Health Law – Page 12 – Duane Morris Health Law

December 3, 2015December 3, 2015 by Amy E. McCracken

CMS released its Focused Dementia Care Surveyor Worksheets

The Centers for Medicare and Medicaid Services (CMS) released its Focused Dementia Care Surveyor Worksheets on November 27, 2015. The Worksheets were developed for a pilot project in 2014 as part of CMS’ continuing effort to reduce the use of antipsychotic medication. The Worksheets are to be used by surveyors in reviewing dementia care at post-acute care facilities. The Worksheets were released so that facilities can use these tools to assess their own practices in providing resident care.

The Worksheets contain specific topics for review, and state that failure of the facility to perform certain practices will result in a deficiency of F309. F309 addresses quality of care, and requires that each resident receive (and the facility provide) the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

Facilities that serve individuals with dementia should have policies and procedures based upon nationally-recognized dementia care guidelines, such as CMS’ Hand in Hand series, the OASIS program, the University of Iowa program, the VA Program (STAR), Johns Hopkins’ DICE program, Alzheimer’s Association materials, NHQCC or other QIO guidelines, Advancing Excellence medication management tools, or the AHCA toolkit.

The Worksheets also evaluate supervision, staff training, and Quality Assessment and Assurance, as well as the care provided to specific residents. All facilities that serve individuals with dementia should obtain and use the Worksheets to evaluate their own practices.

December 2, 2015 by Amy E. McCracken

Final AKS and Stark Waivers in Connection With the Shared Savings Program

The Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) issued the final rule regarding waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the “Shared Savings Program”). For purposes of the Shared Savings Program, providers must integrate in ways that potentially implicate fraud and abuse laws addressing financial arrangements between sources of Federal health care program referrals and those seeking such referrals. The Shared Savings Program focuses on coordinating care between and among providers, including those who are potential referral sources for one another—potentially in violation of the fraud and abuse laws.

In order to provide flexibility for ACOs and their constituent parts, the following five waivers have been created:

ACO pre-participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to ACO-related start-up arrangements in anticipation of participating in the Shared Savings Program, subject to certain limitations, including limits on the duration of the waiver and the types of parties covered.
ACO participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies broadly to ACO-related arrangements during the term of the ACO’s participation agreement under the Shared Savings Program and for a specified time thereafter.
Shared savings distributions waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to distributions and uses of shared savings payments earned under the Shared Savings Program.
Compliance with the physician self-referral law waiver – waives the Federal anti-kickback statute for ACO arrangements that implicate the physician self-referral law and satisfy the requirements of an existing exception.
Patient incentive waiver – waives the Beneficiary Inducements CMP and the Federal anti-kickback statute for medically related incentives offered by ACOs, ACO participants, or ACO providers/suppliers under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes.

The waivers apply uniformly to each ACO, ACO participant, and ACO provider/supplier participating in the Shared Savings Program. The waivers are self-implementing; parties need not apply for a waiver. Rather, parties that meet the applicable waiver conditions are covered by the waiver.

December 2, 2015 by Susan V. Kayser

OIG Issues Annual Work Plan/Long-Term Care Provider Initiatives Included

The HHS Office of Inspector General (OIG) has published its annual Work Plan for Fiscal Year 2016. The Work Plan summarizes new and ongoing reviews and activities that OIG plans to pursue with respect to federal health care programs, including Medicare and Medicaid, during the current fiscal year and beyond. Work Plan agenda items for Nursing Homes, Home Health and Hospice are summarized below. Continue reading “OIG Issues Annual Work Plan/Long-Term Care Provider Initiatives Included”

October 5, 2015 by Elinor H. Murarova

Recent Trends In FCA Litigation Against Hospice Care Providers

The Office of Inspector General identified “reducing waste in . . . hospice care” as one of the “top management challenges” for the 2015 fiscal year. The federal government’s efforts to respond to that challenge are illustrated by several recent developments in False Claims Act (“FCA“) cases brought against hospice care providers. For example, the Robinson-Hill, Betts, and Gooch cases discussed herein underscore the attention given to hospice care providers and their alleged billing and personnel-related practices, and the high monetary settlements that can result from such attention.

Continue reading “Recent Trends In FCA Litigation Against Hospice Care Providers”

August 21, 2015 by Elinor H. Murarova

Seventh Circuit Finds Hospital Not A “Credit Reporting Agency”

In Tierney v. Advocate Health & Hospitals Corp., the Seventh Circuit recently affirmed the dismissal of a Fair Credit Reporting Act (“FCRA“) complaint and found that a hospital was not a “credit reporting agency” under the FCRA. Continue reading “Seventh Circuit Finds Hospital Not A “Credit Reporting Agency””

August 20, 2015 by Philip H. Lebowitz

Another far-reaching FCA decision

The number of far-reaching and burdensome False Claims Act (FCA) decisions increases by the day. In an August 14, 2015 order by the U.S. District Court for the Middle District of Florida, a whistleblower’s complaint survived a motion to dismiss based upon some rather attenuated allegations. Since this matter was decided at the pleadings stage, the facts may ultimately dictate a different outcome; nevertheless, the cost and burden of defending the case may result in a costly settlement precipitated by this decision.

In the case, U.S. ex rel. Bingham v. BayCare Health System, the claim is that BayCare’s construction of medical office buildings, common areas, walkways and garages on the campus of a BayCare hospital (St. Anthony’s Hospital), provided a benefit to referring physicians sufficient to constitute prohibited remuneration under the Stark law. The medical office building was constructed by an entity called “St. Pete MOB, LLC”, which is not described as having ownership by referring physicians. Although the facts are not clear, it appears that the allegedly improper benefit to physicians took the form of BayCare providing a “non-exclusive parking easement” to St. Pete MOB. Continue reading “Another far-reaching FCA decision”

August 13, 2015 by Susan V. Kayser

Court Decision on 60-day Overpayment Rule Imposes Heavy Burden on Providers

As a result of an August 3, 2015 federal court decision, nursing homes and other health care providers that participate in Medicare or Medicaid are well-advised to pay careful attention to the law that requires report and return of any overpayment within 60 days of the date on which the overpayment is “identified.” In Kane v. Healthfirst, Inc. et al., the Southern District of New York found that the word “identified” means the date on which a provider is “put on notice” that a claim may have been overpaid. The court said that providers cannot delay commencement of the 60-day period until the overpayment amount has been definitively determined.

The defendants in the case had argued that simply being on notice of a potential overpayment was not enough to trigger the 60-day repayment rule, which was a provision in the 2010 Affordable Care Act. While recognizing the burden on providers to bring to conclusion a thorough and definitive investigation of a potential overpayment within 60 days, the court was firm in its finding, referring to the “demanding standard of compliance.” However, there was a suggestion that prosecutorial discretion could act to assist a provider that did not comply with the letter of the law but acted diligently to attempt to determine an overpayment amount within the required timeframe.

This case, triggered by a former employee of one of the provider defendants under the False Claims Act whistleblower provision, is important because it is the first time there has been a court opinion addressing the meaning of the term “identified” as used in the law. Draft regulations published in 2012 have not been finalized.

June 30, 2015 by Philip H. Lebowitz

“Per-click” fees OK but don’t count on it

The Stark Law, 42 U.S.C. 1395nn, places restrictions on lease arrangements between physician groups and hospitals for equipment owned by the physicians, leased to the hospitals and then used by the same physicians to treat patients at the hospital. Under the Stark Law, such leases are prohibited unless the arrangement complies with the equipment rental exception, 42 U.S.C. 1395nn(e)(1)(B).

One requirement of the equipment rental exception, which is both statutory and regulatory (42 C.F.R. 411.357(b)), is that the rental charges be “set in advance.” In a recent case from the D.C. Circuit Court of Appeals, Council for Urological Interests v. Burwell, the court considered whether a “per-click” or “per-use” fee could be considered “set in advance” and otherwise meet the criteria for the exception. In an oddly constructed opinion, the court struck down a regulatory prohibition on per-click arrangements, but remanded under terms that would permit the restriction to be re-instated. Continue reading ““Per-click” fees OK but don’t count on it”

June 26, 2015June 26, 2015 by Duane Morris

Duane Morris Partner Lisa Clark Featured in The Wharton Healthcare Quarterly

In the Spring 2015 edition of The Wharton Healthcare Quarterly, Duane Morris partner Lisa Clark’s article, “Affidavit: Healthcare and the Law – Healthcare Reform Update: What’s in a Name?,” discussed the innovations under the Affordable Care Act (ACA). One of the innovations was the Accountable Care Organization (ACO), where a new healthcare reimbursement system was introduced as an alternative to the tradition fee-for-service model. Over the years, the Accountable Care Organizations and other value-based models will be tested and hopefully, there will be buzz around this new model in the next year.

June 1, 2015 by Elinor H. Murarova

Gov’t and IPC Continue FCA Fight In Court

The Government and IPC The Hospitalist Company, Inc. (“IPC”) continue their False Claims Act (“FCA“) fight in court, now disputing the scope of discovery in light of the Northern District of Illinois’ partial denial of IPC’s motion to dismiss (detailed by Duane Morris here). The Government has moved to strike certain of IPC’s general objections to discovery: (1) IPC’s objection to producing documents from IPC’s nationwide operations and (2) IPC’s objection to producing documents dated after December 31, 2010 (“Motion“).

Continue reading “Gov’t and IPC Continue FCA Fight In Court”