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Improve Medicare Policy to Remove Barriers to Bone Marrow and Cord Blood Transplants
Jeffrey W. Chell, MD
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Improve Medicare Policy to Remove Barriers to Bone Marrow and Cord Blood Transplants

Jeffrey W. Chell, MD
Reducing barriers to hematopoetic stem cell (HPC) transplant is critical to supporting patients with one of the more than 70 blood cancers and other blood disorders (such as leukemia, lymphoma, and myloplastic dysplasia) for which a transplant may be the only therapy remaining with curative intent.
Every 3 minutes, an American is diagnosed with blood cancer, and every 9 minutes the disease takes another life. All in all, there are more than a million people in the United States living with or in remission from lymphoma, myeloma, or leukemia alone—and approximately 170,000 individuals will be newly diagnosed in 2016.1

Reducing barriers to hematopoetic stem cell (HPC) transplant is critical to supporting patients with one of the more than 70 blood cancers and other blood disorders (such as leukemia, lymphoma, and myloplastic dysplasia) for which a transplant may be the only therapy remaining with curative intent. Healthy HPCs replace marrow that will no longer recover post therapy or secondary to the underlying disease. Depending on the diagnosis, HPCs may also exhibit a graft versus tumor effect, eliminating residual disease.2

Historically, finding a suitably matched adult donor or cord blood unit(s) has been the primary barrier to accessing an HPC transplant. This is related to the precision matching at a DNA level. Only 30% of patients have a perfect match in their family. However, with growth of the Be The Match Registry, improving international cooperation, and the emergence of successful multiple mis-matched transplants, finding a suitable donor no longer represents the most significant barrier to access.

Recognizing that bone marrow and cord blood transplants often represent the only hope for a cure for these patients,3 the United States Congress created the C.W. Bill Young Cell Transplantation Program,4 which provides for a a national registry of adult volunteer donors and publicly available cord blood units. Today, nearly 10,000 Americans search this registry for a match each day (our unpublished data). To a significant extent, the national registry has solved the problem of providing a mechanism to identify willing donors, and with help from Congress, this registry continues to grow to meet the needs of a diverse population. It currently lists more than 13.5 million adult volunteer marrow donors and 225,000 cord blood units. When factoring in international relationships, the donor base includes approximately 27 million potential marrow donors and 680,000 cord blood units across the globe.5 Be The Match can access all of these HPC sources on behalf of a patient seeking help.

Since 2005, the registry has increased donor diversity, including significant growth in the number of African American, Asian, and Hispanic donors. Today, half of the registry’s donors have diverse ancestry, greatly improving the odds of finding a match for patients with various ethnic backgrounds.

The importance of a registry like Be The Match cannot be overstated, addressing the need of the 70% of patients who lack an adequate marrow donor within their immediate families. For this reason, I have dedicated much of my professional career to Be The Match, operated by the National Marrow Donor Program (NMDP). Since its inception nearly 30 years ago, Be The Match has facilitated over 75,0000 transplants—65,000 in the last 15 years.6

OBTAINING MEDICARE COVERAGE
As we find ways to connect patients with donors, we are breaking down once intractable obstacles to care. However, even as walls come down, there are new challenges to overcome. Currently, Medicare policy is a formidable impediment for older Americans seeking access to transplantation.

While bone marrow and cord blood transplants are used to treat nearly 70 conditions, Medicare only officially covers a few of these indications. Specifically, it covers transplants for:
  1. Leukemia, leukemia in remission, or aplastic anemia
  2. Severe combined immunodeficiency disease and Wiskott-Aldrich syndrome
  3. Myelodysplastic syndromes pursuant to Coverage with Evidence Development (CED), which requires data collection of a Medicare-approved, prospective clinical study.

In January 2016, CMS agreed to cover transplantation to treat multiple myeloma, myelofibrosis, and sickle cell disease through the CED mechanism.7 Currently, Medicare determines whether to expand coverage on an indication-specific basis. Lacking a national coverage decsision, coverage may still be possible on a regional basis, but this is seldom the case. If Medicare decides not to cover the cost of the transplant, the patient and his or her provider is required to pay the full cost of transplant. As a result, patients are placed between a rock and a hard place; if they opt for a potentially lifesaving procedure, they put themselves at risk of financial ruin. And many transplant centers are reluctant to consider a transplant if the funding source is uncertain (TABLE).

It is important to note that Medicare coverage policy differs greatly from commercial and managed care plans, which cover virtually all indications. The divergence makes little sense, considering:
  1. The median age of diagnosis for diseases such as acute myeloid leukemia is 67 years, according to the National Cancer Institute.8 This means that just as individuals reach the age when they are most likely to need treatment, they are covered by a payer that makes facilitating access very difficult.
  2. Medicare beneficiaries already receive nearly 16% of the stem cell transplants facilitated by NMDP/Be The Match, and they are the most rapidly growing age segment for transplant. It is, therefore, quite clear that older Americans are interested in pursuing treatment of these diseases.
  3. Reduced-intensity preparative chemotherapy regimens have made it possible for older patients to tolerate a transplant and experience successful outcomes.
  4. Federal employees have access to transplantation for a wide range of indications through their health insurance benefits.
As the nation’s Medicare population continues to grow and, hence, the number of transplants for the elderly continues to rise, more vulnerable Americans will be put at risk due to limited Medicare coverage.

Payment Gaps
Limited coverage is an undeniable issue, especially for those over the age of 65 years. However, the problem is further accentuated by CMS payment policy, which reimburses significantly below the transplantation’s actual cost. The federal reimbursement rate for bone-marrow transplants is currently 47% below the procedure’s true cost. As a result, hospitals performing marrow transplants for Medicare patients report average losses of nearly $40,000 per transplant.

This gap is evidenced by an analysis of the 2014 MedPAR database looking at 1 item of cost: the acquisition of cells for an unrelated donor or cord blood transplant. The following Table shows the Medicare Inpatient Prospective Payment System (IPPS) rates for each diagnosis-related group, and the average costs of cell acquisition. Depending on the cell source selected, the Medicare payment leaves little or no funds to cover other costs incurred during the inpatient stay.

State-level data, which can vary considerably, show that in some areas, the current rates often do not even cover the costs of cell acquisition, let alone supplementary costs incurred by the hospital for this procedure. In California, for example, providers are already $5001 over the Medicare rate once they acquire bone marrow (our unpublished data). In Rhode Island, providers are an incredible $21,540 over the current rate if they acquire cord blood as the source of cells for a transplant (our unpublished data). As a result of such financial realities, hospitals across the country are contemplating whether they can continue to offer transplant services to Medicare patients. To put it simply, the existing inadequate reimbursement rates have created yet another barrier limiting access to this life-saving therapy.

Following the Solid Organ Reimbursement Model
The most direct way to eliminate this barrier is to reimburse these cellular transplants in the same manner as solid organs. In particular, the model for reimbursing living kidney donors and other solid organs could be adapted to the cellular transplant model. In both instances, the same set of services are necessary to qualify the donation, such as donor evaluation, cell collection, transportation of the cells to the donor, and medical follow-up of the donor post transplant.

For all types of solid organ acquisitions, Medicare provides a pass-through for acquisition costs outside of the IPPS rate to ensure that hospitals are adequately compensated for acquisition expenses. Adopting the solid organ reimbursement model for bone marrow and cord blood would create parity across Medicare transplant policies and reduce the role of cost in limiting access for beneficiaries.

Eventually, barriers to accessing lifesaving HPC transplants can be overcome. The infrastructure is in place to grow the registry and match donors and cord blood units with patients in need. We now need CMS to update its policies and eliminate reimbursement as a barrier to access for Medicare beneficiaries. This policy change will have an enormous positive impact on patients, with a relatively small impact on Medicare spending. As a physician and an advocate, the evidence is clear: it’s time for a change. EBO
Jeffrey W. Chell, MD, is the chief executive officer of the National Marrow Donor Program and Be The Match.

Address for correspondence
Jeffrey W. Chell, MD
Chief Executive Officer
National Marrow Donor Program
500 N 5th St.
Minneapolis, MN 55401-1206.

E-mail: jchell@nmdp.org
References

1. Facts and statistics. Leukemia & Lymphoma Society website. http%3A/llsorg.prod.acquiasites.com/facts-and-statistics/facts-and-statistics-overview/facts-and-statistics. Accessed June 21, 2016.

2. Bone marrow transplant. MedlinePlus website. https://www.nlm.nih.gov/medlineplus/ency/article/003009.htm. Accessed June 21, 2016.

3. Townsend A. Bone marrow donation rewards Shaker Heights donor, recipient. Cleveland.com website. http://www.cleveland.com/healthfit/index.ssf/2011/07/bone_marrow_donation_rewards_s.html#incart_article_small. Published July 11, 2011. Accessed June 21, 2016.

4. H.R. 2520 (109th): Stem Cell Therapeutic and Research Act of 2005. govtrack.us website. https://www.govtrack.us/congress/bills/109/hr2520. Accessed July 6, 2016.

5. Majhail N. Fix Medicare rules to make bone-marrow transplants more accessible for older Americans. Cleveland.com website. http://www.cleveland.com/opinion/index.ssf/2016/05/make_bone-marrow_transplants_a.html. Published May 15, 2016. Accessed June 21, 2016.

6. Connecting patients with life-saving bone marrow donors. Be The Match website. https://bethematch.org/about-us/how-we-help-patients/. Accessed June 21, 2016.

7. Decision memo for stem cell transplantation (multiple myeloma, myelofibrosis, and sickle cell disease) (CAG-00444R). CMS website. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=280. Published January 27, 2016. Accessed July 6, 2016.

8. SEER stat fact sheets: acute myeloid leukemia (AML). National Cancer Institute website. http://seer.cancer.gov/statfacts/html/amyl.html. Accessed July 6, 2016.
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