Laura Joszt

Finalizing parts of a regulatory rule first proposed nearly a year ago, the Trump administration said that private health plans will be required to provide information about negotiated prices and cost sharing, including information about prescription drug prices.

, released by HHS, the Department of Labor, and the Department of the Treasury, finalizes the proposal made 

 as part of the administration’s effort to make opaque health care pricing more visible and transparent to consumers.

The rule affects individual and employer-based health plans, which insure about 200 million Americans. It requires that insurers provide real-time access to cost-sharing information through an online tool. They must also disclose negotiated rates for in-network providers and allowed amounts paid for out-of-network providers.

Thursday’s announcement also includes prescription drug pricing in the form of similar transparency requirements.

Plans must post in-network prescription drug pricing, taking into account any rebates or concessions received after the point of sale; the information must also include the drug’s historical net price.

“When I first identified transparency as a key part of value-based transformation when I started as secretary in 2018, I said you should have the right to know what a health care service is going to cost, and the right to know what it’s going to cost you out of pocket, and that’s what today’s rule will do,” said HHS Secretary Alex Azar, who has railed against pharmacy benefit managers and 

However, the drug pricing information will not include the amount of the rebate itself. According to the rule, the administration noted “that the negotiated rate might be different for branded and generic drugs” and that prices might be set differently according to the plan or the insurer; the rule only requires the disclosure of patient liability and the negotiated amount paid by the health plan. “The Departments anticipate this disclosure generally will not necessitate the disclosure of information on discounts, rebates, or price concessions for a drug,” the rule said.

Another piece of this effort, requiring similar transparency on the part of hospitals in disclosing what they charge for services, is slated to go into effect January 1, 2021. That part of the proposal immediately drew lawsuits from the hospital industry, and 

, the US Court of Appeals for the District of Columbia Circuit heard oral arguments in the case. So far, the American Hospital Association has been unsuccessful in getting the rule overturned.

The hospital piece is just one part of the equation for patients, and the payer provision “fills in those gaps and ushers in a new era of price transparency and patient empowerment in this country,” said CMS Administrator Seema Verma.

Payers must make their information available in data sets for plan or policy years beginning on or after January 1, 2022. Starting on or after January 1, 2023, they must make available pricing information on what the administration called “shoppable” services, and then must make all cost-sharing information for all services available on or after January 1, 2024.

In addition, the rule also allows insurers to enter into what the administration called “shared savings” by encouraging patients to seek care from lower-cost, higher-value providers; payers can then claim that savings as credit in calculating their medical loss ratio (MLR) starting with the 2020 MLR reporting year.

The savings would be counted on the expenditure side of the MLR for health plans, not their administrative costs, said Verma.

Shortly after announcing the final rule, Verma joined the University of Michigan Center for Value-Based Insurance Design (V-BID) for a roundtable discussion led by A. Mark Fendrick, MD, V-BID Center director, professor of internal medicine in the School of Medicine, professor of health management and policy in the School of Public Health at the University of Michigan, and co-editor-in-chief of 

Verma reiterated her comments from the earlier HHS call that the rule is designed to empower patients. By knowing the costs of care on the front end, patients will be able to shop around to get the best price for them and their family, she said.

She added that this rule is part of a larger effort to empower patients with cost and quality transparency.

Kavita K. Patel, MD, MS, nonresident fellow at The Brookings Institution and editorial board member of 

 is that people are looking for value and transparency will help. Providing information about negotiated rates is "incredibly important," she said. The only challenge is that providing this information may leave most Americans "

in a conundrum about what to do with that information."

Niall Brennan, MPP, president and CEO of the Health Care Cost Institute (HCCI), highlighted that impact the rule could have on surprise billing and the ability to shop services better.

"We [at HCCI] think surprise billing is literally an embarrassment for the US health care system" and is just another way American suffer when navigating the system, he said.

HCCI research has shown that 1 in 7 patient admissions were associated with an out-of-network service, and someone in Florida had as high as a 1 in 4 chance of getting a surprise bill from an out-of-network service, Brennan said.

The focus on shoppable services and defining those services is also important, he said. "It's hard to shop when you're in the back of an ambulance," he admitted, but there are many other areas where patients can shop services.

"I think we're all in agreement that the status quo is absolutely not sustainable and we need to act aggressively to reign in health care costs," Brennan said.

enior director of member value at the Pacific Business Group on Health (PBGH), applauded the move to transparency, noting that there have been past efforts—health plans and employers have both created tools—and those will all become more effective now.

She added that PBGH appreciates CMS recognizes quality is an important aspect and she pushed for more transparency around quality. "Cost does not stand alone, it must be coupled with quality," Vela said.

 with health care in the United States is that there have been noncompetitive markets, explained Marty Makary, 

MD, MPH, chief of the Johns Hopkins Islet Transplant Center, and this rule converts those noncompetitive markets to competitive markets.

"It's an American disgrace that the price to deliver a baby in New York City ranges from $6000 to $70,000 with no difference in quality," he said. "It's the Wild West."

Verma added that she was "heartened" by the comments and she called this rule a "turning point," although she acknowledge there is still "a lot of work to do."

Will patients actually use the tools available when they are available? Historically, other industries have shown that if you put this type of information out there, people will use it, she said. The reason they haven't in the past for health care is because the information available has been spotty.

The American patient is begging for change," Verma said, adding "This is an opportunity to turn our whole health system around."

One negative reaction came from the industry association for health insurers and payers, which said the rule would have the opposite effect.

“We are disappointed that the final rule will work to reduce competition and push health care prices higher—not lower—for American families, patients, and taxpayers. This is precisely the opposite of what Americans want in their health care," said 

Matt Eyles, president and CEO of America’s Health Insurance Plans, in a statement.

Articles

The Trump administration finalized rules aimed at making health care pricing more visible and transparent to those with with health insurance from employers or the individual market.

HHS Wraps Up Rule Requiring Price Transparency by Payers

When the first biologic to treat asthma was approved by the FDA in 2003, it needed to be administered subcutaneously in the physician’s office. Now, there are 3 options available for at-home use: mepolizumab, benralizumab, and dupilumab.

During a session at the CHEST 2020 annual meeting, Diego J. Maselli, MD, FCCP, associate professor of medicine, Division of Pulmonary Diseases and Critical Care, University of Texas Health San Antonio, and director, Severe Asthma Program, University Health System, highlighted the pros and cons of in-office and at-home administration of biologics to treat asthma.

However, physicians are faced with a dilemma: where does the therapy get administered and how do they choose what is best for their patient?

The benefits of using biologics to treat asthma in office is that there is increased compliance to the medication, increased provider interaction so patients can ask questions, and, to some extent, improved asthma care.

“Providers can look at [the patient] and see how they’re doing and evaluate their asthma control,” Maselli explained.

In addition, when biologics are administered in the physician’s office, patients can be monitored for side effects, which is particularly beneficial with the first few doses, he said.

However, there is more convenience when the biologics are administered at home. Patients don’t need to worry about traveling to the office, parking, and waiting to be seen. When they have the option to take the biologic at home, patients don’t have to worry about the office visit interfering with school, work, or other important responsibilities.

“Some of our patients, as you know, they work or go to school, and they're very busy,” Maselli said. “And sometimes the only time that they have is on the weekends. So, even though some clinics are open Saturdays, it's still troublesome for some of them to find time to get these shots.”

A study published in February looking at the average distance and time to an administration clinic compared with a regular primary care physician (PCP) office found that patients in rural New England spent considerably more time driving to the clinic to receive their biologic than they would to see their PCP.

The study looked specifically at patients being treated with omalizumab or mepolizumab. Patients receiving omalizumab spent an average of 59 minutes driving to the clinic compared with 19 minutes to the PCP’s office. Patients receiving mepolizumab spent an average of 46 minutes driving to the clinic compared with 21 minutes to the PCP’s office.

Dupilumab is the only biologic that was approved from the start for at-home use; the other biologics gained approval for self-administration at home years after their initial approval. As such, there were some concerns about how patients currently receiving the biologic at the clinic would handle switching to administering the biologic at home, Maselli said.

However, home use is accepted well by patients. A study

 of mepolizumab home use showed that 86% of patients found the biologic very or extremely easy to self-administer using the autoinjector at home; 88% felt very or extremely confident in using the autoinjector at home; and 75% reported feeling no or a little anxiety about self-administering at home. Furthermore, when patients were shown a pictogram of how to use the autoinjector and when clinicians spent a little time to highlight the features of the injector, confidence and ease increased and anxiety decreased.

“So, this just highlights the importance of having a good education, particularly when we're starting a patient from the normal injections,” Maselli said. “And they're not used to having injections, so that they can feel comfortable doing it at home.”

The fact that the safety of the biologics is similar at home and in the clinic is important with the coronavirus disease 2019 (COVID-19), because patients with asthma are at risk for poorer outcomes if they are infected. There has been some discussion about stopping biologic treatment, but current guidance is for patients to continue the therapy, he said. If biologic therapy is stopped, patients could experience exacerbations and end up in the hospital where they could potentially get infected with COVID-19.

Overall, the place of administration needs to be considered on a patient-by-patient basis, Maselli said.

“It's important to know that these medications, fortunately, are a good option for patients,” he said. “They appear to be safe; they appear to be effective and well accepted by the patients, which is important. So, we have that [at-home] option for our patients.”

1. Shaker M, Briggs A, Dbouk A, Dutille E, Oppenheimer J, Greenhawt M. Estimation of health and economic benefits of clinic versus home administration of omalizumab and mepolizumab. 

. 2020;8(2):565-572. doi:10.1016/j.jaip.2019.09.037

2. Bernstein D, Pavord ID, Chapman KR, et al. Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. 

. 2020;57(9):987-998. doi:10.1080/02770903.2019.1630641

Weighing the Pros, Cons of At-Home Use of Biologics for Asthma

Although patients with psoriatic arthritis (PsA) and enthesitis—inflammation at the sites where tendons on ligaments insert into the bone—experience higher disease burden than patients without enthesitis, they are not more likely to receive advanced therapies, according to research 

The researchers conducted a cross-sectional survey of 454 rheumatologists and 238 dermatologists, and their 3157 patients with PsA in Australia, Canada, Japan, the United States, and 5 countries in the European Union (EU5).

“Enthesitis has been suggested as an important indicator of PsA disease severity,” the authors explained. They added that past research has shown patients with PsA with enthesitis have worse patient-reported outcomes and that enthesitis usually needs intense treatment because it is considered resistant to disease-modifying antirheumatic drugs (DMARDs). However, the “impact of enthesitis on physician satisfaction with PsA treatments has not been well characterized.”

Of the 3157 patients, 2951 did not have enthesitis and 205 had enthesitis. The physicians reported that enthesitis was mild in 54.0%, moderate in 41.3%, and severe in 4.6% of the entire sample. For the most part, the demographics between the 2 groups of patients with and without enthesitis were similar; however, less than half (47.2%) of patients were likely to be working full time compared with 58.1% of patients without enthesitis.

Physicians were more likely to rate their patients with enthesitis as having moderate to severe disease (52.2%) than their patients without enthesitis (23.2%, 

 < .001). Patients with enthesitis were also more likely to show a greater number of other PsA manifestations:

Patients with enthesitis were more likely to be taking medication for their pain compared with patients without enthesitis:

Nonsteroidal anti-inflammatory drugs (44.4% vs 22.9%, 

Similar proportions of both groups were receiving targeted synthetic DMARDs (12.2% with enthesitis vs 9.3% without, 

 = .1754) and biologic DMARDs (58.5% vs 58.4%, 

 = 1.000); however, patients with enthesitis were taking conventional synthetic DMARDS at a higher percentage (44.9% vs 34.2%, 

 = .0024). While 84.4% of physicians were satisfied with disease control in the patients with PsA without enthesitis, only 57.6% of physicians treating patients with PsA with enthesitis said the same. Similarly, 79.7% of patients without enthesitis were satisfied with treatment compared with 52.2% of patients with enthesitis.

“Our findings underscore the importance of assessing patients with PsA for enthesitis and ensuring its optimal management,” the authors concluded. “Data on PsA treatment efficacy specifically for enthesitis are needed to expand treatment options for patients and physicians.”

Orbai A-M, Birt JA, Holdsworth EA, et al. Impact of enthesitis on psoriatic arthritis patient-reported outcomes and physician satisfaction with treatment: data from a multinational patient and physician survey. 

. Published online October 14, 2020. doi:10.1007/s40744-020-00242-3

Patients with psoriatic arthritis with enthesitis are more likely to have severe disease than patients without enthesitis, and they and their physicians are less likely to be satisfied with their treatments.

Enthesitis in Psoriatic Arthritis Increases Disease Burden, Decreases Treatment Satisfaction

During the first wave of the coronavirus disease 2019 (COVID-19) pandemic, patients with axial spondyloarthritis (axSpA), rheumatoid arthritis (RA), and psoriatic arthritis (PsA) didn’t see any increase in disease activity despite an interruption in in-person interactions, according to research 

The researchers analyzed patients in the Swiss Clinical Quality Management cohort to understand how partial or complete closure of rheumatology services impacted disease activity as remote consultations were used to partly compensate for the reduced in-person interaction.

“Additional factors may also potentially contribute to disease worsening during the pandemic,” the authors explained. “Some patients may choose to preventively stop immunosuppression out of fear of complications. Moreover, the psychological stress (anxiety about a new disease, economic pressure, less recreational opportunities and so on) encountered during the pandemic should not be underestimated.”

The researchers defined 3 study periods: a pre–COVID-19 phase from January 1 to February 29, 2020; a COVID-19 phase from March 1 to April 30, 2020; and a post–COVID-19 phase from May 1 to June 30, 2020. Patients who had at least 1 patient-reported disease activity measure in each of the study periods were included.

A few disease activity assessments were used: the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axSpA; the Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) in RA; and the Patient Global Assessment (PGA) visual analogue scale for disease activity in PsA. The researchers used the following to define a clinically important worsening:

The study looked at 287 patients with axSpA, 248 with RA, and 131 with PsA. The number of visits dropped 52% from 543 in February to 262 in April; however, there was a 129% increase in web-based application entries (521 to 1195) during this time.

In the pre­­–COVID-19 phase, 15% of patients were nonadherent to their medication. While there was a slight increase in nonadherence during the COVID-19 phase, the researchers noted the increase only reached statistical significance among patients with axSpA.

“Adherence returned to prepandemic levels in the post–COVID-19 phase,” they wrote.

Over the first half of 2020, patient-reported disease activity outcomes were stable. There was a slight decrease during the COVID-19 phase; the decrease was only statistically significant for patients with axSpA (mean BASDAI 3.40 before the pandemic and 3.23 during the pandemic; 

 = .02). There was disease flare in less than 15% of patients for all 3 diseases, which was not statistically different from the pre–COVID-19 phase.

The authors noted that the fact they could only evaluate patients with regular disease activity assessments was a limitation.

“This subset using the smartphone app is probably more invested in disease management and the non-compliance figures might be under-represented,” they wrote.

Ciurea A, Papagiannoulis E, Bürki K, et al. Impact of the COVID-19 pandemic on the disease course of patients with inflammatory rheumatic diseases: results from the Swiss Clinical Quality Management cohort. 

. Published online September 22, 2020. doi:10.1136/annrheumdis-2020-218705

In the first wave of the coronavirus disease 2019 pandemic, patients with axial spondyloarthritis, rheumatoid arthritis, and psoriatic arthritis didn’t have an increase in disease activity despite an interruption in in-person interactions.

Author | Laura Joszt

Articles

HHS Wraps Up Rule Requiring Price Transparency by Payers

Weighing the Pros, Cons of At-Home Use of Biologics for Asthma

Enthesitis in Psoriatic Arthritis Increases Disease Burden, Decreases Treatment Satisfaction

Interruptions to In-Person Visits During Pandemic Did Not Negatively Impact Patients With Inflammatory Arthritis