Laura Joszt

Once the coronavirus disease 2019 (COVID-19) public health emergency ends, telemedicine should continue to be used to increase access and improve care for patients with rheumatic diseases, according to a position statement released by the American College of Rheumatology (ACR). ACR’s position statement also supports continued parity of reimbursement for in-office visits, audio—visual visits, and audio-only visits after the pandemic.

ACR noted that practices have been able to combat the financial strain of reduced in-person visits during the COVID-19 pandemic through the adoption of telemedicine. Policy changes enacted by CMS due to the public health emergency has allowed clinicians to be reimbursed for telemedicine services at the same rate as in-person visits, and ACR supports continued parity reimbursement in order to “preserve the economic viability of rheumatology practices.”

“As providers plan for rheumatology care post-COVID, taking into consideration rheumatology workforce shortages and geographically distant patients, it is apparent that telemedicine could help rheumatology providers improve care models for their patients if the long-term economic and regulatory landscape remains favorable,” Chris Phillips, MD, one of the statement’s lead authors and member of the ACR’s Committee on Rheumatologic Care (CORC), 

ACR noted that telemedicine should be used in conjunction with periodic in-person visits and should not replace essential face-to-face assessments. In addition, ACR stated that reimbursement parity should occur as long the provider—patient relationship includes both in-person and telemedicine services, patients have a choice of provider for telemedicine services, the standard and scope of care provided by telemedicine services is consistent with in-person services, and the provision of telemedicine services is properly documented.

The statement includes another 6 positions, most of which are supporting, as well as 2 opposing positions.

ACR also supports protecting the security and integrity of patient information, proposals that facilitate the interstate practice of telemedicine, outcomes-based research of telemedicine use in rheumatology, and continued access to telemedicine services even after the COVID-19 public health emergency ends. In addition, ACR recommends platforms with a way to obtain informed consent for the delivery of telemedicine services.

In the position statement, ACR opposes geographical restrictions on telemedicine practice and payer policies that would dictate use of specified telemedicine platforms, create restrictive networks, or use telemedicine as a way to divert patients to preferred providers.

“While telemedicine should not replace many of the hands-on skills and in-office assessments rheumatology professionals provide, patients in all areas of the U.S. should have access to telemedicine, regardless of location, and the services should be included in all subscriber benefits and insurance plans,” said Aruni Jayatilleke, MD, one of the statement’s lead authors and member of CORC. “Additionally, rheumatology professionals should be reimbursed equitably for telemedicine services and have access to a streamlined state medical license process.”

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The widespread adoption of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic, as well as reimbursement parity that was enacted by CMS, should be continued once the public health emergency passes, according to a new position statement by the American College of Rheumatology (ACR).

ACR Supports Continued Use of Telemedicine and Reimbursement Parity After COVID-19 Crisis

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month. Since taking office, he has encouraged generic drug competition and the growth of biosimilars in the US healthcare system.

In a note to the FDA, Gottlieb explained that he was stepping down because of the time he has spent away from his wife and 3 young children.

"I know that the opportunity to serve in this role was a privelege, and an endeavor that I'll never be able to replicate in my professional life—the impact of our public health work, the camaraderie, and our ability to improve the lives of Americans," he wrote. "There are many important efforts we undertook together, countless new policies we advanced, and laws we enforced with vigor to protect consumers."

He added that in his final weeks as commissioner, he will continue to cement the work he started and secure the 2020 budget.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” HHS Secretary Alex Azar 

. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family.”

President Donald Trump sent out a tweet thanking Gottlieb for his work:

Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month....

released in 2018 the Biosimilar Action Plan

, which was meant to spur biosimilar competition. The plan addressed 4 key areas in order to spur biosimilar competition:

Improving the efficiency of the biosimilar and interchangeable product development and approval process

Maximizing scientific and regulatory clarity for the biosimilar product development community 

Developing effective communications to improve understanding of biosimilars among patients, providers, and payers

Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products 

 for the year at the JP Morgan Healthcare Conference. These goals included bringing down drug prices through increased competition and a robust biosimilars market.

When Gottlieb was nominated to become FDA commissioner, he was 

 over his industry ties and his opposition to many regulations. Ultimately, he was confirmed mostly along party lines in a 57 to 42 vote.

"Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Azar said. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years.”

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month.

Gottlieb Stepping Down as FDA Commissioner

Biosimilars offer a “big shot” at addressing the high cost burdens patients face for drugs, but they still face a number of barriers in the United States, explained Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, during a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland.

Rifkin highlighted the current high prices patients have to pay for treatments and that the monthly cost of a new cancer drug is $10,000, and that biosimilars offer an opportunity to address those rising costs with lower-cost competitors.

Despite the promise of reducing costs and increasing access, biosimilars have faced big challenges as the manufacturer of the reference product has fiercely defended the originator, prices haven’t been as low as initially expected, and education among providers and payers remains an issue.

“We’ve been hearing about biosimilars for a number of years, but until now, it has been vaporware,” Rifkin said. With another 2 biosimilars expected to be approved by the end of 2018, the challenges facing biosimilars will need to be addressed.

There is going to be a greater need for payer, patient, and provider education to ensure that biosimilars successfully come to market and are used in place of the more expensive reference product. Rifkin noted that after Zarxio had come to market, 1 payer considered it investigational, despite its having FDA approval. Another payer had decided that patients could only get Zarxio if they failed to respond adequately to Neupogen, despite their being the same drug.

Among providers, medical oncologists appear to the be less educated about biosimilars compared with other specialty physicians. The good news, Rifkin joked, is that despite being the least well educated on biosimilars, they were the most willing to accept their lack of knowledge in the area.

“The reason the education lagged behind is because all of us who are busy oncologists don’t want to hear about something that’s coming in 2019, because I’ll pretty much forget that by the end of the day,” Rifkin said.

Rifkin also ran through the major barriers to adoption, which he broke into 3 categories:

Clinical barriers, such as understanding what biosimilars are and whether or not patients can be switched to the biosimilar from the innovator product.

Ease of use barriers, such as whether or not payers will cover the biosimilar, whether the biosimilar is a better deal for patients, and whether using the biosimilar will create more hassle for the clinic and patients.

Economic barriers, such as the cost to patients and the clinic.

Rifkin predicts that 2018 will be important for biosimilars. In 2017, the Supreme Court eliminated the 180-day waiting period after FDA approval to launch a biosimilar, which means that biosimilars can come to market much more quickly once they’re approved, and payers and providers will need to be ready. However, most importantly, biosimilar makers need to ensure a successful product launch.

“Because if you’re product gets approved, and it sits on the shelf at virtually no discount, that really doesn’t help any of us,” Rifkin said. “I think we’re all looking for deep discounts, we’re looking for transparency...to benefit all of our patients, providers, and stakeholders.”

During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland, Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, highlighted the opportunities biosimilars provide to increase access to drugs while decreasing costs, but also the remaining barriers to adoption.

Session Highlights Barriers to Biosimilar Adoption and Lack of Provider, Payer Education

A new online consultation tool may strengthen the interaction between physicians and their patients with rheumatic diseases, according to new research presented at the 2017 American College of Rheumatology Annual Meeting.

Researchers in China developed the new tool to provide more efficient management of chronic illnesses. The Smart System of Disease Management (SSDM) is a series of applications based on clinical data and a mobile app that allows for online consultation.

In China, patients can seek care in any hospital or with any doctor they want, but those with rheumatic disease tend to seek care in large cities, because that is where the rheumatologists are located. This results in patients traveling long distances and even staying at hotels to see a clinician after a long wait.

“It is not uncommon for most Chinese rheumatologists to have to see up to 60 to 100 patients daily.” Fei Xiao, MD, CEO of Cinkate Corporation and a lead author of the study, 

. “Because of the large volume of patients who go to major hospitals for regular clinical care, physicians may only spend three minutes on average with each patient. This limits the time to do objective disease activity evaluations.”

Patients trained to use SSDM are able to perform self-management for their condition, including disease activity scoring of 28 joints, health assessment evaluations, and medication and lab test data entry. The study aimed to determine the benefits of using SSDM for online consultation.

Rheumatologists educated and trained patients on using SSDM, which includes a doctor/patient interface, a self-assessment, medication management, adverse events management, and laboratory records. After patients submit their data to their doctor, the provider may follow-up in person with patients or consult through text or voice with SSDM. Overall, 66.35% of patients said they found their experience with the online consultation “very satisfying.”

More than one-third (35.3%) of the patients who received online consultations lived in a different city than their rheumatologist. As a result, using SSDM saved a significant amount of money. The total fees collected for SSDM consultations was 477,960 yuan RMB; the total cost for patients seeking care at a hospital, including the cost of registration fees, medical expenses, and the average cost of transportation, accommodations, meals, and lost wages was 3,157,200 yuan RMB. In total, the online consultation created a savings of 84.86% for patients.

According to Xiao, patients and providers will benefit from SSDM, with patients more empowered to input data and follow their disease progression, and physicians able to mine and analyze data for research and publication.

“Access to this online program also helps physicians to mine and analyze data for scientific research and publication,” he said. “Based on the trajectory and real-time data, such as disease activity score, lab results, medication and patient’s symptoms, physicians are able to take proactive interventions, and turn passive practice into outcome-driven care. This model can be replicated into the other disciplines and fields of chronic disease.”

Chinese researchers employed a new online consultation tool to improve disease management for patients with rheumatic diseases who travel long distances for a consultation with their rheumatologist and noted significant savings for the patients.

Laura Joszt

ACR Supports Continued Use of Telemedicine and Reimbursement Parity After COVID-19 Crisis

Gottlieb Stepping Down as FDA Commissioner

Session Highlights Barriers to Biosimilar Adoption and Lack of Provider, Payer Education

New Online Consultation Tool Empowers Patients With Rheumatic Diseases, Study Finds