NMQF Responds to Comments on Quality Measure for African Americans with Heart Failure

The National Minority Quality Forum’s (NMQF) proposed trial eMeasure (#2764), “Fixed-dose Combination of Hydralazine and Isosorbide Dinitrate Therapy for Self-identified Black or African American Patients with Heart Failure and LVEF <40% on ACEI or ARB and Beta-blocker Therapy," received more than 40 comments during the National Quality Forum’s public and member comment period for their Cardiovascular Measures 2015 project that closed on November 23, 2015 (see NMQF's response here). The overwhelming majority of the comments voiced strong support for the September 9 decision of the NQF Cardiovascular Measures Standing Committee to approve NMQF’s trial measure, and to enable Measure #2764 to advance to the next stage of voting and to complete required testing of validity and reliability.

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​In their global response to the comment's received during the process, NMQF "concurs with comment #5448, a positive comment in our view, which was submitted by the National Alliance for Hispanic Health. Measure #2764 is designed to address the gap in patient-centric performance measures that must be given priority in light of rapidly changing population demographics. Measure #2764, and the science that supports its specifications, will also open the door for the collection of data on provider experience and patient outcomes that will further the evolution of research and medical practice that is efficacious for all patients.

"The National Minority Quality Forum (NMQF) believes that Measure #2764 is consistent with the recommendations of the 2013 ACCF/AHA Guidelines for the Management of Heart Failure and the science that undergirds their recommendations; promotes clarity among physicians regarding evidence-based therapies for the treatment of Stage III & IV Heart Failure in the specified patient population; and facilitates the elimination of formulary management or economic barriers to this evidence-based therapy.

"The National Minority Quality Forum remains confident that those organizations and individuals who influence treatment guidelines and reimbursement policy are committed to improving the ability of the American health services financing and delivery system to meet the needs of the increasingly diverse American general population. We are challenged, therefore, to comprehend the continued resistance of certain sectors to embrace and promote the science, and to engage proactively to eliminate barriers to accessing this therapy by populations who experience avoidable morbidity and mortality associated with inadequate treatment, and by the physicians who are challenged daily in their efforts to provide high-quality, cost-beneficial services to their patient populations.
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"The National Minority Quality Forum is concerned about arbitrary and flexible definitions of the components of quality healthcare that may create confusion within both the provider and patient communities. The National Quality Forum is an environment that has the potential to eliminate much of this confusion. Measure #2764 is a step in the right direction.

"The National Minority Quality Forum believes that the National Quality Forum process of trial approval, endorsement and maintenance is designed to address quality measurement challenges through constructive and proactive engagement with the delivery system. NMQF has developed Measure #2764 to facilitate and advance this engagement. Failure to allow the process to move forward compromises the system through the lens of providers, patients and payers.

"For the following reasons, therefore, the National Minority Quality Forum asks the Cardiovascular Standing Committee to continue to recommend Measure #2764 so that testing of validity and reliability can proceed unimpeded, and this measure can advance to the endorsement phase of NQF deliberations.

1. "It is the National Minority Quality Forum’s understanding that performance measures should be consistent with current evidence to ensure that appropriate, safe and high quality care is provided by physicians to their patients. Indeed, a negative commenter states that, “It’s true that the ACCF/AHA Heart Failure guideline gives the highest level recommendation to the fixed-dose combination.” Measure #2764 is based upon the adjudicated science that supports that recommendation and that documents the efficacy of the therapy Measure #2764 is designed to measure. Most importantly, it represents a value proposition and supports efforts to prevent unnecessary hospitalizations, to eliminate inequities in healthcare and health status, and to advance efforts to enhance precision in the design of treatment alternatives that are patient-centric.
2. The 2013 ACCF/AHA guidelines recommend off label use of isosorbide dinitrate (a generic of Isordil Titradose) and hydralazine hydrochloride (a generic of Apresoline Hydrochloride), two drugs with indications, labeling, dose and administration that are different from those of the fixed-dose approved by FDA. Based upon our review of the 2013 ACCF/AHA guidelines, the A-HeFT trial results, the 2010 Heart Failure Society of America guidelines, and other peer reviewed resources, NMQF determined that including language in Measure #2764 that would suggest the appropriateness of prescribing the two component compounds separately as equivalent to the fixed-dose combination approved by the FDA was not supported by available evidence, would be inconsistent with the high standards established by NQF for the development of performance measures to support the provision of quality care, and would be legally imprudent for the NMQF given the legal definitions of “generic” and “off-label use”.
3. By law, an authorized generic drug has the approval of the Food and Drug Administration (FDA). To gain that approval, a generic drug must contain the same active ingredients as the innovator drug, be identical in strength, dose form, and route of administration, have the same use indications, be bioequivalent, meet the same batch requirements for identity, strength, purity, and quality, be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products. FDA has said there is no generic fixed dose. FDA monitors approved generics for safety.
4. A comment stated that the 2013 ACCF/AHA guideline writing committee had the option to limit the guideline recommendation to only the fixed-dose combination, yet explicitly decided to allow as equivalent the use of the individual components to ensure that patients have adequate flexibility in terms of drug availability or cost. The commenter offered no references to support the determination of equivalence by the writing committee, and no such references are evident in the 2013 ACCF/AHA Guideline for the Management of Heart Failure.
5. The 2013 ACCF/AHA guideline appears to use as evidence to support their determination of equivalence, evidence that supports only the fixed-dose combination. Therefore, as required by NQF guidance regarding the development of evidence-based performance measures, NMQF specified Measure #2764 based upon the strongest science/evidence, which supports the use of a combination of isosorbide dinitrate and hydralazine hydrochloride – evidence that is available only for the fixed-dose combination that was approved by the Food and Drug Administration (FDA) in 2005. Indeed, the ACCF/AHA recommendation of the two separate compounds as equivalent appears to be based not upon strong evidence, but upon professional opinion and assumptions of affordability challenges inherent in the specified patient population. These concerns are not supported by any references or documentation, nor are they concerns that are de facto generalizable to all patients for whom the therapy in question is indicated.
6. The National Minority Quality Forum supports efforts by NQF and its members to promote the development of performance measures that are consistent with scientific and clinical evidence, and result in improved outcomes of care while containing the growth of unnecessary expenditures. An essential component of accomplishing this objective is clarity and transparency in the development and application of these measures. As NMQF stated during the September 9 meeting of the Cardiovascular Measures Committee and in our application, recommendation of the use of the two component compounds as a “generic” is inconsistent with the statement by FDA that they have not approved a generic for the fixed-dose combination. A copy of the letter can be made available upon request.
7. Given that neither of the two component compounds is indicated for treatment of heart failure, the decision reached by the 2013 ACCF/AHA guideline writing committee constitutes a recommendation of off-label use that may be appropriate within the provider environment, but is not appropriate, we believe, for an NQF endorse performance measure. Therefore, the NMQF believes that Measure #2764 does, indeed, represent the component of the 2013 ACCF/AHA guideline that is appropriate for a performance measure through the lenses of evidence, need, and importance.
8. FDA has stated in writing that there is no generic for the therapy that FDA approved -- a fixed-dose single pill combination of two compounds that are only approved for treatment of chronic heart failure in that specific combination. Separately, neither is indicated for treatment of heart failure, and there is no science to support such an assertion. Promotion of such use can be construed as off-label use that puts providers, insurers and patients at risk.Again, there is no generic of the fixed-dose combination, and there is no science to support the use of the two compounds that comprise the fixed-dose for the treatment of Stage III or Stage IV heart failure.
9. A comment notes that observed differences in formulations (brand vs generic), though valid, are theoretical and not proven to be of clinical consequence. This statement is of concern given that: (1) there is no generic to the brand; and (2) appears to take as evidence of potential equivalence the fact that there is no evidence to support the use of the two compounds separately.
10. Medicare does not reimburse for off-label use.
11. Concerns have been expressed that the challenges of accurately collecting all of the required data from electronic health records must be addressed before Measure #2764 receives full endorsement. The National Minority Quality Forum notes that the trial eMeasure program designed by the National Quality Forum is designed to address such a concern; and such is the objective of the validity and reliability testing protocol that is under development by the National Minority Quality Forum. Further, many of the critical data elements included in the specification of Measure #2764, including race, ethnicity and left-ventricular ejection fraction, are data elements that are mandated by the Joint Commission, by Meaningful Use criteria, or other EHR specifications. Their requirement is not limited to Measure #2764.
12. It has been suggested that Measure #2764, "...is based upon a somewhat questionable assumption that providers have taken a dismissive approach to the evidence for this combination therapy." The National Minority Quality Forum notes that Measure #2764 is based not upon assumptions, but upon data and evidence. The fact is that the fixed-dose combination of hydralazine hydrochloride and isosorbide dinitrate was approved by the FDA over a decade ago. The fact is that the number of eligible patients for whom the approved therapy is prescribed is significantly, indeed disturbingly, lower than the number of patients for whom that therapy is indicated. The fact is that eligible patients who do not receive the indicated therapy are at increased risk for hospitalization, avoidable morbidity, and premature mortality. These facts are sentinels that mandate an intervention by the policy and regulatory environment. Measure #2764 is a response to these facts.
13. Further, it has been suggested that Measure #2764 fails to fully acknowledge the complexity of addressing race in medical practice. This is an interesting statement, since the nature of this "complexity" is not specified. If the referenced "complexity" is in regard to the identification of race and ethnicity, we note that the science that undergirds Measure #2764 is based upon "self-identified" race. Since no peer-reviewed references are offered to support the comment regarding "complexity", this statement may, indeed, be an "assumption" that can be examined only through a testing process. We note again, however, that identification of race and ethnicity is mandated by the Joint Commission and by Meaningful Use. If this "complexity" exists, we submit that Measure #2764 is neither the beginning of this conversation, nor the end, particularly in light of the movement toward precision in diagnoses and treatment that will require an even higher degree of specificity regarding patient characteristics.
14. A commenter suggests that Measure #2764 fails to fully acknowledge the potential adverse consequences of prescribing a costly, TID medication with overt side effects. It is not clear how the issue of overt side effects fits into this discussion. There is the potential for overt side effects for all major therapies. Measure #2764, as specified, does not compromise the ability or the responsibility of physicians to practice medicine based upon their best judgment, and exceptions to address the primary reasons for intolerances and side effects have been defined in the measure.
15. The issue of co-pays for a branded therapy also has been raised. The issue of cost and affordability was discussed during the September 9 meeting of the NQF Cardiovascular Measures committee. It was noted during that meeting that "costly" medications are linked to performance measures for cancer therapies and other "costly" diseases.
16. There were, during the September 9 meeting, assumptions articulated about the ability of the specified patient population to afford the medication, and the extent to which that potentially unaffordable cost would compromise the ability of the patient population to fill prescriptions written by physicians. The particular concern was whether the physician would get "dinged" if the prescription was written, but not filled. The answer was "No", the physician would not get "dinged" if the prescription was not filled. Further, developing performance measures based upon speculation about the potential behavior of insurance companies is, we submit, not appropriate for these discussions. Insurers should rely upon science to inform their coverage and payment decisions. The obverse should never be the case.
17. It is important to remind all stakeholders that performance measures endorsed by the National Quality Forum are voluntary measures. They are made available for care delivery systems and payers who elect to use them to advance the provision of quality care. The National Minority Quality Forum looks forward to working with the National Quality Forum as its processes evolve to embrace heterogeneity of disease presentation and treatment effect, and on the standardization of key components for all performance measures.
18. It has been suggested that Measure#2764 should include language regarding a patient’s right to refuse the therapy. It is NMQF’s understanding that all patients in the United States have the right to refuse any therapy recommended by clinicians. If NQF requires that patient refusal be included in measure specifications, NMQF has indicated will be pleased to make this non-substantive addition to Measure #2764."

NMQF Global Rsponse re: Measure 2764
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