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HEADLINES
Wednesday,
November 18, 2009
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On
The Front Lines
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Journal of Health Care Compliance November/December Volume 11, Number 6
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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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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