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 Capabilities. The 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 Exceptions. Motivated 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 ›

Supreme Court Exposes FCA Defendants To Decade-Old Relator Suits

When the Supreme Court accepted the cert petition to resolve a Circuit split regarding the False Claims Act’s statute of limitations when the government does not intervene, it created the potential that the Court would extend the limitations period for private relators’ FCA actions. That is exactly what happened. The Supreme Court unanimously ruled that a relator can bring suit within three years after a government official knows, or should know, about a potential FCA violation—up to 10 years after the underlying event—and the relator does not count as a government official. Cochise Consultancy, Inc. v. United States ex rel. Hunt, No. 18-315 (U.S. May 13, 2019). FCA defendants may, therefore, face more qui tam suits reaching further back into their memories and records. Read More ›

Michigan Medicaid Issues New Requirements for Nurse Practitioner and Clinical Nurse Specialist Collaboration Agreements

Medicaid Bulletin MSA 19-10

Enrollment and Reimbursement for Clinical Nurse Specialists

On May 1, 2019, the Medical Services Administration of the Michigan Department of Health & Human Services (“MDHHS”), which administers the Michigan Medicaid program, issued Bulletin MSA 19-10 (the “Bulletin”), setting out new general information regarding enrollment, billing and reimbursement for a Clinical Nurse Specialist (“CNS”). CNS is a relatively new category of specialty certification available to a registered nurse (“RN”) in Michigan (Click here to access Bulletin MSA 19-10). The CNS Medicaid enrollment and coverage provisions essentially mirror those that apply to a Nurse Practitioner (“NP”), a long-established specialty certification for RNs in Michigan. Both NPs and CNSs, along with specialty certified nurse midwives (“CNM”), fall within the category of Advanced Practice Registered Nurse or APRN, which have an expanded independent scope of practice under recent amendments to the Michigan Public Health Code (“Code”). Read More ›

CMS Administrator Announces Continuing Effort to Improve Quality and Combat Abuse/Neglect in Skilled Nursing Facilities

Authored by Joanne Lax (retired Member of Dykema)

In a blog post published on April 15, 2019, the Administrator of the federal Centers for Medicare and Medicaid Services (CMS), Seema Verma, reiterated CMS’ “sacred trust” to protect residents of skilled nursing facilities (SNFs) from abuse and neglect and to ensure that they receive high quality care. Ms. Verma outlined five key initiatives that CMS has taken and is presently working on to fulfill this mission. While many sound familiar, the blog post evidences CMS’ renewed intent to impose stricter consequences for underperforming SNFs and to subject all SNFs to enhanced public scrutiny.  Read More ›

HIPAA Isn’t Only About Data Privacy and Security

Authored by Joanne Lax (retired Member of Dykema)

When we think about the Health Insurance Portability and Accountability Act of 1996 (HIPAA), many of us immediately think about protecting the privacy and security of individually identifiable health information. Justifiably so, since voluminous regulations mandate such protection, and because the federal government has stepped up its enforcement of those regulations and collected considerable sums in penalties for non-compliance. But a recent announcement by the U.S. Centers for Medicare and Medicaid Services (CMS) Division of National Standards reminds us not to forget another important set of HIPAA Administrative Simplification regulations. Both HIPAA and the Patient Protection and Affordable Care Act (ACA) require that certain electronic financial and administrative transactions be conducted using standard data content, code sets, and format (the Administrative Simplification Standards). On March 25, 2019, CMS announced that it will audit, via the Compliance Review Program, selected health plans and clearinghouses to determine compliance with these Administrative Simplification Standards. Read More ›

Auto-Deduction for Employee Meal Breaks Can Work for Hospitals, but be Careful!

Under the Fair Labor Standards Act, all employees must be paid overtime for all hours worked over 40 in a workweek. The law also requires employers to keep accurate records of all time worked. Many employers, though—particularly hospitals—often automatically deduct 30 minutes from their employees’ 8.5 workdays assuming that all employees take their regular 30-minute meal breaks. But what happens when an employee is interrupted during the employee’s meal break to answer a call, attend to a code or other emergency, and the like? This scenario has been fodder for lawsuits against hospitals, most recently in an Ohio federal court–Myers v. Marietta Memorial Hospital, No. 2:15-CV-2956 (S.D. Ohio March 27, 2019). Read More ›