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On October 3, 2011, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion regarding a proposed arrangement under which physicians would invest in a company that would provide pathology laboratory management services to a third party.

Under the proposed arrangement, a physician who owns and manages a limited liability company (“Requestor”) would enter into a management contract with a pathology laboratory (“Path Lab”), whereby the Requestor would provide the Path Lab with various clinical laboratory services for a fixed number of hours each year. The Requestor would also provide utilities, furniture, fixture, the exclusive use of laboratory space and equipment, and marketing and billing services. In return, the Path Lab would pay a usage fee to the Requestor that would be calculated based on a percentage of the lab’s income which would be fixed in advanced for a 12-month term.

The Requestor’s owner/manager would offer an opportunity for physicians to invest in the Requestor. The new physician investors are anticipated to have little or no background experience in the clinical laboratory services field. According to the Requestor, the value of the investment interest that would be held by physician investors in a position to generate business for the Requestor through referral of laboratory specimens to the Path Lab would exceed 40 percent. Additionally, the Requestor anticipates that the business generated through referrals by physician investors would equate to substantially more than 40 percent of the Requestor’s gross revenue related to the furnishing of health care items and services. Finally, the Requestor has certified that each of the physician investors would have the option of referring specimens to the Path Lab but referrals are not implicitly or explicitly a condition of the arrangement.

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On October 7, 2011, the United States District Court of New Jersey, made a ruling denying an ambulance services’ request for a preliminary injunction against a Medicare program safeguard contractor (PSC). National Ambulance Services, Inc. (“Nationwide”) sought a preliminary injunction to restrain SafeGuard Services, LLC (“Safeguard”) from continuing its pre-payment audit of the ambulance service Part B claims for non-emergency ambulance transportation to patients. On January 13, 2011, the Centers for Medicare and Medicaid Services (CMS) had notified Nationwide that the PSC for its district would conduct a pre-payment process to ensure that all payments to Nationwide were consistent with Medicare policies. Subsequently, Safeguard conducted a pre-payment audit and recommended that 92.1% of Nationwide’s claims should be denied Medicare reimbursement. At the time of the request for preliminary injunction, Nationwide had only appealed a portion of the total claims to an Administrative Law Judge and none of the claims had reached the Medicare Appeals Counsel level of appeal.

The district court began its analysis by holding that it does not have the authority to make a ruling that involves the interpretation of the Medicare statute in regards to the evidentiary standard for coverage. Judicial review over matters arising under the Medicare statute was not available to the plaintiff until all available administrative remedies were exhausted. The court stated that without a final judgment of the Medicare Appeals Council, the plaintiff had not exhausted its administrative remedies, and consequently, the court lacked the authority to review any claims arising under the Medicare statute.

The court next moved to the issue of awarding Nationwide a preliminary injunction. In order to issue this type of emergency relief, the court stated it must consider the following four factors: (1) the likelihood that Nationwide would succeed on the merits; (2) the extent to which Nationwide will suffer irreparable harm without injunctive relief; (3) the extent to which SafeGuard will suffer irreparable harm if the injunction is issued; and (4) the public interest in the matter.

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According to a breaking news article by HealthData Management, the Centers for Medicare and Medicaid Services (CMS) has sent a Shared Saving/Accountable Care Organizations final rule to the Office of Management and Budget (OMB) for review. A review by OMB is one of the last stages before a rule becomes published in the Federal Register. The final rule is expected to include several changes due to the substantial amount of industry criticism the proposed rule faced during the comment period. According to HealthData Management, the concerns raised about the proposed rule included: (1) the proposed 65 measures would be excessively burdensome for newly formed ACOs, (2) allowing pathologists and laboratory professionals to be included as eligible physicians, and (3) giving ACO-enrolled patients the ability to restrict access to their health information could severely limit the ACO’s ability to improve the health of the individual.

If you have any questions about ACO participation, or any other health law questions, please contact a Wachler & Associates attorney at 248-544-0888.

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Today, the Office of Inspector General (OIG) released the fiscal year 2012 Work Plan. The plan describes the activities the OIG plans to continue, as well as activities it plans to initiate. The 2012 fiscal year, and the programs described, runs from October 1, 2011 through September 30, 2012. Below is a list of several new and continuing OIG activities for various health care providers.

Home Health Services (New)

  • States’ Survey and Certification of Home Health Agencies: Timeliness, Outcomes, follow-up, and Medicare Oversight
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DCS Healthcare, the RAC for Region A, posted four new issues to its CMS-approved issues list for providers in Maryland.

  • Medical Necessity Review (MNR)- MDC 5 conditions of the circulatory system (medical) MS-DRGs: 286-293, 299-305, and 308- 316. Medicare pays for inpatient hospital services that are medically necessary for the setting billed. Medical documentation will be reviewed to determine that services were medically necessary. MS-DRGs: 286-293, 299-305, and 308- 316.
  • Medical necessity: acute inpatient admission neurological disorders MS-DRG’s: 068-074, 103, 312 (Collaborative). RACs will review documentation to validate the medical necessity of short stay, uncomplicated admissions. Medicare only pays for inpatient hospital services that are medically necessary for the setting billed and that are coded correctly. Medical documentation will be reviewed to determine that the services were medically necessary and were billed correctly for MS-DRG’s, 068-074, 103, and 312.
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CGI Federal, the RAC for Region B, added two new issues to its CMS-approved issues list. In addition, two more issues were added to the CMS-approved issues list for DME suppliers who bill CIGNA Government Services.

CGI Federal New Issues

  • Leuprolide 3.75mg incorrect code reported (Region B). The purpose of the complex review is to identify the incorrect use of HCPCS code and corresponding number of units billed for services of Leuprolide (depot suspension) 3.75mg. An overpayment exists when a provider bills for greater than 3 units of service for HCPCS code J1950, as defined by applicable Local Coverage Determination documents.
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In its role of overseeing the Medicare and Medicaid Programs, the Senate Finance Committee released a staff report alleging that the four largest publicly traded home health agencies were providing medically unnecessary care by encouraging therapists to meet the 10 visit threshold in order to receive a  “bonus” payment  under the PPS system.  The report was based on an investigation initiated by Committee Chairman Max Baucus and Senior Member Chuck Grassley.  The Senators instigated the investigation based upon a Wall Street Journal analysis.

Among other findings, the report alleges that an analysis of therapy billings from these home health agencies show a pattern of concentrated billings at or just above the 10 visit threshold.  The report further alleges that the companies encouraged billing of medically unnecessary services to reach this threshold.

Home Health Agencies should be aware that Medicare contractors will likely be closely scrutinizing PT visit frequency and patterns.  Also, providers are likely to see changes in the payment system as a result of this report.

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Andrew Wachler, principal of Wachler & Associates, P.C., was quoted in last week’s American Medical News article regarding the National Practitioner Data Bank’s move to shut down public access to anonymous information about physician activities. The move was made to protect physician confidentiality after a reporter was able to identify an individual physician’s record for a news article. Mr. Wachler stated that the government acted correctly in shutting down public access, which will result in the protection of the peer review process.

If you have questions regarding Medicare, Medicaid or third party payor audits, or have any other health law questions, please contact a Wachler & Associates attorney at 248-544-0888.

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On August 29, 2011, the U.S Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable advisory opinion regarding a health system’s proposal to enter into arrangements to provide neuro emergency clinical protocols and immediate consultations with stroke neurologists via telemedicine technology to certain community hospitals.

The Requestor is an operating division of a not-for-profit corporation with a mission of increasing access to quality neuroscience care by providing access to the nationally ranked neuroscience care available through its flagship program. Under the proposed arrangement, Requestor would provide the following services to community hospitals in its service area free of charge: (1) neuro emergency telemedicine technology, (2) neuro emergency clinical consultations, (3) acceptance of neuro emergency transfers, and (4) neuro emergency clinical protocols, training and medical education. The Requestor would enter into a written agreement with the participating community hospitals, which would establish all of the services that each party would provide under the agreement. In recognition of Requestor’s investment of time and capital in the proposed arrangement, the participating hospital would be required to agree not to participate in any other neuro emergency telemedicine service without prior approval of Requestor for the length of the agreement (anticipated at 2 years). The exclusivity requirement would not (1) restrict a participating hospital’s emergency or attending physician from consulting with any stroke specialist of his or her choice, (2) require either party or its physicians to refer patients to the other party, or (3) restrict the freedom of a patient or physician to request a transfer to a stroke center other than Requestor’s.

Due to the agreement creating the potential for Requestor and the participating hospital to refer federal healthcare business to one another, OIG acknowledged that the proposed arrangement could possibly implicate the Anti-Kickback Statute. However, OIG concluded that it would not subject Requestor to administrative sanctions under the Anti-Kickback Statute for the following reasons:

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The Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) recently released a MLN Matters article providing an overview of Medicare policy regarding chiropractic services. CMS has determined, through numerous audits, that a significant portion of chiropractic service claims have been paid inappropriately. Medicare auditors have discovered that the most common errors include missing signatures, insufficient or absent documentation, and billing Medicare for medically unnecessary services. The MLN Matters article was published to help providers better understand Medicare coverage and payment requirements for chiropractic services. Proper compliance with Medicare coverage, coding and documentation requirements will result in a greater percentage of correct claim payments. Therefore CMS has provided a number of practical tips in an effort to reduce the number of improper payments being paid to chiropractors.

If you have any questions regarding Medicare coverage policies and requirements for chiropractic services, or any other health law questions, please contact a Wachler & Associates attorney at 248-544-0888.

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