amending 42 CFR Part 2

On August 22, 2019, the Substance Abuse and Mental Health Services Administration of the United States Department of Health and Human Services (“SAMHSA”) issued a proposed rule amending the Confidentiality of Substance Use Disorder Patient Records regulations set forth at 24 CFR Part 2. These regulations were initially implemented to provide heightened protection of patient records covering the treatment of substance use disorder (“SUD”) provided by certain federally funded programs (“Part 2 programs”). Read More ›

CMS Repeals Prohibition on Pre-Binding Arbitration for Long-Term Care Providers

On July 16, 2019, the Centers for Medicare & Medicaid Services (CMS) announced its final rule updating regulations pertaining to the use of arbitration agreements by long-term care facilities. Significantly, the final rule reversed CMS’s prior ban on pre-dispute arbitration agreements, imposed in CMS’s October, 2016 “Reforms of Requirements for Long-Term Care Facilities” final rule. Despite the repeal of the ban, the final rule continues to prohibit long-term care facilities from requiring a resident to sign an arbitration agreement as a condition of admission to, or receipt of care at, the facility.  Read More ›

The New Hazardous Waste Pharmaceuticals Rule: A Few Practical Steps to Prepare

On February 22, 2019, the federal Environmental Protection Agency (EPA) issued a final version of the hazardous waste pharmaceuticals rule. The new rule was promulgated under the federal Resource Conservation and Recovery Act (“RCRA”), that provides for significant civil and criminal penalties for violation. According to the EPA, the new rule is a “better fit” for healthcare organizations managing hazardous waste pharmaceuticals (HWPs) because it reduces overlapping regulation by the FDA and the DEA, and it provides regulatory clarity and national consistency on the application of federal environmental law to the reverse distribution and reverse logistics processes used in the healthcare industry. The updated rule also protects the environment by prohibiting the sewering (i.e., pouring down the drain or flushing down the toilet) of all HWPs effective August 21, 2019.   Read More ›

Overpayments and Statistical Sampling and Extrapolation in OIG Claims Audits

In January 2019, CMS amended its subregulatory program integrity guidance to Medicare contractors with more specific instructions on when and how to use statistical sampling and extrapolation to report and return overpayments (“Transmittal 828”). A subsequent February 2019 Report in Brief from the U.S. Department of Health & Human Services, Office of Inspector General (“OIG”) offers insight into this guidance in the context of an audit of inpatient rehabilitation facility claims (“Report”). Notably, the Report suggests that audit findings later overturned in the rebuttal stage or on appeal can nonetheless be credible information of an overpayment requiring further investigation and can justify extrapolation based on a sustained or high level of payment error. See below for links to Transmittal 828 and the Report. Read More ›

New Development: Government Authority to Dismiss Qui Tam Actions

The False Claims Act grants the government the authority to dismiss qui tam actions over the objections of the relator if “the court has provided the person with an opportunity for a hearing on the motion.”  31 USCS § 3730. However, what constitutes a “hearing” under the Act and the extent of the government’s authority to unilaterally dismiss qui tam actions has been the subject of dispute amongst the Courts of Appeals. Read More ›

Developments in Michigan Controlled Substance Regulation: New MAPS Communication Capabilities

NEW MAPS CapabilitiesThe Michigan Department of Licensing and Regulatory Affairs (“LARA”) announced the launch of two new communication capabilities in MAPS, available on July 18, 2019: Read More ›

Developments in Michigan Controlled Substance Regulation: New Exceptions for Hospice Patients

New Hospice ExceptionsMotivated by concerns that the requirements of Michigan controlled substance (“CS”) laws might result in hospice patients being denied timely access to necessary pain control drugs in their final days, the Michigan legislature amended the CS laws to benefit hospice patients, effective July 8, 2019. Two new exceptions give providers more flexibility under the bona fide prescriber-patient relationship requirement and the Michigan Automated Prescription System (“MAPS”) query requirement, both explained below, for meeting the pain control needs of hospice patients. Read More ›