Kusserow on Compliance: U.S. Sentencing Commission Federal Register Notice seeking public comment

This is time sensitive for those interested in making comments

The U.S. Sentencing Commission published a request for comment in the Federal Register seeking public comment and feedback on its list of tentative priorities for the amendment cycle ending on May 1, 2019. This is part of the annual amendment cycle, during which the Commission reviews and revises its guidelines. This year, the Commission is focusing on whether the time has come to prioritize amending Chapter Eight to cover drug-related offenses. Broadly defined, those offenses might include drug trafficking offenses, misbranding and adulteration of drugs, the sale of unapproved drugs, and dispensing certain drugs without a prescription. The Commission will not make final decisions on this subject until it has heard from the public. As such, those that have thoughts on this topic should consider weighing in with this opportunity of giving them feedback. If adopted, this priority could lead to guideline changes with a potential impact on the pharmaceutical, health care, and certain retail industries.  This may in turn impact the seven standard elements of an effective compliance program, and, in turn, the work of compliance officers.

Therefore, those that have thoughts about the proposed changes have the opportunity to have their ideas brought before the Commission. This includes whether this should be a priority for them now and, if so, how broad or narrow they should be on this issue. One area to consider is whether there are ideas and suggestions as to how the Commission should study this issue area over the next couple of years. At any rate, the Commission has opened the door for public feedback, ideas, and suggestions; however this is time sensitive in that the Commission will make its final decision on priorities at a public meeting in August, after considering all the public comments. If this is something of interest, more information is available at the Commission’s website.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG provides Medicaid fraud and overpayment update to Congress

The OIG testified before the Senate Committee on Homeland Security and Governmental Affairs regarding Medicaid Fraud and Overpayments. Up front, it was noted that the Medicaid program has 67 million beneficiaries, costing $600 billion annually with projected improper Medicaid payments at about $59 billion. Key points of the testimony were:

  1. Complete and reliable national Medicaid data—which is necessary for effective program oversight and to quickly detect and address improper payments, fraud, waste, or quality concerns—is limited.
  2. Transformed Medicaid Statistical Information System (T-MSIS) data was mandated to address problems with national Medicaid claims and eligibility data. All states except Wisconsin and the District of Columbia have begun reporting data to T‐MSIS, but the data elements may not mean the same thing across states. CMS must ensure that the same data elements are consistently reported and uniformly interpreted across states.
  3. Eighty percent of all Medicaid beneficiaries receive part or all of their services through managed care entities who are required to report medical claims data to states who then report it to CMS via T‐MSIS. Without accurate and timely data, it is not possible to analyze costs, utilization or trends; evaluate benefits; or determine the quality of services being provided.  Medicaid managed care encounter data was found to be incomplete and CMS needs to ensure this corrected.
  4.  Lack of quality national Medicaid data to identify fraud schemes and other vulnerabilities that cross state lines is hampering enforcement efforts. Identifying schemes in one state can alert other states to patterns of fraudulent or abusive practices that may be occurring in their jurisdiction and can be referred to law enforcement agencies. CMS must improve Medicaid data to ensure T‐MSIS achieves its full potential.
  5. States have not fully enacted enhanced provider screening that prevents bad actors from entering the Medicaid program to reduce improper payments and protect patients from harm, such as conducting fingerprint‐based criminal background checks and site visits. States need timely, complete, and accurate data to identify the providers seeking access to Medicaid monies and patients. CMS must ensure that states timely and fully implement critical safeguards.
  6. The Medicaid improper payment rate is 10.1 percent and CMS is working with state Medicaid agencies to develop corrective action plans that address state‐specific reasons for improper payments as a part of CMS’s Payment Error Rate Measurement Program (PERM). Additional guidance to the states by CMS is needed. OIG has also identified a number of states that inflate payment rates to increase their Federal Medicaid funding and CMS needs to closely review state Medicaid plans and plan amendments for potentially inappropriate cost‐shifting from states to the federal government.
  7. The OIG has found that states are not always correctly determining Medicaid eligibility for beneficiaries. The Affordable Care Act (ACA) allowed states to expand Medicaid eligibility and claim a higher Federal Medical Assistance Percentage, but incorrectly determining beneficiaries’ eligibility could result in the improper shift of costs from the state to the federal government. States must comply with requirements to verify applicants’ income, citizenship, identity, and other eligibility criteria in order to verify eligibility criteria.
  8. Medicaid is overpaying for prescription drugs due to underpaid rebates. Manufacturers are generally required to pay rebates to the states for covered outpatient drugs under the Medicaid Drug Rebate Program that includes reporting product and pricing information to CMS that is used to calculate the rebates owed. Manufacturer misreporting can result in manufacturers’ underpaying rebates, which inappropriately increases federal and state Medicaid costs. Overseeing states’ collection of manufacturer rebates remains a challenge for HHS.
  9. Medicaid must know with whom it is doing business, not only to prevent improper payments to ineligible providers, but also to protect beneficiaries from low‐quality care. The varying standards, and in some cases, minimal vetting, for Medicaid personal care services (PCS) providers, potentially expose the Medicaid program to financial fraud and Medicaid beneficiaries to abuse and neglect. CMS needs to improve states’ ability to monitor billing and care quality by enrolling PCS attendants as providers, or require them to register with their state Medicaid agencies, and assign each attendant a unique identifier.
  10. The OIG found that up to 99 percent of critical incidents of abuse and neglect of developmentally disabled were not reported to the appropriate law enforcement or state agencies as required. The OIG worked with the HHS Administration for Community Living, Office for Civil Rights, CMS, as well as with the DOJ and States to create a joint report entitled Ensuring Beneficiary Health and Safety in Group Homes Through State Implementation of Comprehensive Compliance Oversight. It features suggested model practices for states and CMS with four main aspects of handling critical incidents: investigation, reporting, correction, and transparency and accountability. It also detailed suggestions as to what actions states should take when group homes repeatedly fail to report incidents.
  11. The OIG partners with state Medicaid Fraud Control Units (MFCUs) which, last year, reported more than 1,500 convictions, nearly 1,000 civil settlements and judgments, and more than $1.8 billion in criminal and civil recoveries. The 50 existing MFCUs receive 75 percent of their funding on a matching basis from the federal government but often they encounter severe restrictions on their ability to maintain or expand staff.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Device manufacturer’s misrepresentations result in $12.5M FCA settlement

Medical device manufacturer AngioDynamics, Inc., settled with the United States for $12.5 million following allegations that the company caused health care providers to submit false claims related to the use of the LC Bead® and the Perforator Vein Ablation Kit® (PVAK) to Medicare, Medicaid, and other federal health care programs. The government alleged that the manufacturer both provided instructions to use inaccurate billing codes and misrepresented Medicare billing policy related to the devices. The settlement came as a result of a suit filed under the whistleblower provision of the False Claims Act (FCA) (31 U.S.C. § 3729).

LC Bead allegations

The medical device manufacturer will pay $11.5 million—$10.9 million paid to the federal government and $600,000 paid to state Medicaid programs—to resolve allegations that the company caused the submission of false claims for procedures involving an unapproved drug delivery device marketed with false and misleading promotional claims. The government alleged that between 2006 and 2011, AngioDynamics served as the distributor for the manufacturer of the LC Bead and marketed the product for use as a drug delivery device in combination with chemotherapy drugs. Employees of the manufacturer routinely claimed that this use of the LC Bead was “better,” “superior,” “safer,” and “less toxic” than alternative treatment, despite lack of clinical evidence to support the statements and despite the FDA’s repeated declination to approve the product. Knowing that many insurers did not provide coverage for certain LC Bead procedures, the company instructed health care providers to use inaccurate billing codes for claims related to these uses.

PVAK allegations

AngioDynamics will also pay $1 million to resolve allegations that the company caused the submission of false claims in connection with the use of PVAK, used to close or collapse malfunctioning veins and which was approved by the FDA only for use in treating superficial veins and not for perforator veins. The manufacturer voluntarily recalled the PVAK and reissued the product under the name “the 400 micron kit.” Despite the recall and rebranding, certain AngioDynamics employees took part in a continued campaign to market the device to treat perforator veins, falsely representing to providers that Medicare would cover this use

Kusserow on Compliance: Four physicians charged in $200M prescription fraud scheme

A CEO and four physicians were charged in a superseding indictment in an investigation of a $200 million health care fraud scheme that involved a network of Michigan and Ohio pain clinics, laboratories, and other medical providers. Additional charges included wire fraud conspiracy, money laundering, and distribution of over 4.2 million medically unnecessary dosage units of controlled substances and medically unnecessary injections to Medicare beneficiaries, some of whom were addicted to narcotics. These included oxycodone, hydrocodone and oxymorphone. Some of the opioids were resold on the street.

When a medical review was made of the injection claims, it was found that 100 percent of the claims were not eligible for Medicare reimbursement. In order to conceal the continued billing of these fraudulent claims to Medicare, the defendants created new shell companies and continued to engage in the same billing of fraudulent claims, often changing only the name of the company on the door to the medical practice and/or inventing new suite numbers to conceal the continuation of the fraudulent practices at the same location. Defendants also owned a diagnostic laboratory to enable them to order medically unnecessary urine drug testing from the laboratory. When Medicare conducted a medical review of claims submitted by the laboratory, it determined that 95 percent of the claims were not eligible for Medicare reimbursement and ordered the diagnostic laboratory to repay $6.9 million in improper payments.

Another scheme involved money laundering in connection with a $6.6 million wire transfer and the withdrawal of $500,000 in cash, which was hidden in plastic bags in the closet of the house.  The indictment alleges that transferred proceeds derived from the conspiracy were used to allow the defendants to live an extravagant lifestyle and spend millions of dollars on luxury items—clothing from retailers like Hermes, rare Richard Mille watches, and exotic automobiles such as a Lamborghini and Rolls Royce Ghost. The proceeds were also used to purchase a mansion and other real estate in the Detroit, Michigan area and to sit courtside or in the first row of NBA basketball games, including the NBA Finals.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.