Device for Home Monitoring of Clotting Time

Device for Home Monitoring
of Clotting Time*

HCFA advisory panel rejected device without permitting due process, public notice, or opportunity for company to participate.
Problem
The month after receiving expedited approval by FDA, the device was recommended for a national noncoverage decision by HCFA's Technology Advisory Committee (TAC) in a meeting that was conducted behind closed doors. Coverage discussion for the technology was placed on the agenda without any advance notice. The company was not informed of the noncoverage recommendation and only learned about it three months later. In the meantime, local Durable Medical Equipment Regional Carriers (DMERCs)¹ have rejected all claims made for the product, executing in effect a de facto national Medicare policy against covering this product. At the same time, some 80 percent of private payors' claims have been paid.
Product
The device, called the CoaguChek™ System for Prothrombin Time Self Testing (PST) is designed to measure blood clotting times. It is a portable monitor for home use that permits patients who take blood-thinning drugs to maintain appropriate doses of the drug. The device analyzes a small fingerstick sample of the patient's blood and indicates whether it is in the appropriate clotting range. This information permits the physician to adjust the blood-thinning medication to avoid serious bleeding or a stroke.
Potential Pool of Patients
The American Heart Association estimates that over 57 million (roughly 1 in 5) have one or more types of cardiovascular disease. Many of these diseases place patients at risk for adverse events that can be effectively prevented with properly monitored blood thinning medication. People who have had heart valve replacement, atrial fibrillation (abnormal irregular heart rhythms), myocardial infarction (heart attack), deep vein thrombosis, hip and knee replacements, and circulatory conditions could benefit from home monitoring of clotting time to avoid strokes or major bleeds.
Summary
With respect to obtaining Medicare coverage for PST, the company has experienced almost two years of frustration. FDA approved the device in April 1997. The next month, the Technology Advisory Committee (TAC) — a HCFA advisory panel — reviewed the product and recommended to HCFA that it not be covered. The TAC decided to review and make a recommendation on the device even though the product was not listed on the TAC agenda, the company was not informed that the product would be reviewed, and stakeholders were not permitted to participate in TAC deliberations. In addition, the TAC did not inform the company of its recommendation. The company learned about it three months later, in August 1997, when the minutes of the TAC meeting were posted on the HCFA Internet website. In November 1997, the company submitted data showing the new technology can improve clinical outcomes and save healthcare dollars.
In a February 1998 letter to Congress, Secretary of Health and Human Services Donna Shalala indicated that HCFA would not make a national coverage decision on the product — either approving or denying coverage — until the issues surrounding the TAC had been resolved. Since that time, however, claims for the product have been subject to a de facto non-coverage decision by the DMERCs. This is in contrast to private payors who are paying approximately 80 percent of claims submitted.
The DMERCs have denied coverage despite studies that show that patients who do home monitoring are more likely to remain within the appropriate therapeutic range than those who do not. Other studies have shown that those patients who are in the appropriate therapeutic range are less likely to suffer serious or fatal complications, such as strokes or bleeding.
In an attempt to reverse the decisions by local DMERCs, the company has turned to a formal appeals process for claims denied. The first appeals hearing was held on October 30, 1998, at which time the Medicare beneficiary supported by the company asked a hearing officer to overturn a DMERC denial because the medical needs of the individual patient justified coverage. The company is also supporting other patient appeals on the basis of medical necessity.
Impact
Because of the TAC decision to recommend non-coverage — and the subsequent denials by the DMERCs — Medicare beneficiaries are being denied access to a new technology that can improve health outcomes and save healthcare dollars. The inability of some patients to get to the lab regularly, combined with physicians' fear of bleeding complications in patients not well controlled, has kept utilization of blood-thinning medication down despite clear evidence of benefits to patients. PST reduces many difficulties previously associated with management of blood thinning medication. Medicare coverage of this device would allow greater patient control and fewer adverse events such as strokes or major bleeds.
December 1998

¹DMERCs serve as Medicare's local contractors for processing claims for durable medical equipment, prosthetics, orthotics, surgical dressings, and a wide array of supplies used in the patient's home.
*This case study is intended to illustrate Medicare coverage issues only and not as a source of product information.