Heard of PillPack, Haven, or Alexa? Amazon, the Seattle-based retail giant, has a hand in all of them.

Amazon's Quiet Forays Into Healthcare

 (ACHP) put out last week for how to improve American healthcare over the next 10 years included mentions of telehealth, Medicare Advantage, “consumer-oriented transparency tool” — and biosimilars.

More precisely the report, titled “Health Care 2030: ACHP’s Roadmap to Reform” mentions reforming intellectual property laws used to block biosimilars from getting on the market and taking steps to promote FDA approvals of biosimilars.

, ACHP’s director of public policy, said the pay-for-delay tactics that drugmarkers use to keep biosimilars off the market result in higher prescription drug prices. Bagel pointed to three jurisdictions where changes would help get more biosimilars on the market.

Federal Trade Commission taking steps to curtail anti-competitive practices, including pay-for-delay agreements.

U.S. Patent and Trademark Office issuing fewer patents for changes to products that fall short of true innovation.

FDA prioritizing approvals of biosimilars.

Bagel said all three steps need to be taken in concert. So far, the price differences between brand-name products and biosimilars has been about 20% to 30%. “Well, that’s a start,” said Bagel, while also noting that the full scope of savings from biosimilar won’t be realized till there are more biosimilars on the market to compete against brand-name products and to compete each other.

OneOncology Having Success With Mvasi, Kanjinti

The ACHP comprises many high-profile nonprofit health plans, including Harvard Pilgrim Health Care, Kaiser Permanente and Priority Health. Many of the member plans are owned by health systems.

Bagel said the pace of FDA approvals of biosimilars has slowed this year. So far, the agency has approved just 

 in 2020, Hulio (adalimumab-fkjp), a biosimilar to Humira, and Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta. Although COVID-19 treatments and vaccines have understandably preoccupied the agency this year, Bagel said the “FDA needs to prioritize biosimilars” if more products are to make it on the market and have the intended effect on drug prices.

Articles

The Alliance of Community Health Plans calls for changes to get more biosimilars approved and on the market.

Health Plan Group Puts Biosimilars On Its Roadmap of Needed Healthcare Reforms

The proliferation of biosimilars could be costly for oncologists if each insurer dictates its own biosimilar, according to a leader of one of the larger independent oncology groups in the country.

“It is unrealistic to think you can keep multiple biosimilars of one innovator product in inventory and manage that inventory at a low cost,” Debra Patt, M.D., Ph.D., MBA, said during a talk she gave last week at the 9th annual Patient-Centered Oncology Care® conference, sponsored by the American Journal of Managed Care.®

Patt, a breast cancer specialist in Austin, Texas, is the executive vice president for policy and strategic initiatives for Texas Oncology, a private practice group with about 500 physicians.

In a wide-ranging talk that touched upon many current topics in cancer care and healthcare policies and politics, Patt said that biosimilars are “incredibly important” and a “reasonable switch” from brand-name innovator products. But she said that “frequently, insurance companies will have a ‘flavor of a month’ biosimilar.”

“If you have eight biosimilars (for an innovator product), you can’t have different insurers dictating that you use different biosimilars because these are very expensive drugs, even if they are lower cost than the innovator product,” Patt said.

Patt said costs would be lower if insurers were to embrace biosimilar choices and “weren’t so directive as to which one.”

Patt began her talk on optimistic note, saying that this “unprecedented time of progress in cancer care.” Between 30% and 40% of patients with advanced cancer are receiving targeted therapy, she said, and 25 different types of cancer are now treated with immunotherapy.

Many of the specifics of President Donald Trump’s recent executive order that would peg Part B and Part D drug prices to prices paid in other countries are prices unknown, Patt said. However, Patt said that there are earlier indications that prices would be benchmarked to an average of prices paid in Organisation for Economic Co-operation and Development (OECD) countries with some an adjustment for gross domestic product per capita.

“But exactly how that will be delineated, which drugs will be included, is unclear at this time, so we are light on the details,” cautioned Patt, adding that it is unknown when the program will be implemented, which drugs will be included, and how large the pilot will be.

Patt also discussed alternative payment models. She said the first three performance periods of the Oncology Care Model, a CMS value-based care arrangement, hadn’t shown tremendous savings, but that she thought the “jury was still out” on the model. She also noted the great interest that commercial payers have in alternative payment arrangements.

“My practice alone has five alternative payment pilots with commercial payers, and they mirror many aspects of the Oncology Care Model, so as we try to make the walk from volume to value in oncology, I think alternative payment models are a really important way to do that,” Patt said.

Texas Oncology Executive Vice President Debra Patt says it will be unrealistically expensive for oncologists to keep many biosimilars for the same innovator product in their inventories.

Proliferation of Biosimilars Could Be Costly for Oncologists, Warns Texas Oncology Policy Leader

While COVID-19 is still a major threat and flu season is looming as an additional health-related danger, many patients are still in fear or simply not making visits to the doctor’s office to get their annual physical as they have in year’s past.

Those who have avoided visiting or put off their annual physical appointments at the doctor's office due to fears of contracting COVID-19 do not have put off those appointments any longer, according to Dr. Sachin Nagrani, medical director at Heal.

If you haven't attempted it yet or scheduled an appointment with your doctor recently, doctor's offices are scheduling physical appointments at the benefit of the patient never leaving their home.

atients can use their computer, tablet, or smartphone to download an app or visit their office's website for a telemedicine provider, such as 

 to schedule an appointment and have their physical appointment right through the screen. However, you should be sure the service you've selected provides service in your state before requesting a visit.

It may be deceiving to some patients who don't see how a physical appointment can be held through a screen without physically being in a room with your doctor, but Nagrani says 

"the interaction between (a) patient and doctor over a phone or video-based call enables much of what's completed during a physical appointment to occur, with the exception of the physical exam being somewhat limited. Tests can be ordered to a lab where the patient can go to have the test sample collected, and in some cases test kits can be mailed to patients."

Before attending an over-the-phone physical appointment, it's encouraged - but not required-  patients come prepared with providing their doctor with a list of medications, allergies, vaccine records and any other significant test results in order to be assessed holistically.

If you have a home blood pressure monitor, heart rate monitor, or other devices, many doctors are happy to engage in discussing your health data, as well, Nagrani says.

In addition, he adds patients should ask particular questions in their physical appointment. 

"Ask about what tests are recommended by the USPSTF (

United States Preventive Services Task Force)

 and other preventive screening guidelines, what vaccines are recommended for your age, and whether all the medications you're currently taking are necessary," Nagrani says.

Remaining proactive about your health and finding alternatives during this time is very critical to long-term outcomes.

Nagrani says primary and preventive care is about long-term thinking about your health, similar to how saving for retirement is for your finances. 

"Being proactive enables you to discover things that can be changed sooner by adjusting habits slightly, before your health is impacted and results in drastic changes to your lifestyle," he says.

Those who have avoided visiting or put off their annual physical appointments at the doctor's office due to fears of contracting COVID-19 do not have put off those appointments any longer.

Benefits of an Over-The-Phone Physical Exam

 Nucala (mepolizumab) for use by certain adults and children at least 12 years old who have hypereosinophilic syndrome, or HES. Those patients who have had HES for at least six months with no other identifiable non-blood related cause can be treated with the monoclonal antibody. HES is a group of disorders in which patients have higher than normal levels of eosinophilia, which are disease-fighting white blood cells. When patients have an HES flare, they have skin rashes, asthma, itching, diarrhea and abdominal pain, congestive heart failure, muscle inflammation, and deep vein thrombosis. Nucala had previously received orphan drug designation. The drug is approved for use in severe asthma, eosinophilic granulomatosis with polyangiitis, and for children with severe eosinophilic asthma.

 from FDA, this is the first approval for this patient group in 14 years. FDA’s action is based on results from a randomized trial of 108 patients with HES who received either Nucala or placebo every four weeks over a 32-week period. Fewer patients in the Nucala group (28%) had HES flares compared to those in the placebo group (56%), for a 50% relative reduction. It also took longer, on average, for Nucala patients to experience an initial flare once they started taking the drug.

FDA will update the boxed warning for benzodiazepines to include abuse, addiction, and other serious risks including withdrawal reactions, the agency announced Wednesday.

, FDA said that in 2019, U.S. outpatient pharmacies dispensed an estimated 92 million benzodiazepine prescriptions with Xanax (alprazolam) being the most common (38%) followed by Klonopin (clonazepam0 at 24% and Ativan (lorazepam) at 20%. In 2018, half the patients receiving oral benzodiazepines were using them for two months or longer; they are recommended to be used for weeks or months. Benzodiazepines are approved for use in treating generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder, and are used before some medical procedures. FDA warned that these drugs are being misused, often with opioids or other medications, or with alcohol or illegal drugs.

FDA is requiring changes to Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of prescribing information for all benzodiazepine products. Regulators will also require changes to existing patient Medication Guides.

Approval for treatment of HES, update to address addictive nature of benzodiazepines.

FDA Updates: Approval to Treat Rare Blood Disorders; Label Change for Benzodiazepines

The coronavirus pandemic has shed light on major imbalances within the healthcare system, specifically, the supply and demand of allied health professionals, and the urgent need to invest in community-based care that prioritizes vulnerable populations.

As we think ahead to a post-COVID-19 world, now is a crucial time for healthcare workers and decision makers to start considering what the future of supply and demand in healthcare will look like. Specifically, what are the new skills that the healthcare workforce needs to succeed and what resources will be required to serve all populations.


As a result of COVID-19, interactions between patients and their clinicians has significantly changed. Social distancing protocols combined with patients feeling hesitant to enter medical buildings for non-urgent matters, has led to an accelerated demand for telehealth solutions that is expected to continue well after the pandemic resolves itself. Now is the time for healthcare professionals to become more familiar with virtual, on-demand care through training and education.

Physicians and nurses will need to fully embrace virtual training and education to develop new skills that will allow them to connect with patients remotely in a meaningful way. Sophisticated, virtual learning modules and simulations provide healthcare workers with the skills to deliver the same level of patient care virtually as they would in-person. Virtual training also benefits medical students who are making the transition from an educational environment to a clinical setting. Cutting-edge eLearning programs, that include real life scenarios and interactive tutorials, can accelerate competence, and sharpen decision-making skills required to provide the best possible patient care.

Social equity has been a major focus for healthcare systems, and they will need to think innovatively about how to ensure underserved populations are benefitting from new care methods. For example, providers have begun to expand reimbursement for telehealth services provided during COVID-19. Audio-only services delivered on phones have been expanding to include additional health focus areas such as behavioral health and patient education. Audio-only connections allow providers to connect with all the communities they serve, specifically those who do not have access to smartphones or high-speed internet. This particularly benefits at-risk populations, including seniors, lower-income families, and individuals with disabilities.

Employers proactively investing in employee health.



Now more than ever, organizations must show that they are proactively protecting employees’ health while they are at work, increasing the need for healthcare experts and workers on-site. By investing in these safety measures, employers can show support for their staff and employees can remain productive and engaged.

One area that is growing in popularity in the U.S. is employer-provided healthcare, where nurses and physicians are staffed on the premises. This allows employees to seek health evaluations at work, ultimately reducing concerns about being exposed to dangerous situations. For companies that are still working remotely, many are enlisting the services of medical experts to implement effective safety procedures for when offices do reopen. By taking the next step to hire an in-house occupational health professional, companies can help employees feel confident about returning to and working from the office.

With many organizations requiring that office-based employees be screened to minimize the risk of infection, there has been an increased demand for office temperature takers who are trained to properly conduct temperature checks. While it is uncertain how long the demand for this new role will exist, it demonstrates that organizations are serious about protecting employee health.

The pandemic has not only taken a physical toll, but it has caused people around the world to grapple with fear, isolation and loss.

There will be a continued focus on mental health for the general public beyond COVID-19. By keeping mental health front and center, the hope is that any lingering stigmas that have kept people from seeking treatment will lessen, and that prevention and wellness become the norm. Telehealth advancements have also made it easier for mental health professionals to evaluate and treat patients virtually, allowing patients to get the care they need from the privacy of their own homes.

In addition to the patients they serve, healthcare professionals and front-line workers are also experiencing unprecedented levels of stress, leading to incidents of compassion fatigue, burnout, anxiety and depression. To minimize the negative impact and increase resilience, healthcare systems have implemented resources such as support and mental wellbeing networks and Chief Wellness Officers. Because of the global shortage of healthcare workers, burnout and mental well-being will be an ongoing issue even after the pandemic, so putting these support measures in place now will have longer term benefits.


Prior to the pandemic, healthcare systems had been historically reactive with data. COVID-19 has shown us the value of proactive, real-time analytics and how it allows health care leaders to quickly make important decisions that are backed by facts and numbers.

Through de-identified patient data and algorithms, health systems can track potential infections to mitigate the spread of disease faster than before. Real-time data also allows health systems to prioritize which patients to treat, accelerate treatment development and even analyze supply-use to ensure health providers have necessary equipment in-stock.

To sort through these growing levels of data, data analysts and data scientists will be in high demand. Organizations will rely on these roles to interpret and understand data, implement a data governance strategy, and train staff members on the importance of capturing correct data. 

We still have work to do to manage the spread of the virus in the absence of a vaccine or treatment. Every day, we learn more not just about the virus itself, but about the considerations we must make as a society to address the health and economic turmoil caused by COVID-19. The pandemic has disrupted routines, creating the ideal condition for experimenting and accelerating change. The healthcare industry needs to continue thinking innovatively and preventatively so that we are better equipped to manage forthcoming COVID-19 spikes and waves – and future global health issues.

John Danaher, MD, MBA, is President of Global Clinical Solutions at Elsevier, a leader in information and analytics for customers across the global research and health ecosystems .

The coronavirus pandemic has shed light on major imbalances within the healthcare system, specifically, the supply and demand of allied health professionals, and the urgent need to invest in community-based care that prioritizes vulnerable populations.







How the Healthcare Industry, Worker Roles will Evolve as a Result of COVID-19

Hospital finances and volume took a step back in August after recovering some from the dire months of March and April, according to Kaufman Hall’s most recent 

The "National Hospital Flash Report," which is based on a sample of 800 hospitals around the country shows, showed declines median operating margins, adjusted discharges and emergency department visits compared with August of last year. Kaufman Hall puts out a report for every month, and the reports have provided some measurements of how hospitals are faring financially during COVID pandemic.

The financial numbers in the September report brighten if funds from the Coronavirus Aid, Relief and Economic Security (CARES) Act are added in, but they are still down relative to last year.

“August was a challenging month for hospitals nationwide, as margins fell across the board. The declines follow three months of moderate gains after devastating losses in the early months of the COVID-19 pandemic,” says the report.

Hospital Finances, Patient Volume Numbers on the Mend, Kaufman Hall Report Shows

Median operating margins for the hospitals were 18% lower in August of this year than in August 2019 if the CARES Act money is not included. With the CARES Act, the relative difference narrows to 3%.

The Kaufman Hall numbers show fairly increases in per-patient expenses; for example, the total expense per adjusted discharge was 15% higher in August than in August 2019 and the labor expense per adjusted discharge was 14% higher in August than in August 2019.

Hospitals are seeing a particular larger decline in emergency department visits, according to Kaufman Hall. Visits in August were down 16% compared with August 2019.

Here are some of the volume measures in the report and the relative difference between August of this year and August 2019:

After three months of recovery, financial and volume indicators were off in August, according to Kaufman Halls's monthly report.

Hospital Finances, Patient Volumes Took A Step Back in August

Contract Year 2021 Medicare Advantage and Part D Final Rule

, doubling the weight of patient experience measures used to calculate Star Ratings. The rule also finalized other adjustments, including the calculation of 2021 and 2022 Part C and D Star Ratings to address disruption resulting from the COVID-19 pandemic.

Increasing the weight of patient experience from two to four for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Star Ratings is significant for both health plans and providers. In recent years, CMS has expanded emphasis on patient experience (e.g., 12 months ago this same weight was increased from 1.5 to 2), and the latest final ruling only continues to increase focus and accelerate the significance of patient-centered care and patient experience. Through this move, CMS is now elevating access to care and patient experience to be equal with outcomes measures.

With major financial incentives at stake, it is even more essential for health plans and providers to address negative consumer sentiment and put experience front and center. The time for action is now: The new rules for CAHPS scores will impact Star Ratings in 2023, but will be based on care delivered in 2021. Consequently, health plans should drill into all aspects of their members’ experience this year 

to pinpoint improvement areas in time for next year’s official survey.

While CMS opted to not formally conduct the Medicare CAHPS survey in 2020 due to the pandemic, hundreds of health plans still chose to continue to assess the voice of their members. The CAHPS measures that best capture the sentiments of Medicare Advantage health plan members are:

Overall satisfaction with the health plan

Overall satisfaction with the prescription drug plan (MAPD Only)

Each of these measures contributes to a health plan’s overall Star rating, and, on a national level, each measure’s score increased from 2019 to 2020. While the overall increase is good news, it is critical for each health plan to not just understand their performance and trending, but also know how they compare to other plans throughout the country to stay focused on the ever-moving quality standards.

Plans will need to assess their unique challenges and key drivers of their performance to define the improvement plans that will have the greatest impact on member experiences and Star Ratings. Insurers that are not improving will be left increasingly further behind, as demonstrated again in 2020, where overall scores increased again year over year, setting an even higher standard that will magnify any performance gaps as the higher weights are applied in 2021 and beyond.

Facing new challenges… with the pressure to move quickly

Admittedly, improving patient experience can be tricky, even without the reality of a pandemic. 

Elevating experience is much more nuanced than leveraging a clinical intervention, and then measuring its effectiveness against a national benchmark. 

Plus, the current pandemic adds another layer of difficulty for Medicare Advantage plans, whose members are aged 65 and older and often characterized by multiple chronic conditions — the highest-risk groups for COVID-19 complications, according to data from the CDC.

Because so little was known about the coronavirus in March when cases first started spreading in the United States, health plans struggled with how to respond, and scrambled to reengineer workflows to support their care partners. They found themselves having to constantly adjust their messaging around ever-changing guidance on medical protocols and safety precautions such as face mask practices. They also had to adjust payments and workflows to accommodate the surge in telehealth.

Some of this confusion may have affected payer-provider relationships, which are already challenged. In fact, according to a 

, 35% of health plans and 24% of providers noted that “willingness to collaborate” is their biggest challenge.

Patients are relying on their health plans for guidance and access to care more than ever. Yet some data suggest patients still are not receiving the information and access to care they need. Results of an 

 in May reveal that less than four in 10 (37%) said their health plan has reached out to them with information regarding COVID-19. Nearly 80% of those diagnosed with COVID-19 said their plan had done something to make them question remaining a member, while 70% would switch right now if they could.

Admittedly, navigating life with COVID-19 is new territory. However, the current crisis also offers an opportunity for health plans to demonstrate that they’re more focused on patient experience than ever before.

With these COVID-19 related concerns in mind, and realizing that independent of the pandemic, CMS has materially increased the weighting of patient experience, health plans and providers will need to leverage a more proactive and nuanced strategy to improve patient experience. This should include:

Listening to the voice of health plan members. 

Asking patients key questions is essential: How do they feel about the care they receive, their access to care, their relationship with their provider and understanding of their benefits? Also knowing how those experiences vary for different cohorts (subsets of your population) is imperative. Clarity on members’ perceptions allows the plan to build cohort specific interventions and programs to drive improved experience for the member and maximizes the impact of the dollars invested to drive change and improvement. Health plans should establish protocols to continually survey member experience, allowing ongoing feedback to improvement plans as they are being implemented, as well as, member reactions to changing market conditions (e.g. the emergence of COVID-19).

The best way to communicate to beneficiaries is by utilizing the preferred method of outreach for each specific member, including newer modalities such as email or text messages or combinations of modalities. Patient engagement applications can help providers define the needs of specific demographics — by layering in factors such as clinical data, level of engagement in their own healthcare, and barriers to care — so they can tailor the message (e.g., flu shot reminders) and modality in the most effective manner.

 Look for ways to efficiently enrich members’ understanding of relevant information.For example, COVID-19 related information is craved by many members; adding links to studies in email newsletters, or offering educational webinars, will enable members to learn more about the signs and symptoms of COVID-19 that might manifest. Enhancing web content — for example, chat boxes to health plan home pages — can also encourage members to seek out answers to their most pressing health-related questions or assuage some of their growing concerns.

 CMS has approved telehealth as a means for health plans to gather risk adjustment data, and many providers have implemented some form of telehealth solution. The experience that members have during telehealth consultations – for both acute and chronic-care management needs – will be undoubtedly tied to future CAHPS scores. Yet, according to an ongoing 

, only 50 percent of consumers say their health plan offers telehealth – and among those who are aware that their health plan offers telehealth, only 57% are clear about the cost to use it. Furthermore, 

 showed evidence of a dramatic spike in consumer interest in telehealth in March and April, as the pandemic hit, but indicated consumer interest has reduced substantially since then. If health plans and providers wish to leverage telehealth as a material venue of care moving forward, they need to take strides today to counterbalance consumer sentiment which has waned since the initial outbreak of COVID-19.

Now is an important time for health plans to evaluate their engagement strategies, to ensure patients are receiving the care, information and experience they need. Start with a clear understanding of members’ experiences as a baseline. Then employ action plans targeted at driving meaningful change in the areas most valued by members and most likely to improve the CAHPS measures that contribute to a health plan’s overall Star rating. These health plans will then be poised to not only avoid penalties, but instead benefit from CMS’ dramatic increase in the weighting of patient experience beginning with next year’s Medicare CAHPS survey.

Amy Amick, MBA, is president and CEO of SPH Analytics, which is headquartered in Alpharetta, Georgia.

CMS is putting more weight on patient experience measures in its Medicare Advantage and Part D Star ratings. What health plans can do now to improve their ratings.

Medicare Advantage Star Ratings: The New Patient Experience Imperative for Health Plans

Keith Loria is a contributing writer to Medical Economics.

COVID-19 is certainly important. But oncologists, people with cancer, and complex ecosystem of cancer care in the U.S. are grappling with other important issues as well — reimbursement, distorted incentives, the implications of the massive amount of data that is available, and, of course, high costs and prices. Below are thoughts from five experts on these challenges and how they might be met.

Oncologists hired New Century Health in Brea, California, to help them navigate the CMS Oncology Care Model and other new ways of paying for cancer care. This gave the company’s chief medical officer, Andrew Hertler, M.D., FACP, a front-row seat in the struggle to bring value-based care to organized oncology, which he views as being a long time coming.

“Today’s fee-for-service oncology business model misaligns incentives by rewarding practices for keeping margins and service volumes high — even when it’s wasteful — rather than for optimizing patient outcomes,” he says. “While discussions of drug pricing dominate the cost- control conversation, we as practitioners have been abdicating responsibility and missing the opportunity to address cancer’s financial toxicity.” The term “financial toxicity” was coined to describe the health effects that high out-of-pocket costs can have on patients if they skip treatment, as well as the financial distress itself as they go through their life savings to cover their treatment costs.

In 2018, spending on cancer drugs in the U.S. reached $57 billion, double the total from 2013. The average cost of a new cancer drug was $150,000 in 2017. Under the buy-and-bill system used in Medicare Part B, CMS pays physicians the average sales price (ASP) of a drug, plus a markup, which had been traditionally been set at 6% but is now 4.3%. It is a common critique of buy-and-bill that it creates an incentive to prescribe more expensive drugs (or, at the very least, that it removes any incentive to prescribe less expensive ones) because the markup is a percentage of that higher cost. Moreover, some physicians and hospital outpatient departments get drugs below the ASP.

Hertler says that some of the expensive oncology drugs, old and new, are true game changers that have extended lives by many years. “But oncology is also rife with examples of therapies that dramatically increase the costs to our healthcare system while bringing relatively minor improvements,” he says.

“If you’re among the two additional individuals in every 100 who benefit, it’s a winning proposition,” Hertler continues. “But on a population level, however, the costs to our healthcare system and to society can be significant if we routinely make this decision for all cancers.”

That is why, in his opinion, continuing this reimbursement model of rewarding the selection of more expensive, less efficacious drugs is not sustainable or acceptable, and if unchecked will ultimately limit patient access to care.

New Century Health and Hertler see clinical pathways as a way to deal with drug costs. “These care pathways guide oncologists in their selection of treatment regimens based on the latest clinical data and help prioritize the most effective treatments with the fewest side effects and lowest cost,” says Hertler, who also talks about the need to engage oncologists and keep them involved. “Taken together, this approach is key for allowing oncology practices to take costs into their own hands and drive savings and improvements across the patient journey,” he says.

Jeff Patton, M.D., CEO of OneOncology, believes the biggest issue facing oncology is the high cost of specialty drugs.

“It’s unsustainable for patients, physicians, employers and even health plans,” says Patton, who was named CEO of the large specialty network headquartered in Nashville, Tennessee, in May. “Even when community oncologists don’t bill for their work, the cost of therapies causes too much financial toxicity for patients and difficult decisions about coverage and value for employers and plans.” Also, says Patton, an analysis by OneOncology showed that the high cost of specialty drugs “poses challenges” for practices in value-based care arrangements, such as the CMS’ Oncology Care Model.

Patton says drugmakers could fix the problem of high prices with more rational pricing — or Congress should give CMS the power to negotiate prices.

Dane Dickson, M.D., a practicing oncologist and CEO and founder of Taproot Health in Salt Lake City says oncologists are being asked to do so much more with so much less.

“Decreasing reimbursement, increasing regulations, endless payer requirements and difficulties accessing needed drugs — not to mention the challenges of COVID-19 — are critical problems on their own,” he says. “As oncologists, our priority has always been to patients. How can we provide excellent care for today’s patients, plus participate in valuable cancer research initiatives to help the patients of tomorrow, when reimbursement is being slashed and administrative burdens are outrageous?”

Dickson believes the real-world data that clinics generate can become a powerful method of advancing cancer research and provide financial resources to clinics.

“But (these) data (have) to be organized and shared to have the greatest value,” he says. “Data (are) a commodity worth billions of dollars, yet many oncology clinics ignore this potential revenue stream and may allow it to be siphoned off by others. Oncology clinics need transparent solutions to empower them to collect and share quality data.”

Speaking of data, Dickson pointed to its ownership and patient consent as another trouble spot in oncology. Should patients be asked before their data are taken and sold for private gain? Should clinics have transparent control over the data they are generating?

“Currently, most of the real-world data being provided to third parties is being done without patient consent,” he says. “Some patients may have agreed to a vague disclaimer in any of the endless forms they have to sign before receiving care, but this is not informed consent by any stretch.”

This issue is further complicated by genetic-testing data, which could easily identify patients, especially those with rare cancers.

“The right thing to do is ask patients and clinics if we can collect, organize and transparently share data, so all parties know how their information is being used,” Dickson says.

According to Claire F. Verschraegen, M.D., director of the Division of Medical Oncology at The Ohio State University College of Medicine, even although oncology is seeing the approval of many new drugs, there’s a need to simplify clinical trials. There are a lot of new approvals for new drugs in oncology, and the complexity of the approval process is still challenging. “I feel like we’ve created a monster of administration when we run clinical trials,” she says.

For example, a randomized phase 3 trial may be conducted worldwide at hundreds of sites. Verschraegen believes fewer sites are needed. She also says researchers could pare down the amount of data they are collecting. “If the goal of the study is to measure these 10 items, why are we recording all the things that happen that may have no bearing on the study? Why don’t we just focus on the essentials?” she asks. “I think we should come up with an international reorganization of how we run clinical trials to make them more efficient.”

COVID-19 is certainly important. But oncologists, people with cancer, and complex ecosystem of cancer care in the U.S. are grappling with other important issues such as reimbursement, distorted incentives, the implications of the massive amount of data that is available, and, of course, high costs and prices. Included are thoughts from five experts on these challenges and how they might be met.

5 Changes That Should be Made in Oncology

Enrollment in Medicare Advantage has been increasing steadily since the early 2000s and the growth will continue next year, according to figures recently announced by CMS

 yesterday said 26.9 million Medicare beneficiaries are expected to enroll in Medicare Advantage plans next year, a 10.2% increase from this year’s enrollment of 24.4 million.

The enrollment increase is consistent with the trend of the growing popularity of Medicare Advantage plans relative to traditional fee-for-service Medicare. Enrollment in Medicare Advantage plans has doubled over the past 10 years, according to the Kaiser Family Foundation’s figures. More than a third of Medicare beneficiaries are now in Medicare Advantage plans.

A Dozen Facts About Medicare Advantage in 2020

The CMS press release also said that the average monthly premium for a Medicare Advantage plan is expected to decrease next year by 11%, from $23.60 this year to an estimated $21 next year.

CMS also reported that the that the average number of Medicare Advantage plan choices on a county-by-county basis is expected to increase next year to 47 plans per county compared with 39 per county this year.

CMS says 26.9 million beneficiaries are expected to enroll in Medicare Advantage plans in 2021.

Medicare Advantage Enrollment Increasing By 10.2% Next Year

CMS is making two important changes to ambulance service payment that are designed to cut down on the use of ambulances for nonemergency transport and direct care for nonemergency patients away from hospital emergency departments.

The federal agency announced yesterday that it was expanding the prior authorization program for 

Repetitive, Scheduled Non-Emergent Ambulance Transport 

(RSNAT) nationwide. The program established a variety of prior authorization requirements for RSNAT ambulance services, defined as ambulance transportation for a person that occurs three times or more during a 10-day period or at least once per week for three weeks or longer. It has been piloted in two sets of states, and an outside evaluation by Mathematica found that it reduced RSNAT use and expenditure by over 60% and that the number of ambulance companies providing RSNAT services decreased by about half. 

The second change is the launching of the voluntary 

(ET3) model, which will allow the participating ambulance services to bill CMS for transporting patients to facilities other than the traditional destinations of hospitals, nursing homes and dialysis centers that make the ambulance ride reimbursable. The ET3 model also includes provisions for reimbursement of care delivered at the scene and avoiding ambulance transport altogether.

“It is representative of Medicare no longer chasing down bad utilization,” Michael Phillips, an account manager at 

, a Boston healthcare consulting firm, said about ET3. “It is trying to prevent it before it happens.”

“They are basically taking the low acuity transport and giving them the alternative of taking

 them someplace else that is more in line with the services they need,” added Phillips. The ambulance services will be required to have arrangements with the alternatives to the hospital emergency departments. “It can’t just be, ‘Who is your PCP?” said Phillips. 

Phillips said ET3 could help with so-called frequent fliers, some of whom might, for example, have a substance abuse problem that would be bettered care at facility for people with substance abuse problems that at a hospital.

ET3 was put on hold because of COVID-19, but the first performance year is now scheduled to start in January 2021.

ET3 has lost some of its novelty factor. Because of COVID-19 and the declaration of public emergency, CMS has expanded the list of allowable destinations for ambulance transports. But that expansion is temporary and tied to the duration of the COVID-19 public health emergency declaration.

The evaluation of the RSNAT prior authorization program focused on the impact of the program on Medicare beneficiaries with end-stage renal disease, severe pressure ulcers, or both, because beneficiaries with those conditions make up disproportionate share of RSNAT users. The evaluation showed that prior authorization decreased Medicare expenditures for beneficiaries with end-stage renal disease but not for those only with pressure ulcers. Prior authorization can be impediment to timely care, but Mathematica evaluators said they did not see any impact on quality or access to care. 

According to the evaluation, the prior authorization resulted in savings of about $550 million that are related to RSNAT. But they cautioned that savings realized in what was in effect a pilot program may not be seen in a nationwide program because some of the states in the program had high baseline rates of RSNAT use and therefore presented a greater opportunity for cutting back on it.

Phillips says it bodes well for ET3 that “major players” such as Boston’s Public Health Commission, Mayo Clinic Ambulance and Philadelphia’s Fire Department have been accepted into the program, although it is known yet whether they took the next step and signed a participation agreement.

Phillips said “COVID is going to be the proverbial X factor” with ET3. It’s possible that some nonhospital sites already have some experience dealing with patients arriving by ambulance because of the pandemic and CMS’ relaxation of the rules about where ambulances could take patients and still be paid.

ET3 does not include any downside risk but does make a 5% bonus available to participants who meet certain quality metrics.

“I'm curious to see if the (5%) incentive will be a strong enough incentive to keep participants aligned with the goals of the program, particularly if there's any consternation among the alternate sites of care. I'd imagine this will be relatively new for them too, which could lead to some implementation headaches.”

CMS is taking prior authorization for frequent, non-emergency ambulance transportation nationwide and launching a model that pay ambulance services for taking patients to nonhospital facilities. 