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Home INR Monitoring - CMS Accepting Public Comments (thru 1/19/2008) Regarding Expanded Coverage

Marie B. Walker
January, 2008

Through January 19, 2008, CMS is accepting public comments regarding the issue of expanded coverage for home INR monitoring. To learn more about the issue from the CMS website, go to:
http://www.cms.hhs.gov/mcd/viewnca.asp?nca_id=209&basket=

To submit your own comments, click the orange comment button on the page displayed when you follow the link above, or go directly to the comment form at:
http://www.cms.hhs.gov/mcd/public_comment.asp?nca_id=209&basketitem=

To learn more about patient self testing, go to:
http://www.clotcare.com/clotcare/pst.aspx

Below is a memo provided to ClotCare by ITC, a manufacturer of point of care testing supplies for PT-INR testing.


Home Prothrombin Time/INR Monitoring for Anticoagulation Management (NCD 190.11)
RECONSIDERATION REQUEST: PROPOSED DECISION MEMORANDUM

Background
Medicare began covering prothrombin time/International Normalized Ratio (PT/INR) monitoring in the home in 2002. However, the Centers for Medicare & Medicaid Services (CMS) limited coverage to patients with mechanical heart valves because at that time, the overwhelming majority of patients enrolled in clinical trials evaluating home PT/INR monitoring had mechanical heart valves as the underlying indication for anticoagulation with warfarin (Coumadin®). Medicare coverage still remains limited to patients with mechanical heart valves. However, less than 20 percent of persons on chronic warfarin therapy take the medication because they have mechanical heart valves, and less than 5-percent of anticoagulated patients are monitored at home.

CMS's Proposed Decision Memorandum
In June 2007, the Prothrombin-Time Self Testing (PST) Coalition (comprising HemoSense, International Technidyne and Roche Diagnostics) requested reconsideration of Medicare's National Coverage Determination for home PT/INR monitoring to expand eligibility for Medicare coverage of home monitoring to all patients who need chronic warfarin therapy. The reconsideration request was supported by substantial new clinical evidence published since the time of the initial coverage determination (15 new clinical studies). The PST Coalition agreed that coverage be limited to patients requiring chronic warfarin therapy (at least 3 months in duration) and one self-test per-week, and that patients should be required to undergo education and training.

In response to this request, CMS released a Proposed Decision Memorandum on December 20, 2007 proposing to expand coverage to include patients with atrial fibrillation (a specific type of abnormal heart rhythm associated with increased risk of stroke) and deep venous thrombosis (clots in the veins that are associated with risk of potentially fatal clots in the lungs). If finalized as proposed, Medicare coverage for home PT/INR monitoring could be expanded to apply to approximately 70-percent of patients requiring chronic warfarin therapy. CMS decided not to expand coverage to the other underlying indications for chronic warfarin therapy—e.g., cardiomyopathy, thrombophilic disorders—because the Agency considers the evidence too limited for these additional indications. CMS is also proposing a new coverage criterion—the beneficiary must continue to use the device correctly in the management of anticoagulation therapy.

Comments on the Proposed Decision Memorandum
The PST Coalition is pleased that CMS acknowledges the substantial new clinical evidence supporting the use of home PT/INR monitoring in patients on chronic warfarin therapy and looks forward to more Medicare beneficiaries gaining access to this service. However, the PST Coalition is concerned that approximately 20 to 30 percent of potentially eligible patients on chronic warfarin therapy would remain excluded from coverage. CMS based its decision to expand coverage on new clinical evidence and rejected broader expansion because of a lack of clinical evidence supporting those indications. The reason the data are limited for the remaining underlying conditions for chronic warfarin therapy is that these indications are relatively less prevalent and, therefore, form a small portion of the study population in clinical trials of home monitoring. It is unlikely that substantial new clinical evidence on these less prevalent conditions will become available in the future to support further coverage expansion. Importantly, CMS acknowledges that the data from available studies do not show differences in outcomes by indication. Therefore, CMS has no reason to believe that home monitoring of patients with other indications is any less effective or should not be covered.

The clinical indication for home PT/INR monitoring is chronic warfarin therapy—not the underlying condition for which warfarin is prescribed. Warfarin labeling indicates that age greater than 65 is a risk factor for bleeding on warfarin. Neither mechanical heart valves, atrial fibrillation nor deep venous thrombosis are identified as risk factors for bleeding. Warfarin labeling also indicates that patients at high risk benefit from more frequent INR monitoring. Home monitoring affords the opportunity for more frequent monitoring and can reduce the risk of bleeding with chronic warfarin therapy regardless of the underlying indication for warfarin.

With respect to CMS's proposal that beneficiaries (or their caregivers) must use the device correctly, the PST Coalition agrees. However, CMS should clarify how proficiency is to be measured, rather than leave it to local contractors to define, and ensure that access to this important service is not limited by unnecessarily frequent or burdensome proof of beneficiary self-testing proficiency. We recommend that the appropriate approach to showing continued proficiency in self-testing be left to the discretion of the treating physician and proof of proficiency in the medical record should be sufficient to support continued coverage (following the initial required education and training).

The PST Coalition recommends that interested stakeholders submit comments to CMS on the Proposed Decision Memorandum by January 19, 2008. Specifically, we would recommend that commenters consider the following:

  • Support expansion in coverage to include patients with atrial fibrillation and deep venous thrombosis as the clinical evidence clearly supports such expansion in coverage.
  • Urge CMS to allow coverage for home PT/INR monitoring for all underlying indications for chronic warfarin therapy (who meet the other coverage criteria). CMS acknowledges "[p]roper anticoagulation remains a significant problem for Medicare beneficiaries . . . ." CMS also identifies several reasons why home PT/INR monitoring can lead to improved management of anticoagulation. Expanding eligibility for coverage to all properly selected and suitably trained patients requiring chronic warfarin therapy should help improve anticoagulation management among Medicare beneficiaries.
  • Recommend that the new coverage criterion requiring continued proficiency in self-testing be implemented in a non-burdensome manner.

CMS is now accepting comments on the Proposed Decision Memorandum through January 19, 2008. Comments may be submitted electronically at the following web-locator http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=209.

Following the close of the comment period, CMS will review the comments and will issue a final Decision Memorandum by March 19, 2008.

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Saturday, March 25, 2017