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Law, Explanation and Analysis of Health Care Reform Legislation

HEADLINES
Wednesday, November 18, 2009

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Journal of Health Care Compliance November/December Volume 11, Number 6

Reimbursement Advisor

    In addition to regularly featured columns such as HIPAA, electronic resources, and compliance and quality, the November/December 2009 issue of the Journal of Health Care Compliance includes the following articles:

  • The Permanent Recovery Audit Contractors Program, written by Kathy j. Tayon, discusses the expansion of the RAC program and how providers and suppliers will be affected.
  • Compliance as Asset Protection: The Independent Compliance Review Organization, written by John Fusto, Kendra Dimond, Virginia Evans, and Leslie Platt, stresses the importance of guarding against costly investigations and how organizations may avoid them.
  • Compliance and Program Integrity under Health Care Reform, written by Richard P. Kusserow, focuses how health reform legislation will take aim at eliminating fraud and abuse, including discussion of the new HEAT task force.
  • Not More Compliance Training!, written by Nanette O’Donnell, explains that Medicare Advantage organizations have flexibility over their compliance plans.

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Receivables Report

The CCH HIPAA Security Guide October 2009 update

  • Administration and enforcement of the Security Rules has been delegated to the HHS Office for Civil Rights (OCR), effective August 2009. Previously delegated to CMS, the move consolidates Privacy and Security Rules enforcement. OCR already enforces the Privacy Rules, and the added responsibility is expected to increase efficiencies in the department’s efforts to ensure that health information privacy is protected, according to a press release from HHS.
  • A consumer information organization called Consumers Checkbook was not entitled to HHS’ records for all Medicare claims submitted by physicians during 2004 because the records are exempt from disclosure under the Freedom of Information Act (FOIA), according to the U.S. Court of Appeals for the D.C. Circuit.
  • Effective September 23, 2009, HHS updated its guidance on security technology based on public comments. The update was part of the HHS interim final rule with request for comments on breach notification issued on August 24, 2009.
  • The FTC also published a final rule on August 25, 2009, effective September 24, 2009, regarding breach notification requirements for personal health records (PHR) vendors that are not ‘‘covered entities’’ or ‘‘business associates’’ under the Privacy Rules.
  • To avoid overlap with the HHS regulations, HIPAA-covered entities and entities that engage in activities as business associates of HIPAA-covered entities will be subject only to HHS’ rule and not the FTC’s rule.

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Headlines

MEDICs identify Part D fraud and abuse, OIG reviews

One of the key aspects of CMS' strategy to combat Medicare Part D fraud and abuse is the use of innovative techniques for data analysis by Medicare Drug Integrity Contractors (MEDICs). Beginning in 2007, CMS awarded contracts to three regional MEDICs to address potential Part D fraud and abuse. For this report, the Office of Inspector General (OIG) reviewed MEDIC data covering FY 2008, to determine: (1) the extent to which MEDIC identified and investigated potential Part D fraud and abuse incidents, (2) whether these incidents were identified through external sources or proactive methods, and (3) any issues or barriers MEDICs encountered. The OIG made the following findings: Incidents and investigation. MEDICs identified 4,194 incidents of potential fraud and abuse with eighty-seven percent (3,641) identified through external sources, primarily complaints and 13 percent (553) identified through proactive methods, such as data analysis. MEDICs conducted 1,320 fraud and abuse investigations with ninety-six percent of the incidents identified through external sources. Data access and use problems. MEDICs did not receive access to prescription drug event (PDE) data until August 2007, nearly a year after their contracts began. After receiving access to PDE data, MEDICs reported that important variables were not part of the data. Lack of authority. MEDICs did not have the authority to obtain prescriptions and medical records directly from pharmacies, pharmacy benefit managers, and physicians, only plan sponsors. In addition, while MEDICs are responsible for conducting audits of plan sponsors’ compliance plans, none of these audits were conducted in FY 2008 because CMS did not give its approval. Non-referral by plan sponsors. MEDICs may not have been aware of some potential incidents of fraud and abuse because plan sponsors are encouraged to refer incidents, but not required to do so. OIG recommendations. The OIG recommends that CMS: (1) ensure MEDICs have access to accurate and comprehensive data; (2) authorize MEDICs to directly obtain information from pharmacies, pharmacy benefit managers, and physicians; (3) require plan sponsors to report all potential fraud and abuse incidents that are referred to law enforcement agencies to MEDICs as well; and (4) ensure MEDICs have approval to conduct compliance plan audits. OIG Report, OEI-03-08-00420, Oct. 2009, Health Care Compliance Reporter.

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2010 physician fee schedule changes to MIPPA quality incentives

The 2010 Medicare physician fee schedule (PFS) implements a number of provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (PubLNo 110-275), including provisions related to the Physician Quality Reporting Initiative (PQRI) and the E-Prescribing Incentive Program. PQRI. The PQRI is a voluntary reporting program that provides an incentive payment to eligible professionals who satisfactorily report data on quality measures for covered professional services during a specified reporting period. The term “eligible professional” means any of the following: (1) physician, (2) practitioner, (3) physical or occupational therapist or a qualified speech-language pathologist, or (4) qualified audiologist. Beginning in 2010, participants may earn an incentive payment of two percent of the eligible professionals' estimated total allowed charges for professional services covered under Part B. The PFS moreover adds 30 individual PQRI measures and six measures groups, and an electronic health record-based reporting mechanism to promote the use of electronic health records. CMS will post on its website the names of eligible professionals and group practices that satisfactorily report quality measures following the distribution of the 2010 incentive payments. E-Prescribing Incentive Program. The E-Prescribing Incentive Program provides for incentive payments to eligible professionals who are successful electronic prescribers (e-prescribers). Beginning in 2010, the program will impose penalties on eligible professionals who are not successful e-prescribers. CMS will broaden eligibility for the e-prescribing incentive by including professional services furnished in skilled nursing facilities, domiciliary care, or the home care setting as part of the list of services for which the electronic prescribing measure is reportable, and enable group practices to qualify for a 2010 e-prescribing incentive payment based on a determination at the group practice level, rather than at the individual level. CMS will post on its website the names of individual eligible professionals and group practices that are successful e-prescribers for the 2010 E-Prescribing Incentive Program following the distribution of the 2010 incentive payments. CCH Chicago Bureau, Oct. 30, 2009.

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OIG: Ryan White program grantees compliant

Almost all grantees of the Ryan White program complied with the core medical services pursuant to the Ryan White CARE Act, according to the Office of Inspector General (OIG). The core medical services requirement applies to funds provided under Parts A, B and C of the Ryan White CARE Act. Part A grants are awarded to metropolitan areas for HIV-related services. Part B base grants, along with supplemental funds, are awarded to states and territories to improve the quality, availability, and organization of health care and support services. Part C Early Intervention Services grants are made to public and private nonprofit organizations to fund comprehensive primary health care in an outpatient setting for people living with HIV. Core medical services requirement. The core medical services requirement established in 2006 states that Parts A, B and C grantees must spend at least 75 percent of their funds on core medical services. The core medical services include: outpatient and ambulatory health services; pharmaceutical assistance, including medications provided through the AIDS Drug Assistance Program; and oral health care, among others. Compliance with core medical services requirement. The majority of grantees complied with the core medical services requirement in 2007 and 2008. Parts A, B and C grantees collectively spent an average of 93 percent of their grant funds on core medical services in 2007. The average spending of Part A grantees on core medical services in 2007 and their allocated expenditures in 2008 were 82 percent. Part B and Part C grantees' average spending on core medical services in 2007 were 94 and 95 percent, respectively; in 2008, their allocated expenditures for core medical services were both 94 percent. OIG Report, No. OEI-07-08-00240, Oct. 2009.

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New requirements for patient care technicians

The new conditions for coverage (CfCs) for end-stage renal disease (ESRD) facilities include certification requirements for dialysis patient care technicians (PCTs). PCTs are defined as "any unlicensed staff member who has responsibility for direct patient care, including setting up the dialysis machine for patient use and testing reprocessed dialyzers that have been placed on the machine for presence or absence of germicide." The certification requirements do not apply to those with no direct patient care contact. According to the new CfCs, any PCTs who were hired on or before October 14, 2008, must be certified by a state or national PCT certification program by April 15, 2010. PCTs hired after October 14, 2008, must be certified within 18 months of their hire date. The new certification requirements are already in effect. State agencies have thirty days to disseminate this information. Certification programs. The certification must be obtained from a CMS-approved program. To be CMS-approved, the program must include: (1) a qualified standardized test, (2) an independently proctored and protected testing environment, and (3) ongoing recertification. Sponsoring organizations must apply for approval with CMS. To assist in the research of certification program requirements, CMS released two appendices along with this Memorandum. Appendix A lists states that have state-provided PCT programs or require national program certification, and Appendix B describes the national certification programs. Other PCT requirements. In addition to the certification program requirements, PCTs must meet further federal and state requirements for education, training and competency. For example, federal requirements mandate that a PCT must have a high school diploma or equivalency (GED), with some exception, and complete a job-specific training program related to the CfCs. CMS Memorandum to State Survey Agency Directors, No. S&C-10-03-ESRD, Oct. 30, 2009, Health Care Compliance Reporter.

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On The Front Lines

RACs and HEAT and TARP – Oh, My! –Part 2

by Michael E. Clark, JD

Health care professionals face escalating dangers that increase the likelihood of serious consequences. In Part 1 of this two-Part article, the author discussed the first two of five recent developments that have created this environment. In Part 2, Mr. Clark discusses the remaining three developments: federal contractors' compliance obligations under the Federal Acquisition Regulations (FARs); the conditions on the stimulus funds under the TARP; and amendments to the federal civil False Claims Act. FAR obligations.Since December 2008, healthcare providers funded in whole or through federal contract grants must be mindful of new self-reporting obligations imposed under the FARs, or risk possible suspension or debarment. TARP conditions. As our nation has been struggling to recover from several major economic problems stemming from the subprime debacle and the subsequent broader, threatened collapse of major financial institutions and large employers, our leaders have moved quickly to provide unprecedented amounts of stimulus funds to prevent a systemic collapse and restore consumer confidence. FERA amendments. The Fraud Enforcement and Recovery Act of 2009 (“FERA”), which was signed into law on May 29, 2009, likely represents the most dangerous of the recent developments facing the healthcare community. This article illustrates the new, ongoing, and potentially devastating consequences to professionals and providers operating in this very heavily regulated industry that fail to modify their affairs as and when necessary in light of changing government regulations. Proactive adjustment of corporate governance mechanisms and compliance plans is critical. It is far more cost effective to be proactive than reactive. It is also expected. In today’s world, regulators and the public are not willing to tolerate mistakes, honest or not.

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