The first order of duty for any physician is to do no harm. It is expected and accepted that despite all that medical science and physician skills can do, some patients won’t get better and will eventually succumb to their illness. Nearly all physicians expend Herculean efforts to save their patients from disease; however, no physician, no matter how wellintentioned, should knowingly harm a patient. This dictum is about to play out in another domain.

Oncologists in private offices who supply chemotherapy and biologic infusion therapies for their patients have until recently been exempt from regulations that protect the workplace from aerosolized contaminating agents. International standards—including US Pharmacopeia (USP) General Chapter <800>&mdash;are now considered mandatory for practices where chemotherapy and biologic agents are mixed under hoods. The list of requirements includes venting to the outdoors, a negative-pressure room to safely transfer contaminated air properly, cleanable walls and shelving, an anteroom to avoid general contamination, and separate storage for hazardous and nonhazardous drugs.

In 2014, USP proposed these and other rules to protect healthcare workers and patients from exposure to antineoplastic and other hazardous drugs and avoid the development of infertility and cancer. The FDA, CMS, and the Occupational Safety and Health Administration intend to enforce USP <800> and, in many states, the draft rules are becoming law. The structural changes entail potentially significant architectural and design planning. This, along with construction costs and disruption to clinical operations, could lead to a significant burden for some practices. The concern is that so many practices are on shaky financial footing that this added economic and logistical cost could tip them into insolvency. This could adversely affect patient choice and access as more and more small practices close their doors, particularly in rural areas.

Pharmacy consultant Willis Triplett, PharmD, told 

 that USP <800> is unnecessary and needlessly burdensome. He noted that a number of states, such as New Jersey, have already incorporated versions of the guidelines into their laws, which could expose noncompliant practices to tough penalties. He called the New Jersey statute, which became law this year but has not yet gone into effect, “an abomination.” California has a similar law, with its regulations still being written. Yet other states, including Indiana, Kentucky, Oklahoma, and Texas, are moving against wholesale adoption of USP <800> for practices and may adopt less-stringent versions of the rules, Triplett said.

describes these issues in more detail, including a potential delay of implementation until 2019. Many practices are taking a wait-and-see approach. It is expected that some regulation will take hold because of the risk to staff and patients. It is also unclear—even if regulations are put in place&mdash;what the penalties and level of compliance monitoring will be. With all this uncertainty, many oncologists are unsure what to do. First do no harm. That is our rule of conduct. I believe that oncologists, particularly those in community practice, will do what they need to do, and that is to figure it out. There is always room for discussion with regulators, and if the objective is met&mdash;no one is exposed to workplace toxins&mdash; avoiding excessive cost may be possible.

Articles

Oncologists in private offices who supply chemotherapy and biologic infusion therapies for their patients have until recently been exempt from regulations that protect the workplace from aerosolized contaminating agents.

Doing No Harm Starts With Good Hazardous Drug Management

: Please explain your role as a private payer in the OCM.

Several years ago, CMS made a few wise decisions. One of those was creating the OCM—a multipayer initiative aimed at transforming care delivery. We do need to improve healthcare in the United States this way, so that doctors don’t have to do one thing for Aetna, one thing for Blue Cross, and one thing for CMS. The goals must be aligned.

Of the 48 payers that wanted to be part of the OCM, CMS chose 17, along with 192 oncology practices. We have 5 OCM practices in Oklahoma. We have a university practice, a rural practice, and 3 other practices, located in the 2 largest cities of our state. We have our own care track that is not simply part of the OCM track—it’s patterned 90% after that. The 1 difference is, we wanted to include the doctors, nurses, administrators, pharmacists, and social workers in our modified model because of something called the Quadruple Aim, which includes the goal of improving the work life of healthcare providers.

The OCM project is patterned after the Triple Aim—enhancing patient experience, improving population health, and reducing costs. What it doesn’t do is incorporate the frontline caregivers in the design and development of this project. Blue Cross Blue Shield is including the doctors in the frontline. We think that, as a payer, we are not only part of this multipayer initiative but also part of an expanded-care initiative.

Is Blue Cross Blue Shield mirroring the payments and incentives that CMS has mapped out for practices in the OCM, such as the monthly $160 care management payments? 

When I went to medical school, the care team might have included the nurses, the pharmacists, and maybe the social services staff, nutritionists, and doctors, and now we’ve expanded some 20 to 30 years later to include even the people in the community and the payers as part of the expanded care team.

One of the responsibilities of payers was to outline a payment system roughly similar to the payment structure of CMS. And we did that. We have the care management fees defined by CMS that are known as monthly enhanced oncology services (MEOS) payments. We also have a payment at the end of the care cycle that is based on quality measures and patient and family satisfaction. That’s our own combination. We have a slightly different point of view from CMS regarding how the payment formula should be developed. We put more emphasis on what happens a year later by using measures of quality, such as patient and family satisfaction.

What are your takeaways on the value of the OCM at this point in the pilot? 

Our plan also includes a shared savings component that we think is more important for the financial viability of the practice than the MEOS care management fee. The reason we think that is because of our experience with another CMS Center for Medicare & Medicaid Innovation (CMMI) program, the Comprehensive Primary Care initiative, which was designed to strengthen primary care by offering care management fees and shared savings opportunities. That program ended on December 31, 2016, and has been followed up with Comprehensive Primary Care Plus.

The biggest takeaway is that this gives our patients access to care and, on the back end, payers pay nurses and pharmacies and doctors for the care received.

All insurance companies have cadres of nurse managers, transplant coordinators, physicians, pharmacists, and social workers who all interact with patients above and apart from what happens within the walls of the hospital or doctor’s office. What I see happening is that, someday, all those touches that the payers have will be integrated with the care being given in the other parts of the healthcare world. So, the touches that our transplant nurses or our care managers have with patients with chronic disease or that I, as a physician in population health, have—all of that eventually will be funneled into the electronic medical record. Everybody taking care of the patient will know that Mabel has been communicated with 7 times in the last 3 months by the folks at Blue Cross Blue Shield, and what we have discussed with Mabel about her diabetes or chronic obstructive pulmonary disease or congestive heart failure is all documented in the medical record, allowing for greater continuity of care. That’s the biggest takeaway. Insurance companies are part of a healthcare team, taking care of a patient outside of the walls of a hospital or doctor’s office. 

In a recent interview with Oncology Business ManagementTM, Peter Aran, MD, medical director of population health management for BlueCross BlueShield of Oklahoma, discussed participation in the Oncology Care Model from CMS, which is designed to improve the quality and value of care.

A Payer's Takeaways on the OCM

The storms were powerful. They were headed straight for land. And the forecasts were nearly apocalyptic.

Texas Oncology and Florida Cancer Specialists & Research Institute knew their ability to recover from hurricanes Harvey and Irma would hinge upon the work they did before either storm arrived. Acting on the warnings, both practices built on existing disaster plans already refined by experiences with several tropical storms each year.

Similar preparations led to similar plans and similar success in minimizing the damage to both patient health and practice prosperity, yet there is no way to perfectly protect a business against something as powerful as a hurricane.

The very different nature of the actual storms led to very different experiences in the 2 states. Florida Cancer Specialists & Research Institute lost power at locations from Naples to Jacksonville, but nearly all were operating again a day after Irma left. Texas Oncology felt Harvey’s impact over a much smaller area, but flooding throughout the Houston region was so severe that most local offices closed for an entire week.

“The rain just kept coming, falling harder than any of the monsoons where I grew up in India for days on end,” said Vivek Kavadi, MD, the medical director of Texas Oncology’s Gulf Coast practices. “Some areas got 50 inches of rain, which was enough to flood interstate highways and render much of the region impassable for days after the rain stopped.

“Our facilities escaped without too much damage—6 inches of water in Clear Lake, which is the region’s largest office, and minor flooding in a few others&mdash;but we had several employees whose homes were severely damaged and many whose cars were essentially totaled,” Kavadi said. “Each day brought more bad news. It seemed never-ending, and that was the worst of it. We had to summon the energy and focus to stay in full emergency mode for more than a week.”

Things might have been even worse but for the fact that Texas Oncology had plenty of warning. Forecasters made unusually early and accurate predictions about the behavior of Hurricane Harvey, giving businesses across the region time to adapt normal emergency plans to a storm that was unlike anything to hit Texas in living memory.

Offices located inside the storm’s predicted path prepared for potential flooding using both the latest technology (backing up computers to distant server farms) and the oldest strategies (moving valuable items as far above the floor as possible). They also took the unusual step of moving temperature-sensitive medications away from blackoutprone offices, storing them either at offices equipped with emergency generators or at local hospitals.

Around noon on Friday, August 25, Texas Oncology closed all 12 of the Houston-area offices that lay within the storm’s projected path. The rain began late the next morning.

Before the first drops hit the ground, Kavadi and other regional officials had activated an emergency communications protocol designed to keep the practice’s regional leadership and emergency response team fully connected to employees and patients at each location. Designated individuals served as liaisons between decision makers and the staff and patients from each office, passing information up and down the line each day.

They didn’t stop there. Texas Oncology kept in touch with stakeholders every conceivable way—via landline, cell phone, text, e-mail, Facebook, Twitter, and its website&mdash;not only for the sake of convenience but also to guard against the possibility that some channels would fail, either because of storm damage or overuse.

As things turned out, Harvey did not hinder communications all that much. Its winds were relatively mild, and just 300,000 people in a metro area with 6.5 million residents lost electricity.

Texas Oncology had little trouble keeping in touch with its stakeholders, but the scope of the flooding kept all its Gulf Coast offices closed for nearly a week. When conditions finally allowed some offices to reopen, practice officials created new treatment schedules, giving available slots to patients with the most urgent treatment needs, and then alerted staff and patients.

In many cases, the emergency response team had to direct patients away from the offices they normally used, because those locations were either still closed or could not accommodate all time-sensitive cases. The practice also had to transfer many employees from facility to facility to cover for people who could not make it to work. Roughly 50 of Texas Oncology’s 400 Houston-area employees sustained severe damage to their homes or cars, and many others had to miss work to care for loved ones.

“It was a significant logistical challenge to match the available pool of staff members with the available facilities, and then fill all of the available appointment slots across the region with the patients who were most in need of care, but the system and the tools and the people we had in place performed almost flawlessly,” said Kevin Vineyard, the executive director of Texas Oncology’s Gulf Coast practices. “You need to prepare yourself as best as you can for a wide variety of possibilities, but the specifics of any natural disaster are unpredictable, so you need a plan that allows you to adapt to whatever conditions arise and do the most with whatever resources you have at any given moment.”

Officials from Florida Cancer Specialists & Research Institute emerged with a similar perspective despite facing very different challenges. Irma did flood some regions of Florida—any significant rainfall can cause flooding in a state that’s flat as a pancake and waterlogged even before the first drops hit the ground&mdash;but the wind caused most of the damage. Irma first hit the state as a giant Category 4 hurricane on September 10, buffeting everywhere from Miami to the Panhandle, with sustained winds in excess of 100 mph.

The size of the impact zone made disaster response harder than normal for Florida Cancer Specialists & Research Institute, which has more than 90 locations spread along both coasts of the state and across the Interstate-4 corridor. The practice had always been able to shift operations away from relatively small disaster areas to nearby offices that remained unscathed. It had never faced a storm that made the entire state a disaster area.

Irma’s high winds hindered communications much more than Hurricane Harvey did. Some 4.4 million homes and businesses lost power at some point, and a similar percentage lost landline telephone and Internet service. Nevertheless, Florida Cancer Specialists & Research Institute had virtually no trouble communicating with patients and staff because it pursued the same sort of multichannel strategy that Texas Oncology used. Many people lost access to some form of communication during the storm and its aftermath, but few people lost all access for any extended period.

Many Florida Cancer Specialists & Research Institute offices were ready to open a day after the storm passed, but a significant number were not. Rather than simply keep appointments as normal in the open offices, Florida Cancer Specialists & Research Institute took a regional perspective that prioritized patients undergoing time-sensitive forms of curative therapy. The plan: Delay appointments for less-urgent patients and send the neediest to open offices in their region. That required full integration of things like calendar software and timely communications, but it worked very well.

The other major challenge for Florida Cancer Specialists & Research Institute was getting medications to patients. Like Texas Oncology, Florida Cancer Specialists & Research Institute had moved temperature-sensitive medications to hospitals and other facilities equipped with backup generators. That turned out to be a smart tactic, because power outages would otherwise have ruined some of the $30 million in medication that Florida Cancer Specialists & Research Institute offices have on hand at any given time. (Texas Oncology did not face that situation.)

Proper storage ensured that patients could be treated as soon as offices reopened, but Florida Cancer Specialists & Research Institute never has more than a couple of days’ worth of medication at the ready; without a steady supply, it could not continue offering treatment. Unfortunately, delivery services took the unprecedented step of suspending operations for a couple of days after Hurricane Irma. Florida Cancer Specialists & Research Institute responded successfully with an impromptu plan in collaboration with their drug distributor, Oncology Supply, to ensure that drugs were delivered in a timely fashion to all treatment locations.

“Our people did a very good job planning for the storm and then responding to events as they actually happened, but we also benefited a lot from recent improvements in communications technology. We couldn’t have shifted resources around so quickly or found ways to get our medications if we had nothing to rely upon but landline telephones,” said Brad Prechtl, chief executive officer of Florida Cancer Specialists & Research Institute.

Technology also safeguarded patient records in ways that would not have been possible when everything was kept on paper. As part of its disaster recovery plan, Florida Cancer Specialists & Research Institute ensures all its data and records are backed up in real time to a second data center located in the Northeast.

Officials at Florida Cancer Specialists & Research Institute, like those at Texas Oncology, thought the ability to transfer records might also prove valuable as a means of ensuring continuity of care to patients who evacuated to safer parts of the country, but neither practice received a significant number of data requests from practices in other states.

“We were very happy to be able to transfer records in the other direction on at least 1 occasion,” said Todd Schonherz, chief operating officer of Florida Cancer Specialists & Research Institute. “We had a gentleman who worked for a power company in Illinois, who missed what was to have been his last appointment for active treatment back home, come down with an emergency crew that helped restore power in Florida [right after Irma]. His oncologist sent us the information we needed, and we were able to do that last treatment while he was here.”

Texas Oncology and Florida Cancer Specialists & Research Institute knew their ability to recover from hurricanes Harvey and Irma would hinge upon the work they did before either storm arrived.

Advance Planning Minimized Storm Impact for Oncology Practices

Practice manager Andrea Anderson can tick off the hazardous drug—handling rules that her office does not satisfy, according to her understanding of pending United States Pharmacopeial Convention (USP) General Chapter <800> standards. For starters, the hood for handling biologics isn’t vented to the outdoors, and there’s no negative-pressure room to safely contain and exhaust potentially tainted air. The clinic uses the wrong type of shelving and has no anteroom, no scrubbable walls, and no place to separately store hazardous and nonhazardous drugs.

Practices now have a little more time to finance and plan improvements like these. In September USP said it is postponing the date when the new standard becomes “official” to December 2019, almost a year and half later than previously scheduled. The delay is meant to allow alignment of the rules with the next revision of USP <797>, an older standard on sterile compounding in pharmacies.

Yet the postponement has done little to alleviate fears that USP <800> could broadly hurt community oncology when the rules do become final. Aimed at protecting health care workers from exposure to hazardous drugs that may increase risk of cancer and reproductive problems, the standard will be enforced or mandated by a number of agencies, including the FDA, CMS, and Occupational Safety and Health Administration (OSHA) at the federal level. In many states the rules also have been or will soon be codified into law.

Anderson, who helps run the solo physician practice of Bruce Hayton, MD, in Wildomar, California, said she is in the process of adopting closed-system transfer devices (CSTD) that attach to vials, tubing, and syringes, an important measure to prevent release of drug vapors or liquids. But the office’s location on the ground floor of a 2-story building means there’s no space to build additional rooms or reroute the heating, ventilation, and air-conditioning system (HVAC), which also would be very costly, she said. She looked into using a freestanding trailer for drug compounding but dropped that option when she learned it could cost hundreds of thousands of dollars.

Anderson said she’s in the clear so far because California’s medical board has not yet decided which parts of the drug-handling rules it will enforce. But if the state does fully adopt USP <800> for medical practices, the prospects could be grim. “If they enforced it, if it had severe penalties, if they were going to visit every single practice, we would close our doors. We wouldn’t be able to meet any of it. That’s just the reality of it,” she said. “And we’re not the only ones. Your larger practices that have the infrastructure or the resources have been able to do those compliance buildouts, but your solo practitioners will close their doors. They won’t exist any longer.”

Howard Levine, PharmD, is pharmacy director at Queens Medical Associates of Fresh Meadows, New York, where plans were already in place to make a half-million dollars of upgrades to comply with USP <800>. The delay in implementation won’t change that, as it’s fairly certain that the new standards will be no less stringent following the alignment with USP <797>. “Nowhere [in the delay notice] does it say they’re going to change the USP <800> specs,” he said. Queens Medical was all set to begin renovations in January to meet the previous deadline for compliance.

“We’re probably still going to start renovating, but we’ll probaby not put those last pieces in—which are the expensive pieces for the HVAC&mdash;until we get that much closer.” If there are any changes to the new standards, they probably won’t involve lower costs of implementation, Levine added. Some believe that the difficulty of complying with USP <800> will lead to significant restructuring in the way community oncology is delivered. They say that practices will be forced to shut down or curtail their hazardous-drug administration services.

“You’re going to see widespread consolidation. Some practices will have to close, and some will have to send patients to neighboring centers that are larger,” said Denise Needham, PharmD, regional director of pharmacy at MaineHealth’s Coastal Healthcare Alliance, which has 2 oncologists at 2 small hospitals. “Particularly what you’ll see hit are those in rural areas that allow patients to get chemotherapy in their community. They’re going to have to send patients to the neighboring city.” She noted that her comments reflect her opinions and not necessarily those of MaineHealth.

For a few reasons, however, the effects may not be so dire. The impact is likely to differ among states, which are deciding individually what rules to adopt and how to enforce them. Enforcement might occur infrequently and be advisory in nature or be led by uniformed health officers who impose fines and shut down facilities. Practices that do not have dispensaries are typically overseen by medical boards, which may promote the new rules less energetically than their counterpart pharmacy boards. In most places, pharmacists must substantially comply by December 2019 or their state deadline, whereas some medical boards may not have rules or enforcement mechanisms in place, allowing practices to delay facility upgrades.

Willis Triplett, PharmD, a pharmacy consultant who criticizes USP <800> as needlessly burdensome, noted that a number of states such as New Jersey have already moved to incorporate versions of the guidelines into their laws, which could expose noncompliant practices to tough penalties. He called the New Jersey statute, which became law this year but has not yet gone into effect, “an abomination.” California has a similar law, with the regulations still being written. Meanwhile other states including Indiana, Kentucky, Oklahoma, and Texas are moving against wholesale adoption of USP <800> for medical practices and may adopt less-stringent versions of the rules, Triplett said.

Perhaps because of this variation, many practices are taking a cautious, go-slow approach rather than making renovations to fully comply with the standard. In a survey conducted last year, only 11% of oncology practice managers were actively renovating their compounding facilities, with 26% saying they had already met the standard. Another 18% said they were waiting to see how their state boards of pharmacy would enforce the rules; 26% were studying USP <800>, attending seminars, or working with consultants to calculate the costs; and 24% were doing nothing. The Genentech survey, conducted from July to October 2016, included 91 independent practices, 50 hospitals, and 60 academic centers. Anderson’s practice is in the wait-and-see camp. She said she expects California’s medical board will eventually reach a compromise with the pharmacy board over the rules that practices must follow; in the meantime, she is carefully documenting the measures she is taking toward compliance, such as having staff use CSTD and personal protective devices. In the state labor law that governs medical practices, “showing goodwill and faith in trying to meet some of that goes a long way with USP,” she said.

Similarly, Tri-County Hematology and Oncology, a Massillon, Ohio, practice with 4 oncologists at 2 locations, is updating its drug-handling policies but not making major changes, according to practice manager Ruth Settle. The practice has negative-pressure, externally vented barrier isolators, but its laminar flow hoods are not exhausted to the outdoors, and it lacks anterooms and separate hazardous-drug storage areas. Building anterooms could cost $100,000 and take over space currently used as bedrooms for patients who need to lie down during infusions, Settle said. Ohio has actually had rules similar to USP <800> for some time and is implementing them gradually, she said; for example, existing hoods don’t have to be externally vented until 2019. Settle also said the state board of pharmacy traditionally sends out inspectors only to check new or renovated facilities or if a problem arises, though that could change.

“They say that they’re going to have more inspectors, and they’re going to do more enforcement as this comes out. They’re also saying there could be OSHA and FDA inspectors coming around,” Settle said. “I’m just hoping this little town is off their map.”

If state or federal agencies step up enforcement, she wants it to be realistic and helpful rather than strictly punitive. “I’m hoping that they will see we’ve made some effort to meet their standards and would give us recommendations and a time frame to meet other standards they felt were important,” she said, “because they can just slap a red ticket on your pharmacy and close you down.”

Practice managers say they’re worried because they simply can’t afford upgrades. But Joseph Coyne, a pharmacist and the director of field operations for Clinical IQ, a sterile compounding consultancy, said those fears are largely unwarranted and caused by confusion about the USP standard. Most small practices actually do not need to install a full clean-room setup with a sterile buffer room, an anteroom, and hazardousdrug storage, he said. As long as drugs have a 12-hour by-use date, meaning they are used within 12 hours of being prepared, a clean room is not required.

“Most oncology practices use just-in-time preparation, so they’re using the drug almost immediately. That right away takes the clean-room concept out of the equation,” Coyne said. “That goes from needing several hundred square feet to put a 3-room system together to maybe 100 square feet to take over an exam room. That makes it much more feasible. They need to really understand what their needs are. [Otherwise] they could absolutely be overengineering and overspending for a facility that’s not required for their particular type of practice.” A clinic may be able to limit upgrades to a small compounding area, a 3- to 4-foot-wide hood, and a dispensing cabinet, along with appropriate paint, flooring, and other relatively inexpensive fixes, he said. However, that assumes practices are able to use prepared drugs within the 12-hour time window. At Hayton’s solo practice, short drug expiration dates have proven unworkable, as demonstrated when a compounding pharmacy it uses made upgrades for USP <797> and <800>, Anderson said. “They were delivering only once a week and, though the stability of all compounded drugs were well over 24 hours, the new expiration dates on the labels were within 24 hours or same day.  We can’t use them due to the dating issue,” she said.

Coyne noted some other strategies to make compliance more affordable. Hoods can be vented out the side of a building and up the exterior wall, rather than going up through all the floors of a multistory structure. Many managers also don’t realize that hazardous and nonhazardous products may be stored together as long as all the drugs are subsequently treated as hazardous, he said. Nurses will have to start wearing appropriate gloves when administering hydration or anti-emetics, but that is far less costly and disruptive than building a new room.

Coyne, who is advising the Community Oncology Alliance and numerous oncology providers on the new standard, urged practices not to wait for enforcement before complying. Instead they should look online for a USP <800> gap analysis tool that can help them understand where they are out of compliance, figure out exactly what they are required to do, and move ahead with upgrades, using a consultant if needed.

“There will be costs involved for many practices, if not all. Is it totally going to put them out of business? I don’t believe so. I’ve worked with many in the community oncology space, none of which have needed the 3-room suite or the large 6-figure expense. All of them have been able to reasonably manage the expense to comply,” Coyne said. “Assuming practices choose to do it and are willing, we’re not going to see this regulation force everybody back to the hospital. Absolutely not.”

Regardless of how extensive the impact may be, Levine, of Queens Medical, believes the USP <800> delay is a welcome development. “I’m sure that many of the community practices are going, ‘My goodness!’ Because, honestly, knowing what it costs to do this, a lot of practices won’t be able to do it. So you’ve given them a reprieve.”

Genentech. The 2017 Genentech oncology trend report. https://www.genentech-forum.com/ content/dam/gene/managedcare/forum/pdfs/Oncology-Trends/2017_Genentech_Oncology_ Trend_Report.pdf. Published July 2017. Accessed September 25, 2017.

The hood for handling biologics isn't vented to the outdoors, and there’s no negative-pressure room to safely contain and exhaust potentially tainted air.

USP Eases the Pressure to Improve Hazardous Drug Management

The handwriting is on the wall: alternative payment models (APMs) are the future of Medicare payment.

In April 2015, the Medicare and CHIP Reauthorization Act (MACRA) was enacted. It effectively replaced the flawed Sustainable Growth Rate with the Quality Payment Program (QPP), which is designed to transition from the current fee-for-services system to one based on value and quality performance. MACRA was a bipartisan effort and enjoyed broad support by members of Congress, including then-Rep. Thomas Price (R, Georgia), who now serves as the Secretary of the US Department of Health & Human Services (HHS).

QPP involves 2 tracks: the Merit-based Incentive Payment System (MIPS) and APMs. Although many physicians will participate in the MIPS program at the outset of QPP, MACRA was designed to move as many physicians as possible into APMs.

An APM is a payment model that requires physicians to take responsibility for cost and quality performance and receive payments for providing high-value care, defined as high quality at a low cost. APMs are designed to drive down costs by making physicians financially accountable for costs of care. APMs also improve care through the application of quality measures. In return for their participation in advanced APMs and the additional risk involved, clinicians will receive a 5% increase in payment. In addition, after the initial years of QPP, practices participating in APMs will see higher payment increases than those who remain in MIPS.

The American Cancer Society estimates there were 1.7 million new cancer cases in 2016.1 Of those, 250,000 patients were diagnosed with breast cancer; 225,000, lung cancer; 181,000, prostate cancer; 95,000, colorectal cancer; and 72,100, head and neck cancer. An unpublished, Medicare Surveillance, Epidemiology, and End Results (SEER) data analysis indicates that, of the Medicare patients receiving radiation therapy, 83% had 1 of these 5 primary disease types, accounting for 93% of total Medicare spending on radiation therapy services between 2007 and 2011 Radiation oncology clinics have experienced significant reductions in payment over the past decade. The pinch has been felt in both freestanding and hospital-based settings, with threats of further cuts on the horizon.

Freestanding radiation oncology clinics experienced Medicare payment cuts of approximately 20% from 2008 to 2015. Hospital-based facilities continue to see declines as the Comprehensive Ambulatory Payment Classification system expands, bundling more services and reimbursing them at lower rates.

In 2015, the American Society for Radiation Oncology (ASTRO) worked with Congress to pass the bipartisan Patient Access and Medicare Protection Act (PAMPA), which brought much-needed payment stability to freestanding radiation oncology clinics. The resulting freeze on rates is set to expire January 1, 2019, and ASTRO is strenuously lobbying CMS and Congress to ensure no further payment cuts.

At the same time, ASTRO has formulated a Radiation Oncology APM (ROAPM) that we believe meets MACRA requirements and provides radiation oncologists with an opportunity to meaningfully participate in an APM.

The RO-APM is designed to protect access to care and improve the quality of care for patients with cancer. For practices, this model will help stabilize payment rates for a 5-year period.Without it, many eligible radiation oncologists would be relegated to participating in the MIPS program, which could lead to more significant cuts in payment over time.

The RO-APM establishes episode-based payments according to a practice’s historical payment rates, as well as regional and national averages. The resulting base rate is fixed for 5 years and enables participants to secure a 5% bonus for participation under QPP, an added incentive for delivering efficient, high-quality care.

The RO-APM provides radiation oncologists an alternative to the Oncology Care Model—currently the only oncology care advanced APM eligible for bonuses—and was developed in collaboration with other radiation oncology stakeholder groups. Its features:

Adherence to existing radiation oncology clinical practice guidelines to reduce waste and unnecessary care, resulting in better patient outcomes and lower costs

Application of a common episode-based payment framework applicable to each of 7 disease types: breast, lung, prostate, colorectal, head and neck, brain metastases, and bone metastases

Establishment of shared savings for meeting meaningful, relevant quality benchmarks

Incentives to deliver the most appropriate care, regardless of modality and payment levels

By incentivizing a higher quality of care at a lower total cost during the episode, the model will achieve greater value in the delivery of radiation therapy and effective management of patients with cancer.

Once a patient has decided, along with family and caregivers, to pursue radiation therapy, the model episode is triggered by 1 of 3 distinct radiation therapy Current Procedural Terminology (CPT) codes (77261, 77262, and 77263) combined with an International Classification of Diseases, Tenth Revision (ICD-10) code that corresponds with 1 of the 7 disease types included in the model. The episode of care begins at clinical treatment planning and concludes 90 days after the last radiation therapy treatment. Throughout the episode, participating physicians must adhere to ASTRO and National Comprehensive Cancer Network guidelines to ensure that patient care is appropriate and of the highest quality.

Medicare claims data from a specific reference period will be used to determine payments per episode for a disease type. A target payment rate will be based on the participating provider’s historical rate, which will be weighed against the regional and national benchmark rates for the same episode of care. The provider will be paid a portion of the target rate once an episode begins, as well as a monthly patient engagement and care-coordination fee. The remaining portion will be paid at the completion of the episode. The model features a 2-sided risk corridor in which a provider may share in savings if spending is below the target. If the target amount is exceeded, the provider will be responsible for any overpayment up to a specific amount.

The quality component of the RO-APM model is multipronged. It begins with a patient engagement component that involves shared decision making, nurse care management, care plan development, specialty care communication, and survivorship planning.

ASTRO’s Accreditation Program for Excellence (APEx) and equivalent accreditation standards serve as a quality feature for RO-APM participation. APEx measures the performance of radiation oncology practices and evaluates their clinical programs, focusing on quality and safety of radiation oncology processes.

Additional quality measures based on guidelines that are diseasesite specific will be layered on top of accreditation and will track how frequently participating practices follow those guidelines. Adherence to clinical guidelines can improve the quality, outcomes, and cost effectiveness of healthcare. Finally, the inclusion of the MIPS Radiation Oncology Measures Set meets the requirement that advanced APMs include MIPS-comparable measures.

After a pay-for-reporting period (physicians report on how care they furnish aligns with evidence-based clinical guidelines) to allow for the establishment of benchmark quality data, a pay-for-performance mechanism will be implemented. Similar to the Bundled Payments for Care Improvement model, the base-rate discount will be modified in future years based on quality measures’ performance in a prior year.

ASTRO believes that the RO-APM is highly consistent with the QPP’s recommended characteristics for an advanced APM. It includes requirements that physicians assume accountability for controlling the total cost of Medicare spending for cancer treatment, plus the total cost of Medicare spending on all services the patient receives during the episode of care.

ASTRO has submitted a description of the RO-APM to the Centers for Medicare & Medicaid Office of Innovation (CMMI) for consideration as the agency prepares a report to Congress on APMs in radiation oncology in compliance with PAMPA. The CMMI report is expected this fall.

In addition to collaborative efforts with CMMI, ASTRO has submitted a letter of intent describing the RO-APM to the CMS Physician Focused Payment Model (PFPM) Technical Advisory Committee. The committee is expected to review, comment on, and provide recommendations to the Secretary of HHS regarding PFPMs presented by specialty societies and other stakeholder groups.

Alternative payment models (APMs) are the future of Medicare payment.

November 2017 | Oncology Business News®

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