Articles Posted in Compliance

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In a press release on August 15, 2012 Congressman Dan Boren, who represents Oklahoma’s second Congressional District, announced that letters have been sent to Secretary of Health and Human Services, Kathleen Sebelius; U.S. Congressman Dave Camp, Chairman of the House Ways and Means Committee; and U.S. Congressman Fred Upton, Chairman of the House Energy and Commerce Committee urging a congressional investigation into the Centers for Medicare and Medicaid Services (CMS) Recovery Audit Contractor (RAC), Connolly, Inc.

Congressman Boren accuses Connolly of, “overzealous predatory tactics against several…hospitals with their aggressive, overly critical approach.” He further states that, “[t]hese practices have the potential to create a life-threatening situation for patient care in impoverished rural communities….”

While speaking on a webcast on August 27, 2012, the Congressman said that Connolly treats rural hospitals more harshly than larger urban hospitals. As a result, rural hospitals, that frequently have a much smaller cash flow than their urban counterparts, are faced with a financial situation that could put patient care at risk. He indicated that if Connolly continues to put unnecessary financial strain on rural hospitals, some will be forced to shut down, leaving some rural areas without access to critical care facilities and putting residents in life threatening situations.
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On August 9, 2012, CGS, the MAC for J15, announced that it will begin complex medical review MS-DRG 312, syncope and collapse, based on findings that the claim denial rate for MS-DRG 312 during a probe conducted in Ohio was 79.9%. This means that providers in Ohio could see MS-DRG 312 claims audited as part of the prepayment review demonstration program and in post-payment reviews conducted by the MAC.

The potential for a double audit faced by providers in Ohio is contrary to statements made by CMS during the special open door forum on August 9, 2012. During the forum, CMS stated that a provider may hear from both a RAC and a MAC for claim review but it should not be on the same MS-DRG or the same claim. So far it is unclear how CMS will address this issue.
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On August 27, 2012 the Centers for Medicare and Medicaid Services (CMS) began the Recovery Auditor Prepayment Review Demonstration Program. The program includes prepayment reviews of certain types of claims with high rates of improper payments in eleven states. The states included in the program are Florida, California, Michigan, Texas, New York, Louisiana, Illinois, Pennsylvania, Ohio, North Carolina, and Missouri. Currently, the only claim type being reviewed by the program is MS-DRG 312: Syncope and Collapse. CMS anticipates adding additional claims for review as the program gets underway.
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The Department of Health and Human Services Office of Inspector General (OIG) released a report on July 31, 2012 which indicates that Medicare contractors made overpayments to providers for the breast cancer drug Herceptin. In an audit of Medicare contractor Novitas Solutions, Inc.‘s (Novitas), formerly Highmark Medicare Services, activities from January 2008 through December 2010, the OIG found that incorrect payments were made to providers in four states for full multiuse vials of Herceptin. States included in the audit were Delaware, the District of Columbia, New Jersey, and Pennsylvania.

Herceptin is a breast cancer treatment drug that comes in a multiuse vial containing 44 billable units of the drug. When properly reconstituted and stored, it is viable for 28 days. The OIG audit found that in many cases the vials were used for a single administration and then discarded, with charges entered for the entire vial which included the unused discarded portions. The Medicare Claims Processing Manual states that while single use vials may be charged for any unused or discarded amounts of drugs or biologicals, multiuse vials are only subject to payment for the portions used. The OIG identified overpayments in the amount of $1,576,374.00 for unused and discarded portions of multiuse vials of Herceptin.

The OIG made the following recommendations to Novitas:

1. That Novitas recover the $1,576,374 in identified overpayments;
2. That Novitas implement a system edit that identifies for review line items for multiuse-vial drugs with units of service equivalent to one or more entire vials;
3. That Novitas use the results of the audit in provider education activities.
Novitas concurred with all three recommendations, and commented that claims history adjustments will be initiated.

The OIG audit is part of a national review of the use of Herceptin, which started with a pilot audit, the results of which were released July 10, 2012. Providers can expect a review of this drug in every state. Recovery Audit Contractors (RACs) in two regions have already put Herceptin multiuse vials on their approved issues lists. Connolly in Region C and HealthDataInsights in Region D have approved issues posted for Herceptin. Providers should anticipate that RACs in Regions A and B may follow.
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According to a posted response to a query in the Frequently Asked Questions section of its website, the Centers for Medicare and Medicaid Services (CMS) have begun Meaningful Use Audits of eligible professionals and eligible hospitals participating in the Medicare and Medicaid EHR Incentive Program.

CMS indicated on the website that the contractor for the audits is Figliozzi and Company. If you are selected for an audit you will receive a letter from Figliozzi and Company on CMS letterhead.

EHR Incentive Programs provide incentive payments to providers and hospitals that implement designated meaningful use EHR technologies. Payment is awarded based on attestations that are submitted by providers. Providers are cautioned to ensure that attestations are accurate. Because the attestation is a statement to receive funding from the federal government, false attestations could be the basis for liability under the Federal False Claims.

We recommend that providers include “self-audits” of meaningful use attestations as part of their compliance program to ensure that they will be able to produce documentation to support the meaningful use attestation statements at the time of a future audit.
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On August 2, 2012 the Department of Health and Human Services Office of Inspector General (OIG) issued a report on questionable billing by Home Health Agencies (HHAs). The report found that in 2010, Medicare paid home health claims totaling approximately $5 million as a result of questionable billing, with three specific errors.

The report included recommendations that CMS:

1. Implement claims processing edits or improve existing edits to prevent inappropriate payments.
2. Increase monitoring of billing for home health services.
3. Enforce and consider lowering the 10% cap on the total outlier payments an HHA may receive annually.
4. Consider imposing a temporary moratorium on new HHA enrollments in Florida and Texas.
5. Take appropriate action regarding inappropriate payments and HHAs with questionable billing.

Among the findings of the report, the OIG found that inappropriate payments were made to HHAs for home health claims that overlapped with claims for inpatient hospital stays, overlapped with claims for skilled nursing facility stays, and had service dates after beneficiaries’ deaths–these errors occurred despite the fact that Medicare has automatic edits in place to eliminate these types of errors.

The OIG also found that in 2010, of the HHAs that were found to have questionable billing practices, 80% of those HHAs were located in either: Texas, Florida, California, or Michigan. In fact, the report indicates that in just those four states, more than 2,000 HHAs had questionable billing. Further, 97% of HHAs identified to have questionable billing were located in states that did not have Certificate of Need policies in place limiting the number of HHAs eligible to operate in the state. Nearly one in four HHAs had questionable billing.

In response, CMS concurred with all five OIG recommendations. CMS did, however, disagree with the amount of inappropriate payments made for home health claims that overlapped with inpatient hospital stays and skilled nursing facility stays. CMS comments indicate that it would be difficult to determine what financial impact overlapping claims would have without specific claim data.
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On August 1, 2012 the Centers for Medicare and Medicaid Services (CMS) released a Provider Compliance Interactive Map. The map is an interactive online tool that allows users to view state-by-state contact information and websites for contractors and other Medicare resources. The map is intended to simplify access to contact information for providers in each state.
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In the recently issued Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule for 2013, CMS is soliciting comments regarding policy changes that could be made on the issue of inpatient versus outpatient admission. (To view the CMS factsheet please click here.) CMS is seeking comments on potential changes which could provide some clarity for providers and hospitals regarding inpatient versus outpatient status for purposes of Medicare payment. Comments are due by September 4, 2012.

Currently, when a patient presents to the hospital in a short-stay case, the hospital must decide whether to admit the patient as an inpatient or treat him/her as an outpatient. This decision is not always clear in light of existing Medicare guidance, and the wrong choice can have severe repercussions for the hospital. If the provider orders an inpatient stay, and later, the Recovery Audit Contract (RAC) concludes that the care should have been provided at an outpatient level, the care is deemed not medically reasonable and necessary. Under the current system for reimbursement, the hospital is not reimbursed under Part B for the outpatient services provided unless the hospital undertakes an appeal of the claim denial and is successful before an Administrative Law Judge (ALJ).

Hospitals, in an effort to mitigate costs, err on the side of outpatient care. CMS notes that this practice has doubled in the last four years and that it has a detrimental effect on Medicare beneficiaries.
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On July 17, 2012 the United States Attorney’s Office for the Southern District of New York issued a press release announcing the arrest of 48 individuals in what the release calls the largest single prescription drug diversion scheme ever charged at one time. The result of an organized effort by nearly a dozen state and federal agencies, the government has charged the defendants with operating a massive fraud scheme which diverted half a billion dollars’ worth of prescription drugs dispensed to Medicaid patients in the New York City area.

The government alleges the defendants participated in a scheme to buy prescription drugs from patients, to whom the drugs were legitimately dispensed, and then sell them up a chain of buyers where the drugs eventually ended up in the hands of large scale wholesalers. The defendants are alleged to have fraudulently repackaged and labeled the diverted drugs to make them appear as if they were new, before they sold them to unwitting end-users.. In some cases these diverted prescriptions included HIV/AIDS drugs that were expired and potentially no longer medically effective, yet were still dispensed to unknowing patients.

Because many of the patients who sold the drugs received them through a Medicare or Medicaid benefit, and many of the patients who received the drugs from illegal wholesalers used Medicare or Medicaid benefits to obtain the drugs, the press release is calling the alleged fraudulent scheme a double fraud on the health care system. Medicare and Medicaid essentially paid for these drugs twice, once for the legitimate patient who sold their medication, and then once for the end-user, who obtained the drugs from the wholesalers.
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CGI has added a new issue to its approved issues list for Region B:

Outpatient Bevacizumab (Avastin) services: Bevacizumab (Avastin) represents 10mg per unit and should be billed one (1) unit for every 10mg per patient. Claims for J9035 should be submitted so that the billed units represent the administered units, not the total number of milligrams.

HealthDataInsights has posted a new issue to its approved issues list:

Multi-use vial wastage: Herceptin (Trastuzumab). Multi-use vials are not subject to payment for discarded amounts of drug or biological. Per, the manufacturer label, J9355 Injection, Trastuzumab, 10mg (Herceptin) is only supplied in a multi-use vial. Providers should only bill the units associated with the dose administered to the patient.
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