By Dave Adler, Vice-President, Advocacy
ASTRO leaders, staff and consultants have been analyzing closely the radiation oncology alternative payment model (RO Model) unveiled July 10 and have identified several preliminary key issues.
ASTRO has hired an analytics firm to help analyze the model, but we are still weeks away from getting a clearer picture on whether CMS priced the RO model episodes appropriately and what impact the various model parameters will have on ASTRO members and patients. Analyzing the complex and comprehensive model is a massive undertaking with a rapidly approaching comment deadline of September 16.
While ASTRO is just beginning to digest the model, here are some preliminary perspectives:
- Stable Payments, Higher Quality. ASTRO is pleased that the Centers for Medicare and Medicaid Services (CMS) is moving forward with a model that provides an opportunity for some radiation oncologists to participate in value-based care arrangements, and we see some strong potential for it to achieve our goals of incentivizing higher quality care and stabilizing payments in the long term. The model construct overall will help drive more guideline concordant care, and ASTRO is committed to working constructively with CMS and Congress to improve the model before it’s implemented.
- Mandatory Participation. The model would be mandatory for more than 1,000 radiation oncology practices, which is a significant concern. While ASTRO understands CMS rationale for making the model mandatory, we believe the model should at least start as voluntary until we better understand how it works. Should CMS persist with a mandatory model, 40% of episodes is unwarranted and far beyond what is needed to adequately evaluate the model while still achieving savings.
- Opt Out/In. If the model is mandatory, there should be consideration of a hardship exemption for practices to opt out and an opportunity for practices that want to participate to opt in to the model. Both can be done without compromising the evaluation of the model or savings. Radiation oncology practices deserve an opportunity to choose whether to test their participation in value-based care arrangements.
- Timing. It’s very difficult to imagine that more than 1,000 practices will be notified in early November of their required participation and then start in the model on January 1, 2020. Participating in the model will take far more effort than flipping a switch. CMS should delay implementation until at least April 1, 2020, or consider a rolling start.
- Discounts and Withholds. While the prospective payment is a positive, the discount factors of 4% and 5%, respectively for professional and technical payments, combined with additional withhold requirements for quality (2%), incorrect payments (2%) and, in the future, patient experience (1%), seem excessive and could create cash flow issues for many practices, particularly those with small margins, and undermine the value of prospective payments. In addition, we’re concerned that the adjustments could disadvantage efficient practices.
- APM Incentive Payment. The 5% Advanced APM incentive payment would apply only to professional component services, despite technical payments being subject to the discounts and withholds. According to the Medicare Access and CHIP Reauthorization Act (MACRA) definition of “professional covered services,” the APM incentive payment should apply to payments based on the physician fee schedule, which should include freestanding technical payments. CMS is waiving that requirement due to concerns about a shift in site of service. CMS should find an approach that allows for the incentive payment to be applied to these technical payments, as MACRA intended.
- Episode Payment. We must carefully assess how CMS is calculating the episode-based national payment rates and numerous adjustments to ensure that these payments are fair for a diverse group of radiation oncology practices and different modalities. While some national base rates appear reasonable, others seem low. In particular, we need to better understand whether the base rates properly account for certain common procedures, such as brachytherapy as a boost to external beam treatments, and referrals to other radiation oncologists for specialized services.
- Innovation. The model does not seem to account for the adoption of new technology and new service lines during the term of the model and beyond. This needs further examination, as it could stifle innovation in a rapidly advancing field. There should be consideration of an adjustment to the episode or paying fee-for-service (FFS) for new technology/service lines until there’s enough cost data to incorporate into the episode payment.
- Quality. We believe the selection of quality measures is appropriate, and we are particularly pleased with the emphasis on a patient safety organization that collects radiation oncology specific information.
- Compliance Burden. It’s likely that CMS is underestimating the burden on participating practices, particularly in terms of collecting additional clinical data and monitoring information. It will be critical that CMS only collects what it absolutely needs and does so in the least burdensome way, particularly if the Agency is forcing practices to take on this additional burden by mandating participation.
- All Payer. The model is Medicare FFS only and not an all-payer model. It’s not clear to us why it’s limited in this way. We are concerned about the proliferation of different models among different payers and the confusion and difficulty this will cause for radiation oncology practices.
- Site Neutral. We need to further examine the way CMS is proposing to create national base rates for episodes in a site-neutral manner to ensure an even-handed approach that does not disadvantage freestanding or hospital-based clinics.
ASTRO is looking for input from members and radiation oncology stakeholders on these issues and others. Please send your suggestions to email@example.com.
In addition, ASTRO has begun engaging congressional leaders and radiation oncology’s legislative champions to inform them of the model and ASTRO’s initial concerns, and to consider next steps to improve the RO Model before it’s finalized in November.
By Lisa Braverman and Dawit Tegbaru, Managing Editors
The world of scholarly publishing is rapidly evolving. Here at ASTRO, the journals team works hard to ensure the Red Journal, Practical Radiation Oncology (PRO) and Advances in Radiation Oncology remain leaders in the field. Below, we offer updates about several recent events and initiatives – but we would love to hear from you! Please direct questions and comments about the Red Journal to Lisa Braverman, and Practical Radiation Oncology and Advances in Radiation Oncology to Dawit Tegbaru.
Impact Factors: PRO’s First and the Red Journal Exceeds 6.0
Clarivate Analytics released the 2019 Journal Citation Report (JCR) last month and we couldn't be more excited about Practical Radiation Oncology securing an impressive impact factor (IF) of 2.794! While it is important not to overly depend on impact factors for research assessment, the JCR has a reputation of excellence and integrity for its meticulous selection of top journals. Being selected for Clarivate's Science Citation Index Expanded undoubtedly helps enhance the discoverability of PRO and raise the profile of radiation oncology. PRO is ranked 129/229 in oncology and 46/129 in radiology, nuclear medicine, and medical imaging.
The Red Journal also received wonderful news. For the first time in its history, the journal secured an impact factor (IF) greater than 6.0 – 6.203, in fact. Last year’s IF was a strong 5.554, and this year’s leap is truly tremendous. The Red Journal ranked #30 out of 229 oncology journals and #8 out of 129 radiology, nuclear medicine, and medical imaging journals (up from #40 and #11, respectively).
Congratulations and thanks are due to the editors, authors and reviewers of all three journals for their dedication, investment and labor.
PRO Editor Appreciation
As Practical Radiation Oncology (PRO) prepares for its editor transition over the course of the next year, Anthony Zietman, MD, FASTRO offers a fitting tribute to Dr. Lee in “The ‘Lee Decade’: Bringing PRO from Conception to Maturity.” Dr. Zietman gives a brief history of PRO’s conceptualization and development, and highlights Dr. Lee’s many contributions to the journal and field.
Discussing Gender, Diversity and Inclusion in Radiation Oncology
How do radiation oncologists at different stages of their careers experience gender and diversity? How might programs strive for greater equity, and how is medicine uniquely positioned to embrace diversity? The August 1 issue of the Red Journal includes a special feature titled “Women in Radiation Oncology: Past, Present and Future.” The feature honors the late Eleanor Montague, MD, and contains articles about gender equity in radiation oncology, chairs of RO programs, annual meeting speakers and resident experiences. To accompany this section and add dynamic additional perspectives to the discussion, Editor-in-Chief Anthony Zietman, MD, FASTRO, recorded a wide-ranging podcast on equity and inclusion with Whitney Beeler, MD; Reshma Jagsi, MD, PhD, FASTRO; and Sue Yom, MD, PhD, MAS.
New CME Activities
In addition to traditional, SA-CME credit for select articles in the Red Journal and Practical Radiation Oncology, two new types of journal activities are available through ASTRO Academy. Each December, Red Journal Oncology Scans from that year are grouped together for a seven-credit activity. Additionally, CME is now being offered for all Gray Zone cases and expert opinions. Gray Zone CME is a member-only benefit!
Interested in voicing your opinion in future Red Journal features? Consider signing up to submit a case proposal or become an expert for the always-popular Gray Zone. Write us at firstname.lastname@example.org with any questions!
Stay tuned for information about editor roundtables at the annual meeting!
By Ana Ponce Kiess, MD, PhD, and Freddy E. Escorcia, MD, PhD
Promoting Science through Research and Training Subcommittee
In the past six years, we have seen FDA approval of three novel radiopharmaceutical therapies (RPTs): Radium-223 for bone metastases of castrate-resistant prostate cancer, [177Lu]Lu-DOTATATE for neuroendocrine carcinomas, and [131I]I-MIBG for malignant pheochromocytoma and paraganglioma. But with [177Lu]Lu-PSMA agents and many other drugs also in clinical development, are we only seeing the tip of the iceberg?
Paul Wallner, DO, FASTRO, recently provided a timely historical perspective and summary of current clinical uses of radiopharmaceuticals in the spring issue of ASTROnews. While the recent ASTRO Scope of Practice survey shows that only 30% of radiation oncologists currently use RPTs, it is one of the areas of highest interest for expanding scope of practice. At the upcoming ASTRO Annual Meeting in Chicago, a half-day Theranostics Training Workshop on Saturday, September 14, will provide a refresher on relevant physics, pharmacology and radiobiology as well as logistical and practical training in clinical use of radiopharmaceuticals. It will include specific breakout sessions on Ra-223, [177Lu]Lu-DOTATATE, [177Lu]Lu-PSMA agents, [131I]I-MIBG and [90Y]Y-Microspheres, and will also cover important infrastructure, workflow and financial considerations.
Ongoing research in RPTs is even more exciting and demonstrates the depth of the “iceberg” under the surface. There are currently more than 200 clinical trials listed in this category on clinicaltrials.gov. Industry partners are highly committed to the development of RPTs, and academic research has unleashed the potential for combining molecular targeting with the power of radiation to damage DNA and modulate the tumor microenvironment and immune response.
Generally, there are three main pieces of the RPT puzzle: (1) tumor-selective targeting ligands, linked to (2) a chelating group with selectivity for (3) a therapeutic radioisotope. While identifying tumor-specific molecules is very challenging, the advent of next generation sequencing has significantly improved this pursuit, yielding differentially expressed genes in cancers when compared with normal tissue.
Tumor antigen-selective full-length antibodies (~150 KDa) and antibody fragments (25-75 KDa) have been exploited for several decades by pioneers in the field, ultimately resulting in FDA approvals. Newer methods to engineer diverse proteins and peptides of varying sizes with selectivity to virtually any target of interest has resulted in a myriad of molecules that could be used as ligands for RPT agents. Unsurprisingly, the size of these molecules plays a critical role in both the pharmacokinetics of the drug as well as the penetration of solid tumors, and the agents that have received the most interest are peptide (e.g., DOTATATE) or small molecule (e.g., PSMA targeting ligands) based. Engineered antibodies such as minibodies (~75 KDa), single-chain variable fragments (scFvs, ~25 KDa) and single domain antibodies (~15 KDa) have also demonstrated promise as tumor specific ligands for radiopharmaceutical-based imaging and therapy.1-3 Other molecules such as Affibodies and DARPins have also been explored with varying levels of success.
The diversity and quality of radioisotopes available for preclinical and clinical use has also improved. The Department of Energy has made significant commitments toward ensuring that this critical resource is available for domestic development. Investigators typically select the radioisotope physical half-life to match the blood half-life of the scaffold to which it is coupled. One notable feature that has been exploited is the pairing of a diagnostic imaging molecule that can highlight tumor distribution in vivo prior to administration of the therapeutic partner (e.g., same scaffold, different radioisotope). For example, [68Ga]Ga-DOTATATE is the imaging partner to the therapeutic [177Lu]Lu-DOTATATE.
The type of radioactive emission (e.g., beta, alpha) of a given radionuclide is also important and expected to have different therapeutic and safety considerations. The high linear energy transfer (LET) and short path length (a few cell diameters) of alpha-particles, for instance, confers significant potential for tumor cell kill with sparing of surrounding tissue if targeted specifically to tumors. Theory has become reality as specific cases of Ac-225 coupled to PSMA-targeting ligands have resulted in not only radiographic, but also biochemical complete responses, even in patients who were refractory to the same ligand coupled with Lu-177.4-5 However, there is also evidence of increased side effects compared to beta emitters, such as dose-limiting xerostomia with [225Ac]Ac-PSMA agents.6 Recent reports of Pb-212, another alpha-emitter, conjugated to octreotate (the molecule from which DOTATATE is derived) in patients have demonstrated tolerability.
Importantly, significant work remains to be done in standardizing absorbed dose estimates of systemically administered RPTs, accounting for not only radioisotope and ligand particularities, but also heterogeneity in tumor burden across patient populations. Furthermore, systematic assessments of normal organ dose and function in the setting of therapeutic doses of radioisotopes are needed to rival those we use daily for external beam constraints for organs at risk.
As Dr. Wallner highlighted, this is one of several waves of interest in RPTs over the years. However, this generation of emerging RPTs is likely to continue expanding in the context of advances in identifying tumor-selective markers, ligand generation and radioisotope availability. Radiation oncologists, in partnership with our colleagues in nuclear medicine and medical oncology, are poised to deliver the promise of these new agents safely and effectively to our patients.
Do you use radiopharmaceutical therapies in your practice? Please share your experiences in the comments below.
Learn more about the Theranostics Workshop, taking place on Saturday, September 14, at the ASTRO Annual Meeting in Chicago.
Dr. Ana Kiess is assistant professor and residency program director in the Department of Radiation Oncology at Johns Hopkins University. Dr. Freddy Escorcia is an assistant clinical investigator within the Molecular Imaging Program and the Radiation Oncology Branch at the NCI Center for Cancer Research where he heads the Laboratory of Molecular Radiotherapy.
- Pandit-Taskar N, O'Donoghue JA, Ruan S, Lyashchenko SK, Carrasquillo JA, Heller G, et al. First-in-Human Imaging with 89Zr-Df-IAB2M Anti-PSMA Minibody in Patients with Metastatic Prostate Cancer: Pharmacokinetics, Biodistribution, Dosimetry, and Lesion Uptake. J Nucl Med. 2016;57:1858-64.
- Zettlitz KA, Tavare R, Tsai WK, Yamada RE, Ha NS, Collins J, et al. (18)F-labeled anti-human CD20 cys-diabody for same-day immunoPET in a model of aggressive B cell lymphoma in human CD20 transgenic mice. Eur J Nucl Med Mol Imaging. 2019;46:489-500.
- Rashidian M, Ingram JR, Dougan M, Dongre A, Whang KA, LeGall C, et al. Predicting the response to CTLA-4 blockade by longitudinal noninvasive monitoring of CD8 T cells. J Exp Med. 2017;214:2243-55.
- Kratochwil C, Bruchertseifer F, Giesel FL, Weis M, Verburg FA, Mottaghy F, et al. 225Ac-PSMA-617 for PSMA-Targeted alpha-Radiation Therapy of Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2016;57:1941-4.
- Sathekge M, Bruchertseifer F, Knoesen O, Reyneke F, Lawal I, Lengana T, et al. (225)Ac-PSMA-617 in chemotherapy-naive patients with advanced prostate cancer: a pilot study. Eur J Nucl Med Mol Imaging. 2019;46:129-38.
- Kratochwil et al. 225Ac-PSMA-617 for PSMA-Targeted α-Radiation Therapy of Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2016;57(12):1941-44.