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Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog

Contributors

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 ›

OIG Okays Complimentary Care to Patients in Recent Advisory Opinion

The OIG, in Advisory Opinion 19-03 issued on March 1, 2019, found it acceptable for a medical center to provide follow-up care in patients’ homes at no charge for individuals with congestive heart failure and chronic obstructive pulmonary disease who are considered to be at high risk of readmission to the medical center (the “Program”). Specifically, the OIG determined it would not impose sanctions based on the Program under the civil monetary penalty provision prohibiting inducements to beneficiaries. Read More ›

Medicare’s “3-Day Rule” Continues to Challenge CMS and SNFs

Authored by Joanne Lax (retired Member of Dykema)

Federal Medicare law requires that a Medicare beneficiary be admitted as an in-patient in a hospital for at least three consecutive days, not counting the day of discharge, in order for Medicare Part A to pay for a subsequent skilled nursing facility (SNF) stay (called the “3-day rule”). On February 14, 2019, the U.S. Department of Health and Human Service’s Office of Inspector General (OIG) confirmed that compliance with the 3-day rule is still challenging for the Centers for Medicare and Medicaid Services (CMS) and the SNFs that bill Medicare for Part A stays. Based upon extrapolation from a sample, the OIG determined that CMS overpaid approximately $84 million for non-compliant SNF stays during 2013 through 2015. See OIG Audit A-05-16-00043.  Read More ›

The New Anti-Kickback Statute in Town

On October 24, 2018, Congress enacted a new federal anti-kickback statute as part of its effort to combat the opioid epidemic. Congress established the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA establishes criminal sanctions (up to $200,000 fine and/or 10 years imprisonment) for each kickback violation. Unlike the anti-kickback statute set forth in 42 U.S.C. § 1320a-7b(b) (“AKS”) that only pertains to federal health care programs (e.g., Medicare and Medicaid), EKRA applies to any “health care benefit program” and, thus, extends to services payable by both a federal health care program and a commercial insurer.  Read More ›

A Longer Statute of Limitations for False Claims Act Qui Tam Suits?

A Supreme Court case to be decided this term will determine whether to extend the statute of limitations for private relators’ FCA actions in which the government does not intervene. United States ex rel. Hunt v. Cochise Consultancy, 2018 U.S. LEXIS 6778, at *1 (Nov. 16, 2018). The Department of Justice wants relators to have the same 10 year statute of limitations as the government has in cases where the government does intervene. Read More ›

Pathways to Success ACO Model

Authored by Joanne Lax (retired Member of Dykema)

On December 21, 2018, the U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model.[1] See 83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality. Read More ›

Medicare Coverage for Ambulance Services – Physician Certification Will Not Be Enough

A physician certification for Medicare coverage for ambulance services is not the final word. An ambulance service also must demonstrate the beneficiary’s condition and establish medical necessity when transporting the Medicare beneficiary. In a recent Southern District of Texas decision, the Court affirmed a decision by the Department of Health and Human Services (“HHS”) to deny payment to an ambulance service that provided repeated non-emergency transport to a Medicare beneficiary when the service failed to show that transportation by another means was contraindicated by the patient’s condition. Read More ›

Bona Fide Prescriber-Patient Relationship Requirement for Controlled Substance Prescribing Effective January 4, 2019

Bona Fide Relationship Requirement LawPublic Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”). The Michigan legislature delayed the effective date of the bona fide prescriber-patient relationship requirement to the earlier of (a) March 31, 2019, or (b) the date administrative rules describing the exceptions to the requirement are promulgated. Public Act 247 also requires the prescriber to provider certain follow-up care to the patient to monitor the efficacy of the CS in treating the patient’s medical condition. Failure to comply with the bona fide relationship requirement is considered professional misconduct and may subject the prescriber to professional discipline. Read More ›

If You Have Suggestions for Improving the HIPAA Privacy or Security Rule, Now Is the Time to Speak Up

Authored by Joanne Lax (retired Member of Dykema)

On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1] to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310. OCR will accept responses to the RFI until February 12, 2019. Read More ›