Those health care providers and suppliers who are contemplating accepting donations of electronic health records software and training services should be aware of proposed amendments to the regulations that might protect such arrangements under the anti-kickback statute and the Stark physician self-referral law. The Department of Health and Human Services, Office of Inspector General (“OIG”) is proposing to amend the anti-kickback safe harbor pertaining to electronic health records (“EHR”) items and services found at 42 CFR 1001.952(y).  The Centers for Medicare and Medicaid Services (“CMS”) is proposing the same amendments to the Stark physician self-referral exception pertaining to donations of certain EHR software and directly related training services found at 42 CFR 411.357(w).  The OIG safe harbor and physician self-referral exception were promulgated in 2006 to protect certain arrangements involving the donation by permitted donors of interoperable electronic health records software or information technology and training services.  Both proposed rules make the identical changes to the protections offered under the safe harbor and exception.

First, the proposed amendments would update the provision under which EHR software is deemed interoperable. Interoperable has been defined to mean “able to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings, and exchange data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.” Both CMS and the OIG consider interoperability to be an important concept to reduce the risk that parties might use the donated software and technology to capture referrals. Both considered that, if the donated technology is interoperable, the recipient would be able to use the technology to transmit EHR not only to the donor but to others, including competitors of the donor, and would not be “locked-in” to communications with the donor only.


Continue Reading Proposed Amendments to OIG Safe Harbor and Stark Physician Self-Referral Exception for Electronic Health Records

Medicaid costs for Personal Care Services (“PCS”), designed to allow Medicaid beneficiaries to remain in their homes rather than being institutionalized, totaled approximately $12.7 billion in 2011, representing a 35% increase in spending since 2005. The cost for PCS is projected to grow by approximately 45% by the year 2018, certainly making PCS an area of interest to the federal government. PCS providers should expect to see increased federal oversight and control over these programs.

The Office of Inspector General (“OIG”) published a report in November, 2012 based on its examination of PCS and its findings of significant compliance, payment, and fraud vulnerabilities. The OIG also interviewed Medicaid beneficiaries receiving PCS services and found quality of care problems with PCS attendants, including physical abuse or threats of abuse, property theft, and beneficiary abandonment.

As of August, 2012, the OIG has produced 23 audit and evaluation reports focusing on PCS providers and programs in various states, including one in Louisiana. The Louisiana Department of Health and Hospitals, which oversees PCS programs, concurred with the findings and recommendations in the OIG audit. The OIG’s Office of Investigations and State Medicaid Fraud Control Units also reported an increasing volume of fraud involving PCS. The most commonly reported fraud schemes involved conspiracies between PCS attendants and Medicaid beneficiaries regarding claims for services that were never provided or that were not allowed under the States’ program rules.

Continue Reading OIG Report on Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement

The Centers for Medicare and Medicaid Services (“CMS”) has added a new face-to-face encounter requirement related to the ordering of certain Durable Medical Equipment (“DME”) items in the Medicare Program Revisions to Payment Policies under the Physician Fee Schedule Final Rule that was published in November, 2012 (the “Final Rule”). For covered DME items requiring a written order, physicians must document that a face-to-face encounter with the beneficiary occurred within six (6) months before the written order. The new rule is effective for all covered DME items ordered on or after July 1, 2013. The rule does not apply retrospectively to DME orders prior to July 1, 2013. CMS is not implementing a requirement for a face-to-face encounter for prosthetic devices, orthotics, and prosthetics that require a written order, at this time, and deferred to future rule-making to address this area.

Continue Reading CMS Imposes New Requirements on Health Care Providers for Face-to-Face Encounters for DME Orders

The Louisiana Department of Health and Hospitals (“DHH”) has settled a class action lawsuit filed on behalf of Medicaid beneficiaries receiving Long Term Personal Care Services (“LT-PCS”). The class action is pending in the U.S. District Court, Middle District of Louisiana. The presiding federal judge has issued preliminary approval of the settlement. A final approval

CMS released 2011 recovery results for the Recovery Audit Contractor (RAC) Program. The 2011 figures reflect a significant increase over the amounts recovered or returned to providers in 2010. Through four quarters (October, 2010 through September, 2011), RAC contractors recovered a total of $797.4 million in overpayments, with $141.9 million in underpayments returned to providers.

Since 2003, Louisiana, through the Department of Health and Hospitals (“DHH”) and the Medicaid Program, administers home and community-based health services (“HCBS”) available to disabled citizens. The HCBS includes several programs, one of which is the Long Term Personal Care Services (“LT-PCS”) program. The LT-PCS program provides disabled citizens with a personal care worker to assist with performing personal care or household chores that the disabled citizen would otherwise be unable to perform, in order to avoid being institutionalized. Individuals who do not qualify for LT-PCS or who seek additional or alternative services may enter one of Louisiana’s waiver programs: Elderly and Disabled Adults, Adult Day Health Care, Program of All-inclusive Care for the Elderly, or Money Follows the Person for individuals transitioning from nursing facilities. However, these programs have limited slots, geographical or age limits, and long waiting lists. An individual may be moved to the top of the priority list and immediately obtain a waiver, if the individual has had a hospital stay in excess of 30 days or has been treated in a nursing facility for 120 consecutive days.

Continue Reading Court Certifies Class Action and Finds Reduction in Medicaid LT-PCS Program Violates Americans with Disabilities Act