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Fighting the Good Fight

January 20, 2023

February 2023

By establishing processes to manage insurance issues as well as joining advocacy efforts to effect real change, hematologists and their staff are fighting on two fronts in the quest to improve care for hematology patients.

Leah Lawrence

Leah Lawrence is a freelance health writer and editor based in Delaware.

Peter A. Kouides, MD, likes to say that he is a “post-graduate year 36,” conveying his commitment to lifelong learning. A clinical professor at the University of Rochester Medical Center in New York, Dr. Kouides recalls that when he started as a clinician about 30 years ago, his practice only had one secretary who handled insurance issues. Times have changed.

“Within five years we had two people for insurance requests, and then a few years after that, an actual billing department,” Dr. Kouides said. “Now we have two billing teams, one that handles intravenous medications and other in-hospital needs, and [another] team that handles outpatient requests for medications, particularly the high-end targeted agents that we use in malignant hematology.”

It is daunting, he said, to think that in the span of three decades insurance issues have grown to require all these personnel, which indirectly contributes to the rising costs of medical care in the U.S. 

Dr. Kouides is not alone in his frustration. ASH Clinical News spoke with him and several practitioners or members of their staff about some of the day-to-day insurance challenges they face, how they work through them, and what health care providers can do to try to improve the situation.

Running Into Red Tape

The American Society of Hematology (ASH) released a statement in 2019, “Access to Hematology Care in an Age of Innovation,” that outlined principles to help ensure everyone has access to high-quality, specialized care.1 First among these principles was that treatment decisions should be made between a physician and the patient.

Unfortunately, the reality of the U.S. health care system is that there are often other entities involved in this decision-making process, not the least of which is the patient’s insurance provider.

“There are a lot of obstacles to delivering the best care to many patients based on their insurer’s practices and formulary decisions,” said Jean Connors, MD, associate professor of medicine at Harvard Medical School and medical director of the Anticoagulation Management Service at Brigham and Women’s Hospital and Dana-Farber Cancer Institute. “Mix into that prior authorizations, which take up so much time, and it is all such a waste of resources by health care professionals trying to navigate what drug they can prescribe for their individual patient.”

Payer prior authorizations can affect every part of a hematology practice, from imaging to chemotherapy to access to cutting-edge therapeutics and even standard medications.

Aaron Gerds, MD, of the Cleveland Clinic Taussig Cancer Institute in Ohio and editor-in-chief of ASH Clinical News, discussed the difficulties with prior authorizations in his October 2022 Editor’s Corner column.2 He said, “No matter how awful insurance authorizations get, we do all of this for the patient.”

Still, dealing with insurance challenges can be frustrating and discouraging for physicians. In 2017, the American Society of Clinical Oncology (ASCO) conducted a survey of more than 2,200 adult ­hematology/oncology practices in the U.S.; respondents represented 58% of the U.S. hematology/oncology workforce. Payer pressures topped the list of practice pressures selected by both physician-owned and hospital or health system-owned practices and was third among academic practices. It was also the most common practice pressure among both rural and urban practices. Among the payer pressures, the most frequently selected were prior authorizations and coverage denials and appeals.3,4

Also published in 2017, a single-center study of a pediatric hematology/oncology practice tracked prior authorizations over the course of 150 clinic days. For the 5,583 patient visits that occurred, there were 142 medication authorization requests (prevalence rate of 2.5%). The majority (98.5%) were ultimately approved with “provider efforts” – the median clinic staff time per request was 46 minutes. The researchers found that almost half of the medication prior authorization requests were generated by just two payers.5

Dr. Kouides said that prior authorizations affect almost every prescription or order that he writes.

“This is particularly true for genetic testing,” Dr. Kouides said. “For as inexpensive as genetic tests have gotten, they are often marked up. Payers want to review the suitability of this testing and that can often hold up care.”

Filing prior authorizations requires filling out the appropriate paperwork, which then undergoes review. Sometimes the request is approved. Sometimes it is denied and appealed.

“If they turn it down, they are denying a patient the chance to start treatment or have testing necessary to select the best treatment,” Dr. Kouides said.

He recalled a patient he saw for a blood clot who had a liver lesion noted on computed tomography (CT) scan. The radiologist report said a repeat scan should be done in three months to check the status of the liver lesion.

“I got a note from the patient saying that the payer would not authorize the CT scan because a scan was just done three months ago,” Dr. Kouides said. “This approach is so frustrating because they obviously did not look at the details of the report that advised follow-up. They only looked at how recently the last scan was done.”

Payers also often make decisions about which medications will be covered or at what level of reimbursement. These tiered therapy decisions can have significant effects on patients, according to Dianna S. Howard, MD, professor of internal medicine and co-executive director of the Cancer Service Line at Wake Forest Baptist Comprehensive Cancer Center in Winston-Salem, North Carolina.

Dr. Howard had a patient with pure red cell aplasia after undergoing hematopoietic cell transplantation.

“This is a very nuanced immune-mediated problem and there are new data to suggest that daratumumab is the best option,” Dr. Howard said. “I got the papers together for authorization and sent them through peer review. It was denied on first request, but on appeal it got authorized.”

Dr. Howard began treating the patient with daratumumab, but three months later the patient received a statement that the decision was reviewed and the drug would not be covered.

“They are not going to pay for it,” Dr. Howard said. “Now my patient is at financial risk and my institution is at financial risk. What are the boundaries? Who sets them? What is the payer allowed to do and who will advocate for the patient when something like this happens?”

Practice-Level Response

Dr. Connors said that knowledge of prior authorization restrictions of tiered therapies does not affect her prescribing decisions up front, but that she is often forced to make accommodations down the line. In her practice, she has an administrative employee who initiates prior authorizations, and then a nurse practitioner or an anticoagulant pharmacy specialist who is trained to fill out the appropriate medical details submits the authorizations.

Still, there are many cases that require her direct input. For example, in one recent case, she received notice that a peer-to-peer call was needed for an anticoagulant authorization while she was seeing patients all day. She returned the call the next morning and was notified that the time window on the review had passed and her practice would have to re-file.

Dr. Connors said it took another seven to 10 days to refile the same form and arrange a peer-to-peer call. The second filing was ultimately successful, but she has had other cases denied despite peer-to-peer review.

Paul A. S. Fishkin, MD, a hematologist with Illinois CancerCare, P.C., said he is lucky to have a “fantastic team that absorbs most of the burden for me,” which includes dealing with delays in treatment, inappropriate understanding of imaging, and peer reviewers with no training in hematology or even a related specialty.

Megan Lock, BHS, CPC, is the patient advocate lead for Illinois CancerCare, a large community practice that employs six full-time people who handle insurance issues.

“This is all they do, all day, and sometimes eight hours a day isn’t enough,” Ms. Lock said.

These seasoned employees are split by payer and have years of experience learning the ins and outs of working approvals through each payer’s system.

“For each payer they know what will get through or which drug needs to get substituted for another,” Ms. Lock said. “A lot of practices, especially smaller ones, are not as robust and can’t afford to sacrifice a full-time employee just for this purpose. In those cases, a lot of nurses step up and do this work, which is not ideal.”

At Illinois CancerCare, the team that handles insurance issues coordinated with the organization’s information technology department to come up with a way to flag situations that they know may cause an issue with insurance authorization.

“The system will kick it back to the doctor before we start a prior authorization for something that we know won’t be approved, and it requests a substitution,” Ms. Lock said. “If the clinician says ‘No’ to the substitute, they must enter a reason why. That allows us to put in the reason before we send for prior authorization.”

In both malignant and classical (non-malignant) hematology, there are a variety of reasons why a physician might choose one drug over another even when a payer views both drugs as equal or in the same drug class.

According to Ms. Lock, providing supportive clinical documentation by the physician is essential for staff to be able to accurately communicate the rationale for choosing a particular treatment with the hope that the payer will understand and approve based on best clinical standards. 

“Unfortunately, we find that payers frequently use staff and even peer-review physicians that are not certified in this specialty and are unfamiliar with these standards of care,” Ms. Lock said. “To further complicate matters, these departments are held to cost-saving incentives, including preferred drug use based on contracting. In many instances, providers’ choice of treatment will be overridden by these measures and a less costly treatment will be mandated by the payer unless there is sufficient medical necessity to appeal the decision. The physician must then decide if it is worth the fight or if the alternate treatment is equally effective.”

Patients Caught in the Middle

Dr. Howard said that clinicians are constantly trying to make risk assessments, weighing the effect of delays in care while they wait for authorizations versus going ahead with what they feel is the best care for the patient.

“In practice, there may be situations where a patient needs to start chemotherapy, but it is a holiday or a weekend, and it may be a whole week before things can get submitted through insurance,” Dr. Howard said. “That patient may just get admitted to the hospital for the chemotherapy, and the costs can now be submitted under the DRG [diagnosis-related group].”

As another example, Dr. Howard said there are a lot of rules around the administration of growth factors, which are given after chemotherapy to help with the recovery of white blood cells.

“We generally try to have some distance between the patient’s last chemotherapy and when growth factor is given … that helps you get authorization,” Dr. Howard said. “At the same time, though, you have to get authorized before the time limit runs out.”

Sometimes patients are discharged one day only to have to come back the next for growth factors. If a patient lives far away, the hospital may try to find them housing at a Hope Lodge for the night so they can return to the clinic the next day.

“The whole situation creates this unstable work-around system that contributes to the cost of medical care,” Dr. Howard said.

Both examples reinforce the thought process behind another of ASH’s principles set forth in “Access to Hematology Care in an Age of Innovation”: Medical considerations, not cost, should drive the determination of the site of care for providing high-cost treatments.

Some research has attempted to quantify the effect of insurance type, delays, or denials on patient care and outcomes. A literature review published in 2021 found that of 22 studies that focused on hematologic malignancies and insurance, 17 reported disparities in overall survival based on insurance status and type.6 Researchers said the studies overwhelmingly reported “better survival among patients with insurance compared with those with no insurance and better survival among patients with private commercial insurance compared with other insurance types.”

Another study of insurance in adolescents and young adults showed that patients with non-Hodgkin lymphoma, Hodgkin lymphoma, and acute lymphoblastic leukemia who were publicly insured with Medicaid had worse survival compared to those who had private insurance.7

A more tangible example of how insurance type could affect care is reflected in a 2022 report from the U.S. Department of Health and Human Services Office of the Inspector General that revealed Medicare Advantage Organizations (MAOs) sometimes delayed or denied beneficiaries’ access to services, even when they met Medicare coverage rules. Additionally, some MAOs denied payments to providers for services that met Medicare coverage rules and MAO billing rules.8

“MAO is a managed care plan that manages Medicare, generally costs more, and is more restrictive,” Dr. Howard said. “These plans don’t just go by the accepted coverage of Medicare. I have seen statistics saying there are a huge percentage of claims not authorized that are eventually overturned on appeal because the denials are arbitrary.”

Making a Difference

Dr. Connors encouraged hematologists to get involved and speak up against situations that may be causing harm to patients, because they can make a difference when they work together. Representatives from ASH and the American College of Cardiology (ACC), including Dr. Connors, met with pharmacy benefit manager (PBM) CVS Caremark regarding its decision to remove all but one direct oral anticoagulant (DOAC) from its commercial pharmacy benefit plan.

“Last December [2021], one of my nurse practitioners started getting all of these copies of letters that had been sent to patients on a specific CVS Caremark formulary saying that an anticoagulant they had been on for years was no longer going to be covered and that they would have to switch to another,” Dr. Connors said.

CVS Caremark was requiring patients on apixaban to switch to rivaroxaban or warfarin or request a formulary exception. This type of requirement is called non-medical switching. CVS Caremark said the decision was based on current guidelines and cost considerations.9

“I tweeted about this, and it helped start a whole coalescing of different people – patients, patient advocates, etc. – getting involved,” Dr. Connors said. “They are denying patients these drugs because they want to save money, not because of a medical difference. They don’t understand that there are populations of patients that have a higher bleeding risk with apixaban than rivaroxaban.”

In July 2022, after meeting with the ACC and ASH, CVS Caremark agreed to reverse its decision and returned apixaban as a preferred product within the DOAC classification. Dr. Connors was pleased with this decision but mentioned that a lot of time was spent in the interim guiding patients through the switch to other anticoagulants and filing requests for certain patients to remain on apixaban.

In June 2022, the Federal Trade Commission announced it would launch an inquiry into PBMs to “scrutinize the impact of vertically integrated [PBMs] on the access and affordability of prescription drugs.”10

According to Dr. Connors, the hope is that PBMs would have fair drug pricing practices that don’t try to make such a large profit at the expense of the elderly and those who can’t afford higher drug costs.

“Just now WellCare has moved the anticoagulant drug apixaban from tier 1 to tier 4 coverage; the drug is not being denied but the [cost] is going from $45/month to $250/month – something that many people can’t afford,” she said.

ASH is also part of the Regulatory Relief Coalition, which is a lead sponsor of the Improving Seniors’ Timely Access to Care Act (HR 3173).

“This legislation is geared toward helping seniors, which is a large proportion of the population we treat,” Ms. Lock said. “The bill will work toward more transparency with Medicare Advantage plans and improving electronic prior authorization standards.”

Among the changes would be the requirement to provide real-time decisions in response to requests for items and services that are routinely approved and to annually publish specific prior authorization information, including the percentage of requests approved and the average response time.11

In New York, Dr. Kouides is involved with the patient advocacy group New York State Bleeding Disorders Coalition, which is dedicated to ensuring that people affected by bleeding disorders have access to quality health care. The group is working to help pass legislation that, among other things, would require appropriate peer-to-peer authorization from someone in the same specialty as the ordering physician. Dr. Kouides has also reached out to the state’s Health Commissioner and governor in the past to advocate on behalf of patients when it comes to payer decisions and coverage.

“I have been doing this for 14 years, and every year insurance dictates more and more of how our doctors are able to treat patients,” Ms. Lock reflected. “This takes the human factor out of that patient’s care, and the more we get away from that the worse the health outcomes will be.”

Dr. Kouides said he hopes patient-driven advocacy will result in legislation that improves the situation, but it is currently still a David-versus-​Goliath-type situation.

References

  1. American Society of Hematology. Access to Hematology Care in an Age of Innovation. November 22, 2019. Accessed December 16, 2022. https://www.hematology.org/advocacy/policy-news-statements-testimony-and-correspondence/policy-statements/2019/access-to-hematology-care-in-an-age-of-innovation.
  2. Gerds A. Nightlight for our souls. ASH Clinical News. 2022;8(12):7.
  3. Kirkwood MK, Hanley A, Bruinooge SS, et al. The state of oncology practice in America, 2018: Results of the ASCO Practice Census Survey. JCO Oncol Pract. 2018;14(7):e412-e420.
  4. Lin NU, Bichkoff H, Hassett MJ. Increasing burden of prior authorizations in the delivery of oncology care in the United States. JCO Oncol Pract. 2018;14(9):525-528.
  5. Dickens DS, Pollock BH. Medication prior authorization in pediatric hematology and oncology. Pediatr Blood Cancer. 2017;64(6):e26339.
  6. Crotty K, Lee M, Treiman K, et al. Health insurance, blood cancer, and outcomes: a literature review. Am J Manag Care. 2021;27(6):SP241-SP244.
  7. Alvarez E, Parsons H, Maguire F, et al. Worse outcomes associated with public insurance in AYAs with leukemia and lymphoma. Blood. 2018;132(Suppl 1):977.
  8. S. Department of Health and Human Services Office of the Inspector General. Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care. April 27, 2022. Accessed December 16, 2022. https://oig.hhs.gov/oei/reports/OEI-09-18-00260.asp.
  9. American College of Cardiology. CVS Caremark to reverse change to DOAC formulary classification. June 22, 2022. Accessed December 16, 2022. https://www.acc.org/latest-in-cardiology/articles/2022/06/22/20/10/cvs-caremark-to-reverse-change-to-doac-formulary-classification.
  10. Federal Trade Commission. FTC Launches Inquiry Into Prescription Drug Middlemen Industry. June 7, 2022. Accessed December 16, 2022. https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-launches-inquiry-prescription-drug-middlemen-industry.
  11. Congress.gov. H.R.3173 - Improving Seniors’ Timely Access to Care Act of 2021. 117th Congress (2021-2022). https://www.congress.gov/bill/117th-congress/house-bill/3173.

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