CMS Publishes Stark Self-Disclosure Protocol

(September 30, 2010): The Health Care Reform Act has dramatically changed the future of health care for millions of Americans.  While many of its provisions are directed at access and affordability issues, a significant portion of the Act addresses various loopholes in existing statutory and regulatory provisions aimed at fighting health care fraud.  One of these statutes is the “Physician Self-Referral Statute,” Section 1877 of the Social Security Act, also known as “Stark.”

Section 6409 of the Health Care Reform Act required that the Secretary, Health and Human Services (HHS) work with HHS’ Inspector General of HHS to establish a Medicare self-referral disclosure protocol.  Last week, CMS published a Self-Referral Protocol to be used by providers when disclosing Stark violations.  Notably, this protocol is specifically limited to Stark issues. 

As the protocol discusses:

“Participation in the SRDP [self-referral disclosure protocol] is limited to actual or potential violations of the physician self-referral statute. The OIG’s Self-Disclosure Protocol is available for disclosing conduct that raises potential liabilities under other federal criminal, civil, or administrative laws. See. 63 Fed. Reg. 58399 (Oct. 30, 1998); OIG’s Open Letter to Health Care Providers, March 24, 2009. For example, conduct that raises liability risks under the physician self-referral statute may also raise liability risks under the OIG’s civil monetary penalty authorities regarding the federal anti-kickback statute and should be disclosed through the OIG’s Self-Disclosure Protocol. Disclosing parties should not disclose the same conduct under both the SRDP and OIG’s Self-Disclosure Protocol.”

When evaluating self-disclosures made, CMS has stated that it will consider the following factors in its assessment of whether or not to reduce any amounts that may be owed due to violations of the Stark statute.  These include:

(1) The nature and extent of the improper or illegal practice;

(2) The timeliness of the self-disclosure;

(3) The cooperation in providing additional information related to the disclosure;

(4) The litigation risk associated with the matter disclosed; and

(5) The financial position of the disclosing party.

 Importantly, there are no guarantees.  CMS has no obligation to reduce any amounts that may be owed.   The Stark statute can be quite complicated and providers facing Stark issues should discuss these points with qualified legal counsel when deciding whether or not to use the self-disclosure protocol.

Liles Parker attorneys are experienced in assessing business arrangements which may implicate the Stark statute.  Should you have questions regarding Stark or this self-disclosure protocol, please give us a call at 1 (800) 475-1906.  

Health Care Reform- The Independent Payment Advisory Board (IPAB) And Its Implications on Health Care Providers

(September 14, 2010): As one of the most controversial provisions in the recently enacted health care reform legislation, Congress created the IPAB – a board that is independent from Congress and the United States Department of Health and Human Services (“HHS”) as a mechanism to control Medicare – and potentially all – health care expenditures. Specifically, beginning January 2015, for any year in which the Chief Actuary of the Centers for Medicare and Medicaid Services (“Chief Actuary”) projects that the increase in per capita Medicare expenditures will exceed a defined target level, the IPAB is to develop a detailed proposal to scale back Medicare expenditures for that year. With limited exceptions, unlike the Medicare Payment Advisory Committee, these “recommendations” become binding unless Congress affirmatively acts in an expedited fashion and with a super majority vote to prevent them from becoming law. Additionally, the IPAB is to make non-binding recommendations on controlling expenditures for non-Federal health care programs.

The IPAB provision was developed because the administration and certain members of Congress were concerned that Congress did not have the political will to impose fiscal discipline upon itself. The IPAB has the potential to be a significant player in controlling health care costs overall. However, because some believe that it usurps Congress’ authority, it is also extremely controversial. Complicating the process is the fact that certain provider classes, such as hospitals, are exempted from cost reductions in the IPAB process during the early years, thus placing greater pressure to reduce expenditures for other provider and payor classes. This provision, coupled with a number of incentives in the health reform legislation to change the manner in which providers deliver care, will place strong incentives for the health care community to develop new methods to constrain cost increases without adversely affecting care. These include such mechanisms as coordinating care through such vehicles as Accountable Care Organizations and Medical Homes, bundling of services, and enhanced methods of disease management for high cost patients, as well the use of electronic medical records and more frequent use of email between practitioners and their patients.

Health care entities seeking advice on strategies for adapting to the new health care reform legislation should contact Michael Cook at (202) 298-8750. Also, Mr. Cook has authored a more detailed article on the IPAB and its likely impact on health care entities that is scheduled to be published in October issue of the American Health Lawyers Association Journal on Health and Life Sciences Law. Once that article is published, this website will include an abstract and a link to the article. Additionally, Mr. Cook will be presenting at the Healthcare Reform: Dealing with Hurdles and Building up Success Conference, sponsored by GTCbio, on November 8 and 9, 2010, in Washington, DC.

Liles Parker attorneys represent health care providers in connection with a wide variety of health care projects.  Michael Cook has extensive experience as a health lawyer and is a nationally-recognized attorney.  For more information, please contact Mr. Cook.  He can be e-mailed at: mcook@lilesparker.com  Alternatively, call Mr. Cook for a complimentary consultation at: 1 (800) 475-1906.

Robert W. Liles has Been Invited to be the Guest Speaker at the DOJ / HHS-OIG Quarterly Health Care Fraud Working Group Conference

(September 12, 2010):  Robert W. Liles, Managing Partner at Liles Parker, has been asked to serve as the main speaker at the quarterly Health Care Fraud Working Group conference sponsored by the U.S. Attorney’s Office for the Western District of Texas.  The Working Group consists of Federal civil and criminal Prosecutors, FBI agents, HHS-OIG agents and investigators, MFCU agents and investigators, ZPIC auditors and Investigators and representatives of the MAC responsible for processing Part A, Part B and DME Medicare claims.  The session will focus on changes to the False Claims Act, the Federal Anti-Kickback Statute and the Health Care Fraud Statute as a result of the recent enactment of the Health Care Reform Act last March.   Mr. Liles will also discuss the concerns of health care providers with current enforcement initiatives.

Since 2001, Mr. Liles has worked in private practice, representing the interests of health care providers in administrative actions (such as ZPIC audits of Medicare claims), civil cases (such as False Claims Act cases), and criminal matters (such asAnti-Kickback allegations).  Prior to entering private practice, Mr. Liles worked as an Assistant U.S. Attorney in the Southern District of Texas.  In early 1997, he was selected to serve as the nation’s first National Health Care Fraud Coordinator for the Executive Office of United States Attorneys in Washington, D.C. 

Prior to entering law, Mr. Liles worked for many years in the health care industry.  He received a Master’s in Health Care Administration from Trinity University in 1985.  Trinity is recognized as one of the foremost universities in the country for educating and training future hospital administrators.  In addition to an M.H.A., Mr. Liles also holds an M.B.A.

Mr. Liles’ varied background provides a unique perspective of both the health care industry and the needs and concerns of health providers.

Liles Parker has an office in San Antonio, Texas.  Our attorney in San Antonio is Rebecca Reed.  Ms. Reed is a former Bexar County prosecutor.  Should your practice or clinic have questions regarding a ZPIC audit, RAC audit, False Claims Act allegations or a possible criminal case, please give us a call for a free consultation at 1 (800) 475-1906.

The AHA Expresses its Concerns with Recent False Claims Act Actions

(September 11, 2010):  The American Hospital Association (AHA) has expressed its concern that the Department of Justice (DOJ) and its law enforcement partner, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) may be overreaching in its use of the False Claims Act. As set out in the AHA’s letter dated September 7, 2010:

  “The AHA is concerned that aggressive FCA investigations are being initiated upon the discovery of evidence of a mistake or overutilization, making FCA enforcement through negotiated “settlement” a self-fulfilling prophecy.”

 Citing a “kyphoplasty” initiative current being pursued by at least one U.S. Attorney’s Office, the AHA stated:

 “. . . notwithstanding the fact that kyphoplasty claims have long been subject to changing and ambiguous regulations and guidelines, the kyphoplasty initiative appears to observers to rely on data mining to establish a presumption that hospitals are liable for “knowing” violations of the civil FCA and subject to treble damages and penalties. Targets of the initiative have received letters disconcertingly similar to letters written prior to the issuance of the original “Holder Memo” in 1998 (Guidance on the Use of False Claims Act in Civil Health Care Matters).” (emphasis added).

 As the AHA noted, the threat of an FCA action, and its accompanying liability, forces hospitals to incur specialized legal counsel and outside forensic accountants in order to defend the hospital’s interests.  As a result, some hospitals elect to settle the allegations rather than litigate the issues.  In recent years, our law firm has noted a significant shift in the government’s reliance on data-mining in its development of administrative, civil and even criminal cases.  We share the AHA’s concerns in the regard.  The over-reliance on data mining in the targeting of defendants may lead to a presumption of guilt before any examination of the medical records and association documentation has occurred.  Notably, Robert W. Liles, a Managing Partner at Liles Parker was instrumental in the drafting and implementation of the “Holder Memo.”  A number of our attorneys have extensive experience working on False Claims Act cases.

A number of Liles Parker attorneys have extensive experience handling False Claims Act cases, including those brought under the Act’s Qui Tam provisions (commonly referred to as its “whistleblower”provisions).  Should you have questions regarding the False Claims Act, give us a call for a complimentary consultation.  We can be reached at: 1 (800) 475-1906.

HHS-OIG Issues Report on Improper Claims for Nonemergency Transportation Services Provided to Medicaid Beneficiaries in Texas

(September 6, 2010):  HHS-OIG recently issued its report examining nonemergency medical transportation costs reimbursed by Medicaid.  Pursuant to 42 CFR § 431.53, Texas and other States are required to ensure that Medicaid patients have transportation to medical facilities and providers to obtain covered Medicaid services.  In Texas, the Texas Health and Human Services Commission has contracted with the Texas Department of Transportation to administer this nonemergency medical transportation program. The Department of Transportation has subcontracted with various private transportation providers to provide these services.

 Upon audit, HHS-OIG found that one transportation provider had allegedly provided nonemergency transportation services for which the Texas Health and Human Services Commission had improperly claimed reimbursement by Medicaid.

 As set out in HHS-OIG’s report, Nonemergency Medical Transportation Costs in the State of Texas, 35 of the 100 sampled nonemergency transportation claims sampled were found by the auditors to be unallowable or partially unallowable.  Reasons for denial included:

•  Nonemergency transportation was allegedly provided by drivers who did not have a criminal background check or who had a prohibited criminal history on file with the subcontractor.
• The Medicaid beneficiary allegedly cancelled the transportation request in advance of the trip or was a “no-show” at the origination address.
• The Medicaid beneficiary allegedly did not receive a Medicaid-covered health care service on the transportation date.
• The Medicaid claims were paid at a premium rate applicable for transportation between two counties when the transportation was actually provided within the same county.

 In light of these findings, we recommend that providers review their practices to ensure that these and other specific risk areas regularly encountered in the provision of nonemergency transportation services are incorporated in their Compliance Plan and assessed as part of the provider’s recurring compliance review activities.  In this heightened enforcement environment it is essential that ambulance and nonemergency transportation providers continue to take steps to ensure that all applicable statutory and regulatory provisions are met.

Liles Parker attorneys have represented both ambulance and non-emergency transportation providers reimbursed by Medicare and Medicaid.  Should your transportation company be audited, give us a call. For a free consultation call:  1 (800) 475-1906.

HHS-ONC Names EHR “Authorized Testing and Certification Bodies”

(September 1, 2010):  Earlier this week, the Office of the National Coordinator for Health Information Technology (ONC), an organization within the Office of the Secretary of the Department of Health and Human Services (HHS), has announced named two entities as “Authorized Testing and Certification Bodies.”  They include:

• The Certification Commission for Health Information Technology (CCHIT), Chicago, Illinois, and  Drummond Group Inc. (DGI), Austin, Texas.

These entities are the first technology review bodies that have been authorized to test and certify electronic health record (EHR) systems for compliance with the standards and certification criteria that were issued by HHS earlier this year

As HHS’ Press Release reflects:

Certification of EHRs is part of a broad initiative undertaken by Congress and President Obama under the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act (ARRA) of 2009.  HITECH created new incentive payment programs to help health providers as they transition from paper-based medical records to EHRs.  Incentive payments totaling as much as $27 billion may be made under the program.  Individual physicians and other eligible professionals can receive up to $44,000 through Medicare and almost $64,000 through Medicaid.  Hospitals can receive millions.

To qualify for the incentive payments, providers must not only adopt, but also demonstrate meaningful use of, certified EHR systems.  The law envisions that defined meaningful use requirements will help ensure that the patient and provider benefits of EHRs are realized.  Initial meaningful use criteria were defined in a final rule issued by the Centers for Medicare & Medicaid Services (CMS) on July 28.”

With these appointments, EHR vendors will be able to have their programs certified as meeting criteria to support the “Meaningful Use” which are now required.

Should you have questions regarding these or other health law issues, you should contact your attorney or feel free to call one of the attorneys at Liles Parker.  For a free initial consultation, call: 1 (800) 475-1906.