February 2019

Enhanced Co-Author and Conflict of Interest Verification Processes at the Red Journal

By Lisa C. Braverman, MA, Sue S. Yom, MD, PhD, MAS, and Anthony L. Zietman, MD, FASTRO

Conflicts of interest and authorship status in research are attracting increasing scrutiny, with recent high-profile detections resulting in national media coverage, disgrace of respected thought leaders, and pledges for major reform from institutions and individuals alike. In the face of mounting evidence that verifications of authorship status and conflicted relationships are frequently incomplete or weakly enforced by academic journals, the Red Journal, Practical Radiation Oncology and Advances in Radiation Oncology have instituted new processes to encourage the reporting of conflicts of interest with the utmost care, avoid authorship disputes, and help protect authors against allegations of misconduct.

The Red Journal is fully committed to ethical and transparent publication practices. These processes are intended to help individuals recognize if they are being listed as responsible authors on papers without their knowledge and full consent. Additionally, the editorial team is asking each author to independently verify that any relationship that could be perceived as a conflict of interest has been disclosed. For authors at U.S. institutions, this verification includes checking Open Payments.

To verify co-authorship and conflict of interest disclosures, authors must click a link they receive in an automated email. This link will take them to the Red Journal’s submission system, where they will be instructed to log in and answer two questions about their potential conflicts of interest. Answers to commonly asked questions about the process and troubleshooting tips can be found in the Winter 2018 ASTROnews.

In the first four weeks of instituting these new co-author/conflict of interest verifications, more than 1,000 Red Journal authors completed the questionnaires. Several authors discovered they were listed on papers they did not co-author, and a few oversights in conflict of interest reporting were discovered. We believe this process has already produced tangibly improved protections for our authors.

Undoubtedly, there are challenges associated with this increased form of author engagement. Most of these are technical in nature. Verification can only happen through clicking the personalized links sent in the co-author emails. We also recognize that this system, while technically more burdensome, remains imperfect. Open Payments listings are not exhaustive or always verifiably accurate, and they do not exist for many U.S. authors, and not at all for those practicing outside the U.S. Our staff is committed to working through these barriers and improving these systems as the technological means become available.

Despite current limitations, our editorial team believes the benefits and protections resulting from verification of authorship and conflict of interest outweigh the inconveniences, in the interest of maintaining the highest standards of ethics in publication for our journal and for our authors. Please feel free to comment or ask questions.

Posted: February 20, 2019 | 1 comments

RO-APM: What we know, what we don’t and what it all means

By Anne Hubbard, MBA, ASTRO's Director of Health Policy

On February 12, the Centers for Medicare and Medicaid Services (CMS) issued a transmittal to Medicare Administrative Contractors related to the implementation of a radiation oncology alternative payment model (RO-APM).  This is the surest indication since HHS Secretary Alex Azar’s comments last fall that a RO- APM is on the way. The transmittal, posted briefly by mistake and then pulled down, included just a few details about the model that likely raised more questions than provided answers.

What we know

According to the transmittal, the RO-APM will be applicable in both hospital-based and freestanding settings, so it effectively replaces the Medicare Physician Fee Schedule (MPFS) and Hospital Outpatient Prospective Payment System (HOPPS) for practices participating in the model. The model provides prospective payment for a 90-day episode of care that includes separate PC/TC payments for radiation oncology services. The separate PC/TC payments are made in two installments. The first payment is issued at the beginning of the episode of care when a participant bills one of the new RO-Model specific HCPCS codes assigned to one of 17 disease sites and one of two RO-Model modifiers (PC and TC). The second installment will be issued at the conclusion of the episode. The PC payments are made to the radiation oncologist (identified by NPI/TIN) and cover delivery of care for 17 different cancer types. The model is expected to be mandatory for randomly selected Core-Base Statistical Areas (CBSA).

What we don’t know

While the directive provided us with a glimpse of the model’s design, there is still plenty we don’t know about the RO-APM. While it’s clear the intention is to apply the model in both freestanding and hospital-based settings, it is unclear how payments will be made to those freestanding practices that bill globally (no PC/TC split). We also don’t know what is included in the list of 17 disease sites, but a clue may be found in information CMMI shared at a May 2017 radiation oncology stakeholder meeting.

Making sure the RO-APM meets Advanced APM requirements, so participating physicians can enjoy the 5 percent bonus as prescribed in the Medicare Access and CHIP Reauthorization Act of 2015, will be critical. Based on the limited information in the transmittal, it is unclear whether nominal risk requirements will be met. Most importantly, we don’t know how the payment methodology is being constructed. How the Agency plans to establish benchmark and target prices, as well as whether there will be a blend with national averages, will be very important considerations. Since the model is prospectively paid, there is no reconciliation of payment and no clawback for overspending, which have proven to be burdensome for other models. There is also a lack of information on quality measures and electronic health records certification requirements that are also important to obtain Advanced APM status.

Finally, the mandatory component is still unclear. While CMS states that they plan to mandate participation in selected CBSAs, we don’t know how many CBSAs will be on that list, thus we don’t know just how many practices will be required to participate.  On the flip side, will practices not required to participate be allowed to opt-in to potentially achieve the 5% bonus?  The other big question associated with mandatory participation is whether it will be immediate or phased in. If other mandatory models serve as an indicator, a phased in approach is possible.

What it all means

While there are plenty of unknowns, it is clear that CMS is committed to rolling out a RO-APM and it’s coming fast. We anticipate that many of the unknown aspects of the model will be revealed when CMS issues a notice of proposed rulemaking (NPRM) describing the model. Not only will that answer many of our questions, it will also give us an opportunity to thoughtfully react to the proposal and engage with the Agency on any necessary changes that should be implemented before the model is finalized.

Once the model is issued through the regulatory process, ASTRO will assess the model, review the implications of the proposed rule and provide comments to CMMI on potential modifications that need to be considered before moving forward. Ultimately, we want to ensure that the RO-APM allows radiation oncologists an opportunity to actively participate in an advanced APM that rewards them for delivering high quality care; stabilizes payment rates across practice settings; and ensures patient access to appropriate radiation oncology services.

Radiation oncology practices should look closely at the transmittal and ASTRO’s proposal to help prepare for a likely dramatic change in the way Medicare pays for radiation therapy services.

Posted: February 14, 2019 | 0 comments

#WomenWhoCurie Day

By Adrianna Henson Masters, MD, PhD

Despite the increasing percentage of female medical students, radiation oncology residency applicant numbers have been declining in recent years. It is among the five lowest specialties for the proportion of female applicants. This disappointing trend of gender disparity only worsens at the higher levels of leadership. In order to provide a network for the promotion and support of women in radiation oncology, the Society for Women in Radiation Oncology (SWRO), was founded in 2017 by a group of residents: Drs. Virginia Osborn, Anna Lee, Ashley Albert, Laura Dover, Courtney Hentz, Adrianna Masters, Lindsay Puckett, Kaleigh Doke and Genevieve Maquila with the guidance of faculty mentors Drs. Parul Barry and Reshma Jagsi.

The mission of SWRO:

  • To provide a platform to promote women in the field of radiation oncology through networking and mentoring opportunities for women focusing on career development and the steep transition into leadership roles in our field.
  • To provide a forum to support trainees and faculty who are working to build connections with established women in radiation oncology through sponsorship at all levels.
  • To champion gender equality in oncology, acknowledging the specific challenges of women, and removing barriers to the advancement of women in professional and academic settings.

Emboldened by the victory of such social media campaigns such as #ILookLikeASurgeon, SWRO decided to launch a campaign to highlight the vital role of women in radiation oncology. It was also an opportunity to pay homage to one of the most pivotal leaders in the discovery of radiation and its clinical utility.

Marie Curie was a founder of radiation physics and proposed the theory of radioactivity. She is the only person to be awarded a Nobel Prize in two disciplines. She is also one of three women who have earned the Nobel Prize in physics. In honor of her legacy and the #RadOncWomen whose exceptional dedication diligently advances the field of radiation oncology, SWRO along with ASTRO, and the Radiation Oncology Women’s Facebook group, launched the first annual #WomenWhoCurie Campaign on November 7, 2018.

The world-wide radiation oncology community joined together in an overwhelmingly positive flurry of activity on various forms of social media including Twitter, Instagram and Facebook to post photos of themselves or women that inspire them in radiation oncology. Every inhabitable continent in the world was represented as over 700 people contributed to more than 2,000 photos and messages. The inspiring photos spanned multiple different roles in radiation including physicists, physicians, nurses, therapists, dosimetrist and patient advocates to name a few. Multiple organizations, hospitals and journals contributed, and @ASTRO even generated a twitter moment along with our own @S_W_R_O to commemorate the event. Men and women echoed the importance of women in radiation medicine with over 1.1 million impressions linked to the #WomenWhoCurie hashtag, as measured by Symplur analytics.

We hope that this momentum will continue to bring to the forefront of discussion the need for gender equity in radiation oncology. We represent a small part of the physician community as radiation oncologists in general, and an even tinier portion as female radiation oncologists, but the overwhelming sentiment from #WomenWhoCurie day is that even a small group can make a huge impact on the lives of our patients. For a more detailed report about the campaign and the #WomenWhoCurie hashtag analytics, read our recently published open access article “#WomenWhoCurie: Leveraging Social Media to Promote Women in Radiation Oncology” in Advances in Radiation Oncology.

Posted: February 13, 2019 | 0 comments

What’s Happening at the NRC?

By Cindy Tomlinson, ASTRO’s Senior Patient Safety and Regulatory Affairs Manager

The U.S. Nuclear Regulatory Commission (NRC) has been active over the past 12 months – updating medical event reporting criteria, issuing a revised licensing guidance for Gamma Knife and examining training and experience requirements for radiopharmaceuticals. These new and emerging rules and regulations can have a significant impact on the practice of radiation oncology.

The NRC is responsible for formulating policies and regulations governing nuclear reactors and radioactive materials, including those materials used for the diagnosis and treatment of disease. ASTRO closely monitors and actively engages with the NRC to support regulations that balance important safety considerations and patient access to lifesaving radiation therapies.

Here’s the latest update on major radiation therapy-related issues being discussed in the halls of the agency:

Medical Events

After more than a decade, modifications to 10 CFR 35, Medical Use of Byproduct Material, went into effect on January 14, 2019. The biggest change to the regulations was an ASTRO-supported move from a dose-based definition of medical event to an activity-based definition.

Physical Presence

On January 10, 2019, the NRC released revised licensing guidance for Gamma Knife Perfexion and Icon. The guidance requires an authorized user (AU) and an authorized medical physicist (AMP) to be physically present during the initiation of all patient treatments, with the AMP and either an AU or a physician under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, physically present during the continuation of treatment.

This new guidance is consistent with current physical protection requirements for high-dose-rate brachytherapy. ASTRO has long supported the importance of authorized user (AU) presence during Gamma Knife procedures to ensure patient safety. If you use Gamma Knife, how are you implementing this new guidance? Answer in the comments.

Training and Experience

The NRC staff, as well as the NRC’s Advisory Council on the Medical Use of Isotopes (ACMUI), have been reviewing the training and experience requirements found in 10 CFR 35, Medical Use of Byproduct Material, including the use of radiopharmaceuticals. The NRC has been under pressure to lessen the requirements under the so-called “alternate pathway,” which allows those not already board certified to become authorized users (AUs) provided that they meet certain criteria. ASTRO has long argued that reducing the current requirements will put patients at risk and is ill-advised.

The NRC is also interested in receiving comments on whether the agency should have different requirements for different types of radiopharmaceuticals. ASTRO believes that tailored requirements will cause confusion and are not necessary, as the training is the same regardless of the categorization of the radiopharmaceutical. In addition to sending our own comments to the NRC, ASTRO, together with the American Association of Physicists in Medicine (AAPM), American Brachytherapy Society (ABS), American College of Radiology (ACR), Health Physics Society (HPS), and Society of Nuclear Medicine and Molecular Imaging (SNMMI), sent a separate letter outlining why the current requirements should not be changed. It is important to note that the NRC is currently in a fact-finding stage – no changes in regulations have been proposed. What are your thoughts on obtaining AU status – outside of board certification – for radiopharmaceuticals? Are there challenges for patients in accessing an AU in your community or others? Answer in the comments.

ASTRO will continue to monitor and participate in NRC’s deliberation process. If you have questions or concerns, please contact Cindy Tomlinson, ASTRO’s Senior Patient Safety and Regulatory Affairs Manager.

Posted: February 5, 2019 | 0 comments