Creation/Revision Date: September 02, 2014
September 2, 2014
Marilyn B. Tavenner, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8010
Baltimore, MD 21244-8010
Re: CMS-1614-P—Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.
Dear Administrator Tavenner:
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease.
In the context of the End-Stage Renal Disease Prospective Payment System (ESRD PPS) rulemaking, we are writing to urge CMS to provide greater clarity on coverage of drugs and biologicals for dialysis patients under the ESRD PPS bundle versus Medicare Part D. The genesis of this problem is the 2014 Medicare Part D call letter and accompanying revisions in the Policy Benefits Manual. Previous underlying guidance issued in 2011 by CMS correctly recognized that “drugs used as substitutes for any of [the drugs listed in Table C of the final ESRD PPS rule published August 12, 2010], or used to accomplish the same effect, would also be covered under the ESRD bundled payment and, therefore, be ineligible for separate payment.” However, drugs that were not substitutes would remain outside of the bundled payment, and since drugs and biologicals being used as anti-infectives, in pain management, and in other non-ESRD conditions would not be substitutes, they would accordingly and appropriately remain outside of the bundled payment.
Unfortunately, the 2014 Part D Call letter used language of significantly less specificity than the previous guidance, such as “ESRD-related” and “for the treatment of ESRD”, without further clarification. This has understandably led point of contact parties such as insurers and pharmacies to either require pre-authorizations for the prescriptions, or deny the drugs or biologicals outright. Throughout 2014 RPA has received dozens of inquiries from nephrologists nationwide whose ESRD patients on dialysis with Part D coverage are having all of their drugs either denied or held up for pre-authorization for conditions unrelated to their ESRD such as migraine headaches, bronchitis, chronic back pain and non-ESRD related infections.
While the impact of this problem on patient care and comfort is obvious and deeply troubling, there are also fiscal implications for the Medicare program at large. For example, among the instances of delayed/denied prescriptions that RPA received was one for a generic antibiotic prescribed for a diabetic hemodialysis patient with a non-healing wound on a lower limb. Because of the delay created by the lack of specificity of the Part D call letter, the patient went several days before receiving the antibiotic. This specific issue was ultimately resolved, but a more adverse outcome could have resulted in an unnecessary and difficult hospital admission and procedure for the patient, at an expense to the Medicare program that is orders of magnitude greater than the cost of a generic antibiotic. While we respect CMS’ oversight mission and support the Agency’s responsibility to ensure that services and goods such as drugs and biologicals are not doubly reimbursed, RPA believes that having clinical complications such as those described above arise from imprecise revision of Medicare Part D coverage policy is unacceptable.
For these reasons, we urge CMS to address this issue in the final rule for the 2015 ESRD Prospective Payment System, and to revise the Part D call letter and Medicare Policy Benefits Manual to reflect the more precise guidance language developed in 2011.
As always, RPA welcomes the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to CMS in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at email@example.com.
Rebecca Schmidt, DO