Articles Posted in Compliance

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The Centers for Medicare & Medicaid Services (CMS) recently published a checklist for physicians and treating practitioners to follow in order to help them comply with documentation requirements for the face-to-face examination that must occur prior to the physician ordering a Power Mobility Device (PMD) for a Medicare beneficiary. The checklist contains the information that is essential for Medicare in determining whether payment should be made for a PMD. However, it is vital to note that the checklist is merely a guide and does not replace the underlying medical records. The following is the checklist offered by CMS:

  • Signs/Symptoms that limit ambulation;
  • Diagnoses that are responsible for these signs/symptoms;
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Despite efforts by various groups to have the face-to-face  encounter requirement delayed for hospices and home health agencies, the requirement became effective as of April 1, 2011.  For more information regarding this issue, please see a recently authored article by Wachler & Associates attorneys Amy K. Fehn and Jennifer Colagiovanni entitled New Audit Risk for Home Health Agencies: Face to Face Certification Requirements.

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CMS Recently released a proposed rule which would reverse the policy of heightening restrictions on suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  The proposed rule relaxes previously onerous rules regarding the prohibition of telemarketing and beneficiary solicitation which were implemented on September 27, 2010.  If you have any questions about how this proposed rule will affect your current compliance program, please contact a Wachler & Associates attorney at 248-544-0888.

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If the rumors are true, tomorrow the Centers for Medicare and Medicaid Services, the Office of the Inspector General and the Federal Trade Commission will be releasing voluminous regulations governing the formation of Accountable Care Organizations (“ACO”) and the Medicare Shared Savings Program.  But before we receive all the minutiae of the regulations, we wanted to provide a brief overview of what is already known about ACOs.

1. The purposes of ACOs are to: (1) facilitate coordination and cooperation, (2) improve the quality of care and (3) reduce unnecessary costs.

2. ACOs were created by the Affordable Care Act, which was signed by President Obama approximately one year ago.

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The Department of Health and Human Services Office of Inspector General (OIG) released an unfavorable Advisory Opinion involving a transportation supplier’s proposal to offer skilled nursing facilities (SNFs) two payment plans for transportation of the SNF’s Medicaid-covered residents.  The OIG determined that the arrangement could potentially violate the Anti-Kickback Statute and that administrative sanctions could be imposed.

The transportation supplier (Requestor) provides transportation services in a state where SNFs receive a per-resident daily rate for ancillary and support services form the state Medicaid program.  SNFs that have residents which are eligible for Medicare and Medicaid are responsible for the amount not covered by Medicare that would otherwise be covered by Medicaid as a secondary payor.  The Requestor will offer two payment plans that respond to SNFs’ responsibilities:

(1) The first payment plan would be a capitated rate per resident per day for Medicaid transports regardless of whether the services were needed and whether Medicaid is the responsible payor.  For residents covered under Medicare and Medicaid, the payment would release the SNF from any further liability (including Medicaid deductibles).  The capitated payment would be less than the Requestor’s cost of transportation for Medicaid patients and more for Medicare patients. 

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The Detroit Free Press reported that the Detroit Medical Center has agreed to pay $30 million to the federal government to settle claims that involved violations of the Anti-Kickback Statute and Stark from improper financial relationships with referring physicians.  The majority of the relationships at issue in the DMC matter involved office lease agreements and independent contractor relationships that were either not consistent with fair market value or not in writing.  If you are a provider and would like to ensure that your relationships comply with Stark and the Anti-Kickback Statute, please contact Wachler & Associates. 

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) reported $25.9 billion of expected recoveries and savings in fiscal year (FY) 2010.  The large amount is a combination of audit receivables, investigative receivables and other legislative and cost-saving actions that OIG recommended. 

In addition, the OIG’s semiannual report documented that it initiated 647 criminal actions and 378 civil actions against individuals or entities that engaged in crimes against departmental programs.  These actions included lawsuits under the False Claims Act (FCA), the Civil Monetary Penalties Law (CMPL) settlement and other administrative recoveries related to self-disclosure. 

Finally, the report indicated the Health Care Fraud Prevention and Enforcement Action Team’s (HEAT) success in fighting fraud.  That program alone recovered $71.3 million in investigative receivables.  

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Last week, the House and Senate passed the “Red Flag Program Clarification Act of 2010.”  The Act limits the definition of “creditor” to a person who obtains or uses consumer reports in connection with a credit transaction, furnishes information to consumer reporting agencies in connection with credit transactions, or advances funds based on the recipients’ obligation to repay.  The bill excludes from the definition persons, such as health care providers, who “advance funds” by providing services before receiving payment.  Relevant government agencies, however, are permitted to designate creditors that will be subject to the Rule.  The Agencies will designate based upon the determination that the person manages accounts that are subject to a reasonably foreseeable risk of identity theft.  These designations must be made through agency rule making. 

The enforcement of the Red Flags rule has been delayed several times, with the most recent delay expiring on January 2011.  The FTC previously determined that health care providers met the definition of “creditor.”  While the Clarification Act’s revised definition would not include most health care providers, the FTC could still designate health care providers as “creditors” through the rule making process based on the risk of medical identity theft concerns previously voiced by the FTC. 

For more information on the Red Flags rule, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888. 

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The United States Justice Department reported that in 2009 it collected $3 billion from pursuing health care fraud and other false claims against the federal government.  More than 80% of the recoveries were from healthcare fraud, including qui tam actions under the False Claims Act.  Bloomberg News reported that Tony West, Assistant Attorney General in charge of the Justice Department’s civil division, stated that the Justice Department would hold those who violate the federal False Claims Act accountable, whether they are a corporation or individual.  The $3 billion recovery in 2009, the second largest in history, is evidence of the aggressive nature with which the DOJ is pursuing False Claims Act violations. 

False Claims Act violations can give rise from submission of claims for services not rendered, submission of claims for services that were not medically necessary or were improperly coded and billed.  Further, as a result of the health care reform legislation, False Claims liability can attach to the retention of a known overpayment that is not refunded within 60 days of identification.  For more on the False Claims Act, or for assistance with health care regulatory or billing matters, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888. 

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The device manufacturer, ELA Medical, Inc. agreed to pay the United States $9,178,000 to settle allegations that it violated the False Claims Act by giving kickbacks to cardiologists in exchange for the cardiologists ordering and causing hospitals to order ELA’s cardiac devices.  The settlement resolves a qui tam action from 2006 that was filed by a former ELA employee.  According to the allegations the cardiologists were given gifts, meals and entertainment, tickets to sporting events, travel to medical conferences, travel to Costa Rica, fishing and boating trips and payment of travel expenses for the physicians’ spouses.  In addition to the settlement payment, ELA agreed to pay $485,000 to the relator’s attorneys and ELA also agreed to enter into a Corporate Integrity Agreement with the Officer of Inspector General of the U.S. Department of Health and Human Services (OIG).  The relator’s share of the settlement amount is approximately $1.9 million.

There is also a second qui tam action pending against ELA.  The relator in that action alleges that ELA paid kickbacks to cardiologists by paying excessive compensation for training services.  The parties in the second qui tam action have reported that they are engaged in settlement discussions and that the case has been administratively closed due to those discussions. 

For more information on the False Claims Act and Anti-Kickback Statute, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888.

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