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Category Archives: State & Federal Audits, Investigations & Litigation

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State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

Posted in Fraud & Abuse, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing.  Multiple states have introduced bills that would require pharmaceutical manufacturers to produce information to justify the sales price for their drugs.  But the idea that pharmaceutical manufacturers are unilaterally responsible for the costs borne… Continue Reading

Court Enforces Arbitration Agreement and Requires Employees to Arbitrate FCA Claims

Posted in Fraud & Abuse, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

On Mintz Levin’s Employment Matters blog, my colleague David Barmak recently discussed in a blog post a notable case in which a federal court compelled the arbitration of three nurses’ False Claims Act (FCA) retaliation claims against the hospital that employed them.  As described in the blog post, the court went a step further by also… Continue Reading

OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Posted in Fraud & Abuse, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees and provide operational and management services to a related psychiatric hospital. While finding that the Proposed Arrangement could potentially generate prohibited remuneration under the… Continue Reading

The Corporate Practice Prohibition in New York: What We Can Learn From the ADMI Settlement

Posted in Fraud & Abuse, Hospitals & Health Systems, Payors & PBMs, Physicians, State & Federal Audits, Investigations & Litigation

One of the most frequently asked questions posed to healthcare lawyers is whether State X has a prohibition on the corporate practice of medicine, nursing or other profession, and if so, whether the prohibition is enforced.  As demonstrated by last month’s well-publicized settlement between Aspen Dental Management, Inc. (ADMI) and the New York State Attorney… Continue Reading

Qui Tam Update Highlights Failed Compliance Program and Dermatology Sweetheart Deals

Posted in ACGME, Fraud & Abuse, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & Litigation

Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, analyzing overall trends in 36 recently unsealed health care related whistleblower cases. In this issue, the team highlights a case that was filed back in 2006, with allegations that focus on a hospital’s failure to maintain a culture of compliance. United… Continue Reading

Trinity Homecare Settlement: Five False Claims Trends

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, State & Federal Audits, Investigations & Litigation

New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities.  The case, filed as a qui tam action in federal district court in the Eastern District of New York, alleged that Trinity’s… Continue Reading

OIG Adds New Litigation Unit Focused on Fines and Exclusions

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

On June 30, 2015, the Department of Health and Human Services’ Office of Inspector General (OIG) announced that it would be staffing a new specialty litigation unit whose sole focus will be on levying civil monetary penalties (CMPs) and excluding individuals and entities from participation in Medicare and Medicaid. The litigation unit will be comprised of approximately 10… Continue Reading

Government’s Objections to Non-Intervened FCA Settlement Are Unreasonable – Now What?

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

Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA).  In his opinion, Judge Anderson requested that the United States Court of Appeals take an interlocutory appeal to determine two issues: The extent… Continue Reading

Part D Woes, According to the OIG

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, State & Federal Audits, Investigations & Litigation

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic Hotspots Point to Potential Fraud and Abuse in  Medicare Part D.”  The OIG reports that incidents and investigations… Continue Reading

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Posted in Food and Drug Administration (FDA), Pharma & Medical Devices, Pharmacies, State & Federal Audits, Investigations & Litigation

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international effort of law enforcement, customs, and regulatory bodies (including FDA, the U.S. Department of Homeland Security, and INTERPOL) that fights… Continue Reading

Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment

Posted in Accountable Care Organizations, Accreditation, Licensing & Certification, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Mergers, Acquisitions & Other Transactions, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, Privacy & Security/HIPAA/HITECH, Reimbursement, State & Federal Audits, Investigations & Litigation, Telemedicine

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime. This past March, Governor Baker initiated a year-long review of each and every regulation under the Executive Department’s jurisdiction, which includes the regulations falling under the primary oversight agency for… Continue Reading

Latest Medicare Fraud Strike Force Takedown Is The Most Significant To Date

Posted in Fraud & Abuse, Health Care Reform, Payors & PBMs, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

As we discussed yesterday, the Medicare Fraud Strike Force’s eighth annual nationwide takedown resulted in charges in 17 districts against 243 individuals for approximately $712 million in false billings. It is the most significant of the Strike Force’s nationwide takedowns to date.  By way of comparison, as we noted in our January 2015 year-in review, in… Continue Reading

Government Announces Health Care Fraud “Takedown”

Posted in Fraud & Abuse, Health Care Reform, Payors & PBMs, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history.  The government brought charges against 243 individuals for approximately $712 million in alleged Medicare fraud. The government alleges a wide array of misconduct ranging from conspiracy to commit health-care fraud, violations of the Anti-Kickback Statute, money… Continue Reading

Physician Compensation Arrangements – OIG Fraud Alert Warns of Potential Anti-kickback Statute Violations

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

In a fraud alert released today, the OIG warns that physician compensation arrangements, such as medical directorship compensation, may potentially violate the anti-kickback statute.  The fraud alert reiterates the “one purpose” doctrine (a compensation arrangement may violate the anti-kickback statute if even one purpose is to compensate a physician for past or future referrals of… Continue Reading

Fingerprint-Based Background Checks Begin August 1st for Medicaid Providers

Posted in Fraud & Abuse, Payors & PBMs, Physicians, Reimbursement, State & Federal Audits, Investigations & Litigation

On June 1st, the Centers for Medicare and Medicaid Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid provider enrollment. This sub-regulatory guidance starts a 60 day clock for state Medicaid programs to implement these enhanced provider screening requirements. Meaning,… Continue Reading

OIG Releases Semiannual Report to Congress

Posted in Fraud & Abuse, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31, 2015. The Report highlights OIG’s accomplishments over the first half of FY 2015, including OIG’s expected recoveries of over $1.8 billion, comprised of approximately $544.7… Continue Reading

Supreme Court Decides Qui Tam First-to-File Issues

Posted in Fraud & Abuse, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss. Since January’s oral arguments, the False Claims Act bar has eagerly awaited the… Continue Reading

Medicare Part D Data Release Continues Transparency Trend

Posted in Fraud & Abuse, Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers prescribed in 2013 under the Medicare Part D Prescription Drug Program.  CMS’s press release touted the data as “part of the Obama Administration’s… Continue Reading

DOJ and HHS Annual Report Highlights $3.3 Billion in Settlements and Judgments in FY 2014

Posted in Fraud & Abuse, Health Care Reform, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

On March 19, 2015, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) issued their annual Health Care Fraud and Abuse Control (HCFAC) Program report highlighting that the HCFAC Program obtained $3.3 billion in health care fraud judgments and settlements in FY 2014. Of this amount, the Medicare Trust Fund received… Continue Reading

3 Key Take Aways from AHLA’s Institute on Medicare and Medicaid Payment Issues

Posted in Fraud & Abuse, Health Care Reform, Payors & PBMs, Reimbursement, State & Federal Audits, Investigations & Litigation

Last week I attended the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues in Baltimore, Maryland. Taking a comprehensive approach to reimbursement issues, the program offered a variety of sessions ranging from Medicare and Medicaid program fundamentals to areas of highly-specific technical expertise. Conference faculty included speakers from all parts of the… Continue Reading

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP).  Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to submit accurate ASP data to CMS. ASP reporting was adopted in large part to create a mechanism whereby government drug reimbursement rates for biologics… Continue Reading

Mintz Levin’s Health Care Qui Tam Update

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

Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, highlighting two qui tam cases unsealed in November and December of 2014 and giving an overview of the other 17 cases unsealed during the same time period. Mintz Levin’s analysis of the 19 total unsealed cases revealed that almost half… Continue Reading

Reported Compliance Problems: The Six Stages of Corporate Grief

Posted in Fraud & Abuse, Home Health & Hospice, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Last week, I had the honor of participating in a panel discussion about how health care entities deal with reported compliance concerns at the ABA’s 16th Annual Conference on Emerging Issues in Healthcare Law. The panel was made up of experienced health care attorneys with broad and long-standing health care experience: Richard Westling, current First… Continue Reading

GAO Report Highlights Improper Medicare/Medicaid Payments

Posted in Fraud & Abuse, Payors & PBMs, Physicians, State & Federal Audits, Investigations & Litigation

Despite the efforts of the Department of Health and Human Services (HHS) to combat fraud and contain costs in federal healthcare programs, Medicare’s fee-for-service program (Parts A and B)  and Medicaid were two of the top three culprits for the billions reported to have been improperly paid by the federal government in fiscal year 2014. … Continue Reading