Duane Morris Health Law

January 27, 2016 by Seth A. Goldberg

Dental Providers and Labs Allege Antitrust Conspiracy

Dental and orthodontic practices and dental laboratories around the U.S. are being represented in class actions filed this week in federal courts in Texas and New York, see, e.g., Comfort Care Family Dental, P.C. et al v. Henry Schein, Inc. et al, 1:16-cv-00282 (E.D. NY), that claim defendants Henry Schein, Inc., Patterson Companies, Inc., and Benco Dental Supply Company (“Benco”), alleged to be the dominant dental product distributors in the U.S., together controlling over 80% of the national market for the distribution of dental supplies and dental equipment, conspired to boycott competitors in that market in violation of Section 1 of the Sherman Act.

The Comfort Care complaint asserts that Defendants’ conduct constitutes a horizontal group boycott that resulted in either a per se violation of Section 1 or a violation of the Sherman Act under the “rule of reason,” and alleges that Defendants “frequently communicated with each other at in-person meetings, via electronic mail and texts, and through phone calls” to collectively respond to new competitors and pressure dental associations as part of the group boycott. The Comfort Care complaint also provides economic information purporting to demonstrate that the alleged market is highly concentrated, has high barriers to entry, and has experienced increased pricing despite static or declining demand, all of which support the claim of anticompetitive conduct.

In addition to the private antitrust actions, as the Comfort Care complaint alleges, various state AGs and the FTC are investigating Defendants’ conduct as well, and Benco has already agreed to a consent judgment with the Texas AG pertaining to some of the conduct at issue in the private actions.

January 22, 2016 by Seth A. Goldberg

Another Healthcare Fraudster Convicted

In addition to the sentencing Tuesday of Patricia Akamnonu, owner of Ultimate Care Home Health Services, for 10 years for conspiring with her husband and others to commit healthcare fraud, late yesterday the owner and manager of three Miami-area home health agencies, Khaled Elbeblawy, was convicted on counts of conspiracy to commit healthcare fraud and wire fraud and one count of conspiracy to defraud the United States and pay healthcare kickbacks.

The $57 million healthcare fraud scheme involved Elbeblawy and his co-conspirators submitting false claims to Medicare for services that were not actually provided, not medically necessary, or for patients who were procured through kickbacks to doctors and patient recruiters.

The case was brought as part of the Medicare Fraud Strike Force, which operates in nine cities across the country, and has charged nearly 2,000 defendants who have collectively billed more than $6 billion.

January 22, 2016January 22, 2016 by Seth A. Goldberg

Wife Joins Husband Behind Bars for Healthcare Fraud

On Tuesday, January 19, a federal judge in Texas sentenced Patricia Akamnonu to 10 years in federal prison for her role in a conspiracy to commit healthcare fraud. Akamnonu and her husband, Cyprian Akamnonu, who together owned Ultimate Care Home Health Services, pleaded guilty to their role in the conspiracy, which involved them and others recruiting Medicare beneficiaries for treatment at Ultimate and then billing for skilled nursing services that the beneficiaries either did not qualify for or were not necessary. Mr. Akamnonu is currently serving out a similar 10-year sentence, and both were ordered to each pay $25 million in restitution.

The conspiracy, which raked in $40 million plus for Ultimate and $375 million for all of the co-conspirators, is considered one of the largest healthcare frauds in history. Dr. Jacques Roy, who certified more than 78% of the false claims submitted to Medicare by Ultimate and the Akamnonus, is scheduled to be tried for his role in the conspiracy in May 2016, and faces a possible life sentence.

A reminder to providers that healthcare fraud can carry stiff criminal and civil penalties.

January 15, 2016 by Seth A. Goldberg

False Claims Act Claims Dismissed by Federal Court in Florida

In an important decision for providers facing a lawsuit alleging violations of the False Claims Act, the U.S. District Court for the Middle District of Florida, in U.S. ex rel. Pelletier v. Liberty Ambulance Service, Inc., Case No. 3:11-cv-587-J-32MCR (Middle District of Florida, Jacksonville Division), dismissed the government’s complaint intervening in a qui tam action that alleged that Liberty Ambulance Service, among other providers that settled with the government prior to the dismissal, submitted false claims to Medicare and Medicaid for ambulance services that were never provided, on the basis that the government’s complaint failed to satisfy the heightened pleading requirements under Federal Rules of Civil Procedure 8 and 9.

The Court’s decision is significant because the government attached to its complaint affidavits of current and former employees of Liberty and a dispatcher, along with other materials, suggesting that falsified reports were submitted to Liberty that would be payable by Medicare and Medicaid, but, as the Court found, “the allegations stop short of describing what happened once the run reports were submitted to the Liberty office for processing.” The Court’s decision hinged on the lack of any evidence pertaining to the actual billing process employed by Liberty. In fact, the affidavit of the person who claimed the most familiarity with that process, did not claim to have witnessed the submission to the government of any actual false claims.

Although the dismissal was without prejudice to the government amending the complaint to provide greater particularity, the decision is an important example for providers facing False Claims Act claims of how the heightened pleading requirements under FRCP 8 and 9 may strengthen their defense.

January 13, 2016January 13, 2016 by Seth A. Goldberg

$125 Million Settlement For Alleged FCA Violations

In a settlement with the US DOJ in U.S. ex rel. Halpin and Fahey v. Kindred Healthcare Inc. et al., 1:11-cv-12139, Kindred Healthcare, Inc., a skilled nursing and long-term care company, has agreed to pay the federal government more than $125 million for alleged False Claims Act violations by a therapy services company, RehabCare Group, Inc., acquired by Kindred in June, 2011.

RehabCare contracts with more than 1,000 skilled nursing facilities across the country, and, along with Kindred, is alleged to have caused those facilities to submit Medicare claims for services at the highest reimbursement levels that were not actually provided, or not necessary. Two whistleblowers stand to receive almost $24 million from the settlement.

While all providers need to have strong compliance, this is a reminder that larger providers, whose operations span multiple offices, cities and states, need to be especially vigilant and install strong company-wide compliance programs.

December 9, 2015 by Amy E. McCracken

Supreme Court to Consider Implied Certification theory of FCA

The Supreme Court has agreed to hear a case involving the implied certification theory under the False Claims Act. Implied false certification occurs when an entity has previously undertaken to expressly comply with a law, rule, or regulation, and that obligation is implicated by submitting a claim for payment even though a certification of compliance is not required in the process of submitting the claim. Many relators have tried to use this theory to turn a regulatory violation into a false claim–with its concomitant treble damages and statutory damages.

There has long been a split in the circuits regarding the viability of the implied certification theory. As recently as June 2015, the Seventh Circuit rejected the theory, stating that the “FCA is simply not the proper mechanism for government to enforce violations of conditions of participation contained in—or incorporated by reference into—a PPA [Program Participation Agreement].” Rejection of this theory recognizes that there administrative procedures designed to address regulatory violations.

In contrast, the Ninth Circuit has embraced the implied certification theory, stating “”[i]t is the false certification of compliance which creates liability when certification is a prerequisite to obtaining a government benefit.” The problem in the health care arena is that facilities promise to comply with a myriad of regulations when entering into PPAs, and certify compliance when submitting bills. Thus, under this theory, every single regulatory violation can turn into a false claim.

The health care industry will be closely watching the Supreme Court’s ruling on this important issue.

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”