For the first time since the inception of the End-Stage Renal Disease (ESRD) Prospective Payment System, two drugs qualify for payment outside of the dialysis base rate. The renal community is buzzing with questions about reimbursement, purchasing, clinical protocol, and supply chain logistics for Parsabiv™ (etelcalcetide) and Sensipar® (cinacalet).
I’ve been speaking with clients to discuss their plans for using cinacalet and etelcalcetide in their dialysis programs. Some nephrologists are hesitant to use etelcalcetide until there is a wider body of clinical data, while others are excited and began using etelcalcetide samples as soon as they were available.
Working out the kinks in the cinacalet supply chain may be a tall order for some. I spoke with a client at a freestanding dialysis center who said their group purchasing organization contracts cinacalet out to a separate company. The client had been filling out paperwork for 2 weeks and still had more to do before the process was complete.
A common theme regarding the use of etelcalcetide is the hesitation to prescribe it until payers other than Medicare verify they will reimburse it. While waiting for confirmation, a number of dialysis programs continue using samples. Because of conflicting reports regarding whether etelcalcetide will be reimbursed, I was told that some dialysis programs who purchased the drug are waiting to administer it until the last treatment of January 2018. In that way, they can risk relatively little while waiting to find out through the claims process which payers will reimburse etelcalcetide.
As I spoke with clients, I noted that several had been given incomplete or incorrect information regarding coverage for etelcalcetide. For example, one of our clients with a significant population of Medicaid patients reported they had received “confirmation” that Medicaid in their state would cover etelcalcetide. Initially, I was thrilled at hearing this, but decided to investigate further to confirm the information.
I contacted the person who had assured my client of Medicaid reimbursement, but rather than confirming this, he told me he had no direct knowledge of the state’s Medicaid’s policy. Instead, he had received the information from a supervisor and immediately started sharing the news with customers and prospects. When I pressed for additional information, he hesitated and then gave me a phone number so I could speak with a person who is an authority on this subject. When I called the number, the person stated they did not know if my client’s Medicaid payer would reimburse for etelcalcetide. They would only add what is common knowledge: Medicaid coverage varies from state to state and the only way to be certain etelcalcetide would be reimbursed is to verify benefits at the patient level. The bottom line is that it is wise to ask for source documentation from the payer and be wary of blanket coverage statements.
A hospital-based outpatient dialysis program reported to me they looked at purchasing etelcalcetide through the hospital pharmacy. However, at the rate the hospital would charge, the dialysis program would pay more than 80% of the Medicare allowed amount. The facility looked at contracting with a retail pharmacy that would ship cinacalet to patients’ homes. However, the dialysis program was not allowed to do this and, instead, their patients will be required to obtain their prescription from the hospital’s pharmacy.
Pharmacies and ESRD patients are also confused with cinacalet no longer being covered by Medicare Part D plans. Beginning January 1, ESRD patients were to begin receiving cinacalet through their dialysis programs. Medicare Part D sent letters to patients that have used cinacalet to notify them that new prescriptions will require a preauthorization.
ESRD patients with primary coverage under a Medicare Advantage Plan, Medicaid, or commercial policy should contact their insurance provider to determine if their benefits for cinacalet have changed.
Outpatient dialysis programs will want to review their patients’ coverage under Medicare Advantage Plans. These plans normally reimburse dialysis facilities using one of two payment models. The first is a contracted, per treatment rate that is often all-inclusive. An all-inclusive rate will likely mean the payer will not provide additional reimbursement for cinacalet or etelcalcetide. The second payment model is the use of claim-pricing software that closely mimics Medicare’s payment methodology. If payers update their payment system to include etelcalcetide and cinacalet, the dialysis program may be reimbursed for those drugs, depending on the language in your contract. For Medicare Advantage Plans where no contract is in force, dialysis programs should contact the payer to determine if etelcalcetide and cinacalet will be covered.
Renal providers may also be confused by the remittance advice sent by Medicare and other payers. Medicare plans to include the payment and coinsurance amounts associated with etelcalcetide and cinacalet in the bundled payment amount and not itemize them separately on the remittance advice.
Payments secondary to Medicare will also need to be watched closely. Medicaid and commercial policies that pay the assigned coinsurance amount are the most likely to pay correctly. However, Medicaid in a number of states calculates how much they will pay as secondary by calculating the amount they would have paid if they were primary and then subtracting the two amounts. In this circumstance, if Medicaid does not include reimbursement for etelcalcetide and cinacalet in their calculations of how much they would pay as primary, dialysis providers will see their Medicaid reimbursement drop.
Sarah Tolson is the director of operations for Sceptre Management Solutions, Inc., a company specializing in billing for outpatient ESRD facilities, nephrology practices, and vascular access among other specialties. Your questions are welcome and she can be reached at firstname.lastname@example.org, 801.775.8010, or via Sceptre’s website, www.sceptremanagement.com.