National Kidney Foundation, Inc., New York, New York

The National Kidney Foundation (NKF) is the nation’s oldest and largest voluntary health agency serving the needs of kidney patients and the health care professionals who care for them. The National Kidney Foundation’s clinical practice guideline development program, known as the Kidney Disease Outcomes Quality Initiative, or KDOQI, has facilitated enhanced care for Medicare beneficiaries with chronic kidney disease (CKD). The Medicare Prescription Drug Program should enable Medicare beneficiaries to realize KDOQI recommendations if drug plans provide access to medically necessary treatments for chronic kidney disease.

Chronic Kidney Disease (CKD) affects 20 million people in the U.S., with another 20 million Americans at potentially increased risk.[1]  Between 1992 and 2002, the percentage of Medicare beneficiaries with a diagnosis of CKD, including, but not limited to, those who receive benefits under the Medicare End-Stage Renal Disease (ESRD) Program, increased from 3.1 % to 6.8 %. In 2003, Medicare patients with CKD consumed 23.6 % of the Medicare budget.[2]  Moreover, the number of Americans with kidney failure (ESRD) who are treated either with dialysis or transplantation, and, therefore, become entitled to Medicare without regard to age, is expected to increase 85% between 2000 and 2015.[3]  Oral medications can prevent or slow the progression of CKD to kidney failure, as well as limit the consequences of the complications of CKD (anemia, bone disease, heart disease) for those covered by Medicare who do not yet require dialysis or a kidney transplant to survive. They can also reduce morbidity and mortality experienced by Medicare beneficiaries with ESRD. Therefore, it is important that Medicare prescription drug plans provide affordable access to the spectrum of medications needed by beneficiaries with CKD, so that this Medicare population is not discouraged from enrollment or inclined to disenroll in Part D plans.

The implementation of the Medicare Prescription Drug Program has raised a number of concerns in the kidney community. 

Enrollment

One plan has mailed misleading letters to people with ESRD stating they are not eligible to enroll in a stand-alone drug plan because they have ESRD.  Although the communication was the result of a programming change in the letter template, patients may assume the letter is correct and discard their enrollment packet and ID card.  CMS should approve or reject templates of letters before they can be mailed to applicants and members.

Some people who applied online and have confirmation of enrollment have waited months to learn if applications were approved.  Some have been told that computer glitches held up enrollments.  Without any Part D ID, these patients have been unable to use Part D to get prescribed drugs.  CMS states that plans must approve applications made in one month by the first of the next month.  CMS should require plans to track the time it takes them to approve applications made through the Medicare website.  This would allow outlier plans to be identified and procedures developed to help them process applications in a timely manner so patients would be able to use Part D when promised.

Some who applied for plans in 2005 received plan IDs and enrollment materials and were using those plans.  However, because of facilitated enrollment, they were placed in different plans in April.  There should be a better way to cross-check plan enrollment and utilization to avoid enrollments into two plans which could result in disenrollment from the plan the patient prefers.

Some who enrolled in plans and were using them received notice that their plan enrollment was terminated without explanation.  No one at the Medicare helpline or the plan could explain why.  CMS should require that every disenrollment notice include the reason for disenrollment and appeal rights.

Some people with kidney disease who are dual eligible never received notice of plan enrollment and were not auto-enrolled in plans.  Reportedly this related to communications problems between databases.  Even with a Medicare ID and active Medicaid cards, they were not enrolled in Wellpoint, the fallback plan, because pharmacists did not know about the fallback plan or did not trust they would be reimbursed.  Patients were shuttled back and forth between Medicare and Medicaid without problem resolution.  Many were charged full price for drugs that should have been covered by Part D.  CMS is working on database communications.  There should be alternate ways to communicate with pharmacists since all were not aware of the safety net procedures in place.

Premium Payment

Some people requested that premiums be deducted from Social Security checks.  Some who applied in January had never had premiums deducted by May.  Many worry that their coverage will be terminated for nonpayment.  It would help if people could be notified that their request for deduction of premiums had been received.  Also, CMS provided information indicating that only a maximum of three month’s premiums would be deducted and that plans could bill if outstanding premiums covered a longer period of time.  There should be some assurance that duplicate payments will not result.

Part B vs. Part D issues

Pharmacists continue to have difficulty knowing whom to bill for immunosuppressants needed to prevent rejection of transplanted organs and when to bill Part D or whether they should bill Part B.  Doctors should be encouraged to write Part B or Part D on prescriptions to help pharmacists.  If a drug is covered by Part D, the pharmacy should bill Part D.  However, if the drug is covered by Part B and the pharmacy does not have a Medicare provider number to bill Part B, CMS should require the pharmacy to tell the patient to consult with his/her transplant program about where he/she can get drugs under Part B rather than trying to bill Part D.  Problems with Part B vs. D have placed patients at risk of losing transplants due to delays in getting essential immunosuppressants. 

Drug Utilization Limits

Prior authorization requirements have been imposed on Medicare beneficiaries who have received solid organ transplants and are entitled to Part D coverage for immunosuppressant medications. This has occurred despite the promise of access to all or substantially all of these immunosuppressant drugs under Part D.  Prior authorization has placed a paperwork burden on busy physicians and created delays in patient access to essential medications. Plans should have to abide by the requirement that those who have been treated with these medications under Medicaid drug programs or with other third-party payment should not be subject to prior authorization requirements.

Excluded Drugs

The statutory exclusion of prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations, has proved problematic. Oral iron is needed by patients with CKD, other than in-center dialysis patients, to treat the anemia that accompanies chronic kidney disease. (In-center dialysis patients receive iron supplements intravenously.) Dialysis patients need special vitamins because dietary restrictions limit their intake of essential vitamins and minerals, the dialysis procedure removes essential vitamins and minerals, and because most standard vitamins contain high levels of fat soluble vitamins and certain minerals that rise to toxic levels in people with impaired kidney function.

Formularies

Not all plans provide coverage for the spectrum of medications that are effective in   addressing problems of bone and mineral metabolism experienced by Medicare beneficiaries with CKD. Disturbances in mineral and bone metabolism are common in patients with CKD. These patients have bone pain, increased incidence of bone fractures and deformity, myopathy and muscle pain and ruptures of tendons. Elevated blood levels of PTH exert significant adverse effects on the function of almost every organ and may require parathyroidectomy. Furthermore, there is growing concern about the long term effects of these derangements on soft tissue calcification. All of these conditions can be managed with appropriate pharmacological interventions but clinicians must have access to as wide an array of medications as possible to individualize therapy for these multiple conditions and avoid harmful drug interactions.

CMS Formulary Guidance

CMS has published guidelines that the agency will use in reviewing prescription drug plan formularies and procedures and thus, fulfill the requirement of the Medicare Modernization Act to assure that drug plans do not discriminate against any particular types of beneficiaries. However, CMS needs to operationally define when enrollment is considered to be “substantially discouraged” as well as develop a program to identify and compare actual Part D enrollment by beneficiaries with CKD as opposed to expected enrollment. Furthermore, CMS should track formulary changes, including drug utilization limits affecting beneficiaries with CKD during the course of the benefit year, as well as the number of beneficiaries with CKD who drop out of the program.

The following comments concern the draft formulary guidance that CMS published in March, 2006. 

P & T Committee Review

Because of the size of the Medicare population with CKD, and the extent of Medicare program expenditures associated with this condition, there should be a requirement that P & T committees include members with expertise regarding the pharmacological needs of kidney patients.

Drug List Review

• Problems of access to the drugs that prevent transplant rejection were noted above. Unfortunately, the CMS formulary guidelines for 2007, as drafted, will not resolve these problems. While the relevant section on page 7 of these draft guidelines, reads as follows: “CMS will continue to require Part D plan formularies to include all or substantially all (immunosuppressants),” on page 4 it is stated that, if a USP formulary key drug type is primarily covered under Part B, CMS will not expect these drugs to be represented on formularies. (Immunusuppressants are primarily covered under Medicare Part B.) Finally, on page 3, it is stated that plans that use a classification system that is consistent with USP’s will have a safe harbor. Regrettably, USP has deleted immunosuppressant drugs for transplant recipients from its model formulary for 2007. Unless these inconsistencies are addressed, transplant recipients enrolled in Part D will continue to experience problems in accessing the drugs they need to protect their transplants and avoid the need for re-transplant. Immunosuppressants, and other drugs that are primarily covered under Part B, must be included in Part D formularies in order to minimize confusion and insure that patients will not be placed in a life-threatening situation when their prescriptions cannot be filled. 
• CMS should utilize the analysis of the USP model formulary that was developed by ESRD Network 8 in evaluating whether plans are providing appropriate access to necessary drugs for those with kidney disease and kidney failure, including those with kidney transplants.   
• Formularies should contain separate pharmacologic classes for fixed dose combinations of antihypertensive drugs to promote adherence of patients to regimens that can prevent or delay the progression of chronic kidney disease and/or its complications.

Prior Authorization, Step Therapy, and Quantity Limits

Plans should be reminded that once a request for coverage determination is approved, it covers the plan year, as long as the doctor prescribes the drug, the patient takes the drug, and the patient is still on that plan.  Some plans are requiring doctors to provide prior authorization multiple times per year.

Long Term Care Accessibility

With regard to accessibility for Medicare beneficiaries in long term care facilities, many of these patients require unit dose packaging and CMS should require PDPs/MA-PDs to make this service available.

Conclusion

Thank you for the opportunity to provide these comments on the implementation of the Medicare prescription drug program. The National Kidney Foundation is available to assist the Centers for Medicare and Medicaid Services in developing strategies to assure that Medicare beneficiaries with chronic kidney disease have access to high-quality, cost-effective drug coverage.

[1] K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and

   Stratification. Am J Kidney Dis 39:S1-S000, 2002 (suppl 1).

[2]  United States Renal Disease System 2005 Annual Data Report.

[3]  D. T. Gilbertson, et al., Projecting the Number of Patients with End-Stage Renal Disease in the United      States to the Year 2015. J Am Soc Nephrol 16: 3736-3741, 2005.