Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

Federal Judge Rules to Allow Extrapolation on More Than 50,000 Patient Admissions in FCA Case

Posted in Fraud & Abuse, Long-term Care/Skilled Nursing Facilities, State & Federal Audits, Investigations & Litigation, Uncategorized

Written by:  Ellyn L. Sternfield and Samantha P. Kingsbury

Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 patient admissions by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).

Life Care Centers is accused of billing for unnecessary care between 2006 and 2012.  To prove its claims, the government wants to review a random sample of 400 patient admissions and then extrapolate its findings related to false billings to more than 50,000 additional patient admissions (comprising 154,621 total claims).  In ruling for the government and rejecting Life Care Centers’ motion for summary judgment, the judge noted that FCA cases often involve a high number of claims and it would be too burdensome to require government attorneys to build a discrete case for every allegedly false claim.  He further explained that “[t]he purpose of the FCA, as well as the development and expansion of government programs as to which it might be employed, support the use of statistical sampling in complex FCA actions where a claim-by-claim review is impracticable.” 

In rejecting Life Care Centers’ objections, the judge found that the defendants could still fight the government’s extrapolation by challenging the government’s methodology, cross-examining statistical experts and calling its own expert witnesses (thus curing any due process concerns).  He also acknowledged that while the FCA does not explicitly authorize the use of extrapolation, it does not bar the practice – a restriction that Congress could have easily imposed had it intended to preclude the use of statistical sampling.

Continue Reading

Antitrust Article Examines FTC’s Recent Scrutiny of Quality of Care Efficiency Defenses in M&A Activity

Posted in Antitrust, Health Care Reform, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, State & Federal Audits, Investigations & Litigation, Uncategorized

Written by: Stephanie D. Willis

Dionne Lomax and Helen Kim, our colleagues in the Antitrust Practice, have authored an article in Competition Policy International’s September 2014 edition of the Antitrust Chronicle observing that, even in the wake of the Affordable Care Act, which is intended to encourage efficiencies in health care delivery to improve health care quality overall, the antitrust enforcement agency has been limiting the ways that health care providers can assert these goals as a justification for consolidation.

The article profiles recent cases that we have featured on the blog and in the firm’s advisories, including the St. Luke’s case initially profiled here earlier this year by Bruce Sokler, Chair of Mintz Levin’s Antitrust Practice.  But more importantly, it provides a framework ”that parties can apply when presenting quality improvement claims that may help parties demonstrate that their efficiency claims are credible, merger-specific, and likely to occur.”  Read Dionne and Helen’s article here and reach out to them or to our other Antitrust Practice attorneys if you have questions.


A Brave New World of Transparency Reporting: CMS Launches Open Payments Website

Posted in Pharma & Medical Devices, Physicians

Written by: Thomas S. Crane and Kimberly J. Gold

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).

Mandated by the Affordable Care Act, the Sunshine Act creates a regulatory scheme requiring drug and device manufacturers and group purchasing organizations (GPOs) to report a variety of information about payments and other transfers of value to physicians and academic medical centers.  The first data reporting period was for August 2013 through December 2013, and this data is now available on the Open Payments website.

Unlike last year’s launch of the federal health insurance exchange website, the Open Payemnts website appears to be working smoothly.  CMS reported that the payment information includes over 4.4 million payments valued at nearly $3.5 billion.  More than 26,000 physicians and 400 teaching hospitals registered through the Open Payments data system.

Continue Reading

Cliff Notes from the Joint OCR/NIST HIPAA Security Conference

Posted in Hospitals & Health Systems, Physicians, Privacy & Security/HIPAA/HITECH

Written by:  Dianne BourqueKimberly Gold, Kate Stewart, and Stephanie D. Willis

As a service to our readers, we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance through HIPAA Security” into three phrases:  (i) risk assessment, (ii) workforce training, and (iii) adequate encryption.  For those of you willing to read more than three phrases, we elaborate on them below and provide our view on the important takeaways from the conference. Continue Reading

A Cautionary Tale for Companies With Potential False Claims Act Exposure

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by: Heidi Lawson and Danny Harary

A False Claims Act suit can be a company’s worst nightmare, as it may potentially result in large settlements and awards on account of the statute’s trebled damages provision.  However, the nightmare for AmerisourceBergen was compounded by the fact that the company’s insurer, ACE, denied coverage for the claim based on the “prior or pending litigation exclusion.”  Even worse, a Pennsylvania appellate court upheld ACE’s disclaimer based upon the exclusion. The impact of this recent ruling is very unsettling for many companies who may not know about a qui tam suit for several years after it is filed, which is typically the case in the qui tam context, where the complaint is filed under seal to allow the government to investigate the relator’s claims.  Continue Reading

“Access Denied” – Understand How Your Electronic Health Records Are Controlled

Posted in Accountable Care Organizations, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Physicians, Privacy & Security/HIPAA/HITECH

Written by: Rachel Irving Pitts

Earlier this week, my colleague Dianne Bourque commented on a small medical practice’s inability to access its patients’ medical records one July day after its EHR vendor blocked the practice from pulling the data stored in the EHR.  In the Boston Globe article, the EHR vendor compared the situation to an electric company turning off the power after months of nonpayment. As technology advances, we abandon “outdated” ways of doing things – our cordless phones won’t work when our power is shut off, and a doctor who has switched to an EHR can’t grab the paper chart off the stacks when its EHR shuts down. A main purpose of the push for providers to adopt EHR is to streamline patient care – a doctor at the hospital doesn’t have to wait for the primary care provider’s chart with the relevant medical history to be delivered or faxed, but just uploads the relevant data set with the patient’s history so they can diagnose and treat the patient.  But that all goes out the window if your EHR goes dark, and you can’t get to the records.  Continue Reading

CMS Releases MSSP and Pioneer ACO Data on Shared Savings and Losses – Where Do We Go From Here?

Posted in Accountable Care Organizations, Health Care Reform, Uncategorized

Written by:  Andrew J. Shin, Stephen M. Weiner, and Stephanie D. Willis

On September 16, 2014, the Centers for Medicare & Medicaid Services (CMS) announced key shared savings and losses results of Accountable Care Organizations (ACOs) that began participating in the Medicare Shared Savings Program (MSSP) or the Pioneer ACO Program (PACO) in 2012 and 2013.  Thus far, of the ACOs still participating in the MSSP or PACO at the time the data was collected:

  • Fifty-three out of the 204 ACOs generated shared savings totaling more than $300 million during their first performance year;
  • Nine out of the 34 ACOs participating in the Advanced Payment model option of the MSSP generated gross shared savings of $58.53 million, but over a third (34.5%) of that gross amount was generated by one ACO;
  • One ACO participating in the risk-sharing/shared-losses option (Track 2) of the MSSP generated losses of $9.97 million and will have to repay $3.96 million to CMS;
  • Two ACOs participating in Track 2 of the MSSP generated gross shared savings and will receive performance payments from CMS of nearly $17 million; and
  • During the second year of the PACO, 11 out of the 23 Pioneer ACOs earned $68 million in financial bonuses.

CMS provided a table with details about the gains and losses generated by the ACOs that will be updated as new information becomes available. Continue Reading

OCR Issues Guidance on HIPAA and Same-Sex Marriage

Posted in Privacy & Security/HIPAA/HITECH

Written by: Kimberly J. Gold

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance last Wednesday to help covered entities and business associates understand the privacy implications of the 2013 Supreme Court decision in United States v. Windsor (“Windsor”).

The Supreme Court ruled in Windsor that Section 3 of the Defense of Marriage Act (“DOMA”), which provided that federal law would recognize only opposite-sex marriages, was unconstitutional.  Since Windsor, HHS has already extended Medicare coverage to same-sex couples.

The HIPAA Privacy Rule provides some protections to family members, including spouses, of patients.  For example, Protected Health Information relating to the patient’s care may sometimes be shared with family members of patients.  In addition, the protections against the use of individuals’ genetic information for underwriting purposes under the Genetic Information Nondiscrimination Act (“GINA”) extend to certain information about family members.

Continue Reading

CMS Continues to Struggle with How to Provide High Quality Care to Dual Eligibles

Posted in Health Care Reform, Payors & PBMs, Pharma & Medical Devices

Written by:  Tara E. Swenson

Last week CMS announced that it would not execute its option to terminate its 2015 contracts with Medicare Advantage Plans and Part D plans that had scored three stars or less for three consecutive years.  At the same time, CMS announced that it was seeking information from insurers and others in the industry regarding how serving a disproportionate share of dual eligible enrollees causes Medicare Advantage and Part D plans to receive lower quality measure scores.  In the alternative, CMS is also seeking information regarding how certain Medicare plans that serve dual eligible achieve high performance levels.   In order to be considered, comments must be received by November 3, 2014.

While CMS seeks this information, it is continuing to confront a variety of challenges to its Duals Demonstration Project under which it is attempting to partner with states to coordinate providing care through managed care entities able to provide both Medicare and Medicaid services.  Since the start of the Duals Demonstration, CMS has seen some states exhibit interest in participating but ultimately decline to engage and some managed care organizations go through the process to be approved to provide the plans and then pull out of participating.  The Duals Demonstration is currently facing legal challenges in California where a variety of groups are claiming that the passive enrollment process violates individuals’ due process rights.

CMS’ RFI provides a good opportunity for industry participants to explain the challenges of serving and providing managed care to a low income population that can be more difficult to contact and engage than the traditional Medicare population.

Department of Justice Criminal Division Will Increase its Review of False Claims Act Cases for Criminal Prosecution

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by Laurence J. Freedman and Samantha P. Kingsbury

On Wednesday, during a speech before the Taxpayers Against Fraud Education Fund conference in Washington, D.C., Leslie R. Caldwell, Assistant Attorney General for the Department of Justice’s (DOJ) Criminal Division, announced that her office will be stepping up its review of False Claims Act (FCA) qui tam complaints for potential criminal prosecution. She also invited potential qui tam relators (whistleblowers) to contact criminal authorities prior to filing qui tam complaints in the event there is potential criminal conduct.

 Ms. Caldwell stated that the Criminal Division has implemented a procedure so that all new qui tam complaints are shared by the Civil Division with the Criminal Division as soon as the cases are filed.  Under this process, she said, experienced prosecutors in the Criminal Fraud Section are immediately reviewing these qui tam complaints to determine whether to open a parallel criminal investigation. Ms. Caldwell noted that the Criminal Division has “unparalleled experience prosecuting health care fraud, procurement fraud and financial fraud” and that it will “bring that expertise to bear by increasing [its] commitment to criminal investigations and prosecutions that stem from allegations in False Claims Act lawsuits.”  Beyond its expertise, the Criminal Division has relationships with foreign governmental agencies and criminal investigative tools (e.g., search warrants, wire taps, undercover operations and confidential informants) that it will be able to contribute to FCA cases.

By reviewing FCA qui tam complaints immediately, the Criminal Division will be able to streamline the process of assessing these cases for possible criminal charges.  Ms. Caldwell also indicated that her division’s deeper involvement in FCA cases will mean a shift in priorities with respect to the types of defendants on which DOJ focuses its attention.  Specifically, Ms. Caldwell commented that “cases involving fraud by executives at health care providers, such as hospitals, are [ ] a high priority” and that DOJ may increasingly bring criminal charges against corporate entities.