Mary Caffrey

 is the subject of proposed changes under CMS’ annual Medicare Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center (ASC) Payment System rulemaking. For several years, CMS has proposed a model that would test whether making site-neutral payments to physician practices, including free-standing radiation therapy centers, would “preserve or enhance” care quality while reducing Medicare spending.

However, the head of the organization representing radiation 

 criticized CMS’ plans; Thomas J. Eichler, MD, chair of American Society for Radiation Oncology (ASTRO), declared, “Access to radiation therapy for people with cancer is under attack.”

The RO Model has been discussed since 2014. ASTRO has said it agrees with the concept of value-based care but has disagreed with CMS on reimbursement levels and whether to make the model mandatory. Then, in the wake of 

 and missed screenings due to the pandemic, efforts to implement a 5-year performance period under the RO Model were extended: first under the 

 and again under the Consolidated Appropriations Act, 2021. The appropriations act delayed the start of the RO Model until January 1, 2022.

 for the 2022 Medicare HOPPS and ASC Payment System Rule addressed a number of areas that have been affected by the COVID-19 public health emergency, including the RO Model. According to a summary from CMS, the proposed 2022 rulemaking puts forth the following:

The 5-year performance period would begin on January 1, 2022, and end on December 31, 2026

The baseline period would shift from 2016-2018 to 2017-2019.

Discounts would be lowered to 3.5% for the Professional Component and 4.5% for the Technical Component

Brachytherapy would be removed from the list of modalities under the RO Model; it would be paid under fee-for-service

Cancer inclusion criteria would be revised, and liver cancer would not meet the criteria for the model

If a beneficiary switches from Medicare to Medicare Advantage during an episode before treatment is complete, CMS would deem the episode incomplete, and radiation therapy would be paid the traditional Medicare rate

CMS would adopt an “extreme and uncontrollable circumstances” policy, which would offer flexibility to limit reporting and other administrative burdens of RO Model participation; payment would be adjusted as necessary

In its proposal, CMS calls for excluding hospital outpatient departments that are taking part in the Community Transformation track of the CHART Model from participation in the RO Model. In these cases, the same policy for overlap between the RO Model and the Medicare Shared Savings Program would apply.

In his statement, ASTRO’s Eichler asked why CMS has “singled out” radiation oncology for payment cuts when cancer incidence rates are rising, following the delayed screenings seen during COVID-19.

“By proposing to cut high-value radiation treatments by as much as 22% and proceeding with more than $160 million in reductions under the RO Model, CMS is jeopardizing the ability of the nation’s radiation therapy professionals to continue to provide essential care for their patients now and in the future,” he said. “Access to life-saving cancer treatments will suffer, and the viability of clinics already reeling from the pandemic will be at considerable risk if these proposals are finalized.”

ASTRO called on President Joe Biden, given his history of advocacy for patients with cancer, to intervene in changing the RO Model proposals and other Medicare Physician Fee Schedule cuts. Eichler said the group would once again appeal to Congress for direct relief if its plea to the administration is not successful.

The radiation oncologists, he said, are “committed to value-based care and to constructively engaging with CMS on reasonable ways to improve these policies. We are eager to help President Biden achieve his goal of ending cancer as we know it, and we are developing promising approaches to reduce health care disparities in cancer treatment. These difficult policy challenges require investments in our human and technological cancer care infrastructure that would be virtually impossible under the current proposals.”

Articles

Due to unprecedented disruption and missed screenings during the pandemic, efforts to implement a 5-year performance period under the Radiation Oncology Model were extended twice.

CMS Seeks Changes to Radiation Oncology Model; ASTRO Responds

The combination of sacubitril-valsartan, sold as Entresto, that is currently the only FDA-approved for patients across the spectrum of heart failure, may have additional benefits for those with heart failure with reduced ejection fraction (HFrEF), findings of a pilot study show.

 examined the effect of the first-in-class angiotensin receptor neprilysin inhibitor (ARNI) on chronic sympathetic nervous system (SNS) overactivity. Sacubitril-valsartan has been shown to cut the risk of death from cardiovascular causes as well as hospitalization from heart failure for those with HFrEF.

When the SNS is unregulated, it can lead to high blood pressure and elevated heart rate. The single-arm, open-label prospective study sought to examine the physiological benefits of sacubitril-valsartan; the pilot looked at how the drug inhibited SNS effects in patients with HFrEF, thus offering additional benefits beyond those already demonstrated in clinical trials.

The pilot study was very small, with just 9 patients who were all stable in either New York Heart Association Class II or Class III. Patients with HFrEF were assessed; their muscle sympathetic nerve activity (MSNA) heart rate, and arterial blood pressure were assessed; their average age was 69 years, with a body mass index (BMI) of 28.6 kg/m2. All were on guideline directed treatment and were later started on sacubitril-valsartan. After 2 months, all measurements were repeated, with the following results:

Sacubitril-valsartan reduced MSNA burst frequency; patients went from 43 ± 10 bursts/min to 36 ± 10 bursts/min; 

Burst incidence also declined, from 68 ± 16 bursts/100 heartbeats to 55 ± 16 bursts/100 heartbeats; 

Heart rate and blood pressure were unchanged following treatment; 

According to the authors, “The preliminary findings provide new evidence regarding the ability of sacubitril-valsartan to rapidly reduce SNS activity in patients with HFrEF, suggesting the presence of a novel sympathoinhibitory effect of this new drug class.”

Bunsawat K, Ratchford SM, Alpenglow JK, et al. Sympathoinhibitory effect of sacubitril-valsartan in heart failure with reduced ejection fraction: a pilot study. 

Published online June 24, 2021. doi: 10.1016/j.autneu.2021.102834

When the sympathetic nervous system is unregulated, it can lead to high blood pressure and elevated heart rate. 

Pilot Suggests Additional Benefits of Entresto in Patients With HFrEF

DaVita, 1 of 2 dominant players in US dialysis care, and Kent Thiry, its former CEO, were indicted today on federal antitrust charges, with the indictment alleging that the company and the onetime CEO conspired with competitors not to compete for certain employees.

The indictment alleges there were 2 separate conspiracies. The first count charges DaVita and Thiry with conspiring with Surgical Care Affiliates (SCA) and its affiliates, who were charged in January, and the second alleges that DaVita conspired with a different, unnamed health care entity. The indictment alleges the conspiracy with SCA from February 2012 until July 2017; the second conspiracy began in April 2017 and continued until as late as June 2019, according to a statement from the Department of Justice.

Both DaVita and Thiry were charged with 2 counts of violating the Sherman Antitrust Act.

“Those who conspire to deprive workers of free-market opportunities and mobility are committing serious crimes that we will prosecute to the full extent of the law,” said Acting Assistant Attorney General Richard A. Powers of the Justice Department’s Antitrust Division. “We are grateful for our partnership with the FBI and our shared commitment to rooting out illegal collusion targeting labor markets.”

Assistant Director in Charge Steven M. D’Antuono, of the FBI’s Washington Field Office, added, “These charges show a disturbing pattern of behavior among health care company executives to conspire to limit the opportunities of workers.”

The defendants are scheduled to appear July 20 before US Magistrate Judge Kristen L. Mix of the US District Court in Colorado. DaVita faces a maximum fine of $100 million per count, while Thiry faces a maximum penalty of 10 years in prison and a $1 million fine per count, according to the statement.

Karen Crummy, a spokeswoman for Thiry, issued a statement refuting the charges.

“These allegations are false and rely on a radical legal theory about senior executive recruitment without precedent in U.S. history. The government took steps to ignore – and even hide – key evidence. The facts bear it out decisively: No antitrust violations occurred, these companies hired DaVita executives for years, and the companies are not competitors.”

DaVita and Fresenius Medical Center North America 

 both US and North American kidney care; DaVita’s 2020 US market share was estimated at 37% while Fresenius’ was pegged at 35%, whereas smaller providers are in the single digits. In recent years, CMS has tried to create new payment models and shift more dialysis to home-based care, but the agency has met resistance to some changes. DaVita's most recent 

 for 2020 reported annual revenue of $11.5 billion.

Dialysis is a growing and lucrative business because the number of people who need treatment is increasing, due to an aging population and rising obesity rates. Patients may need dialysis due to end-stage renal disease brought on by diabetes or perhaps due to an acute injury to the kidney during an accident or surgery. In dialysis, an machine does the work that the kidneys would do to clean the blood of toxins, excess salts, and water; it must be done several time a week for the person to stay alive until a transplant occurs, if the person is healthy enough to receive one.

More patients are experiencing kidney failure due to COVID-19.

The dialysis company faces a $100M fine for each of 2 antitrust counts.

DaVita, Former CEO Indicted for Market Collusion

The American Society of Clinical Oncology (ASCO) and the Community Oncology Alliance (COA) today released updated standards for the Oncology Medical Home (OMH), putting renewed emphasis on the importance of palliative care and ASCO’s 

, which seek promote safety and best practices in the administration of chemotherapy.

A joint statement from the 2 groups states that the new standards offers a roadmap for delivering “equitable, high-quality cancer care.

“In releasing the new standards, ASCO and COA seek to achieve a broad consensus among all stakeholders—including patients, clinicians, payers, purchasers, and employers—on what patients with cancer should expect and receive from their cancer care teams,” the groups said. Details on the new standards were published 

In their statement, ASCO and COA say that the standards “provide an opportunity for the entire oncology community to work towards a value-based model of care that will benefit all patients with cancer.”

“Every single patient has the right to high-quality, evidence-based, and cost-effective cancer care. However, our challenge as clinicians and as a broader oncology community has been to define what that high-quality cancer care looks like,” ASCO President Everett E. Vokes, MD, FASCO, said in the joint statement. “These new, comprehensive standards will remove ambiguity and serve as a strong foundation for all stakeholders to work together to ensure that every single person receives the care they deserve, throughout the entire patient journey.”

COA members have been working with OMH standards since 2012; the effort grew out of an earlier initiative on the patient-centered medical home. The idea of creating standards for care coordination, informed decision making that involves both doctor and patient, and communication standards that ensure patients and families are active participants in cancer care—that care is something done 

 them—guided the development of CMS’ Oncology Care Model (OCM), which is set to expire next year.

“These new OMH standards provide oncology practices with a single set of cancer care delivery expectations that benefit patients, payers, employers, and other stakeholders,” said COA President Kashyap Patel, MD. “As practices transition into value-based care delivery, those that adopt this framework will be able to focus on a standardized process that measurably demonstrates high-quality, patient-centered, and efficient care.”

The new joint standards are the basis of an upcoming 2-year, ASCO-led OMH certification pilot, which will be detailed over the next few months. The standards will cover 7 areas of cancer care, including 2 new areas, or domains, that have been designed since the original set. They are:

(1) patient engagement, which includes shared decision-making

(2) access to care in the right place at the right time

(3) value-based treatment, including documentation of the use evidence and clinical pathways, and referral to clinical trials

(4)access to equitable, comprehensive, and coordinated, team-based care

(5) continuous practice quality improvement, including the use of data and patient-reported outcomes

(6) advance care planning, palliative, and end-of-life care, including discussions of goals

(7) adherence to chemotherapy standards based on QOPI certification program standards

Bo Gamble, COA’s director of Strategic Practice Initiatives, told 

® that the new standards were developed with multistakeholder a team of physicians, a nurse, patient advocates, and leaders from employer coalitions who fund healthcare. The updated standards reflect the addition of the domains to elevate the importance of end-of-life care and adherence to QOPI certification, he said.

The hope is that payers can coalesce around a common set of pay-for-performance standards, as least with regard to care delivery. All oncology payment models have 3 basic elements, Gamble said: care delivery, payment methodology, and performance measures. He pointed to research COA presented that showed its members were dealing with up to 35 different 

“It’s gotten crazy,” Gamble said. Such diversity becomes impossible for practices to manage. It would be preferable, he said, to reach agreement with payers to at least standardize the platform for care delivery, with payers differing on the payment methodology.

Some experts have said a multimodel system can be unethical, if physicians feel the evidence points to one method being superior.

Will payers buy in? Gamble is encouraged by early discussions as COA works with ASCO on the upcoming OMH certification pilot. “So far, so good,” he said. Compared with the last iteration of the OMH, “this program is much more structure and goal oriented.”

This pilot, he said, will address a major weakness of the current OCM—a dashboard will gather clinical data to offer real-time information with comparisons to peers. The information delay in the current Center for Medicare and Medicaid Innovation (CMMI) program means providers find out about weaknesses well after the fact.

With oncology practices still waiting to hear what will come 

 in 2022, “We hope that CMMI will take notice,” he said.

The new standards come as community oncology practices await word on the future of the oncology care model, which will expire in 2022.

Mary Caffrey

Articles

CMS Seeks Changes to Radiation Oncology Model; ASTRO Responds

Pilot Suggests Additional Benefits of Entresto in Patients With HFrEF

DaVita, Former CEO Indicted for Market Collusion

ASCO, COA Release Updated Standards for Oncology Medical Home