Dykema Gossett PLLC

Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog

Contributors

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 ›

CMS Continues to Enhance Oversight of Accrediting Organizations

The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331. CMS will accept responses to the RFI until February 19, 2019. Read More ›

PBJ: The Sandwich that Bites Back

Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now. CMS uses this data to publically report each SNF’s nurse staffing level on its Nursing Home Compare website and to calculate each SNF’s Five Star Rating. Publication of this PBJ data is part of CMS’ initiatives to keep consumers informed about SNF quality, so that market pressure will incentivize SNFs to improve their performance. But the PBJ data is now going to bite some SNFs through survey enforcement. Read More ›