National Coverage Determinations Proposed for Removal (March 2015)

In response to CMS’s proposed NCD removal for apheresis, I would urge CMS to ensure access to current LDL apheresis patients and to consider expanded access for patients who need this treatment. I agree that their current guidelines are too restrictive for patients who need lifesaving apheresis which has a Class 1 indication. Their current guidelines are clearly outdated as outlined by the National Lipid Consensus on LDL apheresis. As one of the largest LDL apheresis units in the US, both my patients and I can attest to its importance for clinical therapy to prevent cardiovascular events and improve quality of life. I am requesting CMS expand the current restrictive clinical guidelines and reimbursement. If this is best accomplished by removing the current NCD and using local contractors, then I would support this proposal. My fear is that local contractors would restrict rather than expand clinical guidelines for LDL apheresis which would negatively impact patients’ lives. Many lives have been saved with the treatment of apheresis. It is therefore critical that local contractors utilize current evidence-based guidelines outlined by the National Lipid Consensus for this procedure. In summary, an updated clinical indication and reasonable reimbursement for LDL apheresis are both overdue.

Less

My comment is in regards to NCD Manual Citation 110.14 Apheresis (therapeutic pheresis). I am in support of the decision to retire this document.
The current NCD document is generally outdated and does not accurately reflect evidence based patient care advances in the discipline of Apheresis Medicine. The current NCD document also creates unnecessary confusion for staff of local Medicare contractors and Medicaid programs in their deliberations regarding appropriate apheresis coverage decisions. Many well established evidence-based indications for apheresis are not identified in the current document while some approved indications in it are no longer appropriate.

Sharing pertinent and focused evidence-based reviews and evaluations with local Medicare contractors will best serve the interests of patients being considered for apheresis therapy while enhancing their care and safety. It is hoped that such an approach will also engender more thoughtful, cost effective and scientifically rational applications of apheresis technologies in advancing clinical care.

Less

Less

April 16, 2015
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD. 21244

RE: Proposed Removal of National Coverage Determination for Apheresis

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 renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. RPA is writing to urge CMS to not remove the National Coverage Determination (NCD) for Apheresis but instead formally reconsider, revise, and update the NCD and post a tracking sheet to that effect on the Coverage website.

RPA makes this recommendation for the following reasons:

• Apheresis is a first- or second-line therapy for many conditions (we refer CMS to the American Society for Apheresis 2013 Indication Categories for Therapeutic Apheresis), which lists no fewer than 31 conditions for which apheresis is either a first- or second-line therapy.
• Patients will be treated with this therapy because it provides the best likelihood of desired clinical outcome for a variety of severe disorders alone or in combination with other therapies.
• Given this preponderance of conditions for which apheresis is a crucially important therapy, RPA believes that subjecting the service to the local coverage determination (LCD) process, which in our view lacks consistency and uniformity, would be a disservice to Medicare beneficiaries who rely on the availability of therapeutic apheresis.
• Growth in the use of therapeutic apheresis in terms of both indications and the physician specialties providing the service is not only appropriate but also indicative of its clinical utility. As a result, we believe that a decision to remove the NCD would have far reaching negative implications for Medicare beneficiaries who depend on the availability of, and consistent Medicare coverage for, therapeutic apheresis.

RPA therefore strongly urges CMS to formally reconsider the therapeutic apheresis NCD and not to remove it from the list of NCDs.

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 rblaser@renalmd.org.

Sincerely,

Rebecca Schmidt, DO
President

Less

Less

Therapeutic apheresis remains a critical procedure in the management of patient with pediatric cancer and blood disorders.

Less

I have witnessed multiple patients who have received apheresis treatments that have a much greater quality of life after the treatments.

I have also seen several patients who spent the majority of their life in emergency rooms to treat sickle cell pain. Once red cell exchanges were started, these same patients only visited the emergency room 1-2 times a month if at all. They were also happier and had a better relationship with their families and friends.

If it were not for apheresis, many people would spend much of our tax payer dollars to seek treatment (not long term treatment) in emergency rooms. Or, these same people would/could become drug addicts due to a perceived lack of care and compassion by the medical community.

If apheresis were to be covered by Medicare and Medicaid, many people would be more productive members of society and lead happier lives.

Less

Less

As a member of AABB, ASFA, ASBMT, ASH and ASCO and as hematology carrier advisor for Oregon, I am very concerned about retirement rather than updating of NCD's. Local coverage decisions will lead to different coverage in different MAC regions. While I know there is an effort to coordinate LCD's among MAC's I am skeptical. I am very worried that what has happened here with apheresis will extend to more difficult decisions with transplant and chemotherapy coverage. I serve as CAC for hematology for Oregon and I serve as alternate for oncology, so I will get to review the LCDs Noridian wants to implement. However CAC meetings are at best scheduled twice yearly. CAC representatives are advisory only and have no veto power over LCD's that violate standard of care. I lived through Trailblazers have 1500 LCDs in region when it was a fiscal intermediary. Taxol for metastatic breast cancer was denied because of a simply coding problem-mets are a generic code and if the primary was resected completely like with a mastectomy, the breast cancer became a V code and hence a history of -not eligible for use on bills. I am very worried that the fiscal pressures on MACs without national standards like NCDs will leave patients vulnerable. If we must have healthcare rationing, all of us should care that fairness and justice be principles. Different access to needed care in different MAC regions is neither fair or just. LCD's can easily become a method of rationing care

I spoke to a Noridian medical director about the apheresis NCD. His comment to me was that MAC's are seeing routinely requests for plasma exchange to treat fibromyalgias. Not every state has a hematology CAC. Its work that is unpaid for. These CAC meetings are poorly attended.

I want to give you all pause to ponder. It may be better to for CMS to update NCD’s so that there is uniform standard of care across country. Otherwise true justice and access to needed care may not be served

Less

Less

As a therapeutic apheresis provider, I have encountered issues with CMS/Medicare non-coverage of therapeutic red cell exchange for sickle cell disease. We have had instances in which Medicare has covered the procedure but not the red blood cells and others in which the red blood cells were covered but not the procedure itself.

In the past it was recommended that I investigate our Local Coverage Determination (LCD). Upon reviewing this information with one of our financial analysts, I discovered that sickle cell disease had been an approved LCD in the past, but is now a retired LCD and therefore not acceptable for a reconsideration request. Also, neither LCD nor NCD identify sickle cell disease as a covered entity for therapeutic red cell exchange which is ironic since it accounts 99.9% of indications for which we would perform this procedure and is covered by several private insurance carriers.

I have been denied second and third level appeals for a particular patient.

Sadly our patients are faced with two bleak options: 1.) risking their health by not having the procedure or 2.) facing a huge financial burden. This is an issue of great concern to me as well as many other providers who care for sickle cell patients. Sickle cell disease NEEDS to be a covered entity for therapeutic red cell exchange.

Less

Dear Sir or Madam:

The American Red Cross (Red Cross) appreciates this opportunity to provide comments concerning the Centers for Medicare and Medicaid Services’ (CMS or agency) proposal to remove the national coverage determination (NCD) for Apheresis (110.14). As we explain below, the Red Cross supports the removal of this outdated NCD.

The Red Cross is an independent, nonprofit, tax-exempt, charitable organization, established pursuant to a charter granted to it by the United States Congress. The Red Cross, through its 35 Blood Services regions, supplies more than 40 percent of the nation’s blood for transfusion needs. In addition, the Red Cross is a leading provider of apheresis services, performing more than 10,000 therapeutic apheresis procedures per year. The Red Cross is committed to the safety of donors and patients, and to meeting the needs of the public we serve.

The evidence base for therapeutic apheresis has evolved significantly since the Apheresis NCD was last updated in 1992. As a result, the NCD does not reflect current standards of care and lags far behind the American Society for Apheresis’s clinical guidelines, which were updated in 2013 and include more than 30 indications for which therapeutic apheresis is recommended. The NCD also has not kept pace with the policies of leading national insurers for example, Aetna, Anthem, and UnitedHealthcare have all updated their coverage policies for apheresis within the past year, and the number of covered indications in each of these policies far exceeds the 13 covered indications listed in Medicare’s NCD.

We believe that removing the outdated NCD for apheresis will help to ensure that Medicare beneficiaries have appropriate access to this important therapy. Therefore, we support CMS’s proposal to remove the Apheresis NCD using the expedited administrative process described in the August 7, 2013 Federal Register notice. In addition, if CMS decides to finalize this proposal, we ask that the agency communicate to stakeholders that the NCD is being removed because the evidence base for therapeutic apheresis has evolved significantly since the NCD was last updated in 1992, and not due to reasons related to infrequent utilization or obsolete technology. In the meantime, while the current NCD remains in place, we urge CMS to clarify to local contractors that when therapeutic apheresis is used for an indication that is not listed in the NCD, the intent of the NCD is not to prohibit coverage, but to leave the coverage decision to contractor discretion.

The Red Cross appreciates this opportunity to provide comments on CMS’s proposal to remove the Apheresis NCD. If you have questions about our comments or would like additional information, please contact Peter Giamalva, Senior Vice President, Sales and Marketing, at 407-412-2014 (phone) or peter.giamalva@redcross.org (email).

Less

As a practicing physician of transfusion Medicine and apheresis since 1979. I have see significant studies to support therapeutic apheresis in multiple acute and chronic diseases. If properly used at appropriate time; apheresis treatment has shown to be lifesaving, improving quality of life, decreasing morbidity and mortality. It has also decreased hospital stay and cost.

In 1992 CMS document for national coverage of therapeutic apheresis was appropriate. 23 years later with greater experience, clinical trials and multicenter studies, new data has emerged from ASFA and international society of Apheresis to modify that document and bring it to current standards so as to help patients and improve their quality of life.

I will recommend with out hesitation the new guidelines for acceptance as published by ASFA in 2013.

This will help to provide timely, appropriate, cost effective, lifesaving therapy of therapeutic apheresis to many patients. This will not only save their lives and decrease home care, nursing home care and in some diseases to prevent end stage renal disease and hemodialysis dependency.

By accepting new guidelines as published by ASFA; it will decrease anxiety amongst patients about unnecessary denials and delay in treatments and thus decreasing morbidity and mortality. Patient may be able to return to work. It will save cost to CMS

Less

April 17, 2015

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality (OCSQ)
Centers for Medicare and Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Via Electronic Submission

Dear Ms. Syrek Jensen:

Grifols Incorporated (“Grifols”) appreciates the opportunity to respond to the comment request issued by the Centers for Medicare and Medicaid Services (“CMS”) with respect to its March 18, 2015 proposal to remove NCD 110.14 for apheresis. Grifols commends CMS for its policy of reviewing NCDs that are older than ten years to ensure its coverage policies keep pace with rapidly evolving therapeutic and diagnostic landscapes.

For 75 years, Grifols has strived to develop therapies derived from human blood plasma to treat rare, chronic, and often life-threatening diseases. Based on our extensive experience in the use of apheresis and the important developments that have taken place since the NCD’s last review, Grifols respectfully recommends that CMS remove NCD 110.14.

Since the NCD was last reviewed in 1992, significant advances have been made in the use of apheresis and in the evidence suggesting that use, including clinical trials and the wide acceptance in the relevant clinical community of some new indications. Significantly, the American Society for Apheresis (“ASFA”) issued evidence-based guidelines on the use of therapeutic apheresis in 2007. These guidelines, which are considered “the state of the art” in apheresis medicine¹, currently include some indications not present in the NCD. Some of these indications are now widely accepted, indicating that the NCD does not reflect either the current state of the evidence or the current consensus of relevant clinical opinion.

Taking into account the most recent evidence presented in the guidelines, private payors have expanded their coverage of apheresis therapy to include a number of indications not present in the NCD. Importantly, the NCD covers only thirteen indications and is based on evidence that is over 23 years old. Accordingly, consistent with CMS’ own proposal, we urge the agency to remove the NCD because the evidence base CMS previously reviewed is now outdated such that the NCD “no longer contain[s] clinically pertinent and current information.”²

We believe local coverage policy is the appropriate mechanism to address apheresis coverage. Local variations in practice suggest that a national coverage policy would be ill-adapted to the coverage assessment need. For example, regional differences in BlueCross BlueShield’s coverage across the United States suggest variations in the clinical use of apheresis in different regions. Additionally, the continued exploration of new indications through ongoing research and clinical trials indicates that an NCD may not be the most appropriate vehicle here. If the NCD is not removed, CMS will be forced to engage in frequent, cumbersome, time-consuming, and costly reconsiderations of the NCD with each new development, or risk denying coverage to patients for whom apheresis may be a necessary and life-saving therapy.

For these reasons, Grifols respectfully recommends that CMS remove NCD 110.14, as proposed.

Grifols is a biopharmaceutical company with 14,000 employees in over 25 countries, who share the mission of treating rare, chronic, and often life-threatening conditions through the research, development, manufacture, and distribution of plasma-related medicines and technologies.³ Since its creation in 1940 by Dr. Jose Antonio Grifols, the company has been at the forefront of the plasma industry. In 1943, Grifols patented the process of lyophilization, and began developing plasma-related products which laid the foundation for Spain’s first private blood bank in 1945.⁴

In fact, in 1950, Dr. Jose Antonio Grifols Jr. developed the plasmapheresis technique, which was published in the British Medical Journal in 1952. The plasmapheresis technique was quickly embraced by the global medical community and remains one of the most frequently used plasma extraction techniques in blood banks and hospitals worldwide, in addition to its important therapeutic use in certain clinical circumstances.⁵

Today, Grifols continues to be at the forefront of the plasma therapeutics industry, pioneering many of the sophisticated techniques used for collecting, testing, and manufacturing plasma-derived medicines. Grifols continues to promote innovation by investigating therapeutic options for patients. Additionally, Grifols is responsible for creating the world’s largest network of plasma donation centers, including over 150 donation centers in the United States alone. ⁶

With over 75 years of experience developing apheresis therapies and striving to improve patient care, Grifols is uniquely positioned to understand the important developments in apheresis that have taken place in the 23 years since the NCD’s review. As the evidence base in this area continues to evolve and expand, new and potentially life-saving uses are being identified and tested. Due to the potential negative impact inflexible policies may have on patient access to innovative, but effective therapies, a national coverage policy is not appropriate here. Because such a policy will be unable to keep pace with the rapidly evolving evidence base, Grifols respectfully recommends that CMS remove NCD 110.14.

On February 14, 1986, CMS issued National Coverage Determination 110.14, which provided coverage of apheresis for the treatment of Guillain-Barre Syndrome and for the treatment of life-threatening Systematic Lupus Erthematosus. Last revised almost 23 years ago, on July 30, 1992, the NCD currently limits coverage to only thirteen indications. Five of these indications are further qualified by language that restricts coverage to patients who have failed to respond to other therapies or who receive apheresis “as a last resort treatment.” ⁷

The NCD does not account for some conditions for which apheresis has since been proven effective, including a number of conditions for which apheresis is now a widely accepted first- or second-line therapy. As a result, the NCD is limited in scope and does not reflect the most current advances in and uses of therapeutic apheresis.

Since CMS’s last review of the NCD in 1992, the scientific community has made significant strides in apheresis research and development. New evidence suggests that the policy conclusions reached in the NCD are no longer supportable because the NCD is both too narrow and too broad. That is, the NCD excludes some indications for which apheresis is now widely accepted as an effective first-line treatment, and it includes some indications which have since been called into question. While it is not possible to detail every major development in this comment letter, below we provide a sampling of some of the most significant changes in the apheresis landscape since the NCD’s review.

Since 1992, the American Society for Apheresis has released five Special Issues of the Journal of Clinical Apheresis which include significant updates in apheresis therapies. Importantly, beginning in 2007, AFSA’s Special Issue has included evidence-based guidelines for the use of apheresis. The guidelines are created by the ASFA’s JCA Special Issue Writing Committee, which reviews, updates, and categorizes indications for therapeutic apheresis using a systematic, evidence-based approach. ⁸

The guidelines currently include individual fact sheets for a number of diseases, each of which is assigned an indication category (I-IV) describing the accepted use of apheresis as well as a grade recommendation (1A-2C) based on the strength of the evidence. Indications for which apheresis is accepted as a first and second line therapy fall in categories I and II respectively. Category III includes indications for which apheresis use is not yet conclusively established. Category IV includes disorders for which the evidence suggests apheresis may be ineffective or harmful. Additionally, the guidelines provide grading recommendations which range from 1A (strong recommendation, high-quality evidence) to 2C (weak recommendation, low-quality evidence).⁹

These guidelines represent “the state of the art in apheresis medicine.”¹⁰ They have been recognized worldwide and have been adopted by many international apheresis societies. Additionally, many private payors have based their coverage decisions on the evidence included in the guidelines.¹¹ Despite the fact that the guidelines represent the most comprehensive source of evidence regarding apheresis use, the NCD has not been revised to reflect the guidelines’ recommendations. The NCD fails to cover even some Category I recommended uses of apheresis, such as sickle cell disease.

Additionally, based on the guidelines, the NCD also appears too broad because it provides coverage for some conditions which lack sufficient evidence regarding the effective use of apheresis. Specifically, the NCD provides coverage for some conditions which fall in Category IV. For example, SLE nephritis falls under category IV, which indicates that apheresis may be ineffective or even harmful. Put simply, based on the guidelines, there is little to no evidence supporting the use of apheresis for this condition. Accordingly, the NCD’s coverage is inconsistent with the evidence-based guidelines.

Between 2000 and 2012 alone, 7,841 articles on the use of apheresis and 53 randomized controlled trial studies were published.¹² Additionally, since 1992, 401 apheresis-related clinical trials have been initiated across the world, with 288 conducted in the United States alone.¹³ Of the 288 U.S. studies, 98 are ongoing and may result in important new discoveries, including new indications for apheresis.¹⁴

Furthermore, numerous apheresis registries have been initiated in the years since the NCD’s last review. For instance, in 2002, the World Apheresis Association (“WAA”) initiated a world-wide apheresis registry to gain insight into the use of apheresis therapies. The WAA registry merged existing registries in France, Canada, and Sweden.¹⁵ Additionally, ASFA initiated a registry in the United States in the summer of 2013.¹⁶ These registries are likely to result in new insights into apheresis use in the coming years.

As discussed above, private payors tend to map their coverage decisions to the recommendations included in ASFA’s guidelines. Indeed, a review of ten payor policies for apheresis revealed that private payors tend to cover a number of indications not covered under the NCD. Specifically, we reviewed the payor policies used by United Healthcare, BlueCross BlueShield North Carolina, Healthpartners, Aetna, HealthNet, Medica, Cigna, Health Plan of Nevada, Anthem, and PacifiCare.¹⁷

In addition to covering some additional indications, the coverage in the private policies tends to align more closely with the most recent evidence listed in the ASFA guidelines. For example, many of the policies include babesiosis (I) and sickle cell disease (I). The support for those important uses is very strong. Furthermore, the private payor policies exclude conditions listed in the NCD which are no longer widely accepted as indications for apheresis use. For instance, many of the policies exclude SLE (IV), which has been called into question in recent years.

As discussed above, there have been a number of important developments in apheresis since the NCD’s last review in 1992. While much progress has been made over the years, the state of apheresis research is still in flux with many researchers continuing to explore the use of apheresis for some additional indications. There have been numerous clinical trials exploring possible new conditions in recent years. For example, recent clinical trials have examined the use of apheresis for conditions such as preeclampsia and sickle cell disease.¹⁸ Indeed, a review of the literature suggests that in the last 15 years more than 370 apheresis-related clinical trials, of varying types, have been undertaken¹⁹, and more than 7,841 articles on the use of apheresis have been published.²⁰

As the insurer of over 50 million Medicare beneficiaries, CMS’ decisions about the coverage of new therapies and technologies have the potential to impact patient care across the country.²¹ Not only do NCDs impact the care of Medicare beneficiaries, but they also influence the coverage policies of private payors, many of whom adopt Medicare’s coverage decisions.²² In our view, an NCD is not the most appropriate vehicle here because the field of apheresis medicine incorporates multiple disease conditions, diverse medical specialties, multiple technologies, and numerous settings of care. As a result, apheresis usage varies by region²³ and by center.²⁴

A review of eight BlueCross BlueShield coverage policies in different regions in the United States illustrates this point. Of the eight policies identified, four (NC, FL, AL, and NY) covered an almost identical list of indications, but three others included broader lists (RI, GA, MN), while the Montana policy involved fewer indications.²⁵ The differences in coverage across the United States suggests variations in the clinical use of apheresis in different regions. An NCD, which is binding on all regions, could not take into account legitimate regional variations.

Because the NCD process is a long one and NCDs often preclude any additional coverage without a reconsideration process²⁶, CMS has acknowledged that “the vast majority of coverage policy is determined on a local level.” Indeed, as of 2003, CMS made about 300 national coverage decisions over 30 years, whereas contractors made about 9,000 local coverage determinations in just ten years.²⁷ As CMS explains, NCDs are typically reserved for issues that affect a large number of Medicare beneficiaries or which have the greatest overall impact on Medicare.²⁸

Local decisions, given their more flexible timing and process, are typically preferable because NCDs are binding on all Medicare Administrative Contractors (“MACs”), fiscal intermediaries, carriers, Quality Improvement Organizations (“QIOs”), Qualified Independent Contractors (“QICs”), Administrative Law Judges (“ALJs”), and the Medicare Appeals Council, but require a quite burdensome and extended process for any reconsideration to occur, regardless of the strength of the accumulated evidence. For instance, in 2001, CMS issued ten NCDs, six of which exceeded CMS’s self-imposed time frame of 180 to 270 days.²⁹

In contrast, local decisions, which apply only in the contractor’s jurisdiction, are easier to undertake and have the advantage of also allowing the MACs to take into account regional variations. Accordingly, local decisions are more flexible and better suited for adapting to developments and differences in apheresis therapy.

Given the rapidly evolving nature of the evidence development for apheresis therapies and the need for continued innovation, an NCD for apheresis is not appropriate. Even if revised based on new evidence obtained since the last review in 1992, the NCD will be unable to keep pace with continuing innovations and the expanding evidence base. Accordingly, NCD 110.14 should be removed, and coverage decisions should be made at the local level.

Grifols appreciates the opportunity to comment on CMS’ proposal to remove NCD 110.14. Thank you in advance for considering the issues discussed above as the Agency moves forward with making its decision regarding the NCD.

Sincerely,

Pete Hatala, Pharm.D.
Director, Medical Affairs
(919) 316-6351
pete.hatala@grifols.com

Cc: William A. Sarraille, Sidley Austin LLP

SOURCES:

Less

Less

Please re-reconsider retiring the National Coverage Determination for Therapuetic Apheresis (TA). I work in a Children's hospital and last year we performed almost 2000 TA procedures on children who had life threatenting diseases. If not for TA, many of these children would not be alive today and if they were, they would not have the quality of life that TA has afforded them.

Please think about your decision to retire NCD for TA. Some child's life may depend of such therapy.

Less

Less

Dear CMS 1992 Apheresis NCD Consideration Group,

This letter is written on behalf of the American Society for Apheresis (ASFA), the American Society of Hematology (ASH) and AABB to support the retirement of the 1992 National Coverage Determination (NCD) document.

We believe that the current NCD document is outdated and does not accurately reflect advances in the discipline of Apheresis Medicine and its patient care applications. The current NCD document creates unnecessary confusion for staff of local Medicare contractors and Medicaid programs in their deliberations regarding apheresis coverage determinations for patients needing this extracorporeal therapy. Many well established evidence-based indications for apheresis are not identified in the current document while some approved indications in it are of questionable clinical efficacy and value.

Applying pertinent and focused evidence-based reviews and evaluations at the local contractor level to requests for apheresis intervention determinations, we believe will best serve the interests of patients being considered for this therapy while enhancing their care and safety.

It is hoped that such an approach will also engender more thoughtful, cost effective and scientifically rational applications of apheresis technologies in advancing clinical care. In these regards our societies are willing to work with the CMS to achieve such ends.

Thank you for your considerations in this matter.

Respectfully,

Marisa B. Marques, MD
President
American Society for Apheresis (ASFA)

David A. Williams, MD
President
American Society of Hematology (ASH)

Lynne Uhl, MD
President
AABB

Less

Less

Less

Less

Comment re: Apheresis

Red Blood Cell Exchange (Erythrocytapheresis)

Red Blood Cell Exchange is almost exclusively used for patients who have sickle cell disease, a disease that predominantly affects African Americans. It is sadly underutilized due to the poor reimbursement for this life saving intervention. The reimbursement for photopheresis (a procedure that is has limited indications, but is also a lifesaving intervention) is approximately five times the rate for red cell exchange. Plasmapheresis which uses the same platform and takes only slightly longer per procedure is reimbursed at two to three times the rate for red cell exchange.

What are the benefits of red cell exchange for sickle cell patients?
The standard therapy for stroke, stroke risk, acute chest syndrome, and other complications of sickle cell disease has traditionally been simple transfusion. There are limitations to simple transfusion: 1) It can produce volume overload as you are adding red blood cells to a patient who already has normal blood volume with anemia. In order to reduce the abnormal sickle cells you have to dilute with normal blood, this is sometimes not possible by just adding more blood. Circulatory overload (TACO) is a common event in critical patients which can lead to stroke. 2) The common side effect of frequent red cell transfusion is iron overload. This is a lethal complication of simple transfusion that can be treated with oral iron chelators. Unfortunately this medication is not routinely prescribed to patients with sickle cell disease and when prescribed is not used appropriately by the patient. It is also expensive, a hidden cost of transfusion that can cost as much as one hundred thousand dollars a year. The testing for iron overload and hospitalization for iron overload can be twice this amount or more.

Red cell exchange is being used more commonly (though in California where I practice it is not used in Southern California due to the poor reimbursement) to treat sickle cell disease. The advantage to exchange transfusion are multiple: 1) The exchange is isovolumetric, meaning that the same amount of blood is removed as is transfused in every procedure. There is no fluid overload. There is no TACO involved with this procedure. The level of hematocrit or the percent of sickle cell blood can be predicted and prescribed by the physician with each transfusion. 2) Due to the fact the amount of red cells given is balanced by the amount of red cells removed there is no iron overload, or it is reduced significantly. This removes the “hidden cost” of iron chelation and monitoring saving literally hundreds of thousands of dollars per year per patient. 3) One of the complications of treatment of sickle cell red blood cell transfusion is the formation of antibodies to the red blood cells. This can be reduced by using phenotypically matched red blood cells. In spite of the fact that more red blood cell units are needed for red cell exchange it has been shown in multiple studies the antibody formation is less. It is speculated that this is due to tolerance due to the volume of red cell exposure, but the reason is not known. 3) In patients who have high hemoglobin levels this procedure is the only way to reduce the level of sickle cells, simple transfusion is impossible due to the issue of TACO.

I hope that you research this issue and come to the same conclusion that those caring for sickle cell patients have come to: this is a lifesaving procedure critical to the care of these patients.

Less

Less

To whom it may concern:

Methodist Healthcare - Memphis Hospitals is supportive of the removal of the Apheresis NCD. If the is NCD is not removed, we would like to request that the diagnosis of Sickle Cell Disease be added as a covered indication. Please find attached a letter from Dr. Lee Schwartzberg and Dr. Nada Elmagboul, Medical Director for Methodist Comprehensive Sickle Cell Center. The letter outlines the usage of apheresis as a standard of care for these patients.

Thank you for your consideration.

To whom it may Concern,

I'm writing you regarding the importance of Exchange transfusion (apheresis) in sickle cell disease (SCD).

As you knovv, SCD is a hematological disease altering the shape and texture of RBC s, hence affecting the viscosity, oxygen carrying capacity and microvascular perfusion of organs.

Observational studies and randomized clinical trials have demonstrated that RBC transfusions can alleviate and prevent many complications of sickle cell disease.

Among the many severe consequences of SCD, stroke remains one of the major causes of long term morbidity. In 1998, a study [I], demonstrated that approximately 11% of patients have clinically apparent stroke before the age of 20, which increases by 24% by the age of 45.

Transfusion has been indicated for various complications of sickle cell disease, particularly stroke. Early treatment wi th exchange transfusion may limit the extent of cerebral ischemic injury. thereby decreasing the risk of subsequent stroke. A multi institutional retrospective study [2] found that exchange transfusion was associated with a lower risk for subsequent stroke compared with simple transfusions. Recurrent stroke occurred in 8 of 14 (57%) patients initially managed with simple transfusions and in 8 of 38 (21%) individuals treated with RBC exchange transfusions. It was also documented that subsequent blood transfusions [3]. [ 4] help prevent secondary stroke. Indefinite transfusion therapy is recommended as discontinuation at any time after short term or long term prophylactic transfusion has led to recurrent stroke. Chronic transfusions also prevents initial stroke in high risk patients as demonstrated in the Stop trial.

The use of erythrocytapharesis (Exchange Transfusion) has proved to be a more beneficial way of delivering transfusions to adults wi th sickle cell disease than simple transfusions. It was found to be more effective in reducing the well-knov·m complications of simple transfusion like alloimmunization [5] and iron overload [6] . It also provides better reduction in disease complications such as pain and acute chest syndrome, improves oxygen saturation [7] and significantly reduces the level of Hb S [8].

At this time we have 5 patients on exchange transfusions, for either primary or secondary prevention of stroke. They have all been stable since starting the exchange transfusions with minimal complications and a better quality of life confirming that this is the standard of care we would like to pursue.

We appreciate your support in helping us sustain a better patient care.

Thank you,

/s/
Lee Schwartzberg, MD
Medical Director

/s/
Nada Elmagboul
Medical Director
Methodist comprehensive Sickle cell center

Less

April 14, 2015

Dear Ms. Syrek Jensen:

Terumo BCT respectfully submits these comments to the Centers for Medicare and Medicaid Services ("CMS or “the Agency”) in response to its proposal to remove the National Coverage Determination (NCD) for Apheresis (Therapeutic Pheresis) (110.14), which was released in 1992. We commend the Agency for taking action to address this outdated NCD. As more fully set forth below, we believe that the best course of action is to revise the NCD rather than withdraw it. However, if CMS decides to withdraw the NCD, we respectfully submit recommendations that we believe will be helpful for providing patients with coverage under the Medicare program.

Terumo BCT, established in 1964 as COBE Laboratories, is a global leader in blood component, therapeutic apheresis, and cellular technologies. Terumo BCT is headquartered in Lakewood, Colorado, with sales in over 120 countries. Terumo BCT is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. Terumo BCT manufactures the Spectra Optia® Apheresis System, the successor to the COBE® Spectra Apheresis System.

The existing NCD specifies coverage for use of apheresis in only thirteen disease conditions, with limits based on setting of care and physician supervision requirements.

1. As of 2013, over 30 disease conditions are recognized by the American Society of Apheresis’ Guidelines on the Use of Therapeutic Apheresis in Clinical Practice (“2013 ASFA Guidelines”) as Category I recommendations, with another 31 disease conditions recognized as Category II.[1] The 2013 ASFA Guidelines are comprehensive, peer-reviewed and are widely used in clinical practice.
2. Other leading medical societies in this practice area now also recommend apheresis as a standard of care for conditions not covered by the NCD, such as the American Academy of Neurology (AAN) [2] and the International Society for Nephrology.[3]
3. The National Heart, Lung, and Blood Institute also released an Expert Panel Report in 2014 on the Evidence-Based Management of Sickle Cell Disease.[4]
4. Some of the disease conditions covered by the NCD are no longer clinically relevant. In addition, a robust portfolio of scientific evidence has been generated regarding the use of apheresis.

Terumo BCT submitted a formal Request for Reconsideration of the NCD in April 2014, in which we sought to include the use of apheresis in certain disease conditions not currently covered by the NCD. We were motivated by concerns about Medicare claims denials for the use of apheresis in disease conditions for which apheresis is recommended as a first- or second-line therapy under the 2013 ASFA Guidelines even though they were not included in the NCD. Our Request emphasized the importance of including clear language in a revised NCD to specify that the NCD is not restrictive and that the use of apheresis in conditions not included in the NCD may be covered at the discretion of the Medicare Administrative Contractors (MACs). Following the submission of our Request for Reconsideration, leading physicians, patient advocates and Members of Congress weighed-in with CMS in support of an updated NCD to provide appropriate access to apheresis for patients and providers.

Terumo BCT is pleased that CMS has decided to take action by proposing expedited removal of the current NCD to remove the coverage restrictions imposed by an outdated NCD. However, Terumo BCT respectfully requests CMS to fully consider the potential impacts of withdrawal of the current NCD.

1. An updated NCD could reflect the consistency of coverage for apheresis found in many major insurance carriers’ policies.[5] If the NCD were instead withdrawn, patients and providers would likely encounter a lack of consistency in coverage determinations made by MACs based upon the sheer volume and complexity of scientific literature concerning apheresis. An updated NCD could provide valuable guidance to MACs. Additionally, the apheresis industry has limited field support to assist MACs with the transition to a coverage determination in which an NCD has been withdrawn.
2. An updated NCD would provide clarity that the NCD does not exclude coverage of apheresis for conditions that are not included in the NCD. We have heard reports of certain MACs denying claims for apheresis coverage on the basis that the condition is not listed in the NCD, even though the clinical guidelines recommend the use of apheresis. Although there may be other reasons for those denials, any denials based solely on the lack of inclusion of a condition in the NCD are deeply concerning.
3. The guidance provided by an NCD could assist in lowering Medicare spending. Apheresis procedures treat certain conditions that would otherwise require increased use of drugs like intravenous immunoglobulin (IVIG) or other interventions that are often more expensive when compared to therapeutic plasma exchange (TPE).

However, Terumo BCT would be concerned about CMS launching a formal Request for Reconsideration if it could result in an NCD that is more restrictive (e.g., national non-coverage, Coverage with Evidence Development), or if it could result in a lengthy delay before CMS addresses the current NCD’s coverage deficiencies.

If CMS decides to withdraw the NCD, then Terumo BCT respectfully requests that CMS engage with MACs to explain the reasons for the withdrawal of the NCD. In particular, we are concerned that MACs might misinterpret CMS’ withdrawal of the NCD under the expedited review process as CMS’ determination that apheresis is an outdated technology.[6] CMS should explain that it used the expedited review process because the clinical evidence supporting apheresis has evolved substantially since the NCD was issued in 1992.

In the interim period before CMS issues its decision, we urge the Agency to clarify for the MACs that the NCD is not restrictive. The NCD does not contain words, such as “never” or “only if,” to indicate that the coverage provided in the NCD is meant to be restrictive. This action would assist in addressing the concerns raised above relating to claims denials as CMS considers its final decision.

Conclusion

Terumo BCT appreciates this opportunity to comment on CMS’ proposal to remove the NCD for therapeutic apheresis using the expedited removal process. We urge CMS to issue a final decision that will best ensure beneficiary access nationwide to this important therapy. We would be pleased to speak further with CMS regarding these comments. Please do not hesitate to contact me at: Jen.Seda@TerumoBCT.com or 303.231.4357.

Sincerely,

Less

Comment Concerning Apheresis Coverage

Red Blood Cell Exchange (Erythrocytapheresis)

Red Blood Cell Exchange is almost exclusively used for patients who have sickle cell disease, a disease that predominantly affects African Americans. It is sadly underutilized due to the poor reimbursement for this life saving intervention. The reimbursement for photopheresis (a procedure that is has limited indications, but is also a lifesaving intervention) is approximately five times the rate for red cell exchange. Plasmapheresis which uses the same platform and takes only slightly longer per procedure is reimbursed at two to three times the rate for red cell exchange.

What are the benefits of red cell exchange for sickle cell patients?
The standard therapy for stroke, stroke risk, acute chest syndrome, and other complications of sickle cell disease has traditionally been simple transfusion. There are limitations to simple transfusion: 1) It can produce volume overload as you are adding red blood cells to a patient who already has normal blood volume with anemia. In order to reduce the abnormal sickle cells you have to dilute with normal blood, this is sometimes not possible by just adding more blood. Circulatory overload (TACO) is a common event in critical patients which can lead to stroke. 2) The common side effect of frequent red cell transfusion is iron overload. This is a lethal complication of simple transfusion that can be treated with oral iron chelators. Unfortunately this medication is not routinely prescribed to patients with sickle cell disease and when prescribed is not used appropriately by the patient. It is also expensive, a hidden cost of transfusion that can cost as much as one hundred thousand dollars a year. The testing for iron overload and hospitalization for iron overload can be twice this amount or more.

Red cell exchange is being used more commonly (though in California where I practice it is not used in Southern California due to the poor reimbursement) to treat sickle cell disease. The advantage to exchange transfusion are multiple: 1) The exchange is isovolumetric, meaning that the same amount of blood is removed as is transfused in every procedure. There is no fluid overload. There is no TACO involved with this procedure. The level of hematocrit or the percent of sickle cell blood can be predicted and prescribed by the physician with each transfusion. 2) Due to the fact the amount of red cells given is balanced by the amount of red cells removed there is no iron overload, or it is reduced significantly. This removes the “hidden cost” of iron chelation and monitoring saving literally hundreds of thousands of dollars per year per patient. 3) One of the complications of treatment of sickle cell red blood cell transfusion is the formation of antibodies to the red blood cells. This can be reduced by using phenotypically matched red blood cells. In spite of the fact that more red blood cell units are needed for red cell exchange it has been shown in multiple studies the antibody formation is less. It is speculated that this is due to tolerance due to the volume of red cell exposure, but the reason is not known. 3) In patients who have high hemoglobin levels this procedure is the only way to reduce the level of sickle cells, simple transfusion is impossible due to the issue of TACO.

I hope that you research this issue and come to the same conclusion that those caring for sickle cell patients have come to: this is a lifesaving procedure critical to the care of these patients.

Less

Less

Less

Less

Less