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A coalition of provider and insurers is backing legislation that would allow audio-only telehealth visits to be used in the process that sets risk-adjustment levels that are a crucial part of the calculations for how much Medicare Advantage plans get paid.

The risk-adjustment issue, although of keen interest to Medicare Advantage plans, is just a slice of the large question about the future of audio-only healthcare, which in plainer English is a phone call between a patient and a provider.

Few doubt that telehealth has become a permanent feature of American healthcare because of the COVID-19 pandemic, even if use has slacked off some. Less certain is the audio-only version. Proponents say it opens up telehealth to people who don’t have good internet connections or devices capable of handling data-heavy video. A survey commissioned last year by the Better Medicare Alliance, a lobbying organization for Medicare Advantage, found that roughly a third of people below the federal poverty line have no internet access and that the same is true for a third of those ages 85 and older. Opponents say phone calls should only be used in limited circumstances and are not the means for conducting many healthcare encounters.

The Better Medicare Alliance is one of the groups backing federal legislation introduced in the House and Senate that would permit diagnoses arrived at through audio-only visits to be factored into risk adjustments to payments to Medicare Advantage. Other groups that signed a letter to the sponsors of the legislation included the Association for Community Affiliated Plans, the American Occupational Therapy Association, American Physical Therapy Association, and the U.S. Chamber of Commerce. The alliance put out a press release today. The letter is dated April 15.

“The data obtained through audio-only telehealth visits is necessary for accurate calculation of the following year’s benchmarks in Medicare Advantage, without which it will be difficult to keep out-of-pocket costs low for beneficiaries and meet expectations for use of supplemental benefits,” says the letter.

Payments to Medicare Advantage are risk adjusted to reflect the added cost of taking care of people that are sicker and have more illnesses that need to be managed or treated. The Medicare Advantages plans say that if the data obtained through audio-only healthcare encounters can’t be factored into their risk adjustments, they will suffer financially for paying for the care of patients who are sicker without the upward increase that risk adjustment would bring.

Many pieces of telehealth legislation have been introduced in Congress and a significant proportion of them include provisions that would make ayment for audio-only healthcare encounters permanent beyond the temporary allowance that was made as part of the response to the pandemic.

Articles

A Medicare Advantage group and other organizations are endorsing legislation that would allow data collected during audio-only visits to be used to set risk adjustment payment levels to MA plans.

Telehealth Is Here to Stay. The Fate of the Audio-Only Version Is Far Less Certain. 

What if cancer patients could better self-manage their medications via text message reminders? How might that affect the treatment of their disease?

A study underway at Memorial Sloan Kettering Cancer Center in New York City may answer some of those questions. Researchers at the cancer center at testing the effectiveness of mobile technology intervention on breast cancer patients' self-management of the oral anticancer medication Ibrance (palbociclib).

A major concern for patients on oral anti-cancer therapy is their ability to self-manage the treatment regimen, a role that includes making sure the medications are taken on time, proper diagnostic testing, and attending scheduled doctor visits, the researchers wrote in an article in the 

Patients who do not effectively self-manage may experience inappropriate dosing,

 inadequate laboratory monitoring, failure to report side effects, and further cancer metastases, according lead author Ann M. Mazzella Ebstein and her colleagues. “Since patients with metastatic breast cancer require oral anticancer medication for extended periods, it becomes imperative that healthcare providers find interventions that facilitate access to supportive resources to help patients self-manage their anti-cancer therapy,” Ebstein and the others wrote.

The smartphone may be an untapped resource that can fundamentally improve a patient's ability to self-manage their oncologic treatment regimens while improving communication and satisfaction with healthcare providers, they added.

The study will test whether text messaging support will decrease the necessity for patient-initiated phone conversations and help manage the workload of nurses. “Mobile technology actively engages the patient as an equal partner in determining their health care and thus has the potential to change future care delivery models,” they wrote. 

Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone. The researchers will collect self-reported survey responses at three time points: at consent, at the end of treatment cycles, and at the follow-up clinic visits.

Comparing a regular breast cancer patient group and an intervention group, the researchers will also compare demographics, quality of life, laboratory testing, and the nurse's workload in caring for the study patients.

“Given the importance of taking oral anti-cancer medications and the difficulties patients experience in achieving it, the effective use of mobile technology interventions can actively engage patients in their care and improve medication self-management of anticancer treatment regimens,” the researchers wrote.

Automated texts may also lessen the workload on nurses.

Self-management Being Put to the Test in MSK Study of Patients Taking Ibrance 

I have to go back to 2019, before the pandemic. At that point, the head of the Center for Innovation at University of Pennsylvania, 

, was talking to our chief medical officer, 

, and wanted to address the issue of health equity. This brought together a group of us at Independence, along with 

 radio, which is the largest African American talk radio station in Philadelphia and the surrounding counties. The idea was: could we find a topic that we could address where health equity is a problem, and work together using the trust that WURD has with the African American community in order to make this successful. 

We discussed various projects that we thought would be worthwhile. We looked at diabetic screening, diabetic treatment, we looked at cancer detection. We settled on colon cancer screening. The FIT test (

), which is a screening test for colon cancer, is a relatively simple test — the logistics of mailing the test to somebody who was interested, getting the test back and getting a result are all relatively simple with regards to what would be required as far as education of what the person should do. So after some planning, we had everything worked out, and then the pandemic hit. That put everything on hold at that moment. So we took some time.

Not that we weren't aware of the health equity issues, because that's what really started this in the first place, but clearly the pandemic even intensified everybody's understanding of the health equity issue. In Philadelphia, we have the 

, who have gained tremendous trust in the Philadelphia area and highlighted the need to have spokespeople in the African American community to accomplish the type of health equity that we are trying to accomplish. So we retooled the program a little bit and worked with University of Pennsylvania so that we could have everything done correctly from a medical and legal aspect and also logistical aspect. And that's really why we started with the FIT program.

The program, which we named “Go to Know,” is being discussed and advertised on WURD. We've had panel discussions featuring African American physicians and more. The program is going to be running for about six months. And we're trying to tie this into other events like Mother's Day, Father's Day. And we'll continue to have speakers on WURD radio, again so that we can build that trust.

The radio station came to us with Roy Rosen, the director of innovation at the University of Pennsylvania. They were a part of the group of people that brought the idea to us. In the future, we may expand the program, but for the first go around we wanted to have somebody who was very invested in it. The CEO of the radio station, Sara Lomax-Reese, is a person who has ties to the medical community. Her father was a physician in the area and had a large practice as an African American physician. There were ties there also with regards to the health equity.

African Americans disproportionately affected by colon cancer

African Americans actually are 40% more likely to get colon cancer than non-Hispanic whites, and actually 20% more likely to die from colon cancer than non-Hispanic whites. So the health equity issue is significant. We hope that this will become a model that we can then use to attack other projects, like screening for breast cancer, screening for diabetes, and diabetes control.

Videos

Brooks, senior medical director of Independence Blue Cross in Philadelphia, was a key member of the team that created a health awareness campaign launched earlier this month in cooperation with local radio station WURD and other partners including the Colorectal Cancer Alliance, the Independence Blue Cross Foundation, Penn Medicine, Labcorp, and the Health Care Improvement Foundation. The campaign, called “Go To Know,” sets out to increase colon cancer screenings among African Americans by providing free Fecal immunochemical, or FIT, tests. 

Ron Brooks of Independence Blue Cross Shares New Campaign Toward Colon Cancer Screening for African Americans

The lines have already gotten increasingly blurry between payers and providers as payers have moved to buy or partner with a variety of providers, especially those delivering primary car. And the trend may pick up speed because of the COVID-19 pandemic. Many independent providers have run into cash crunches because of declining patient volumes that may never return to their pre-pandemic levels. Meanwhile, payers are eyeing control of primary care as a way to manage costs and perhaps address healthcare disparities.

“Plans and providers are looking for lower-cost sites of care,” says
Kulleni Gebreyes, M.D., a principal with Deloitte Consulting in Charlotte, North Carolina. As a result, “payers are moving from being financers of care to providers of care.”

“Insurers are going really, really deep into primary care,” says Heidi Leeds, sector leader for health insurance with health insurance consultancy Korn Ferry. “Before they dabbled. Now it’s front and center.” Although some payers “are looking to expand their footprint” by acquiring primary care providers, others are getting involved in the primary care sector through partnerships and joint ventures, Leeds says.

“It’s part of a longer-term strategy,” says Fred Bentley, managing director at Avalere, a healthcare consulting firm in Washington, D.C. Teaming up or acquiring a primary care provider is a means for health insurers to have “even more control and influence over members’ care and engage with them.” The move also is designed to control costs, as “primary care is the gateway to the patient healthcare journey,” Bentley says.

The country’s largest insurers have definitely developed a strong appetite for the insurer-primary care mashups. Humana, for example, announced in March that Conviva Care Centers, one of its wholly owned subsidiaries, was buying a primary care physician network in South Florida that includes 12 health centers and 40 physicians. Earlier in the year, the company announced that another subsidiary, Partners in Primary Care, would add up to 20 new primary care centers in 2021, with locations in the Atlanta and Houston areas, Louisiana and Nevada. Humana said in the press release announcing the Conviva deal that the company now owns 170 “senior focused” primary care centers that are “payer agnostic” — people don’t need to be in Humana Medicare Advantage to be patients at the centers.

CVS Health, which acquired the health insurer Aetna in 2018, has been in the primary and urgent care business for 15 years. The first MinuteClinics in CVS retail outlets opened in the Twin Cities and Baltimore in 2006. Then in 2019, company launched its HealthHUBs, which provide a broader array of services than MinuteClinics and are geared toward chronic disease management. Despite the pandemic, CVS aims to have 1,500 HealthHUBs open by the end of this year.

The company also introduced the Aetna Connected Plan this year in the Kansas City area. Members of the plan don’t get charged at MinuteClinics and HealthHUBs. CVS says the premium is 20% lower than other preferred provider organization products in the market.

UnitedHealth Group CEO David Wichmann said during an earnings call in January that the company’s Optum division started this year with 50,000 physicians and 1,400 clinics and had a goal of adding “at least” 10,000 employed or affiliated physicians this year. In March, the company made a splash in Massachusetts when its Optum division announced that it was acquiring Atrius Health, the largest independent physician group in the state. State and federal regulators need to review the deal before it goes through.

In Florida, Florida Blue, a part of GuideWell, has partnered with Sanitas Medical Centers to offer primary care with no copays for members of some of its medical plans. For emergency care, the company has partnered with Crucial Care to create GuideWell Emergency Doctors. The offices are staffed by board-certified emergency doctors, and some plan members have no copayments for the first two visits.

These kinds of partnerships and acquisitions will be a “strategic priority for many (health) plans,” Bentley says, but he doesn’t expect them in every market. Instead, it will depend on the size of the payer and whether there are primary care practices with which to form strong relationships. “We’re still in the middle innings with this,” says Bentley.

Humana began its push into senior-focused primary care in the Kansas City area, establishing four Partners in Primary Care standalone clinics in 2017, and then setting up two clinics at Walgreens drug stores the following year.

The insurer now has four clinics at Walgreens in the Kansas City area and one in South Carolina, says Renee Buckingham, president of Humana’s care delivery organization. After initial concerns over whether consumers would understand that the Walgreens clinics were offering full-service primary care, rather than just urgent care, and whether doctors would be willing to work at a clinic located at a drug store, Humana has been “pretty happy about the retail experience,” says Buckingham. And consumers, particularly those who have mobility or transportation issues are happy to get their healthcare where they can also do some shopping, she says.

Many of Humana’s senior-focused clinics are in Sun Belt locations that have large senior populations. When identifying clinic locations, Humana looks for communities where seniors are underserved by primary care providers, Buckingham says. Care coordination for chronic conditions can suffer where there’s a shortage of providers, she notes, adding that seniors are “one of the most vulnerable populations in the country.” The COVID-19 pandemic has made that even more apparent. About 80% of the deaths from the disease have been among those ages 65 and older, according to the CDC.

Closing healthcare disparities is on many agendas these days.
Although insurers have plenty of purely business reasons for moving into primary care — containing costs, capturing a chunk of the premium dollar, forging tighter, multifaceted relationships with members — they also see primary care as a way to address healthcare disparities, says Leeds at Korn Ferry. Through their primary care practices, payers can “serve segments of the population that may otherwise have been left behind,” she says.

Primary care practices with staffs that include behavioral health providers and social workers are in a position to address mental health problems and social determinant of health, says Gebreyes, noting, “They treat the whole person.”

Primary care is also feeling the effects of the shift to some version of capitated, value-based care. Prior to the pandemic, many primary care practices relied on fee-for-service payment. That made sense. “They knew volumes were going to go up,” says Bentley, “That’s not true anymore.” With a shift to value-based care, “the financing and delivery of care are becoming more interlinked,” notes Gebreyes. It has become something of a truism that physicians who had adapted to value-based care have fared better during the pandemic. Older physicians who have spent their careers in a period when payment was fee for service may be more willing to sell their practices now that value-based payment is taking hold.

For consumers, the shift to value-based care should result in better access to quality care, Gebreyes says, and Leeds says that should benefit insurers: “Every health plan wants to do everything it can to keep the patient out of the emergency room.”

Susan Ladika is an independent journalist in Tampa, Florida, who covers healthcare and business.

Insurers are taking a hands-on approach to primary care, buying or partnering with practices or setting up their services.

Dr. Health Plan Will See You Now

A month prior to the Office of the National Coordinator for Health IT (ONC) enforcing the final rule of the Cures Act of information blocking and improving interoperability provisions, many health organizations did not meet these basic interoperability standards. As of April 5, the final ONC rules are now effective.

This information was found in a recent survey by Life Image, a medical evidence network for clinical and imaging data, which was deployed this March to nearly 4,000 clinical, technology and administrative leaders from provider, payer, IT, and other organizations.

The survey shared there was a broad lack of awareness and readiness to comply with the federal information blocking rules, which may indicate general confusion around rule requirements and the specific steps organizations must take to prepare.

The final ONC rules aim to improve electronic access, exchange, and use of health information, granting patients ownership of their health data without special effort or additional cost. While 70% of participants in the Life Image survey stated they were aware of the rules going into effect, up to half of the same participants also reported using practices defined by ONC as information blocking and will be noncompliant under the new rules – such as sharing records by paper or CDs, or charging patients fees to obtain records.

Further key findings from the survey include:

Nearly half of the respondents had either not made any changes or did not know how to ensure their facility meets all of the rule requirements.

A majority of healthcare organizations reported not using digital solutions to share healthcare data with patients, with 66% still using paper and 32% using CDs.

47% were not familiar with the term “information blocking.”

48% were not aware of practices or policies that would be considered “information blocking.”

39% did not know they could incur civil monetary penalties for information blocking practices/

15% currently charge $25 or more for patients to obtain records.

“Our recent survey validates what Life Image has been witnessing across the healthcare ecosystem in terms of interoperability readiness. While the COVID-19 pandemic created massive challenges and delayed many interoperability initiatives, it also underscored the paramount importance of the final ONC rules for advancing patient care and driving innovation,” said Matthew A. Michela, President and CEO, Life Image. “As many organizations are facing a long, complicated journey to ONC compliance, we’re dedicated to helping the industry navigate this new data revolution.”

According to HIPAA regulations, providers must give patients, upon request, access to their protected health information in the form and format of the individual’s choosing, including electronic format and via third-party application. In order to address ongoing industry resistance and barriers to interoperability, in March 2020 the ONC released the Final Cures Act Rule, which is grounded in the 

 and mandates that patients be allowed greater control and access to their health data, targeting vendors and technologies that block information access.


In order for different types of organizations, such as larger health systems or rural hospitals to meet these guidelines, Michela recommends leaning on vendors like EHR, image vendors and more, because "interoperability is not a something you can necessarily do and weeks and necessarily months."

He adds communication with vendors will ease challenges many health systems could face in this process.

"So the first thing they have to do is have to go to their vendors," he says. "Talk about 'what are you doing for interoperability?' And 'what are you doing with your product and service to make sure that it is compliant with what we need,' they have to do that."

"(Next) you have to make sure that you do a proper vendor evaluation process, you got to do your due diligence on it, because there's so much demand out there. You don't want partners who are going to over promise they can help you and solve these things and then fall short because your procurement folks haven't done a serious enough look. The careful vendor and partner evaluation process is really the first thing, but rely on others to do it. Make sure that they understand that there's consequences to them if they don't comply. And you've got to project manage it."

Though working toward meeting these requirements may bring challenges, it's an opportunity to transform healthcare, Michela says.

"When you reduce these barriers, you accelerate access to information," he says. "When you empower patients they seek out quality and better costs; they seek out their own options. When you accelerate access to data, you accelerate drug development."

A new survey revealed a majority of health organizations have lack of awareness and are unprepared to comply with the ONC's final rule act of information blocking and improving interoperability provisions. Matthew A. Michela, President and CEO, Life Image, shares how to get on board.

Many Healthcare Organizations Aren't Ready for the Now Enforced ONC Cures Act Final Rule

J&J reaches out. Pfizer, Moderna weren’t interested.

You’re on your own. That seems to be the message that Pfizer and Moderna delivered to Johnson & Johnson when it approached the two companies about speaking “with one voice about safety,” according to a story in the 

Citing unnamed sources, the newspaper reported that J & J “sought to build an informal alliance to communicate the benefits and risks of the shots and address any concerns raised among the public by the blood-clot cases.” Six women have developed blood clots after receiving the J & J vaccine and one died. Pfizer and Moderna declined the invite, saying that they didn’t want to duplicate the efforts of regulators, according to the newspaper. AstraZeneca, whose vaccine has also been associated with blood clots, was interested, according to the 

A third shot will probably be necessary, says Pfizer’s Bourla. And annual shots after that.

Bertha Coombs, Karen Lynch, Albert Bourla

It never seemed like the coronavirus was going to be a one-and-done, but now the reality is setting in, especially with the emergent of variants. “The COVID virus looks more like the influenza virus than the polio virus,” Pfizer CEO Albert Bourla said during a

 program produced by CVS Health that was posted on Thursday (April 15). With 

 listening, Bourla went on to talk about the likelihood of the need for a third dose of the two-dose Pfizer vaccine and annual shots thereafter. “A likely scenario is that there will likely be a need for a third dose somewhere between six and 12 months and then from there an annual re-vaccination, he said, adding though that “all of that needs to be confirmed.”

Bourla’s prediction got some pushback. “How can Albert Bourla and Pfizer say we will need booster shots when their own vaccine data and Moderna tx’s at 6 months look very solid, and there are no data to how mRNA vaccine’s lack of protection against any variant,” tweeted 

FDA, CDC hit the pause button on J & J. Controversy ensued.

There was whiff of a problem last week the European Medicine Agency said it was reviewing a “safety signal” about the single-dose J & J vaccine and a possible association with blood clots. This week that whiff got a whole lot stronger, although the Twittersphere was full of commentary that the  pause on the vaccine would do more harm (possibly resulting in more COVID-19 cases) than good (maintaining public confidence in vaccine safety regulation and possibly avoiding a very slight risk of blood clots — if the vaccine is, in fact, associated with them).

And this week’s news about a possible link to blood clots came after last week’s quality problems: It’s been a bumpy ride for the J & J vaccine

The story started to unfold on Tuesday (April 13) when the FDA’s 

, M.D., issued a statement said that “out of an abundance of caution” they were recommending a “a pause in the use of this (the J&J) vaccine.” They mentioned six reported U.S. cases of cerebral venous sinus thrombosis occurring among people after they received the J&J vaccine; all six were women between the ages of 18 and 48. Cerebral venous sinus thrombosis is a rare (perhaps about 5,000 cases a year in the U.S.) type of stroke caused by blood clots blocking blood drainage through cerebral veins and 

. Marks and Schuchat also noted the denominator of more than 6.8 million doses of the vaccine that have been administered in the U. S. “Right now, these adverse events appear to be extremely rare,” said their statement. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.

 the same day that it had  “proactively delayed” rollout of its vaccine in Europe and paused clinical trials testing the vaccine.

Then the CDC’s Advisory Committee on Immunization Practices (ACIP) swung into...inaction. The ACIP is a group of outside experts that formulate vaccine recommendations — they are only recommendations, although they are often followed by the CDCand others. The committee held an emergency meeting on Wednesday (April 14) but put off a making a decision. Some more details emerged during that meeting, including the possibility of seventh case. The CDC has scheduled a 

 of the ACIP for this coming Friday, April 23, starting at 11 a.m. to further discuss the J&J vaccine and presumably arrive at some recommendations.

 M.D., M.P.H., dean of Brown University’s School of Public Health, was among those that took to Twitter to criticize the committee for delaying a decision. “ACIP should have recommended continuing pause for women 18-49 but resuming for everyone else. Keeping vaccine paused for everyone makes little sense. Risk-benefit keeping vaccine paused for everyone WAY off,” he said in a thread on Wednesday (April 14). 

As of Friday (April 16) at 6 a.m., vaccine data reported to the CDC showed 202,282,923 vaccine doses administered, an increase of 23,445,142 increase, or 13%, over last Friday (April 9). The CDC’s tally shows that 127,743,096 individuals have received at least one dose of a vaccine, an increase of 13,307,057, or 11.6%, from last Friday. As of yesterday, the CDC’s numbers show 38.5% of the U.S. population has received at least one dose of a vaccine and 24.3% is fully vaccinated.

Not enough vaccine? Soon the problem may be getting enough people to take it.

 on Friday (April 16) in projecting a slacking off in demand for vaccine.

The foundation, which has been tracking public opinion about COVID-19 vaccines since December, said it was too soon to tell what the effect of the pause on the J&J vaccine in an update published on Friday (April 16). Public confidence in the vaccines has increased, the update said, but with a “small but persistent group opposed to getting the vaccine and many others still on the fence, the U.S. may soon hit a point where vaccine supply exceeds demand, a situation that is already the case in certain communities.”

The update took issue with “media narratives” that have focused on certain groups being vaccine hesitant. Yes, a greater share of people who identify as Republicans say they don’t intend to get vaccinated and more Black adults have a “wait and see” attitude. But the foundation says its research shows that a majority across all demographics are “at least somewhat open to getting the vaccine.”

More COVID disproportionality: Low vaccination rate among the incarcerated.

Disproportionality has been a theme of the pandemic, and incarcerated people are among the groups that have been affected more than others. According to the 

, 2,443 incarcerated people in the U.S. have died from COVID-1 as of yesterday (April 16) and 162 members of prison staffs have perished. In a 

 blog post on Thursday (April 15), Lauren Brinkley-Rubinstein, Ph.D., a co-founder of the COVID Prison Project, and her co-authors said project had counted 137, 064 people incarcerated in state or federal prisons who have received at least one vaccination as of April 1, which would work out to be about 6% of the estimated 2.2 million incarcerated people in the country.

Shingles seen as side effect of the Pfizer vaccine among those with AIIRD

Six patients among 491 with autoimmune inflammatory rheumatic diseases (AIIRD) developed shingles after being vaccinated with the Pfizer vaccine compared to none among 99 controls, 

 on Monday (April 6). Four of the patients who developed shingles had rheumatoid arthritis, one had Sjogren’s syndrome and one, undifferentiated connective disease. The cases of shingles were mild, they reported, except for one that involved 

 in a patient with rheumatoid arthritis that was being treated with Xeljanz (tofacitinib).

“To date there is no data available on the safety of mRNA COVID-19 vaccination in AIIRD (autoimmune inflammatory rheumatic disease) patient as immunosuppressed patients were excluded from the vaccines’ trials,” wrote Victoria Furer, M.D., and her colleagues. "Therefore safety and monitoring of vaccinated patients is especially warranted in this population.”

Antibodies to platelet factor to blame for blood clots after AstraZeneca vaccine? Evidence grows.

accine-induced immune thrombotic thrombocytopenia

 (VITT) after the AstraZeneca vaccine. In this study, 21 of the 23 patients had high levels of antibodies to platelet factor 4 (PF4) a phenomenon seen in the relatively rare instances when people develop blood clots in reaction to heparin, known as 

. Heparin is given to prevent blood clots, so HIT is the exact opposite of the intended effect. Lead author Marie Scully, M.D., and her colleagues said the evidence so far does not show heparin would aggravate the VITT. Even so, they recommend using a nonheparin anticoagulant, such as argatroban, danaparoid, among others.

The other two NEJM studies have also implicated antibodies to PF4 as possibly playing a role in VITT. An 

 warned, though, against jumping the gun and settling on them as culprits. The understanding of the pathogenesis of VITT is incomplete, wrote wrote 

, and the usefulness of measuring pathogenic anti-PF4–related antibodies in vaccine recipients has not been established: “To close the loop, the next step should be a direct demonstration that the anti-PF4 antibodies described here cause thrombosis and thrombocytopenia in an in vivo model.”

And, as many others have, Cines and Bussel also emphasized that VITT is rare and the benefits of vaccination have to be weighed against the risks. At the same time, they also left the door ajar to some vaccines perhaps being more suitable for some populations than others and the need to monitor for rare compliations.

Let’s prevent the next one. Researchers look for “pancoronavirus” vaccine.

SARS-CoV-2 didn’t surprise coronavirus experts. It’s just one variety of a slew of coronavirus, and it’s a safe bet that another will mutate in such a way as to become transmissible among humans. Jon Cohen, an award-winning science journalist for 

, wrote this week about early-days research efforts to develop a “

 that would immunize humans against emerging coronavirus.

“Beyond bats, coronaviruses infect camels, birds, cats, horses, mink, pigs, rabbits, pangolins, and other animals from which they could jump into human populations with little to no immunity, as most researchers suspect SARS-CoV-2 did,” wrote Cohen in a piece published on Thursday (April 15).

Although cool to the idea in the past, the National Institute of Allergy and Infectious Diseases (NIAID) has solicited applications for “emergency awards” to pursue pancoronavirus vaccine development, reported Cohen. An international nonprofit, the 

Coalition for Epidemic Preparedness Innovations

, is also funding research, according to Cohen.

The Pause on the J&J Vaccine, a 3rd Shot of Pfizer Likely, Research into Causes of the AstraZeneca Blood Clots and Other COVID-19 Vaccine News This Week

Below is a short Q&A excerpt of an interview with Steven Pearson of ICER. Text has been edited for length and clarity.

I would probably shy away from calling it in the same class just because that has some technical kind of meaning, but its therapy will be very similar. Now, a couple of things, our report is done, but the FDA has not yet formally decided whether to approve this drug or not. They haven't been able to get overseas to check the factories and there's some interesting issues there. It's also a drug that even though it's administered, it's done just twice a year, as opposed to every two weeks. 

There's a feeling that may have some for some patients in particular, a clinical benefit, because they can get it in the doctor's office and make sure that they get it when they come in for their biannual visit for many of these patients. There's a sense that it may provide a nice addition to the armamentarium of doctors who are always looking for new ways to make sure that patients bring their cholesterol down. 

The other thing about this drug is not only is it not FDA approved, but again, at this stage, we don't have a clinical trial results on strokes, heart attacks and mortality that will come again in a few years. So we're kind of assuming for the time being the reduction in cholesterol will kind of translate through into those good outcomes for patients in the same way. But we'll know more in a couple of years, and we may need to revise our report.

In this third part of a three-part series, Steven D. Pearson, M.D., M.Sc., founder and president of ICER talks the drug Inclisiran and its relation to PCSK9 inhibitors.

Is Inclisiran a PCSK9 Inhibitor?

Pharmacy benefit managers, or PBMS, and other factors in the prescription drug market remain to take a hit when it comes to "costly" drug prices, according to results from a recent 

Scripta, a cloud-based healthcare IT solution that helps self-insured employers contain their pharmacy benefit spend, surveyed over 350 respondents ages 18 to 60 and older, in the first quarter of 2021 to dig deeper into American attitudes and behaviors around prescription drug pricing. All respondents have health insurance through their employer and take one or more prescription drugs on a regular monthly basis.

In the survey, there were three key themes: a hidden culprit for high prescription drug prices, the PBM; the doctor is trusted and a key stakeholder in consumer-directed healthcare; and patients are eager, regardless of household income, to make a prescription change to save as little as $15 monthly.

Despite having health insurance, on average, two-thirds of survey respondents (

) think they pay too much for prescription drugs. Upon further review, that sentiment grows and directly correlates to how much they spend out of pocket monthly: ranging from 45% for those spending under $15, to an alarming 

Who’s to blame? People believe pharma companies are the number one offender (

) most to blame for high prescription drug prices, followed by insurance companies (

 blame PBMs, according to a Scritpa release.

What’s driving prescription drug pricing? Respondents think it’s three main factors equally responsible (approx. 

 each): marketing/advertising, drug ingredients/manufacturing, and research and development. Only 

In reality, industry data shows that PBM fees and rebates actually drive many of patients’ problems and misunderstandings of U.S. drug prices. Drug Channels Institute estimates that the gross-to-net bubble—the dollar gap between sales at brand-name drugs' list prices and their sales at net prices after rebates and other reductions—reached $175 billion in 2019.

Scripta’s survey also reveals most people (

) believe coupon and discount services like GoodRx, Blink Health and Amazon Pharmacy are helping to solve the high cost of prescription drugs. Yet, despite the fanfare, only 

 of people report looking for a coupon when they can’t afford their meds.

“Pharmacy coupon and discount services aren’t treating the condition of high prescription drug prices, they’re merely treating its symptoms; they’re not getting rid of your brain tumor, they’re just making your headache feel better today,” said Eric Levin, CEO, Scripta Insights. “Coupon services are all promoting the same PBM-based system that is the hidden culprit behind the high costs on the majority of drugs in the U.S.”



Patients Becoming Better Prescription Shoppers, Want Price Transparency

According to the survey, people are carefully monitoring their prescription spend and aren’t afraid to ask for pricing information:

) of people who are on a deductible plan know where they are with their deductible and the impact it will have on their prescription costs before they go to the pharmacy

At the pharmacy counter, more than half of people (

) have asked if the cash price of a drug is cheaper than the price through their insurance

 of patients have asked their doctor the cost of a drug when getting a new script



The doctor remains the go-to source for patients seeking more affordable drug options, but patients feel doctors are lacking critical pricing information and need better tools:

When faced with pharmacy counter sticker shock, the most popular action people take is to ask their doctor for a cheaper option. Next, they ask their pharmacist.

) don’t believe their doctor knows the price they will pay for the drug they’re prescribing

“People trust their doctors and want to take the medicine their doctor prescribes, but affordability has a major impact on adherence—I’ve seen it with my own patients,” said Paul Bradley, M.D., Chief Medical Officer and head of the P&T Committee at Scripta Insights. “Believe it or not, most doctors don’t know the cost of a drug or what the member copay is on your insurance plan when they write your prescription. At Scripta, we provide our members with the information they need to be better prescription shoppers and have more informed conversations with their doctor.”

Patients are Very Willing to Change Medications to Save on Rx

) have received a recommendation to take a different less expensive drug for their medical condition, with advice coming from trusted sources, including experts like their doctor or pharmacist (

) or non-experts like a family member or friend (

The top three reactions to this news? Overwhelmingly, people are “interested” (

) to learn there could be a cheaper option out there.

 of respondents are willing to make a prescription change (i.e. switch their script, change forms or where they fill their medication) to pay less for their meds. Nearly half of those surveyed (

) are willing to switch to a new medication to save as little as $15 per month.

The most popular prescription switches people are willing to make include switching from a brand name to a generic drug (

) and switching to a different brand name drug (

 of patients are also willing to take the following actions to save on Rx:

Get a new prescription for a higher dosage pill and split it in half with a pill splitter

Take two prescription drugs instead of one

Take a different form of drug (i.e. a gel instead of a cream)

Take the drug more frequently (i.e. 2x daily instead of 1x daily)

A recent survey by Scripta Insights shows 96% of consumer are willing to make a prescription change as far as switching their medications, forms and where they fill in order to save money.

Consumers Are Considering Prescription Changes and More Over High Drug Prices

ow that the Biden administration is putting a new team in charge of CMS, advocates for accountable care organizations (ACOs) are preparing to push for changes that they say will bolster CMS’ ACO programs and make risk sharing more palatable.

The National Association of ACOs (NAACOS) says that ACOs have worked as intended to slow the rate of spending growth for the Medicare program. In January, the group put out a statement saying that the new administration should increase what CMS pays hospitals, health systems and physician groups that participate in the Medicare Shared Savings Program (MSSP) and give them more time to take on downside risk. NAACOS noted that number of ACOs participating in MSSP, the largest CMS ACO program, has dropped from a high of 561 in 2018 to 477 this year. NAACOS says that MSSP deserves credit for being CMS’ largest, most successful value-based program. NAACO President and CEO Clif Gaus, Sc.D., says making the incentives to participate more attractive and the risks more manageable would lead more provider groups to participate. NAACOS has proposed that shared savings be split 50-50 between CMS and the ACOs instead of the current 60-40 ratio. The organization also wants an on-ramp of three years before shared savings starts. “Our healthcare payment and delivery system needs to desperately change, and ACOs offer the leading way to make that happen,” Gaus says. “A steady erosion of ACO participation damages our ability to get to where we need to be.”

Data that CMS released in September show that the MSSP ACOs had two years of record savings in 2019 and 2018. In 2019, Medicare spent $2.6 billion less than the CMS spending targets for ACOs. The net savings worked out to $1.2 billion after shared-saving payments — money ACOs receive if they spend less than financial benchmarks based on past spending — are factored. In 2018, MSSP ACOs spent $1.7 billion less collectively than CMS’ financial benchmarks. The net savings were
$740 million after accounting for shared-savings payments and collecting shared-loss payments.

Last June, CMS paused or adjusted many of its value-based programs because of the COVID-19 pandemic and the dramatic decline in the use of healthcare services not related to COVID-19. Among the most significant changes are those that affected Next Generation ACOs. The Next Generation ACO Model, which has 41 participants, gives ACOs a chance to take home higher levels of shared savings, but they are also on the hook for larger shared losses if their spending exceeds their financial benchmarks. ACOs that participate also get waivers from several CMS rules, such as the requirement that admission to a skilled nursing or rehabilitation facility be preceded by a three-day hospital stay. The Next Generation program was supposed to end last year, but the Trump administration CMS, citing the pandemic, granted it a one-year reprieve.

CMS was also gearing up to start the Direct Contracting Model at the beginning of this year but moved out the start to April 1 because of the pandemic. On March 5, the Biden administration said it would stick with that date. As designed during the Trump administration, any provider organization can apply to participate in the program. The model is designed to test two varieties of risk-sharing arrangements. The “professional” track of the program sets shared savings and losses at 50%; the participating provider organization would get half of the difference between a financial benchmark and actual spending if it came in under budget (the shared savings) but also risk paying half of the difference between the benchmark and the actual spend if it went over budget (shared losses). The other “global” track is the full-risk option, meaning providers would get 100% of the savings or pay 100% of the losses.

In a letter to CMS in December, Gaus said that his organization had hoped the direct-contracting initiative would cater to existing ACOs willing to take on more risk. Instead, in Gaus’ view, CMS has provided incentives for health plans to participate in the program and put existing ACOs at a disadvantage. As designed, the direct-contracting program could cut into the current enrollment in ACOs by allowing new direct-contracting entities to take away members (under Medicare’s patient attribution rules) from ACOs, which, Gaus wrote, have served the Medicare program well for the past decade and have reduced the cost of care.

“These ACOs embraced the transition to value early on and worked with CMS to grow and refine the models so they would be successful long term,” Gaus added. “These providers were on the forefront of the value transition and took great risk to blaze a trail for other providers to follow. Many did so without financial backing and by investing their own resources with uncertainty about a return on their investment. Their commitment to clinical transformation and value-based care has advanced the entire healthcare industry, and they should be rewarded, not penalized, for these efforts.”

America’s Physician Groups (APG) also is aware of these concerns, but APG President and CEO Don Crane, J.D., says his group remains confident about the future for both the Next Generation ACO and direct contracting. His organization, which represents 345 physician groups in 44 states, has long supported CMS’ efforts to promote value-based payment models that use risk sharing, he says.

APG wants CMS to cast a wide net. “We want CMS to move forward with the Direct Contracting Model and with the risk-sharing arrangements in Next Gen ACOs,” he says. “We’re interested in all of the models, frankly. That’s why we say to Medicare, ‘Let’s go forward with these models.’”

Under professional-risk arrangements, a physician assumes the financial risk for the care and services delivered to patients, Crane explains. That’s a lower level of risk than global risk, in which a physician or physician group is responsible for the cost and quality of all the care a patient receives from the health system, whether that care is delivered in a hospital or from a specialist physician.

“What distinguishes APG and its members is that we’re all generally committed to the movement toward value-based care and more specifically to risk-based contracting,” Crane says. “We view capitation as being the ultimate destination for payment. Capitation used to be a dirty word but no longer.”

oseph Burns is an independent journalist 

in Brewster, Massachusetts, who covers healthcare.

The number of participants in the Medicare Shared Savings Program has tapered off, and the Direct Contracting Model may put accountable care organizations at a disadvantage. The National Association of ACOs wants the Biden CMS to make some changes.

Whither the ACO? 

 Did the pricing of the PCSK9 inhibitors put ICER on the map?

 Well, we have been in existence already for almost seven, eight years at that stage and so if there had already been notice to our work, especially around the time of the new, big budget-buster drug for hepatitis C that was on people's radars, it helped bring more attention. Not too long after the hepatitis C drugs came the PCSK9 inhibitors, and what was unique about them was that they were a completely new paradigm of care for patients with high cholesterol. 

Related: ICER Chief on Bempedoic Acid and Inclisiran: Don’t Repeat the PCSK9 Mistake

There are obviously a lot of patients in the country who have high cholesterol in spite using the available pills. The potential for the budget impact was so high that it raised people's attention. So our approach is not to worry so much about the short-term budget impact but to really try to capture the long-term value in the way that we look at value. Even looking at the PCSK9 data at the time of its launch, we did take the list price that they came out was far too high to match up with what was going to be the likely clinical impact, because remember, by that point we didn't even have the clinical trials that said it did prevent heart attacks and strokes. We just had trials that showed it lowered cholesterol.

So taking that on, we did a model that said connecting to the likely downstream reduction in heart attacks and strokes, how valuable would these be and what would a fair price be so when we came out with a much lower price, it affirmed what many payers and others were feeling - which was that this seemed like an expensive drug for the for the clinical value, that it was going to provide for the average patient for every patient, but for the average patient.