CANCERSCAPE Session to Demystify Site-Neutral Payment Policy
By Amanda Patton, ACCC Communications
In recent months MedPAC, the Centers for Medicare & Medicaid Services (CMS), Congress, and the GAO have ramped up attention on the impact of consolidation and integration, shifts in sites of service, and how unequal payment rates across settings of care are affecting Medicare costs.
Adding to the controversy (and confusion) around site-neutral payment as a solution to reducing the Medicare “spend” is the recently passed Bipartisan Budget Act of 2015 at Section 603, “Treatment of Off-Campus Outpatient Departments of a Provider.”
Although the issues surrounding site neutral payment policy are complex, “Section 603 is pretty straight forward,” says Ronald Barkley, MS, JD, of the CCBD Group. “It’s the downstream unintended consequences that cancer programs need to understand.” In a session at the upcoming ACCC Annual National meeting in Washington, D.C., March 2-4, Barkley will demystify site neutral payment policies, lay out pros and cons, and provide a realistic assessment of the potential impact of Section 603. Attendees will leave with a 360-degree understanding of the issues and a “knowledge base to work from” going forward, Barkley said.
Site-neutral payment policies have the potential to affect revenue and budgeting, strategic planning, pro forma development, and 340B Drug Program participation. Thus, a thorough understanding of Section 603 is critical for today’s cancer program leadership.
Time is of the essence, according to Barkley. “There is a window of opportunity to take your message to CMS before [the agency] translates the [Section 603] legislation into regulation.”
Attend the ACCC 42nd Annual Meeting, CANCERSCAPE, from March 2—4, 2016, in Washington, D.C., and gain strategic insight into key drivers of change impacting our evolving oncology care delivery system in sessions focused on Policy, Value, and Quality. Learn more here. Want to discuss this issue with your elected representatives on Capitol Hill? See what’s planned for ACCC Capitol Hill Day on March 2.
ACCC Advocacy Update
By Leah Ralph, Director, Health Policy, ACCC
Congress closed out 2015 with a bang, passing a number of large, end-of-year spending bills to keep the government funded through 2016 and several provisions that will impact ACCC members.
The omnibus appropriations bill (H.R. 2029) boosted NIH funding by 6.6 percent to $32.1 billion, the largest increase NIH has seen in 12 years. A separate package of Medicare provisions, the Patient Access and Medicare Protection Act (S. 2425) passed just before Congress adjourned for the year. This legislation created a blanket hardship exemption for meaningful use penalties in 2015, making it easier for the Centers for Medicare & Medicaid Services (CMS) to review and process hardship exemption requests. (To apply for an exemption, physicians must apply by March 15, 2016, and hospitals by April 1, 2016.)
The Medicare bill also froze payment rates to freestanding radiation therapy centers at 2016 levels for two years, CY2017 and CY2018. It is important to note that the Medicare bill ultimately did not include a provision that would have exempted “under construction” off-campus outpatient facilities from an earlier law (the Bipartisan Budget Act of 2015) that reduced Medicare payments to newly built or acquired hospital outpatient departments.
Before year-end President Obama signed both H.R. 2029 and S. 2425 into law.
As attention shifts toward elections in 2016, with divergent views on the future course of the nation’s healthcare policies, we are sure to see even more movement on policies that will impact the provision of quality cancer care. Make your New Year’s resolution today to join us for ACCC Capitol Hill Day March 2, 2016. Learn more and register here.
An Easy—and Empowering—New Year’s Resolution
By Leah Ralph, Director, Health Policy, ACCC
New Year’s resolutions are the very definition of trope: a common or overused theme. But they don’t have to be. Today I’m asking you to set aside the old standbys of weight loss or more exercise and look at the bigger picture—specifically what you can do to improve the lives of the cancer patients you treat each and every day.
Last year ACCC mobilized members from 23 states and held over 80 meetings with legislators on Capitol Hill about issues of importance to the oncology community. We effected real change. Shortly after our ACCC Hill Day visits, Congress passed a permanent repeal to the Sustainable Growth Rate (SGR) formula, guaranteeing predictable physician payment rates and setting in motion a wave of Medicare reimbursement reforms. Our voices made a difference!
This year, we’re growing our annual Capitol Hill Day program and making some exciting changes: more comprehensive training, more face time with legislators, and, most important a greater focus on helping you tell your community’s story—the one that your legislators most want to hear. What’s going on in your home town? What’s keeping you up at night? What are the stressors that are having a negative impact on your cancer patients?
So whether you’ve attended a previous ACCC Capitol Hill Day or you’re an “advocacy newbie,” here are three solid reasons to make the ACCC 2016 Capitol Hill Day your New Year’s Resolution:
- More comprehensive training. The ACCC policy team will host webinars and conference calls to prepare for your congressional meetings. We’re planning a comprehensive training and reception for Tuesday, March 1, plus an additional advocacy review on the morning of Hill Day, Wednesday, March 2.
- More face-time with legislators. Gather for lunch with your ACCC colleagues and congressional members to discuss key issues that impact your program, such as reimbursement for supportive care services, drug costs, staffing shortages, and how excessive data collection and reporting is cutting into the time you can spend on direct patient care.
- Less focus on specific bill numbers. You don’t need to be a “policy expert” or familiar with specific legislation in 2016. It’s a chance to share YOUR STORY so lawmakers understand how policy impacts oncology care in YOUR COMMUNITY. (Now, if you want bill numbers, we’ll have those too.)
Policymakers rely on healthcare providers—not policy staff—to provide real-world perspectives on policy issues that matter. As the leading national multi-site, multidisciplinary organization, ACCC is uniquely positioned to serve as a resource. This is our value to legislators. The diversity and sophistication of our membership requires a nuanced, balanced approach to policy challenges—and we stand ready to offer insights on how cancer care is delivered today.
As our experts, we invite you to come to Washington, D.C., to do what you do best. Talk about your programs, your processes, and most importantly your patients. Our annual Capitol Hill day is an important and rewarding opportunity to advocate for policy change. Resolve to attend ACCC Capitol Hill Day 2016, and help to put the voice of the cancer care team and cancer patient at the center of policy decisions. Learn more at accc-cancer.org/HillDay.
ACCC Comments on Proposed 340B Guidance
By Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC
On October 27, 2015, the Association of Community Cancer Centers (ACCC) submitted comments on the Health Resources and Services Administration (HRSA) “mega-guidance” on the 340B Drug Pricing Program. ACCC supports HRSA’s effort to provide more clarity in the program and we commend HRSA for taking this important step amid legal challenges and Congressional pressure. But just how far the guidance will go remains unclear. While HRSA’s guidance does not have the strength of a rulemaking, it does inform 340B participants how the agency believes the program should operate, and we can expect it will be used as a basis for future audits. It remains to be seen whether Congress will codify the guidance or move any other legislation related to 340B.
HRSA’s guidance largely focuses on laying out a narrower definition of a patient under the program. Essentially the guidance proposes to significantly strengthen the relationship between the 340B covered entity (CE) and patient in order for that patient to qualify for 340B discounted drugs. The CE would now need to provide much more comprehensive service to a patient in order to receive a 340B drug discount.
Specifically HRSA proposes a six-prong test to determine patient eligibility:
- The patient must have received a healthcare service from a registered CE.
- The healthcare service is provided by a CE-associated provider (employed by or an independent contractor of that CE).
- The drug prescription is a result of the service provided by the CE and, importantly, the service is not limited to the dispensing or infusion of a drug.
- The service is consistent with the CE’s grant or contract (typically for grantees only).
- The prescription is the result of an outpatient service, determined by how the CE bills the payer.
- The CE maintains access to auditable health records, demonstrating a provider-to-patient relationship and that the CE is responsible for that patient’s care.
So what does this mean for cancer care? This guidance will likely have significant implications for referrals and follow-up care, limiting the ability of cancer patients to move between sites of care. For example, under the guidance, when a patient sees a physician at a non-340B site as a referral or follow up to care, even though the patient’s care originated at a CE, that patient would no longer be eligible to receive a 340B discount. Further, under the guidance, if a community practice physician (i.e., a non-CE-physician)—potentially without the infrastructure or resources to provide certain oncology services—sends patients to a CE for an infusion, that patient would not be eligible for 340B drug pricing. This is because the guidance stipulates that the service the CE provides cannot be limited to the infusion or dispensing of a drug.
In our comments to HRSA, ACCC weighed in on the potential unintended consequences and administrative burden this revised patient definition may present for CEs. We urge the agency to consider the complexity of today’s multi-site cancer care infrastructure and to ensure that cancer patients retain access to appropriate, quality cancer care. Further, in order to qualify for 340B drug pricing, a CE must provide associated healthcare services to a referred patient beyond just dispensing or the infusion of a drug. ACCC urges HRSA to coordinate with the Centers for Medicare & Medicaid Services (CMS) to ensure CEs understand what constitutes a healthcare service for purposes of 340B drug pricing. ACCC also urges HRSA to clarify any specific requirements regarding the content of a CE’s patient records in order to demonstrate a provider-to-patient relationship for purposes of the 340B program. Finally, ACCC notes the multitude of new administrative and accountability requirements for CEs, and encourages HRSA to work with stakeholders to collect data on the financial and operational impact of these new requirements.
The agency may issue final guidance sometime in the following months. ACCC will be monitoring closely. Stayed tuned.
2016 Medicare Payment Rules Finalized
By Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC
The Centers for Medicare & Medicaid Services (CMS) on Oct. 30, 2015, released the final 2016 Physician Fee Schedule and Outpatient Prospective Payment System rules. With the exception of radiation therapy codes, the final rules align quite a bit with the proposed rules. A preliminary summary is included below. Stay tuned for detailed summaries and analysis on an upcoming ACCC members-only conference call on these 2016 final rules.
Highlights of 2016 PFS Final Rule
Radiation Oncology
In a noteworthy departure from the proposed 2016 PFS rule, CMS did not finalize new radiation therapy treatment payment codes. CMS responded to concerns expressed by ACCC and other stakeholder groups and delayed implementation of new radiation oncology codes, continuing use of current G-codes and values for 2016. However, the agency did finalize its proposal to increase the linear accelerator equipment utilization rate assumption from 50 percent to 70 percent over two years. CMS continues to seek empirical data on costs and usage of capital equipment, including linear accelerators.
Advance Care Planning
For 2016, CMS finalizes its proposal to establish separate payment for advance care planning services, consistent with the recommendations of the American Medical Association and other stakeholders, including ACCC. These new codes compensate providers for shared decision-making conversations at various stages of a patient’s illness.
Biosimilars
For 2016, CMS finalized its proposal to include all biosimilars of a reference biological product within the same billing and payment code. ACCC had commented against this proposal, raising concerns regarding traceability and administrative burdens expected with the use of a single code. While ACCC supports efforts to increase patient access to biologics, ACCC maintains that a system must be in place to track the specific biosimilar product used for each patient.
“Incident To”
CMS finalized its proposal to clarify requirements for billing for “incident to” services. CMS now formally requires that the physician or practitioner billing for “incident to” services must have directly supervised the auxiliary personnel providing these services. Addressing stakeholder concerns about the treating physician’s supervisory role in “incident to” services, the final rule clarifies that the supervising physician need not be the treating physician for billing purposes.
Highlights of 2016 OPPS Final Rule
CMS finalized its proposed cut in hospital outpatient payment rates of – 0.3 percent. Within this calculated –0.3 percent rate update is a –2 percent cut, applied due to the agency’s calculation of excess packaged payment for laboratory services in 2014. As a result of this year’s rate cut due to miscalculations in packaging policies, ACCC urged CMS to proceed cautiously with any additional packaging proposals to ensure future negative adjustments would not be necessary. However, CMS finalized its proposal to expand conditionally packaged services to include three new APCs: level 4 minor procedures, and level 3 and 4 pathology services. CMS notes that packaging of these services is consistent with the agency’s overall packaging policy.
Advance Care Planning
ACCC had also advocated for separate payment under advance care planning codes in the hospital outpatient setting. The 2016 OPPS final rule calls for conditionally packaging payment for these services, permitting separate payment in the hospital outpatient setting in limited circumstances.
Biosimilars
In the 2016 OPPS final rule, CMS finalized its proposals to pay biosimilars based on ASP+ 6% of the reference biologic product, and to allow biosimilars to be eligible for pass-through status. ACCC supported these proposals, noting that providing equivalent payment rates in the physician office and outpatient setting for biosimilars removes incentives to select one setting over another.
Two-Midnight Rule
CMS also finalized proposed changes to its two-midnight rule regarding hospitalization payment status. CMS will now allow certain patients not expected to meet the two-midnight stay requirement for inpatient status to still be classified as inpatient. CMS indicates that qualifying patients are those that require inpatient hospital care, as determined by the admitting physician and supported by the medical record, despite the expectation that their stay will last less than two midnights.
ACCC continues to analyze the 2016 payment rules and will update its members in the coming weeks.
National Oncology Conference—Keep the Conversation Going
Featured speaker Peter Bach, MD, MAPP, delivers the opening presentation of the ACCC National Oncology Conference.
By Amanda Patton, ACCC, Communications
From the opening presentation by featured speaker Peter Bach, MD, MAPP, to the final sessions focused on cancer survivors and the workplace and providing survivorship services on a shoestring budget—last week’s ACCC National Oncology Conference covered challenges large and small facing cancer programs and practices across the country.
Macro challenges—occurring at the health system and population health level—are well known to the oncology community. Among these are the high cost of cancer drugs and new therapies, the transformative shift in payment from volume to value, workforce shortages, reimbursement constraints, and the many issues tied to ever-increasing demands for data collection and reporting.
Micro challenges—occurring at the service line and individual provider and patient level—range from adapting delivery infrastructures to meet the evolving treatment landscape, to determining metrics to track and how to best to communicate these to leadership, to ensuring patient access to supportive care services that remain unreimbursed, to fostering a holistic, patient-centric culture of care.
Common themes across conference sessions and conversations: Collaboration, integration, evidence-based medicine, and value. Five key takeaways from the conference:
Cancer programs and providers must collaborate outside the box and across the care continuum.
Attendees heard first-hand from programs that are already making this work—from implementing virtual tumor boards, to engaging primary care physicians in survivorship care, to collaborating across disciplines to provide cancer prehabilitation services, and more.
There are formal & informal operational pathways to create integrated delivery networks with stakeholders for quality patient care.
Panelists in the Advancing Quality Care session agreed: to achieve a truly integrated delivery network transparency and trust between all partners is needed.
Oncology programs are increasingly turning to dynamic dashboards to demonstrate value to payers and patients.
Solutions and tools may exist outside the oncology service line. Reach out to the data analytics team or business intelligence team within your organization. Take advantage of or adapt existing resources and tools.
From personalized medicine to immuno-oncology, cancer treatment is undergoing a transformative shift.
For both providers and the patients they serve, the value proposition presented by genomic medicine is that it allows clinicians to make better therapeutic decisions.
Patients are key stakeholders in healthcare integration efforts.
“Successful integration will depend on aligned patient-centered care, patient-focused care, and patient engagement,” said ACCC President Elect Jennie Crews, MD, in the panel discussion on Advancing Quality Care. Panelists touched on the findings included in a new ACCC white paper released at the National Oncology Conference that outlines forward-looking essential steps to ensure quality patient care in the increasingly integrated healthcare environment.
ACCC encourages members to keep the conversation going by sharing your key conference takeaways in our members-only online community ACCCExchange.
Save the date and join us in Washington, D.C., March 2-4 for the ACCC Annual Meeting: CancerScape 2016.
Key Takeaways from NCCN Summit on Value, Access, & Cost of Cancer Care
By Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC
On September 11, 2015, the National Comprehensive Cancer Network (NCCN) convened healthcare experts for a policy summit on “Value, Access, and Cost of Cancer Care.” ACCC policy staff was in attendance, along with a host of provider and patient organizations. The summit explored methods to achieve optimum cancer patient care while considering rising care costs, and NCCN’s work groups on Value, Access and Cost also reported their findings. Some key takeaways follow.
Views on Value
The discussion on value centered on appropriate measures for value from the patient, provider, and payer perspectives. Panelists generally agreed that a broader view of healthcare is necessary to assess value. This includes consideration of the continuum of care, rather than just a specific episode of care. The full cost burden of cancer care on patients must also be addressed, and may include employment, caregiver, and housing and transportation issues.
Access Issues
Panelists explored access issues, focusing on the growing demand for cancer care services and its impact on access. Health exchange plans were identified as a source of disparate care, in that enrollees choose plans based on cost and then, upon cancer diagnosis, are faced with inadequate provider networks and prescription drug coverage. The discussion also touched on recent legislation driving providers to value-based reimbursement, and projected impacts on patient access to academic cancer centers. For the employer-insured population, one panelist commented on a shift to contracts with specific hospitals for second opinion and potential treatment of specific malignancies.
Cost Control
Among potential methods for curbing costs, panelists cited caution in use of high-cost diagnostics, treatments and therapies; avoidance of hospitalizations and emergency room use; and increased emphasis on palliative and end-of-life care. The panel noted that savings in provider care costs are possible, particularly through increased care planning and patient navigator uptake.
In discussing the cost of anti-cancer therapies, panelists pointed out that oncology is unique in that there is currently maximum use of generics with little opportunity for shifting to lower-cost prescription drugs until the further introduction of biosimilars. While drug costs make up just 15% of cancer care costs, they represent the fastest rising cost in cancer care. The panel acknowledged the challenges to containing prescription drug costs, and noted that some pharmacy benefit managers (PBMs) are looking to employ an indication-based formula for drug pricing, reimbursing for drugs by value and differentiating claims by condition. In the context of biologics, greater approval and high usage rates of biosimilars will be important to cost containment in the coming years.
The policy team at ACCC will continue to engage in this discussion of rising cancer costs and challenges in patient access to care.
Continue the Conversation
Join ACCC in Portland, Oregon, Oct. 21-23, at the 32nd National Oncology Conference and continue the conversation in sessions that will explore issues of value, cost, and patient access to care including:
Patient Access and the Cost of Cancer Care Across Specialties
Peter B. Bach, MD, MAPP, Center for Health Policy and Outcomes,
Memorial Sloan Kettering Cancer Center
What Will It Take? Must-Haves for Alternative Payment Models
Erich Mounce, MSHA, The West Clinic, PC
Palliative Care Models: Solutions for Programs of All Sizes
Moderator: Michael Kolodziej, MD, FACP, Aetna; Amy J. Berman, BS, RN, The John A. Hartford Foundation;
Sibel Blau, MD, Northwest Medical Specialties; and Brad Smith, Aspire Health
The full conference agenda and registration information is available here.
ACCC Responds to CMS on Proposed 2016 PFS Rule
By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC
On September 8th, ACCC submitted comments on CMS’ proposed 2016 Physician Fee Schedule rule. This year, the proposed PFS was released later than usual and contained a number of provisions that ACCC will be watching closely in the coming months.
Read on for a quick roundup of major provisions and ACCC recommendations to CMS:
Radiation Oncology Cuts
CMS proposes several significant changes to payment for radiation oncology procedures that would collectively result in drastic cuts for radiation oncology providers – an estimated 3% for radiation oncology and 9% for freestanding radiation therapy centers. CMS is proposing payment rates for new CPT codes that would effectively reduce Medicare reimbursement for IMRT and other radiation treatment delivery services. The agency also proposes to remove several essential direct practice expense inputs from the new radiation treatment delivery codes, including the on-boarding imaging equipment that is essential to providing safe and accurate radiation treatment. Finally, CMS proposes to adjust the equipment utilization rate assumption for the linear accelerator used in image guidance from 50% of available time to 70% of available time over two years, reducing reimbursement for services that make use of that equipment.
In our comments, ACCC expressed significant concern to CMS that these deep, simultaneous cuts in radiation oncology reimbursement will have the effect of forcing some cancer care providers, particularly those operating in rural and underserved areas, to close their doors. ACCC urges CMS to take the necessary steps to mitigate this threat, for example, by not implementing the proposed increase in the equipment utilization rate. ACCC will be monitoring this closely and stands ready to work with CMS to find ways to implement any appropriate changes over a period sufficient to allow providers to absorb the changes while not compromising access to critical radiation oncology services.
Biosimilar Reimbursement
CMS proposes a payment methodology for biosimilar products in which all biosimilars with the same reference product would be assigned a single HCPCS code and reimbursed based on the volume-weighted average sales price (ASP) for all products under the code plus 6% of the reference product’s ASP.
ACCC asks CMS not to finalize this proposal. We expressed concern that assigning multiple biosimilar products a single HCPCS code would create new and unnecessary administrative burdens for physicians and other providers when treating patients with biosimilar products, as they would not only need to enter the HCPCS code into the medical record, as they do now, but also the specific biosimilar therapy used for the patient. Additionally, this approach could significantly impede effective tracking of safety information and other information about the patient experience with specific biosimilar products—after these enter the market. We urge CMS to promote effective tracing of safety information and to minimize administrative burdens on providers who prescribe biosimilars.
Advance Care Planning
CMS proposes to establish payment rates for the two CPT codes adopted by the AMA CPT Editorial Panel to describe advance care planning services. ACCC strongly supports this proposal and asks that the payment rates for these services adequately reflect the cost to physicians of providing advance care planning.
As ACCC believes advance care planning services are equally important in the hospital outpatient setting, where they also take substantial time and resources and contribute significantly to the quality of patient care. In our comments to the proposed 2016 Outpatient Prospective Payment System rule, we urged CMS to pay separately for these two CPT codes in the outpatient setting as well.
Chronic Care Management
CMS recognizes that Medicare’s payment rates for the CPT codes for transitional care management (TCM) and chronic care management (CCM) do not fully account for the cognitive work that primary care physicians and other practitioners perform in managing and delivering care, particularly to chronically ill beneficiaries. CMS identifies add-on codes as one potential means of establishing payment rates that appropriately value the additional time and intensity of physicians’ cognitive work often involved in delivering care management services. ACCC encourages CMS to develop such codes, and to work with ACCC and other provider organizations to ensure that any new add-on codes are structured and valued appropriately.
ACCC also has concerns related to CMS’ proposal for chronic care management in the 2016 OPPS proposed rule. On the hospital outpatient side, CMS is proposing to permit only one hospital to bill for CCM services during a calendar month. ACCC points out to CMS that because cancer care is highly multidisciplinary, it can be difficult to agree upon who should be the designated CCM physician, and we are concerned that CMS’ rules for these services already make it very difficult for hospitals to seek payment for them. We urge CMS to continue to consult with hospitals and physicians on the best way to determine which entities should bill for these services.
“Incident To” Services
CMS proposes to require that the physician or other provider who bills for an “incident to” service must also be the physician or other provider who directly supervises the auxiliary personnel in providing that service. If CMS were to finalize this proposal, ACCC urges the agency to provide education to physicians and other providers on the revised requirement to ensure providers do not experience unwarranted disruption in billing for appropriate “incident to” services.
CMS is expected to finalize the 2016 Physician Fee Schedule rule in late October. Stay tuned, as ACCC will keep members updated as CMS revises and finalizes these important proposals.
340B Mega Guidance: What Providers Need to Know
By Maureen Leddy, JD, Policy Coordinator, ACCC
On August 27, 2015, the Health Resources and Services Administration (HRSA) released the much-anticipated mega-guidance for the 340B Drug Pricing Program. The 340B program provides discounted outpatient drug pricing for specified safety-net healthcare organizations, known as covered entities. The guidance was long-requested by covered entities and drug manufacturers, both of whom seek clarity in definitions and various elements of the program. HRSA considered proposing a regulation last year, but determined it did not have rulemaking authority. Consequentially, it has now proposed guidance, which while not legally binding, does inform 340B program participants on how HRSA believes the program should operate. From the perspective of a healthcare provider seeking to avoid audit under the 340B program, HRSA’s guidance should be given significant weight.
Providers should note HRSA’s definitions of both a 340B patient and a covered entity. The guidance appears to narrow the definition of a patient, allowing 340B drug eligibility on a drug-by-drug basis, specific to the medical issue for which the patient is being treated as an outpatient at the covered entity. Previously, a covered entity could provide a patient with any necessary drugs under 340B pricing, regardless of the scope of treatment.
The guidance also proposes a new standard that a child site of a covered entity hospital must provide services with associated Medicare outpatient costs and charges, in addition to the current standard that the child site be listed on a reimbursable line of the covered entity’s Medicare cost report. HRSA also makes clear that a covered entity’s inclusion in a larger organization such as an accountable care organization, does not qualify the larger organization for the 340B program. Finally, HRSA requests feedback on ways to demonstrate eligibility of off-site facilities.
Also notable from the provider perspective is guidance related to audit processes. HRSA proposes a notice and hearing process for 340B audits by the agency. Covered entities found not to be in compliance may be subject to corrective action plans, and loss of eligibility in the 340B program. HRSA also tightens standards for manufacturer audits of covered entities, requiring “reasonable cause,” while failing to impose any requirement that the agency act upon manufacturer audit results.
ACCC will continue to review this 340B mega guidance leading up to the October 28, 2015 comment deadline, and welcomes member input and questions.
Defining Value in Cancer Care
By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC
Earlier this summer, ASCO released its much anticipated “value framework,” a proposed methodology designed to assist physicians and patients in assessing the value of different cancer treatment options. Comments on the framework were due last week, and a variety of stakeholders – including providers, patient groups, and manufacturers – provided feedback on the model.
While most would agree the framework is not yet ready for the clinical setting, it represents an important step in the broader conversation about measuring value in cancer care. As a conceptual framework, it seems to have done its job. But as ASCO points out, it is critical to consider this tool in context. The methodology contains notable limitations in data, practicality, and scope, and payers and policymakers should be cautioned that this framework is not meant to serve as a basis for reimbursement or coverage determinations.
ASCO’s approach uses randomized clinical trial data to compare new treatments with an established standard of care under two different scenarios: the advanced disease setting and the adjuvant (potentially curable) setting. A treatment receives a net health benefit (NHB) score (up to 130 points for advanced and 100 points for adjuvant) by combining a score for clinical benefit (up to 80 points), toxicity (up to 20 points), and up to 30 bonus points for quality of life measures, including palliation of symptoms and treatment-free intervals in the advanced disease setting. The NHB score is intended to demonstrate the added benefit patients may receive from a new cancer drug compared with a current standard of care.
Under the proposed framework, the clinical benefit score gives most weight to therapies that increase overall survival, followed by progression-free survival, and response rate. ASCO chose these clinical endpoints because they represent data most commonly collected and reported in clinical trials. So, for example, when survival data is not available and/or only noncomparative trials have been preformed, as is often the case with breakthrough therapies, response rate will be used to determine the effectiveness of the drug until survival data becomes available.
The combined clinical benefit, toxicity, and bonus points make up the NHB score, which is then displayed next to (and, notably, separately from) cost. Here ASCO uses drug acquisition cost, and concedes that while this is not the most complete or meaningful measure, particularly for the patient, it was the most straightforward to quantify. Of course any methodology to truly determine value should include total cost of care, including estimated costs for diagnostics, surgery, imaging, hospitalization, and provider charges. Ultimately ASCO envisions including another figure, the cost to the patient, which will have to be individualized based on the patient’s specific health benefit design. ASCO also notes the goal is that the patient will also be able to modify the importance of both clinical benefit and/or toxicity based on his or her personal values and treatment goals.
As we know, defining value is not an easy task and ASCO recognizes several limitations to this model. The first is that the NHB calculation is only valid within the context of the clinical trial, which does not allow for intertrial comparisons. Additionally, this model does not include the patient’s perspective on value, excluding critical endpoints such as quality of life and patient-reported outcomes in the calculation of NHB. We also know that the relative value of a given treatment will likely change over its lifetime; how will this conceptual framework become a practical, dynamic tool that will repopulate data and update NHB scores over time?
From the physician’s perspective, many questions remain. How exactly will this tool be used in a clinical setting? When will this conversation happen at the point of care? Who will ultimately perform the analysis, input the patient’s cost-sharing data and preferences, and present the numbers to patients? Some physicians will use the tools themselves, while others will rely on nurses, administrators, or pharmacists to perform the analytics. While ASCO is clear the proposed framework is “not meant to substitute for physician judgment or patient preference,” in current form, it may leave the patient with more questions than answers. We encourage ASCO to develop a strategy to provide the appropriate guidance, support, and education to providers to assist them in explaining these values to patients in the next iteration of this framework.
ACCC recently submitted comments on ASCO’s value framework, and we look forward to continuing to engage with ASCO and others on the challenging issue of cost and quality in the cancer care delivery system.
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