January 2, 2018

Might this be a good year for your anesthesia or chronic pain practice to resolve to zero in more closely on compliance and documentation? A compelling reason to consider doing so—though certainly not the only one—is that civil monetary penalties, assessments and exclusions against individuals and entities based on prohibited conduct and violations of several major healthcare laws, including the Stark Law, the Anti-Kickback Statute (AKS), the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA)—have risen substantially.

For example, early this past year, the Department of Justice increased the per-claim range of penalties for the second consecutive year under the False Claims Act (FCA). The FCA imposes severe penalties on clinicians who have submitted false claims to Medicare, Medicaid and other government healthcare programs.  The Bipartisan Budget Act of 2015 mandated that civil monetary penalties be raised by August 2016 to account for inflation. Those penalties had not been increased for more than 20 years. As a result, for example, FCA defendants are now subject to penalties ranging from $10,957 to $21,916 per claim submitted in violation of the FCA.  These and all other civil monetary penalties will be adjusted for inflation on an annual basis.

The Health and Human Services Office of Inspector General (HHS OIG) reports in its most recent Semiannual Report to Congress that in FY 2017 it brought criminal actions against 881 individuals or organizations engaging in crimes against HHS programs and their beneficiaries, and an additional 826 civil actions, including false claims and unjust-enrichment lawsuits filed in federal district court, civil monetary penalty settlements and administrative recoveries related to provider self-disclosure matters. OIG excluded 3,244 individuals and entities from participation in federal healthcare programs.

In July 2017, OIG also brought charges against more than 400 defendants in 41 federal districts related to schemes involving approximately $1.3 billion in false Medicare and Medicaid billings—the largest national healthcare fraud takedown in history.  Notably, 120 defendants were charged for prescribing and distributing opioids and other narcotics, and 295 individuals received exclusion notices for opioid diversion and abuse.

In addition to Stark, FCA, HIPAA and AKS, the less well known Civil Monetary Penalties Law (CMPL) also authorizes HHS OIG to impose administrative penalties, assessments and exclusions against an individual or entity for a variety of prohibited activities. OIG concluded cases involving more than $22.8 million in civil monetary penalties and assessments during the most recent reporting period.

As the OIG report notes, a person who submits, or causes to be submitted, to a federal healthcare program a claim for items and services that the person knows, or should know, is false or fraudulent is subject to a penalty of up to $15,270 for each item or service falsely or fraudulently claimed, an assessment of up to three times the amount falsely or fraudulently claimed, and exclusion from participation in federal healthcare programs.  For the purposes of the CMPL, “should know” is defined to mean that the person acted in reckless disregard or deliberate ignorance of the truth or falsity of the claim. 

Following are summaries of some recent settlement agreements reported on OIG’s website. We offer these summaries to show the range of prohibited activities and to spark thinking, discussion and education within your practice regarding potential compliance and risk management improvement initiatives for 2018.

• On December 5, 2017, an addiction care center entered into a $79,880.50 settlement agreement with OIG, which alleged that the provider received improper remuneration from Millennium Health, LLC in the form of point of care test cups that resulted in prohibited referrals. OIG alleged that the referrals were prohibited because the remuneration created a financial relationship that caused Millennium to present claims for designated health services that resulted from the prohibited referrals.
• On December 4, 2017, a neurologist in Saint Louis, Missouri, agreed to be excluded from participation in all federal healthcare programs for three years for allegedly violating the CMPL. OIG alleged that the neurologist received vials of Botox® and Myobloc® at no charge.  The medications were supposed to be used for specific patients covered by private insurance. Instead of discarding the unused portions of the medications in the single-dose vials, the neurologist kept and stored the remaining medications and then used them on Medicare patients, but submitted claims for payment to Medicare as if she had purchased new vials.
• On December 4, 2017, a North Carolina physician entered into a $60,000 settlement agreement with OIG to resolve allegations that she billed for services provided "incident to" her supervision despite her absence from the office suite; routinely billed for services provided by unlicensed individuals; and received remuneration from laboratory companies in the form of "process and handling" payments in exchange for referring patients for laboratory testing services, which were paid by Medicare.
• On July 21, 2017, a Utah-based pain management specialist and his practice entered into a $399,895.92 settlement agreement with OIG. The settlement agreement resolved allegations that the practice, through the pain specialist, submitted false or fraudulent claims for payment by inappropriately using modifier 59 for multiple units of HCPCS code G0431 (Drug screen, qualitative; multiple drug classes by high complexity test method) when only a single unit may be billed per patient encounter.
• On March 8, 2017, a Michigan pain management specialist agreed to be excluded from participation in Medicare and the State healthcare programs for three years following a referral to OIG by Kepro, the Beneficiary and Family Centered Care Quality Improvement Organization (QIO). An investigation determined that the physician substantially violated the obligation to provide services (1) of a quality that met professionally recognized standards of health care, and (2) that were supported by evidence of medical necessity and quality in such form and fashion and at such time as was reasonably required by the QIO in the exercise of its duties and responsibilities. Specifically, OIG alleged that he failed to sufficiently document his response to the results of urine drug screenings and discussions with patients regarding the urine drug screening results when these patients (1) tested positive for illicit drugs; (2) tested positive for controlled substances he did not prescribe; and (3) tested positive for noncontrolled substances he did not prescribe; or (4) tested negative for controlled substances he prescribed.
• Effective July 11, 2016, OIG excluded a physician from participation in all federal healthcare programs for three years following a referral to the OIG by Kepro, the QIO. An OIG investigation determined that the physician violated his obligations to provide services to five Medicare beneficiaries: (1) when, and to the extent, they were medically necessary; (2) of a quality that met professionally recognized standards of care; and (3) supported by the appropriate evidence of medical necessity and quality in a form and fashion and at such time as they were required by the QIO. The doctor violated his obligations through prescription practices and choices of medications that violated professionally recognized standards of care, through documentation that did not support the proper management of chronic conditions or diseases in the patients, through failure to assess pain or response to treatment in patients with chronic pain, and for failure to document response to treatment or patient progress for pain, edema or gastrointestinal upset.
• A Texas physician and pain management center entered into a $26,587.20 settlement agreement with OIG to resolve allegations that the physician submitted claims for Healthcare Common Procedure Coding System code G0452 (molecular pathology procedure; physician interpretation and report) where: (1) no consultation request had been made; (2) no written narrative report by a consultant physician was produced; and (3) no exercise of medical judgment by a consultant physician was required. In addition, OIG contended that multiple units of this code may have been submitted for each patient encounter where multiple units may not have been medically necessary.

Resources

For more information, see the updated booklet published in November by the Centers for Medicare and Medicaid Services, Avoiding Fraud and Abuse:  A Roadmap for Physicians.

The OIG also offers the educational materials listed below:

• A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse (PDF), a self-study booklet.
• A companion PowerPoint presentation that can be used to teach the material contained in the Roadmap.
• The speaker note set (PDF), for assistance in giving the PowerPoint presentation.
• For physicians who may be unable to attend a live, didactic presentation of the material contained in the Roadmap, a narration of the speaker notes to accompany the PowerPoint slides.
  
  The following presentation summarizes the main federal fraud and abuse laws (and provides tips on how physicians should comply with these laws in their relationships with payers (e.g., the Medicare and Medicaid programs), vendors (e.g., drug, biologic and medical device companies) and fellow providers (e.g., hospitals, nursing homes and physician colleagues).
  
  Download this audio narration as a file (WMV, 300 mb)

With best wishes for a happy, healthy and productive new year,

Tony Mira
President and CEO