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CMS Publishes Proposed Changes to the Cytology Proficiency Testing Program
The Centers for Medicare and Medicaid Services released its proposed rule Jan. 15 with recommended changes to the Cytology PT program—changes that CAP believes do not go far enough in reforming the fatally flawed regulation.
The proposed rule comes almost four years after the College and other pathology societies first appealed to CMS to initiate changes to a program that most in the medical community agree is scientifically unproven and out-of-date.
A statement released by the College outlines that the lengthy passage of time to propose these changes demonstrates the need for a different approach that makes it easier for proficiency testing programs to be modified to keep pace with changing medical science.
According to the statement from the College, “The agency should seek a true dialogue with the community it seeks to impose standards upon and should realize it has failed the test of collaboration when all of the major organizations have recommended a different approach.”
The College and its 60+ partners in the Cytology PT Coalition rallied and garnered significant bi-partisan support in the 110th Congress for alternative legislation that would have corrected the major shortcomings of the current regulatory schema.
This new legislation laid the foundation for an appropriate and preferred pathway to correcting the current program, and was widely viewed as a workable solution, evidenced by its passage in the House and the support of 43 Senate co-sponsors before the session closed.
The future of the proposed regulation is now in question after Pres. Barack Obama issued an Executive Order Jan. 20 freezing advancement of any proposed regulations until the new administration has an opportunity to evaluate the need for any regulation proposed by the previous administration.
CAP’s Washington staff is working with the Office of Management and Budget and Department of Health and Human Services to identify whether this recently issued Executive Order also applies to the Cytology PT rule. In the meantime, CAP is preparing comments to submit to HHS before the close of the 60-day comment period March 16.
ICD-10 Codes Released Along with New College-Recommended Compliance Date
The Department of Health and Human Services released the long-awaited ICD-10 codes Jan. 15 along with a new transitional timeline of five years for adoption of the codes.
Transition to a national electronic health record system will be reliant on the adoption of ICD-10 codes—which include 138,000 additional codes from the ICD-9 set, and is intended to provide more details in electronic transactions.
The College anticipates tremendous advantages for the adoption of ICD-10 code sets and the electronic health record system, but voiced concern about the original transition timeline of three years, stating that more time would be needed.
The new date, effective Oct. 1, 2013, gives pathologists now using the ICD-9 code set an additional two years to prepare for compliance.
Similar to the proposed Cytology PT regulation, the future of the ICD-10 transition is now in question after the presidential Executive Order issued Jan. 20 froze advancement of any proposed regulations until the new administration has an opportunity to evaluate the need for any regulation proposed by the previous administration.
CAP Requests CMS Provide PT Referral Policy Addressing Sanctions for Unintentional Referrals
Noting that current enforcement activities are hampering good laboratory practices, the College requested that the Centers for Medicare and Medicaid Services provide a Proficiency Testing Referral policy for accredited laboratories that adequately addresses severe sanctions for labs that unintentionally refer PT specimens.
Concerns have been raised that labs following well-established procedures for a specimen would refer PT samples to another lab for testing, and despite a lack of premeditation, the referral can be considered improper and subject to CLIA sanctions.
In a comment letter sent to CMS, the College also expressed concern that CMS has not clearly delineated a policy for the unintentional referral that would ensure accreditation organizations, laboratory directors and personnel are able to utilize emerging technologies in order to ensure quality lab testing.
In CMS’s response to the comments, the agency states that they expect that their continued review of all cases until further notice will permit CMS to experience enough scenarios so that in the future, they will be effectively able to define the term “unintentional.”
To view the complete recommendations, please visit CAP’s Advocacy Web site, under “Comments to Regulatory Agencies.”
Report Released By CMS on the 2007 PQRI
CMS released a report providing a detailed analysis of the 2007 PQRI reporting experience outlining some of the challenges and successes of the program.
The report, entitled, “Physician Quality Reporting Initiative: 2007 Reporting Experience,” describes several issues identified for 2007 that affected physician’s ability to participate successfully, as well as some of the business reasons that may explain why these challenges occurred.
For example, almost half of the 14 million quality data codes entered in 2007 were invalid; or did not include an NPI number necessary to appropriately credit the physician. Moving forward, CMS may now make changes to their analysis of the 2008 data to adjust for technical factors that contributed to invalid reporting identified in the 2007 PQRI.
CMS expects that additional eligible professionals will qualify for an incentive payment for both 2007 and 2008 based on these efforts, which will be completed by the fall 2009.
The report is available
on the CMS Web site.
(For Statline reprint permission, please contact Justin Herman.)
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