Implications of Medicare Part D in CKD Anemia Treatment Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD Treating chronic kidney disease (CKD) anemia successfully requires not only making the correct diagnosis and choosing the appropriate treatment but also taking the steps needed to ensure that residents have access to treatment. This can be challenging with regard to the erythropoiesis-stimulating proteins (ESPs). To ensure access to these products, physicians must be health insurance literate, knowing how different Medicare parts cover the erythropoietin (EPO) products. For example, Medicare Part A places the responsibility for medications on the provider. This means that a long-term care facility is responsible for covering the cost of medications used during the Medicare Part A skilled stay. Medicare Part B covers medications that are provided “incident to” a physician service, including injectables provided by physicians in their offices or during dialysis treatments. Managed care plans, which provide coverage under Medicare Part C, are responsible for all of the benefits available under Medicare Parts A and B. The newest Medicare Part is D,
the prescription drug benefit introduced in January 2006. Medicare Part D covers most medications administered to residents in a long-term care facility. For the dually eligible—that is, residents covered by both Medicare and Medicaid—the Medicare Part D program replaces Medicaid drug coverage. Unfortunately, the criteria by which these prescription plans choose to cover products such as ESPs are not based on any specific standard but vary greatly by plan as each has the right to determine coverage criteria. In addition to individualized plan criteria, each plan defines its own process for prior authorization, appeals, and exceptions. Understanding the basic rules of coverage is essential to ensuring access to the ESPs for residents with anemia of CKD. (J Am Med Dir Assoc 2006; 7: S13–S16)
INTRODUCTION
ASSESS THE PAYER
After a physician has thoroughly worked up the diagnosis of anemia in the long-term care resident who has chronic kidney disease (CKD) and determined that an erythropoiesis-stimulating protein (ESP) is required, the next challenge is to decide how the patient can get access to the medication. This process involves a careful understanding of the opportunities and barriers provided through the Medicare program’s different parts. First, assess the payer and then evaluate enrollment to be sure the patient has met all coverage requirements. Medicare ultimately has several intermediaries that play important functions, such as the facility, provider, managed care plan, and now, prescription drug plans. Understanding this process is vital to being able to access these important medications.
Medicare began with Parts A and B as the foundation of the program in 1965. Part A—also called hospital insurance— covers inpatient stays in hospitals and the skilled stay within nursing homes, as well as some home health and hospice care (Figure 1).1 Medicare Part B—also called medical insurance— covers physician and outpatient care, as well as some equipment and medications provided incident to a physician. In 1997, managed care was added to Medicare as Part C. Initially called Medicare Plus Choice, the Medicare Part C managed care plan has been renamed the Medicare Advantage.2 In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act, more commonly referred to as the Medicare Modernization Act, that created Medicare D, the Medicare prescription drug benefit that went into effect on January 1, 2006.2 Under Medicare Part D, most beneficiaries must enroll in a private prescription drug plan (PDP) and pay a monthly premium.3 Each PDP has its own monthly premium (on average $32.20 per month in 2006), benefit design, formulary coverage, and pharmacy network.4,5 After the Medicare recipient has satisfied the annual deductible ($250 in 2006), the PDP pays 75% of the prescription drug charges up to $2250.4 Medicare Part D does not apply when a long-term care resident’s stay is being covered by Medicare Part A. When
Health Policy Institute, University of the Sciences in Philadelphia, Philadelphia, PA. Address correspondence to Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD, University of the Sciences, 600 South 43rd Street, Philadelphia, PA 19104. E-mail:
[email protected]
Copyright ©2006 American Medical Directors Association DOI: 10.1016/j.jamda.2006.09.006
SUPPLEMENT
Keywords: Medicare; chronic kidney disease (CKD); anemia; erythropoiesis-stimulating protein (ESP)
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Fig 1. With the addition of prescription drug coverage in Part D, Medicare now has 4 parts.1
someone is in a facility during the Part A stay, that is a skilled stay, and the financial responsibility for all the medications belongs to the facility. Nevertheless, Medicare Part D can have important implications for long-term care facilities. If a resident who has Medicare Part D is diagnosed with CKD and anemia during a Part A stay and the clinician determines that an ESP is required, the facility—not Medicare Part D—assumes the financial responsibility for the medication during the Part A stay. Similarly, if a patient is covered by Medicare Part B for care in a dialysis center and a clinician prescribes an ESP, the Medicare B program, not Medicare Part D, would cover the cost of the medications. Outside of Medicare parts A and B providing coverage for these products in unique settings, it is the prescription drug plan that covers those residents enrolled in Medicare Part D. To determine available coverage for those residents, it is now important to record the patient’s selected Medicare Part D PDP or Medicare Advantage provider on the medical record face sheet. These plans will dictate the requirements to gain access to medications through tiering, prior authorization, or other utilization tools. Tiering does not apply to those residents who are dually eligible, having both Medicare and Medicaid coverage. In this case, they pay no copay or deductible for Part D covered drugs. Prior authorization and other restrictions, however, still very much apply to all Medicare beneficiaries, despite the increased frailty commonly associated with long-term care residents.
no prescription drug coverage. Barely half (56%) had medication coverage under Medicaid.6 The introduction of Medicare Part D is likely to improve these statistics, but only if residents are educated on the complex enrollment process. The United States has about 43 million Medicare beneficiaries (Figure 2).7 The enrollment numbers available after the end of the initial enrollment process on May 15th showed that a little over 5 million Medicare beneficiaries remained uninsured, according to the Center for Medicare and Medicaid Services (CMS). Of the 38 million who had some sort of drug coverage, about 16 million were in free-standing PDPs and 6.07 million were in Medicare Advantage provider managed care plans. About the same number represent the dually eligible, covered by both Medicare and Medicaid; they were automatically enrolled into free-standing PDPs via a completely random process that did not consider such factors as the medications being prescribed. This process can result in a single long-term care facility being accountable for a dozen or more different private PDPs if residents are not educated about which prescription plans provide the greatest access to medications for them. Another 6.9 million are covered through employer-sponsored plans, and about 5.5 million through military Tricare and other federal programs.7 A key point to be made is this: Most residents and their families are not aware of the problems with not enrolling in a Medicare Part D plan. As physicians realize all too well, once they diagnose anemia in a patient with CKD and write a prescription for the medication, if that person has no access to prescription drug coverage, it can be very difficult for patients to fill that prescription. Part D charges a late enrollment penalty of 1% per month for every month that a senior who is eligible for Medicare Part D fails to enroll or does not have creditable coverage. Seniors eligible for Medicare Part D who delay enrollment from age 65 until age 70, for example, would be charged a 60% higher premium as a result of delaying their enrollment.8 In addition,
Total Medicare Beneficiary Drug Coverage (June 11th 2006) Drug Coverage (Medicare or Former Employer)
- Stand-Alone Prescription Drug Plan (PDP)
10.37
- Medicare / Medicaid [autoenrollment]
6.04
- Medicare Advantage (MA-PD)
6.07
- Medicare Retiree Drug Subsidy (RDS)
6.90
- FEHB Retiree Coverage
1.60
- TRICARE Retiree Coverage
1.86
- Veteran’s Administration (VA) Coverage
2.01
- Indian Health Service Coverage
0.11
ENROLLMENT
- Active Workers with Medicare Secondary Payer
2.57
- Other Retiree Coverage, Not Enrolled in RDS
0.10
The tendency has been to believe that residents in longterm care facilities have prescription drug coverage, typically through Medicaid. That is often not the case, as a study reported by Dr Bruce Stuart and his University of Maryland colleagues pointed out.6 The group examined the records of 789 residents who had a mean skilled nursing home stay of nearly 9 months and took an average of 5.7 medications each. The records revealed that 20% of nursing home residents had
- State Pharmaceutical Assistance Programs
0.59
Total
38.22
UNINSURED TOTAL
5.38
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Fig 2. Just less than 1 month before the May 15, 2006, cutoff for enrollment in Medicare Part D, only 30 million of the nation’s 43.4 million Medicare beneficiaries had enrolled for Medicare Part D.7 JAMDA – November 2006
once enrollment closes, an eligible Medicare beneficiary can be locked out of prescription drug coverage until the next enrollment period. If the day after enrollment for Medicare Part D closes, a patient is diagnosed with an illness requiring costly medications—for example, CKD and anemia—prescription drug coverage will be unavailable for up to a year. Being locked out can be significant. CMS has granted 3 groups—the dually eligible, those accepted into the lowincome subsidy program, and a specific group of Medicare beneficiaries affected by Hurricane Katrina—the ability to enroll in a prescription drug plan outside of the enrollment periods.9,10 If a patient who needs treatment for CKD anemia discovers that the PDP he or she has selected does not cover ESP medications prescribed, the long-term care facility or a dialysis center can help. Changing PDPs in Long-Term Care One tool available to long-term care residents is the special enrollment period. If a Medicare recipient who picked a PDP that was appropriate in the community is admitted to a long-term care facility and has difficulty gaining access to the medications that he or she needs, it is possible for that person to change plans. Most Medicare Part D recipients are, for the most part, locked into the PDP they select for up to a year. The dually eligible and all long-term care residents, however, have the ability to change plans on a monthly basis. Often, it is easier to educate a resident and their family on the process of changing prescription plans rather than fighting through an appeals and exceptions process to gain access to an essential medication. ACCESSING ANEMIA TREATMENTS Each PDP has its own formulary of medications covered under Medicare Part D. The United States Pharmacopeia, however, was given the task under the Medicare Modernization Act of developing the model categories and classes for PDPs to use in developing their formularies (Figure 3).11 While all PDPs need to include ESP products in their formularies, prior authorization and other restrictions can limit access. Further, the health care provider must identify and follow whatever prior authorization process is dictated by the plan, and the prior authorization processes can vary greatly from one plan to the next. One way to assess which PDPs make the most sense for the most residents in a long-term care facility is by going to www.Medicare.gov. That Web site has 3 important features. First is The Landscape of Local Plans that shows all the PDPs available to residents in a particular facility. For example, in Pennsylvania, there are 202 different PDPs available within the state. Searching each one individually could be a nightmare, but the process is made easier on the Medicare Web site. Second, the Web site has Formulary Finder, a search tool that allows a clinician to type in a medication, such as an ESP product of specific interest. The Formulary Finder shows what plans cover that medication and identifies any restrictions, such as the requirement for prior authorization. SUPPLEMENT
Fig 3. Erythropoietin medications are one of the United States Pharmacipeia key drug types in their model guidelines for Medicare prescription plans.11
Third, and probably the most helpful for facilities and medical directors, is the Compare Medicare Prescription Drug Plan. A long-term care medical director, consultant pharmacist, or other team members can type in the facility’s zip code, up to 25 medications of particular interest, and the institutional pharmacy provider. The Compare Medicare Prescription Drug Plan searches and produces a list of available PDPs, organized from the lowest to the highest cost, as well as identifying prior authorization and other PDP restrictions.5 Medications Not in the PDP’s Formulary Gaining access to a medication not on a plan’s formulary can be especially challenging. One approach is the arduous journey through an appeals and exceptions process—a trip avoided by taking the time to ensure that nursing home residents are educated about the plans that make the most sense for them. If and when it becomes necessary to engage in the appeals process, one way to deal with this process is to use the standard 1-page form provided by CMS at www.CMS.gov. Each plan has its own appeals and exceptions process, but the CMS form helps to standardize this process. CONCLUSIONS Every question about Medicare Part D in the early stages has the same answer: “It depends.” The criteria for access to ESP medications often include prior authorization, but what a plan means by prior authorization depends on the plan. There is no standardization. For example, Humana Gold Choice has identified these clinical criteria for prescribing an ESP: hematocrit ⬍33%, hemoglobin ⬍11 g/dL, kidney disease, and decreased plasma erythropoietin (EPO) level. Other plans may not even specify the hemoglobin level or other criteria that a prescriber can submit. Medicare Part D offers residents an opportunity to gain access to medication at lower out-of-pocket expenditures. For facility medical directors and attending physicians, the only way for that to work in an efficient and effective manner is to pull together an interdisciplinary team that includes intake Stefanacci S15
coordinator, nurses, physicians, and a consultant pharmacist. Then, it is important to develop systems, including a standardized form for the long-term care facility to use to identify the critical components in documenting and treating anemia in a patient with CKD. Finally, a medical director needs to be fortified with persistence and documentation to provide to the prescription plan to ensure that patients have access to those medications needed to treat the anemia of CKD. In the end, it is important to remember that it would be meaningless to have made the correct diagnosis and order the proper medication only to find that the patient is unable to access that medication. Medicare Part D can help with access, but only if physicians know the rules. REFERENCES 1. Centers for Medicare & Medicaid Services. Medicare and you handbook: 2006. Available at: www.medicare.gov/Publications/Search/Results.asp? PubID⫽10050&Type⫽PubID&Language⫽English. Accessed September 29, 2006.
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2. Biles B, Dallek G, Nicholas LH. Medicare advantage: deja vu all over again? Health Aff (Millwood) 2004;(Suppl Web Exclusives):W4-586-97. 3. Stefanacci RG. Medicare reform’s impact on long-term care. J Am Med Dir Assoc 2004;5:418 – 421. 4. http://www.cms.hhs.gov/apps/media/press/release.asp?Counter⫽1530. Accessed May 16, 2006. 5. Stefanacci RG. Are you health insurance literate? A question for physicians. J Am Geriatr Soc 2005;54:166 –168. 6. Stuart B, Simoni-Wastila L, Baysac F, et al. Coverage and use of prescription drugs in nursing homes: implications for the Medicare Modernization Act. Med Care 2006;44:243–249. 7. http://www.statehealthfacts.org. Accessed March 28, 2006. 8. Stefanacci RG. Ten most asked questions about the Medicare prescription drug program. Clin Geriatr 2005;13:9 –12. 9. http://www.bcbsla.com/web/medicare_part_d/MedicarePartD2_Welcome. asp. Accessed May 16, 2006. 10. http://www.medicalnewstoday.com/medicalnews.php?newsid⫽41724. Accessed May 16, 2006. 11. United States Pharmacopeia. Model Guidelines Version 2.0 Tracked Revisions. Available at: www.usp.org/pdf/EN/mmg/modelGuidelinesV2.0 TrackedChanges-2006-02-06.pdf. Accessed September 29, 2006.
JAMDA – November 2006