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ePolicy News February 2014

Friday, January 31, 2014



ASCP Responds to PFS Final Rule, Addresses Harmful Coding Changes Finalized for IHC and Prostate Biopsies

As the CY 2014 Medicare Physician Fee Schedule rule-making process comes to a close, ASCP continues to advocate on behalf of our members and the patient community they serve.

On Monday, Jan. 27, ASCP submitted a comment letter in response to the CY 2014 Medicare Physician Fee Schedule (PFS) Final Rule. Comments reiterated policy concerns previously addressed in ASCP’s response to the CY 2014 PFS Proposed Rule and responded to flawed coding changes finalized but not previously made available to the public for comment. In particular, ASCP’s comments on the PFS Final Rule:

  • Expressed gratitude toward CMS  for eliminating its proposal to cap non-facility PFS rates at Hospital Outpatient Prospective Payment System (OPPS) rates, but voiced concern with CMS’s stated intent to revisit this proposal;
  • Reiterated concerns that CMS has not provided adequate information/transparency in its implementation approach to revaluing the Clinical Laboratory Fee Schedule (CLFS);
  • Expressed appreciation that CMS will exempt physicians with zero applicable measures from a negative payment adjustment under the Physician Quality Reporting System (PQRS), but encouraged CMS to consider long-term solutions to capture pathologists’ existing quality efforts;
  • Reiterated concern that CMS is advancing the Value-based Payment Modifier (VBM) program too swiftly, prior to ensuring it will fairly/accurately compare cost and quality performance; and
  • Responded to two new billing changes not presented in the proposed rule for comment, regarding the reimbursement of immunohistochemistry staining and prostate biopsies.

ASCP addressed the following two billing changes that were finalized but not previously introduced in the proposed rule:

The Creation of Two New G-Codes for Immunohistochemistry (IHC): As part of the PFS Final Rule, CMS rejected an American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel revision to the immunohistochemistry (IHC) code, CPT code 88342. The Agency also rejected the Panel’s creation of a new add-on code (CPT code 88343) for CY 2014 that was intended to capture potential efficiencies when multiple antibodies are placed on the same slide, rather than separate slides, during IHC staining. CMS did not feel that the new add-on code adequately captured all potential efficiencies that may aid in curbing overutilization and, therefore, proposed two new G-codes (G0461 and G0462) instead. The G-codes displace “antibody” as the billing unit for IHC staining and replace it with “specimen.” As a result, rather than reducing reimbursement for each additional antibody placed on a slide, the G-codes lower reimbursement for each additional slide developed on a per specimen basis. This reduced reimbursement rate for each subsequent slide is applied regardless of whether or not there are multiple antibodies on the slide, the slide was derived from the same block, and/or the slide was derived from blocks created from separate tumors within the same specimen. The G-codes therefore reimburse multiple IHC stains performed as a multiplex “cocktail” on a single slide at the same reimbursement rate for a single stain performed on a single slide.

ASCP Primary Concerns: CMS is reducing reimbursement too drastically, based on efficiencies not truly present at the specimen-level. The new G-codes will reimburse IHC staining on each additional slide per specimen at the same rate that the add-on code was intended to reimburse for each additional antibody per slide. This reimbursement approach is fundamentally flawed based on the obvious differential in the additional physician work exerted and practice expense accrued on a per specimen basis compared to a per antibody basis. “Specimen” is also not an appropriate billing unit because there is too much variability in how it is defined, based on how the tissue is extracted and how it is contained prior to processing. Moreover, the G-codes wrongly discount the additional practice expense and work associated with performing multiple IHC stains on a single slide by reimbursing multiplex cocktail stains at the same rate as a single stain. As such, rather than reducing reimbursement for each additional antibody on a single slide, as intended by CPT code 88343, the G-codes would not reimburse at all for additional antibodies on a single slide.

Final Rule Verdict: CMS finalized the two new G-codes for the billing of IHC staining without previously presenting them in the Proposed Rule for comment.

ASCP Response: IHC staining is a complex service and its delivery varies drastically based on a significant and complex set of variables at the specimen-, block-, and antibody-levels. The challenge behind curbing potential overutilization of IHC services is rooted in the fact that there are no uniform standards for service delivery that are able to differentiate overutilization from appropriate utilization. As a result, a one-size-fits-all approach will not be effective in accurately targeting true overutilization of IHC staining. ASCP encourages CMS to consider Stark reform as a more appropriate and effective means of curbing overutilization.

Revisions to Saturation Biopsy Codes G0416 through G0419: CMS modified the descriptors for HCPCS codes G0416-G0419 (surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling). In doing so, CMS deleted past references to the designation that these codes are specific to saturation prostate biopsies. Now, individuals who review prostate biopsies resulting in 10 or more separately identifiable specimens will be required to use the revised G codes to bill for these services, regardless of whether the prostate biopsy is saturation or routine. The new descriptor bundles multiple specimen routine prostate biopsies at a single rate, as it has historically done for saturation prostate biopsies, rather than paying the per specimen rate previously paid.

ASCP Primary Concerns: It is inappropriate, from a coding and workload perspective, to place equal value on the reimbursement for saturation prostate biopsies and routine prostate biopsies. Accordingly, CMS’s application of this bundled payment scheme to the billing for routine prostate biopsies is based on the false assumption that efficiencies are gained, as is the case for the less resource-intensive saturation prostate biopsies. This results in a reimbursement rate for routine prostate biopsies that does not accurately reflect requisite work and resource costs.

Final Rule Verdict: CMS failed to adhere to the proper administrative procedure requirements, as this coding modification was finalized without adequate explanation, public notice, and/or opportunity for public comment.

ASCP Response: Given that this was the first opportunity for comment even though it is within a Final Rule, ASCP merely urged CMS to abandon this descriptor modification and revert to the previous language for these G codes.

In addition to the policies mentioned above, ASCP reiterated concerns regarding the following three policies previously addressed in our response to the proposed rule:

The OPPS Payment Cap: CMS’s proposal to limit non-facility PFS payment rates to the Hospital Outpatient Prospective Payment System (OPPS) payment rates for certain services. CMS would cap PFS rates at OPPS rates only when they exceeded OPPS rates for the same service.

ASCP Primary Concerns: This policy inappropriately compares two inherently dissimilar payment systems, ignores site-of-service cost variance in economies of scale, and violates statute specifying PFS rates must be based on the direct cost inputs involved in providing a specific service. Implementation would result in reimbursement rates for affected services that do not adequately cover the cost of service provision, thereby threatening affordable supply of these services.

Final Rule Verdict: CMS did NOT finalize this proposal for CY 2014. ASCP is pleased that the Agency was responsive to the Society’s advocacy efforts on behalf of the pathology community. However, concern remains that CMS revealed its intentions to revisit this proposal in the CY 2015 PFS Proposed Rule.

ASCP Response: After developing an action alert that garnered 10,000 messages to Congress and CMS, ASCP’s efforts to convince CMS to abandon this policy for CY 2014 were successful. ASCP will continue to monitor CMS’s regulatory actions for mention of any plans to revisit this proposal and notify our members accordingly.

Revaluation of the CLFS: Beginning with the CY 2015 PFS Proposed Rule, CMS will propose CLFS codes for revaluation in an effort to better reflect technological changes. CMS will also seek public nomination of additional codes to be reviewed and potentially revalued.

ASCP Primary Concerns: This revaluation appears to be duplicative of the productivity adjustment already applied to CLFS rates and may, therefore, result in unfair duplicative cuts to reimbursement. CMS’s failure to specify a cap for the number of codes to be reviewed each year may result in inadequate information collection/public input on an overwhelming number of codes and, subsequently, inaccurate revaluation. Finally, CMS’s failure to provide the public with the reasoning behind and information supporting the revaluation of specific codes may mitigate the ability of stakeholders to provide substantive and targeted feedback.

Final Rule Verdict: CMS finalized this proposal, with modifications, for CY 2014. However, the Agency has left many unanswered questions and, consequently, leaves much room for potential concern and ongoing stakeholder feedback.

ASCP Response: In response, ASCP is currently working with a coalition of pathology and laboratory organizations to develop recommendations to guide a fair and effective implementation approach that involves assessment of the full scope of technological impact; establishes firm schedules and guidelines; ensures meaningful and timely stakeholder input; and mitigates the impact of price cuts on laboratories serving a disproportionate share of vulnerable patient populations.

Developing Quality Reporting Programs: CMS increased the number of measures required to fulfill PQRS, introduced new quality reporting measures, and expanded group practice reporting options. However, CMS clarified that eligible professionals may report on as many PQRS measures as are applicable to their practice in order to fulfill PQRS requirements. CMS increased the dollars at risk under both PQRS and the Value-based Payment Modifier (VBM) program. The Agency also declared quality-tiering mandatory, introduced a new cost measure, and finalized a specialty-based risk-adjustment approach to ensure fair quality comparisons under the VBM program.

ASCP Primary Concerns: For CY 2014, no additional pathology-specific measures have been added to the PQRS measures set while pathologists remain limited in their available reporting mechanisms/group practice reporting options. Current quality reporting programs are limited in that quality measures must be directly tied to billing data results in condition- and treatment-specific assessment of patient-level quality improvement efforts. Conversely, pathologists’ quality improvement efforts tend to be system-wide with broad, hospital-level and/or laboratory-level impact. Accordingly, CMS’s existing quality reporting programs fail to effectively capture pathologists’ quality reporting and improvement efforts already in place. This failure translates to CMS’s inability to capture quality at the essential core of healthcare service delivery, thereby challenging the comprehensiveness of current quality assessment altogether.

Final Rule Verdict: CMS finalized a substantial increase in the number of measures required to earn an incentive payment and avoid a negative adjustment, but then clarified that physicians with zero applicable PQRS measures will not be subject to a negative payment adjustment. While the pathology community is grateful for this allowance, CMS is sending mixed messages by finalizing drastically enhanced program requirements despite its acknowledgement that many physicians still do not have any applicable measures. The Agency also failed to address long-term concerns regarding the general inapplicability of quality reporting programs to certain specialties.

ASCP Response: ASCP communicated both short-term and long-term recommendations for the future of CMS-developed quality reporting programs. Short-term recommendations aimed to ease and even enhance pathologists’ ability to successfully participate in these programs. Long-term recommendations were intended to fundamentally improve the efficacy and comprehensiveness of quality reporting, while expanding the scope of quality assessment to better capture both large- and small-scale quality improvement efforts across all specialty type providers. Accordingly, ASCP is meeting with CMS to further discuss the Society’s long-term recommendations. ASCP has also recently released educational materials to help aid pathologists in successful PQRS participation and achievement of a positive value modifier under the VBM program.


ASCP Welcomes Nomination of Deborah Birx

ASCP is applauding the nomination of Deborah Birx, MD, as the next U.S. Global AIDS Coordinator, a post responsible for leading the President’s Emergency Plan for AIDS Relief (PEPFAR) and overseeing the U.S. relationship with the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

Dr. Birx began her career as a clinician in pediatric and adult immunology, focusing on clinical HIV/AIDS, vaccine research, and global health. She served as Assistant Chief of the Allergy Immunology Service at Walter Reed Army Medical Center, Bethesda, Md., and earned the U.S. Meritorious Service Medal for her leadership in refining, validating, and standardizing cell-mediated immunity testing in HIV-infected patients. During her military career, Dr. Birx brought together the U.S. Navy, U.S. Army, and U.S. Air Force in a new model of cooperation, increasing the efficiency and effectiveness of the U.S. Military’s HIV/AIDS clinical and basic research.

Since 2009, Dr. Birx has served as the Director of the Division of Global HIV/AIDS in the Center for Global Health at the Centers for Disease Control and Prevention (CDC). Her leadership galvanized support for laboratory strengthening initiatives across Africa, leading to accreditation and enhanced laboratory infrastructure, essential to quality and timely patient care.

Dr. Birx will be assuming this role at a critical time for the PEPFAR. Her leadership will be essential in achieving the goals laid out in the PEPFAR Blueprint for Creating an AIDS-Free Generation. Once confirmed, Dr. Birx will succeed Ambassador Eric Goosby, who was U.S. Global AIDS Coordinator between 2009 and 2013.


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