41 minute read
Community cancer care amid COVID-19
Stakeholders adapt during pandemic Community Cancer Care Amid COVID-19
When it comes to delivering cancer care amid the COVID-19 pandemic, it takes a village: Pharmacy benefit managers, Pharma, providers and clinic directors all are pulling together to ensure adequate access despite social distancing and other unprecedented pressures, experts noted during an April 3 webinar.
“We can shut down the country, but we can’t shut down cancer,” said Ted Okon, the executive director of the Community Oncology Alliance (COA). “Cancer keeps going. With hospital campuses overflowing with COVID-19 patients, community oncology facilities have been essential to keeping cancer patients treated and monitored so that they are out of the hospital.”
Sponsored by the Association for Value-Based Cancer Care, the webinar focused on the impact of COVID-19 on the cancer care delivery ecosystem and featured insights from more than 20 industry experts.
COA has established a regularly updated COVID-19 webpage with practice resources and protocols for community oncologists, as well as a listserve for health care providers.
Tennessee Oncology, one of the nation’s largest community cancer networks, has established three primary strategies to protect its patients, said the network’s president, Jeff Patton, MD: 1. Patients who are not in active treatment should stay at home and maintain checkups via telehealth. 2. Continue treatment for active-treatment patients. “We are still treating both curative and palliative patients, and keeping our clinics open and providers and patients safe is our focus,” Dr. Patton said. “Our visits for nonacute patients are down by 30%, but chemotherapy visits are off by only 2%.” 3. Acute diligence practices should be done in the clinic, including use of N95 masks and personal protective equipment for clinicians and CDC risk assessment of all patients and caregivers at the door. Only one caregiver is allowed to accompany each patient.
Lucio Gordan, MD, the president of Florida Cancer Specialists (FCS), the largest independent medical oncology/hematology practice in the United States, said cancer care providers in the state are “bracing for impact.” He noted that infusion visits in the practice were down by only about 7%, but weekly follow-up visits had declined by 33% and new patient visits by almost 25%. Radiology also has declined, with CT scans down by almost 13% and PET scans down by nearly 10%.
“Telehealth is operational across our more than 100 clinic sites,” Dr. Gordan said. “We gave our chief technology officer three days to get it up and running and he had a solution in 19 hours.”
The practice has the vast majority of nonclinical staff working from home with information technology support, including 85% of IT staff, 70% of the revenue cycle team, and 90% of the outpatient pharmacy group. “It was a herculean effort to get appropriate technology to allow more than 1,000 people to work from home over the course of four to five business days,” Dr. Gordan said. “But we were able to do it.”
Protecting Front-Line Staff
FCS took additional steps to ensure its oncology pharmacy dispensing staff was protected immediately. “They have been sequestered in their own ISO 9 [clean]room with a separate entrance and its own HVAC system,” said pharmacy director Ray Bailey, BPharm, RPh. “They are masked and gloved and go through temperature checks and questionnaires at the beginning and end of their shifts.”
FCS also has suspended all pickups in the pharmacy and any shipments to the clinic; everything now is being shipped by FedEx. “They have adapted and will not require physical signatures from our patients,” Mr. Bailey said. “They will ring the doorbell, and once they see the patient take the package, they sign ‘COVID-19’ on the signature pad.”
He noted that for drugs with Risk Evaluation and Mitigation Strategies (REMS) requirements of periodic inperson laboratory or imaging tests— which include many cancer therapies—the FDA is temporarily allowing providers to waive such requirements during the public health emergency. (To access details on the agency’s easing of some REMS requirements, visit bit.ly/2wZ7r5j).
Expanded Telehealth
Like many other providers during the COVID-19 pandemic, FCS also has expanded its telehealth program, with services now available to patients at all FCS sites. The strategy is intended to increase patients’ access to providers
At Florida Cancer Specialists, by early May, telehealth was operational across more than 100 of the network’s clinic sites.
while helping to reduce the potential spread of, or exposure to, illness, Telehealth visits, FCS noted, are covered by most insurance plans, and patients can expect “to pay the same or possibly less than an in-office visit.”
Minimal Supply Chain Disruptions
To date, the oncology pharmacy supply chain has not experienced significant disruptions as a result of the pandemic, said webinar participants representing manufacturers and wholesalers.
“We have multiple redundancy plans built out to ensure continued operations during this crisis,” said Barry Fortner, PhD, the senior vice president and president of specialty physician services at AmerisourceBergen. “The foundational oncology pharmacy space has not seen major disruptions to date, other than those we were already dealing with before this pandemic, and those specifically accentuated by COVID-19 such as hydroxychloroquine.”
Brian Morrissey, the vice president of the strategic customer group for oncology at Pfizer, cited similar progress. “All of our plants in [effected] areas are fully operational, and in fact we have increased production and shifted demand to our most critical products,” he said. “We are also seeing unprecedented cooperation with regulatory authorities. Things that usually take months take weeks, and things that typically take weeks happen in days.”
Eric Dozier, the vice president of Oncology North America for Eli Lilly, said that the company is “able to maintain strong supplies across the oncology channel.” Both Mr. Dozier and Mr. Morrissey noted that while pivotal trials of new oncology agents are continuing, manufacturers have halted recruitment for new trials. “The last thing we want to do is be a burden on the system,” Mr. Dozier said.
PBMs Step In
Many pharmacy benefit managers (PBMs) have adapted their policies and practices in light of the COVID-19 pandemic, said oncology pharmacy specialists participating in the webinar. “Many [PBMs] are now allowing 90-day fills and not requiring signatures from patients,” said Michael Reff, RPh, MBA, the founder and executive director of the National Community Oncology Dispensing Association. “A number of PBMs have also suspended audits, and in many cases pre-authorizations have been delayed or suspended. We really appreciate those efforts from the PBMs.”
Mr. Reff noted that oncology practices also are innovating in response to the pandemic. “They are reaching out to local and state legislatures to find out if they can keep some oral therapies in-house as opposed to [using] mailorder pharmacies, to increase continuity of care.” —Gina Shaw
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Hype Over Hydroxy
continued from page 1
metropolitan Atlanta. On the day the president began touting the benefits of hydroxychloroquine—an old medication normally used for malaria and autoimmune diseases such as lupus and rheumatoid arthritis (RA)—to treat COVID-19, Mr. Katz put in a larger order.
He had been researching potential therapies for COVID-19 for a while, and had already tried to gather a little extra hydroxychloroquine in case it proved useful. “Then when President Trump discussed it, I reached out and ordered a bottle of 500 pills.”
In the front of Mr. Katz’s mind was the small number of patients who rely on Little Five Points Pharmacy for a regular supply of hydroxychloroquine. Many people with lupus and RA have moved on to biologic therapy, but “there are some who take it,” he said. “I wanted to make sure I had it for them.”
Securing a Supply
During the height of the hydroxychloroquine hype, pharmacists had to do what they could to secure a reliable supply of the drug for conventional indications. But the initial run on the medicine—and an allocation of more than 30 million doses to the federal stockpile— made their job difficult. Chuck Kray, RPh, the owner of Hershey Pharmacy and HersheyCare, in Pennsylvania, said that at the time, his pharmacy had “enough for another month probably, and then we were going to hurt a little.” Mr. Kray added that he heard of several other pharmacies that had completely sold out of their supply.
Such shortages were not surprising, based on an analysis of hydroxychloroquine and chloroquine prescription data by The New York Times (nyti. ms/2YjrEO7). Soon after the president’s touting of the antimalarials, first-time prescriptions of the drugs poured into community pharmacies at more than 46 times the average weekday rate, according to the analysis. The nearly 32,000 prescriptions came from a spectrum of prescribers—rheumatologists, cardiologists, dermatologists, psychiatrists and even podiatrists, the data showed.
Preventive Measures
Mr. Katz said he received electronic prescriptions from patients and doctors he did not know, with no diagnosis code—something he said has never happened before. “I didn’t fill them; I didn’t know the patient and I didn’t know the doctor.” Mr. Kray, for his part, said he received multiple prescription requests for hydroxychloroquine from doctors seeking personal supplies. “We set a policy that unless it’s confirmed COVID-19, we would not fill it.”
Chain pharmacies also took steps to preserve their supply of hydroxychloroquine. Walgreens, for example, suggested that pharmacists who received a new prescription for chloroquine or hydroxychloroquine for patients who did not have a prior history of use should provide no more than a 14-day supply. Patients who regularly take the medication should be limited to a 30-day supply, and all active 90-day prescriptions should be changed to 30 days. These guidelines were intended “to help ensure these medicines remain available for those who need them,” Walgreens spokesperson Rebekah Pajak said.
Some states made such restrictions official: In New York state, the governor signed an executive order that stipulated that pharmacists can only prescribe hydroxychloroquine for indications approved by the FDA, or for patients with COVID-19 who have documented positive test results, and no prophylactic use is permitted.
Michael DeAngelis, a spokesperson for CVS Health, said the company’s retail pharmacies followed all state dispensing guidelines. In states without guidelines,
Soon after the White House touted chloroquine and hydroxychloroquine, first-time prescriptions for the drugs poured into community pharmacies at more than 46 times the average weekday rate.
the pharmacies limited hydroxychloroquine for COVID-19 patients to a 10-day supply with no refills. CVS Health’s pharmacy benefit manager, Caremark, worked with its PBM clients to set “appropriate coverage limits” on the drug for plan members being treated for COVID-19, which would not apply to plan members who have been receiving hydroxychloroquine for approved uses. “Our goal [was] to limit stockpiling of medication that could result in future shortages and gaps in care,” Mr. DeAngelis said.
Such restrictions provided some relief, but not enough, Mr. Kray said. Before the surge in demand, he could purchase one pill of hydroxychloroquine for 9 to 10 cents; during the pandemic, prices have been as high as $2.75, he noted.
Taking Adverse Events to Heart
The financial fallout from indiscriminate use of hydroxychloroquine or chloroquine is not the only consequence that community and managed care pharmacists should be concerned about. Recent data underscore how potentially toxic the medications can be. A cohort study of COVID-19 patients from Wuhan, China, found that nearly 20% of treated patients showed signs of cardiac injury, and those who did were significantly more likely to die (51.2% vs. 4.5% of patients without cardiac injury; P<0.001) (JAMA Cardiol 2020 Mar 25. [Epub ahead of print]. doi: 10.1001/jamacardio.2020.0950).
Due to such emerging data, in late April, the FDA issued a warning that health care professionals should closely screen and monitor patients receiving hydroxychloroquine or chloroquine to reduce the risk for an adverse event (bit. ly/2ztpQYO).
Fortunately, there are steps that pharmacists, providers and other stakeholders can take to reduce those cardiovascular risks, including prescribing no more than 600 mg per day of hydroxychloroquine in divided doses, and for no more than a 10-day course, according to a guidance issued by the American College of Cardiology (bit.ly/ 3bVzzp1). The organization also urged providers to consult physician and pharmacist infectious disease specialists when prescribing these medications.
The Pressure Eases
As for next steps in managing supplies of hydroxychloroquine, that job has gotten much easier. Due in part to the release of several negative clinical trails on hydroxychloroquine’s efficacy against COVID-19, the run on the drug appears to have waned. By mid-May, although it still was listed on the ASHP’s drug shortages site, some formulations were noted as being available (bit.ly/ 3bPGwrx; sidebar). —Alison McCook
The sources reported no relevant fi nancial relationships.
PBMs and the Run on Hydroxychloroquine
Leading pharmacy benefit managers (PBMs) say the initial flood of demand for the antimalarial drug hydroxychloroquine, sparked by suggestions from the White House that it was an effective treatment for COVID-19, finally is showing some signs of easing. This has lessened pressures on supplies of the drug for FDA-approved indications, such as lupus and rheumatoid arthritis.
Prime Therapeutics’ ongoing monitoring of utilization trends for hydroxychloroquine showed a rapid spike between March 17 and 25, which caused many community pharmacies to scramble to maintain adequate supplies for the FDA-approved uses, as noted above. “During this time, we did receive a few escalated member inquiries regarding drug supply issues. This was primarily due to local/ regional supply chain inventory adjustments,” said David Lassen, MD, Prime’s chief clinical officer. “We assisted these members by redirecting to pharmacies with known inventory. We also took measures to limit quantities of prescriptions for new COVID-19 users to prevent further drug shortage concerns and/or potential stockpiling.”
Between late April and early May, after new reports suggested that the drug did not help hospitalized COVID-19 patients and the FDA warned against the use of hydroxychloroquine outside of the hospital setting or a clinical trial due to risk for heart rhythm problems (bit.ly/2WFOEog), Prime saw its utilization of the drug return to pre-baseline levels. This suggests that there is no longer a high demand for the product as a COVID-19 treatment in the outpatient setting, “which is consistent with the evolving clinical trial data suggesting that the risks
Text continued from page 10 (cardiovascular) may outweigh any benefits for this drug in the treatment of COVID-19,” Dr. Lassen said.
On May 7, an observational Columbia University study of more than 1,400 hospitalized patients—the largest study of hydroxychloroquine to date in COVID-19—added to the data questioning the antimalarial’s role in COVID-19. The study found that the drug was not associated with either a greatly lowered or an increased risk for the composite end point of intubation or death (N Engl J Med 2020 May 7. [Epub ahead of print]. doi: 10.1056/NEJMoa2012410).
Abarca’s Response
The Florida- and Puerto Rico–based PBM Abarca also observed intermittent shortages of hydroxychloroquine during the mid-March utilization spike. “During that time, we continually monitored shortages and recommend strategies to prevent and address shortages, especially to protect those patients who use medications chronically,” said founder and CEO Jason Borschow, adding that the company also has seen a return to pre- pandemic demand in the past few weeks. “Despite the sharp drop-off in utilization, our clinicians continue to monitor access to hydroxychloroquine. At this point, we have not received any complaints of patients who can’t obtain their supplies due to shortages,” he said.
CVS Health reported that its retail, mail service and specialty pharmacies have adequate supply of hydroxychloroquine and are taking all necessary steps to maintain those supplies. “Very early on, we implemented quantity limits (with client consent) to help meet the needs of patients with conditions such as lupus,” said spokesperson Trey Hollern. “We continue to balance the growing interest in off-label use of certain prescription medications to treat COVID-19 pneumonia (like hydroxychloroquine) with the ongoing needs” of chronic-care patients.
Increased demand for other medications being prescribed to treat COVID-19 and its complications has led to some temporary shortages, Mr. Hollern added. Besides hydroxychloroquine, these medications include azithromycin, which often is given in combination with hydroxychloroquine in COVID-19 patients, as well as albuterol inhalers, which are approved for treatment of lupus, bacterial infections, HIV, rheumatoid arthritis and asthma but often are used adjunctively in COVID-19.
“In addition to standard processes at the pharmacy level,” Mr. Hollern said, “CVS Health implemented new measures across our enterprise for these medications, such as adhering to state-level dispensing guidelines in our retail pharmacies and, as a PBM, setting coverage limits on quantity for pharmacies in our network.”
ASHP Shortage Data
Underscoring the moving target of hydroxychloroquine and azithromycin shortages, both drugs were still listed as being in short supply by the ASHP’s drug shortages website in early May. But a deeper dive into the listings shows that the drugs can be obtained, albeit in a limited range of formulations. According to ASHP’s “Current Drug Shortages” list (bit.ly/2yLFoab), Concordia and Milan had hydroxychloroquine available
in 100-count/200-mg dosages, while several other suppliers had the drug on allocation to customers and contracted wholesalers for approved indications. As for azithromycin, three suppliers— Athenex, Fresenius Kabi and Slate Run Pharmaceuticals—were listed as having IV lyophilized powder for injection available in 10-count packages of 500- mg vials. —Gina Shaw
The sources reported no relevant fi nancial relationships.
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COVID-19 and Health Care Reform a Bad Mix
With the COVID-19 pandemic derailing nearly every aspect of health care, experts are speculating that the ongoing crisis will reshape everything from drug pricing reform initiatives to universal health care policy debates and insurance accessibility.
Health Care Reform stimulus package that Congress passed
By the time Congress gets to proposed during the COVID-19 crisis included a health care reform, the political landpretty significant increase in funding that scape may be very different from what it is today, potentially with a different could be used by manufacturers to repatriate some of their activities back from Personal views on universal health president, noted Chris Sloan, an associoverseas into the United States.” insurance ‘are so heavily entrenched that ate principal at Avalere, a health care consulting firm in Washington, D.C. Medicare for All even a global pandemic isn’t going to
“Assuming the focus remains on The argument in favor of a Medicaresway people’s minds.’ COVID-19, the next opportunity for for-all system could be bolstered in light major health care policy reform might of an increasing number of unemployed —Chris Sloan, Avalere not be before 2021,” Mr. Sloan said during and uninsured individuals and “negative a recent Avalere podcast. If former Vice health care experiences,” such as surprise and after it resolves, Mr. Sloan noted. care for underserved populations, telePresident Joe Biden wins the election, his hospital bills for COVID-19 treatment, With most clinic appointments, tests and health likely will continue to be paid for health care proposals will look “very difMs. Andel noted. However, not all agree elective procedures postponed, pharmaand used more frequently even after the ferent than some Republican priorities, with that assessment. According to Mr. ceutical manufacturers, insurers and paypandemic is resolved, he suggested. (For when it comes to Medicare drug pricing Sloan, personal views on the topic of ors are trying to preserve as much access more details on telepharmacy reimbursenegotiations, for example,” he said. (For universal health insurance “are so heavily as possible to treatments and are encourment, see page 13.) more on drug pricing, see sidebar.) entrenched that even a global pandemic aging adherence to medications. “EveryThe financial effects of current and isn’t going to sway many people’s minds. one has an incentive to avoid a spike in future changes in health care utilization Drug Supply Chain Weaknesses “What I do think we may see are some new diagnoses and complications and a are keeping health plan managers up at
Although some initiatives are stalling state-specific efforts to widen the availwave of uncontrolled medical costs after night, Matt Kazan, a senior health policy due to the COVID-19 crisis, others will be ability of patient health care safety nets, COVID-19 subsides,” he said. advisor at Avalere Health, noted during prioritized because of their relevance to like Medicaid,” he said. “Losing comOne way stakeholders have been the podcast. “They’re looking at how the current pandemic, experts believe. For mercial insurance coverage in New York addressing some of the gaps in care is the unanticipated costs of treatment example, shortages of health care supplies is very different than losing it in Texas, through the use of telehealth, which saw a for members who develop COVID-19 and a recent shutdown of pharmaceutical where Medicaid is limited, so some states nearly 1,600% surge in claims at the height weigh against any savings from reduced manufacturers in Baddi, India—a key drug with less generous social programs may of the COVID-19 pandemic, according utilization of health care services durmanufacturing hub—likely will accelerate be pressured to expand these programs.” to IQVIA data presented by Doug Long, ing this time,” he said. initiatives to fix vulnerabilities in the drug MBA, the vice president of industry The chronic care gap Mr. Kazan pointsupply chain and reduce dependence on Access to Care relations for the firm, during a separate ed to is underscored by IQVIA data: As China and India, said Melissa Andel, the Health care stakeholders are keeping seminar (see page 1). These claims are the COVID-19 pandemic took hold at vice president of health policy for Applied a close eye on how much the pandemic being reimbursed widely, according to the end of March, medical claims for Policy. “In fact, the third phase of the affects health care utilization both now Mr. Sloan. Because it facilitates access to diagnostic visits in physician offices and institutions plunged by 63.2% and 72%, respectively, according to Mr. Long.
During Pandemic, Drug Pricing Overhaul Not Likely When Care Returns
The COVID-19 pandemic and resulting public health emergency likely have sidelined any opportunity to when their annual price outpaces inflation. House Democrats, many Sen
Once the health care system reopens, another set of costs will start to be felt, implement broad drug pricing reform in 2020, a health ate Republicans and the president Mr. Kazan noted. When that happens, policy expert said during an AMCP webinar. agreed to these ideas in principle, he explained, clinic visits, elective “The Trump administration and Congress’ attention is focused on mitigating the impact of the public health emergency on the nation, and this work is likely to continue beyond the immediate crisis but also up through the election,” said Melissa Andel, the vice president of health polbut a Senate discussion on the matter barely made it out of the committee, and it squeaked by with one vote.
“Majority leader [Sen.] Mitch procedures and tests presumably will resume, and patients will start treatments for new diagnoses that had been missed during the height icy for Applied Policy, a consulting firm in Alexandria, Va. McConnell’s refusal to bring this of the pandemic. The problem is “Clearly, there will be massive challenges facing the econto the floor for vote appears to be that the increased utilization “[will omy and within health care, and immediate aid to providers the one thing keeping it from being come] right when plans are setting and hospitals is going to take top priority.”
It’s possible there could be an opportunity in November, during the lame-duck session, to include drug pricing reform in a legislative package with various health extenders, Ms. Andel said, “but that legislation is going to passed into law,” Ms. Andel said. “Therefore, even a slight change in the Senate makeup could influence the future of that legislation.”
Mr. McConnell himself is up for reelection this fall. their premiums for 2021,” he said. “It’s yet to be seen how all of these costs will affect the price of insurance.”
Along with the loss of insurance that need to move quickly, and any compromises would need Senate seat elections are critical, because that will detertens of millions of newly unemployed to be negotiated ahead of time.” It’s relatively unlikely mine the ultimate fate of drug reform, Ms. Andel said: “Even Americans are facing, possible higher that the Trump administration would take any independent executive action, she said, because that could have a negative effect on investor markets, especially in the pharmaceutical sector. if the Democrats outperform expectations and somehow win back the Senate, it’s important to keep in mind they would have a very slim majority, and they have a lot of moderate and conservative members that decrease the chance they premiums, Mr. Kazan noted, would place health insurance further out of reach for many. —David Wild
There has been bipartisan agreement on restructuring would be amenable to a radical reform.” —Karen Blum the Medicare Part D benefit, as well as an inflation penThe sources reported no relevant alty that would be applied to drugs covered by Medicare Ms. Andel reported no relevant fi nancial relationships. fi nancial relationships.
One goal: getting your 20% Medicare add-on payment for COVID-19 Be Prepared, Be Innovative and Be Safe!
In the unprecedented crisis of
COVID-19, the first instinct is to triage our activities, often weeding out the ones that seem to be the least important. Some of those will never surface again and just become part of the detritus left behind.
However, documentation mustn’t be one of them. From a clinical standpoint, documentation is critical to caring for patients with COVID-19; it’s essential to tell the patient’s story accurately and completely. When this is done in a codable manner, it’s the key to bringing in desperately needed income and decreasing financial toxicity for the patient who’s often eligible for expanded resources. Such efforts also will help avoid medical billing and payment issues in the months and years following this pandemic.
Tucked into the recent CARES Act, the Coronavirus Preparedness and Response onse Supplemental Appropriations Act (also also known as the stimulus package), is a is a provision that temporarily removes the the Medicare sequester from May 1 through ugh Dec. 31, 2020, and extends it an additional onal year past its original end date. This his provides you with a guaranteed 2% % increase on all Medicare payments. The he caveat: The claim needs to be clean and nd complete with no inaccuracies, errors ors or missing information to be processed ed quickly and paid completely.
I’m urging you to find someone within thin your department who can shoulder the the responsibility of making this happen. PerPerhaps it’s someone, even working from a m a remote location, who will be the steady eady driving force for financial solvency. The The stimulus package is providing the fundunding, but it’s up to each one of you to ask ask for it and use it wisely to help cover COVOVID-19-related expenses and lost revenue. nue
The supplement also provides a 20% add-on payment to the DRG rate for COVID-19. This Medicare add-on payment applies to patients treated at hospitals that are reimbursed through IPPS with a new ICD-10-CM diagnosis code, U07.1. An enhanced grouper assignment effective for discharges on or after April 1, 2020, corrects the underpayments possible from the original grouper assignment. Other key features include: • eliminating $8 billion in Medicaid disproportionate share hospital payment cuts in FY2020, FY2021 (a $4 billion reduction with implementation of cuts is delayed until Dec. 1, 2020); • extending Medicare and Medicaid programs set to expire on May 22 until Nov. 30, setting up a potential vehicle for legislation to ban surprise medical bills and address prescription drug prices after the 2020 election; • mandating more reporting requirements about where drug companies source their materials and allowing the FDA to prioritize drug applications that could help address a shortage; and • covering vaccines that meet certain effectiveness standards with no cost sharing.
Telehealth Shines!
In addition to several initiatives, HHS will waive federal licensing regulations so that out-of-state physicians can treat COVID-19 patients through telehealth in states that have large outbreaks. The agency also is helping on the payment front by developing and implementing a new payment rule for federally qualified health centers and rural health clinics that provide telehealth services to eligible patients. Payment rates would be based develop documentation tools,” and also outline temporary telehealth services that could be implemented during the COVID-19 pandemic.
on the payment that currently applies to comparable telehealth services under the PFS. In addition, HHS is to issue guidance on using telehealth for home health services. This allows Medicare beneficiaries to use telehealth services regardless of whether they had seen the provider in person in the preceding three years.
“Reimbursement
Matters” is a tool for maintaining your health system’s fiscal health. Please email the author at bonniekirschenbaum@ gmail.com with suggestions on reimbursement issues that you would like to see covered.
Bonnie Kirschenbaum, MS, FASHP, FCSHP
A Reimbursement Lexicon
AMA, American Medical Association; CMS, Centers for Medicare & Medicaid Services; DRG, diagnosis-related group; FY, fiscal year; HHS, Department of Health and Human Services; ICD-10-CM, International Classification of Diseases, 10th Revision, Clinical Modification; IPPS, Inpatient Prospective Payment System; PFS, physician fee schedule
On March 20, CMS released two digital telehealth tool kits, one specific to general practitioners (go.cms.gov/2XVuR6p) and the other for providers treating patients with end-stage renal disease. “Each toolkit comprises electronic links to telehealth resources to reduce the amount of time providers spend looking for answers on new regulations,” the agency stated. “The toolkits is structured to help you learn more about the general concept of virtual care, choose telehealth vendors, initiate a program and health counseling and preventive health screenings. For a list of frequently asked questions regarding the telehealth initiative, visit bit.ly/3bu0JmR. Additionally, CMS issued a MLN Special Edition with more guidelines (go.cms.gov/2VmrjZe) and the subsequent edit to it is published in the MLN Special Edition – Friday, April 3, 2020 (go.cms.gov/2VEZ3jw). Medicaid also has telehealth provisions related to COVID-19 (bit.ly/3eur85J). On April 23, the Trump administration issued its own telehealth toolkit to accelerate states’ use of the technology (bit.ly/ 34ZRTdS). For more information on COVID-19 and telehealth, see page 22.
Put These Into Your e-Library!
According to CMS's March 17 fact sheet (go.cms.gov/34KhxmN), clinicians could bill immediately for dates of service starting March 6, 2020. Telehealth services are paid under the PFS at the same amount as in-person services. HHS also is waiving certain Medicare telehealth payment requirements to enable telehealth services to be provided in all settings, including a patient's home, and enables Medicare beneficiaries to use telehealth services even if they aren’t in a rural community. A range of health care providers will be able to offer telehealth to Medicare beneficiaries with services including common office visits, mental
HIPAA Comments
The HHS Office for Civil Rights (OCR) announced it will waive potential penalties for HIPAA violations against health care providers who serve patients through widely available communication apps such as FaceTime or Skype. Officials at the OCR said the agency will exercise its enforcement discretion when providers use apps “in good faith” for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to COVID-19. “In support of this action, OCR will be providing further guidance explaining how covered health care providers can use remote video communication products and offer telehealth to patients responsibly,” OCR said. Providers are encouraged to enable all available encryption and privacy modes when using such applications.
Officials noted that Facebook Live, Twitch, TikTok and similar video communication applications are public facing and should not be used to provide telehealth services, as reported in Fierce Healthcare (bit.ly/3ewIeQz). ■
Breakthrough Therapy for Advanced Cholangiocarcinoma Approved
The FDA approved pemigatinib (Pemazyre, Incyte Corp.), the first treatment approved for adults with cholangiocarcinoma that is locally advanced or metastatic and who have tumors that have a fusion or other rearrangement in fibroblast growth factor receptor 2 (FGFR2).
“This [accelerated] approval demonstrates that while we continue to focus our efforts on addressing the COVID-19 pandemic, the FDA remains committed to the important work of reviewing treatments for patients with cancer and other serious conditions,” said Richard Pazdur, MD, the acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “With Pemazyre, we considered the observed efficacy
results to be clinically meaningful and the overall risk-to-benefit assessment for patients with tumors harboring FGFR2
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gene fusions and other rearrangements to be favorable, particularly when we considered that these patients have no other good options following first-line treatment with chemotherapy.”
A Rare Cancer
Cholangiocarcinoma is a rare form of cancer that forms in the bile ducts. At diagnosis, most patients with the malignancy have advanced disease that is no longer treatable with surgery. For these patients, there have been no FDAapproved therapies; various chemotherapy drugs have been the standard initial treatment, the FDA noted in a statement announcing the drug’s approval.
FGFR2 fusions have been found in the tumors of approximately 9% to 14% of patients with cholangiocarcinoma. Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading.
The drug’s approval was based on the results of a clinical trial that enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement, who had received previous treatment. During the clinical trial, patients received pemigatinib once daily for 14 consecutive days, followed by seven days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects.
Patients were monitored by scans every eight weeks. The trial used overall response rate (ORR) to measure the number of patients who experienced a complete or partial shrinkage of their tumors during treatment. The ORR was 36%, with 2.8% of patients having a complete response and 33% having a partial response.
Of the 38 patients who had a response, 24 (63%) had a response lasting six months or longer and seven (18%) had a response lasting 12 months or longer.
The most common adverse reactions occurring in 20% or more of patients who received pemigatinib were hyperphosphatemia and hypophosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain and dry skin. Ocular toxicity also was a risk of pemigatinib.
“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center in New York City, said in a press release from Incyte. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”
Will COVID-19 Clog Generics, Biologics Pipeline?
The drug pipeline for 2020 is heavy on generics, biosimilars and 505(b) (2) drugs that are slight variations of existing products. But whether those launches will be affected by the ongoing COVID-19 pandemic is a bit more difficult to predict, industry experts noted during an AMCP webinar.
A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics.
Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said.
Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted.
Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.
505(b)(2)s and Biosimilars In the Pipeline
About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), an oral dopamine receptor agonist for the offperiods experienced by patients with Parkinson’s disease, pending approval in May. Given that 40% to 60% of these patients develop off-periods that can worsen and a transdermal product is seen as more convenient than apomorphine injection (Apokyn, US WorldMeds), this product could be used extensively, Dr. Fish said.
This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September; and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab.
“We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said.
New Branded Products
The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a firstin-class adjunctive therapy for patients requiring additional cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.
Pandemic Pressures
The COVID-19 pandemic could affect new drug approvals, Dr. Fish said during a question-and-answer period. The FDA has been back and forth, saying there would or would not be delays, she noted. As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021. —Karen Blum
The speakers were scheduled to present at AMCP’s Managed Care & Specialty Pharmacy annual meeting, which was canceled because of the COVID-19 pandemic. The organization made the information available via a webinar instead. Other than their employment, the speakers reported no relevant fi nancial relationships.
Marketplace Shakeup
continued from page 1
Mr. Long cited prescription abandonment rates as an example of a particularly concerning market trend that could worsen during the COVID-19 pandemic. Bailing on a prescription is primarily a Before COVID-19, telehealth was used mostly for treating mental illness, depression and anxiety, whereas more recently it has been adopted for managing asymptomatic chronic conditions such as hyper
Vaccines, including those for flu and shingles, helped the business of new therapy starts in 2018 and 2019, particularly in the retail setting, Mr. Long noted. These vaccines made up 6.8 million of 7.5 million new starts in 2018. Other new starts in conditions such as chronic obstructive pulmonary disease, autoimmune diseases, diabetes and atopic dermatitis grew traditional spend declined. Generics that were launched in the U.S. market from 2009 to 2018 have generated about $375 billion in cumulative savings.
function of cost pressures, he explained: as a patient’s cost exposure rises due to tension, type 2 diabetes and high cholesterol. Overall, telehealth claims were up slightly in the same period.
2020 Rx Pipeline a Bit Murky
Drug manufacturers launched a record number of innovative medicines in 2018, bringing 59 new treat
copays and other cost-shifting factors, abandonment skyrockets. IQVIA data about 1,000% from March 13 to March 27, Mr. Long said, mainly driven by prescribever, fewer vaccines have been administered because more people are staying but it is difficult to predict what will happen in 2020, with the FDA slowed
show, for example, that when patient out-of-pocket costs reach approximateers who are new to the technology. This mode of care could become a regular part at home and not going to their doctors’ offices, he said. down and some manufacturers choosing not to launch their products. The
ly $250, new patient abandonment rates approach 80%. And it’s not just a probof how outpatients are treated as more people become comfortable with these
During the COVID-19 pandemic, howment options to patients. According to Mr. Long, 2019 also was a good year,
lem at the high end: even when patient visits, even after the pandemic resolves. lipid regulators, are growing at about a included specialty and niche therapies across a range of diseases.
The top 10 therapy areas, led by antihypertensive agents, mental health and late-stage pipeline was dominated by oncology drugs in 2018, he said, but
5
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Artificially inflated by Kaletra a , which is being used as a potential treatment for COVID-19 (-8.5% without Kaletra)
–11.1
–8.6
–4.2
–11.6
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There have been slight shifts in methods of payment for prescriptions over the
–11.1
–15 ing prevalence of common, chronic Autoimmune Cholesterol CKD/ESRD Depression Diabetes Epilepsy HIV Hypertension diseases; medication nonadherence or noncompliance, which remains the
Figure. Declines in new therapy starts.
CKD, chronic kidney disease; ESRD, end-stage renal disease. Data analysis through March 27, 2020. Source: Doug Long, IQVIA a AbbVie largest avoidable cost for health care systems; rising cost of care and increasing scrutiny around value; and increasing connectivity and health care consumerism. In addition, he said, patients are becoming more involved in their costs are in the $50 to $75 range, abanA Broader Look 3% rate, while the top 10 products, led by health care decision making and more donment rates approach 30%, according Mr. Long discussed medication usage atorvastatin, lisinopril and levothyroxine, vocal about about what they want in to IQVIA data. trends for 12 months ending February are growing at a 4.8% rate. new therapies.
James T. Kenney, MBA, RPh, a man2020, noting that specialty growth is outReal net per-capita spending on drugs —Karen Blum aged care pharmacy consultant and the pacing traditional product growth and grew by only $44 from 2009 to 2018, he 2019-2020 AMCP president, who modnow has about a 48% share of the total, added, even while the specialty spend The sources reported no relevant erated the presentation, agreed that prenon-discounted drug spend. In February nearly doubled during that time and fi nancial relationships. scription abandonment is a major cause alone, the specialty spend grew by 10.5% for concern, both before the COVID-19 while traditional spend increased just pandemic hit and beyond. “This is something we worry about, trying to balance 0.3%, he said. The impact of COVID-19 on these numbers is yet to be seen. Doug Long’s 8 Key the benefit design with the patient’s out-of-pocket costs, and the [IQVIA] Three therapeutic areas have been responsible for two-thirds of the absoCOVID-19 Disruptions data identified a significant percentage lute growth and domination of new 1. A sharp decline in physician office visits and lab diagnostics abandonment rate starting in the $75 to $125 threshold,” Mr. Kenney said.
From a health plan perspective, “you launches from 2018 to 2019: autoimmune, oncology and diabetes. Anticoagulants also are growing. By contrast,
want patients to take the medications as the pain and mental health categories 3. A surge in telehealth volume (falls short of total lost volume prescribed,” he added. “But in fairness, if had less volume, in part because mental of patient visits) new treatments cost $30,000, $40,000 or $50,000 a year, insurers are not necessarihealth has some generics, and it is now harder to get pain prescriptions,
2. A downturn in new diagnoses and new therapy starts affecting nearly every therapeutic area
ly going to offer them at a $5 to $10 copay. There’s an expectation that a patient on a much higher cost medication would have Mr. Long said.
4. An increase in unemployment that has been pushing more patients onto Medicaid and into economic uncertainty
Adjusted prescription growth rates through February 2020
past two years, with cash remaining flat, declines among third-party and Medicaid payments, and a continued increase in discount cards, which now make up 4.8% of adjusted prescriptions.
Several strong forces are driving changes in health care, Mr. Long noted: a steadily aging population creating more demand for mental health care, home care and assistance; an increas
5. Providers are financially strained due to decreased office and clinic visits, elective surgeries and reimbursement rates
to pay a bit more.” were up 5%, with a bigger 6. Some practices have closed temporarily and physicians have jump projected for March due stopped providing any routine care Explosion of Telehealth
Mr. Long discussed one final COVID-19 to more people obtaining 90-day supplies of their medicines. About
7. Hospitals have been losing money on COVID-19 treatment; rural locations in danger of closing
trend before moving on to a broader look at the health care market: the explosion of telehealth brought on by the pandemic. 90% of prescriptions for 2020 were dispensed as unbranded generics through February.
8. Patients lack access to health care, diagnostics and surgeries, potentially compromising clinical outcomes
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