ML Strategies has posted its weekly Health Care Reform Update. This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. Click here to read this week’s Update.
PRIME Act: New Legislation to Curb Health Care Fraud
Posted in Fraud & Abuse, Reimbursement, State & Federal Audits, Investigations & LitigationWritten by: Brian P. Dunphy
The United States Senate and House of Representatives recently introduced bipartisan legislation designed to reduce fraud, waste, and abuse in the Medicare and Medicaid programs. The legislation, entitled “Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2013,” or PRIME Act (S. 1123, H.R. 2305), seeks to curb improper payments by: reducing Medicare overpayments; requiring the Secretary of the Department of Health and Human Services (HHS) to address vulnerabilities identified by Recovery Audit Contractors (RAC); and sharing certain data among state and federal programs and agencies. Continue Reading
Fourth Circuit & FTC: State Dental Board Subject to Federal Antitrust Laws in Teeth-Whitening Case
Posted in AntitrustThe health care industry is familiar with the FTC’s enforcement presence for anticompetitive business practices in health care markets. But in a case involving the market for teeth-whitening services in North Carolina, it seems that state boards might now have to watch their steps too. Attorneys from Mintz Levin’s Health Care Antitrust Practice recently authored an alert entitled, Fourth Circuit Holds State Agencies Operated by Market Participants Are Private Actors for State Action Purposes, that discusses the case and why the Fourth Circuit agreed with the FTC’s determination that the North Carolina State Board of Dental Examiners illegally excluded nondentists from the state’s teeth-whitening market.
The Fourth Circuit held that the dental board is subject to federal antitrust law because it was acting as a private party, not a governmental agency, when it issued cease-and-desist letters to teeth-whitening providers who were not dentists. They also agreed that the dental board is operated by market participants who are elected by market participants. State boards and quasi-governmental agencies should be aware that their activities may not be immune from antitrust enforcement actions.
First Circuit Rules First-Filed Complaint Need Not Satisfy Rule 9(b) to Bar Subsequent Qui Tam Actions
Posted in Fraud & Abuse, State & Federal Audits, Investigations & LitigationWritten By Kevin McGinty
To incentivize whistleblowers to bring false claims promptly to the government’s attention, the False Claims Act (FCA) includes a so-called “first-to-file rule“ (31 U.S.C § 3730(b)(5)), which bars a person other than the government from “bring[ing] a related action based on the facts underlying” a pending action alleging violation of the FCA. In a recent case of first impression, the First Circuit affirmed dismissal of a qui tam complaint under the first-to-file rule even though the relator argued that the previously filed complaint had not pleaded the alleged FCA violation with the particularity required under Rule 9(b) of the Federal Rules of Civil Procedure. See United States ex rel. Heineman-Guta v. Guidant Corp., No. 12-1867, slip op. at 2 (1stCir. May 31, 2013) (Heineman-Guta). Continue Reading
Is Data Mining Coming to a State Medicaid Fraud Control Unit Near You?
Posted in Fraud & Abuse, State & Federal Audits, Investigations & LitigationStarting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in the Federal Register on May 17. This final rule reverses previous regulations that prohibited MFCUs from using federal matching funds for data mining.
Now that MFCUs can make use of data mining to pursue Medicaid provider fraud, the question is what impact will data mining by state MFCUs have on Medicaid fraud investigations and enforcement actions at the state level? Ellyn Sternfield, an attorney in Mintz Levin’s Health Law Practice, who was the former head of the Oregon Department of Justice Medicaid Fraud Control Unit, says that many state MFCUs won’t be able to take full advantage of data mining’s potential. She enumerates their challenges in OIG Final Rule Allows State MFCUs to Use Federal Funding for Data Mining Technology, an article published last week in Bloomberg BNA’s Health Care Fraud Report.
In addition to a backlog of cases and the challenges of Medicaid managed care growth, she says, some state MFCUs do not have a great working relationship with the Medicaid agency in their state. Still Medicaid providers should prepare for what these new data mining powers may bring as far as fraud investigations and enforcement actions are concerned.
Agencies Seek Comments to Inform Future Health IT Regulation
Posted in Clinical Trials & Research/FDA, Pharma & Medical DevicesWritten by: Kimberly Gold and Stephanie Willis
As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communication Commission (FCC) – are following a specific mandate under Section 618(a) of the Food and Drug Administration Safety and Innovation Act (FDASIA) to pursue a collaborative approach in regulating HIT. Continue Reading
FDA Delivers Its First Mobile Medical App Inquiry
Posted in Pharma & Medical DevicesWritten by Kim Gold
The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. Late last week the FDA sent a letter to Biosense Technologies Private Limited, asking the company to either identify an FDA clearance for its uChek urine analyzer app or explain why it does not believe that FDA clearance is required. According to the FDA, the uChek app, which allows users to check urinalysis results by taking photos of test strips, and a mobile phone function together as an automated strip reader that requires 510(k) clearance as a “urinalysis test system” because the app allows the phone to be used to analyze the test strips.
The Pressure Is On: Deadline for States to Pass False Claims Laws Looms
Posted in Fraud & Abuse, State & Federal Audits, Investigations & LitigationWhat’s at stake for states that fail to bring their false claims laws in line with new federal standards by the August 31 deadline? A 10% share from settlements of Medicaid fraud lawsuits which, considering the $4.2 billion the federal government recovered in fiscal year 2012, could mean big money. But is it a big enough incentive for states?
Ellyn Sternfield, an attorney in Mintz Levin’s Health Care Fraud Enforcement Defense Practice, weighs in on what some states are thinking in, States Pressured to Match Their False Claims Acts to Federal Law, an article published last week in Thomson Reuters. Many state lawmakers, she says, are reluctant to change their state false claims laws, fearing the resources required to investigate Medicaid false claims and having to share recoveries with whistleblowers may not make it cost-effective.
CMS Conducts First Call on Physician Payments Sunshine Act Implementation
Posted in Hospitals & Health Systems, Pharma & Medical Devices, Physicians, State & Federal Audits, Investigations & LitigationWritten by Karen Lovitch and Kate Stewart
In anticipation of the start of data collection under the Physician Payments Sunshine Act, the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance on data collection and reporting in an effort to address the many questions being asked by affected parties. As discussed in previous posts, applicable manufactures (“Manufacturers”) and group purchasing organizations (“GPOs”) must begin collecting data on payments and other transfers of value given to physicians and teaching hospitals as of August 1, 2013, and initial reports are due to CMS by March 31, 2014.
To educate affected parties about the Open Payments Program, CMS is holding a series of National Provider Calls. The first call took place last week. Those who missed the call can access the slide presentation on CMS’ website, and CMS plans to post an audio recording and transcript at a later date. Continue Reading
Highlights of the Joint NIST and OCR Safeguarding Health Information Conference
Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation, UncategorizedWritten by Dianne J. Bourque and Stephanie D. Willis
Earlier this week we attended the National Institute of Standards and Technology (NIST) and HHS Office for Civil Rights (OCR) 6th Annual Safeguarding Health Information Conference in Washington, D.C. (the NIST-OCR Conference). The agenda focused on recent amendments to the privacy and security laws, including changes under the HIPAA Omnibus Rule, as well as technological developments aimed at improving quality of care while maintaining the integrity of patient information. The NIST-OCR Conference also provided a forum for participants to discuss new requirements with regulators. The agenda includes links to all of the presentations. Continue Reading
