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.
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
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.
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.
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.
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.
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.
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.
by Amanda Patton, ACCC, Communications
Featured speaker Peter Bach, MD, MAPP, addressed a packed room in the opening session of the ACCC National Oncology Conference on Oct. 22, in Portland, Oregon. Dr. Bach is Director, Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center.
Dr. Bach’s remarks centered on four prime issues challenging oncology today: the cost of cancer drugs, the need for oncology to do a better job on comparative outcomes research, the 340B drug pricing program, and the importance of incorporating end-of-life care into cancer program services.
Finding a rational way to address drug costs matters on both the macro level [in terms of the impact of healthcare costs nationally] and on the micro level at point of care when “drugs are being left at the pharmacy counter because patients can’t afford the copay,” he said.
Conference sessions throughout the day focused on challenges and innovative solutions that can have powerful micro- and macro-level impacts on cancer programs and providers, and the patients they serve: From “how to” sessions on benchmarking salaries, applying lean principles for staffing, establishing a virtual tumor board, distress screening, and preparing for alternative payment models, and more, to a big picture session on Advancing Quality—from Oncology Medical Homes to Integrated Delivery. One cross-cutting takeaway message: work across disciplines and siloes—think about how to collaborate outside the box and across the care continuum.
Stay tuned for more conference highlights. Follow conference on Twitter at #ACCCNOC.
by Amanda Patton, ACCC, Communications
Cancer care professionals from across the country are gathering in Portland, Oregon, this week for the ACCC 32nd National Oncology Conference.
Yesterday’s pre-conferences set the stage with sessions on oncology pharmacy issues and a program designed for administrators new to oncology.
One hot topic under discussion at the Oncology Pharmacy Education Network (OPEN) pre-conference: Institutional Review of Biosimilars. Jim Koeller, MS, PharmD, of the University of Texas at Austin, told attendees that “nationally, what we hope to create…we’re really trying to get to is a national standard on how biosimilars should be reviewed [by institutions].” Until that time, what can P&T Committees do to be ready for institutional review? Setting up a subcommittee or working group for biosimilars is an important first step, Koeller said.
While biosimilars will be less expensive, they will still be costly and reimbursement for biosimilars will “take a long time to figure out,” Koeller warned.
Key takeaways for oncology pharmacists and the oncology pharmacy:
- Biosimilars are not generics: Use of biosimilars will require clinical review by a multidisciplinary team through the P&T Committee or other mechanism
- A systematic review process will be necessary, looking at product, manufacturing, and institutional factors
- Interchangeability is generally a state issue; keeping up with state laws will be essential.
A common theme across both pre-conferences: Oncology today requires multidisciplinary leadership.
“Almost everything in oncology practice is interdisciplinary,” said presenter John Hennessy, MBA, CMPE, in a New to Oncology session on Leadership and Organizational Structure. To succeed, oncology programs must have processes in place for identifying and training future leaders and aligning incentive across all team members, he said.
Stay tuned for more from the ACCC National Oncology Conference. Follow the conference on Twitter at #ACCCNOC.
By Amanda Patton, ACCC Communications
“The promise of immunotherapy that was seen 100 years ago is now a reality,” said ICLIO Advisory Committee Chair Lee Schwartzberg, MD, FACP, in remarks kicking off the first Institute for Clinical Immuno-Oncology Conference on Oct. 2, in Philadelphia. “Where we are today, particularly with checkpoint inhibitors, is just the tip of the iceberg. . . . We are starting a new era with combination immunotherapy. . . . The challenge is how we will afford these new treatments.”
Conference sessions reflected the reality that adoption of immunotherapy in the community setting comes with challenges, and that strategies for successful implementation are already emerging. Read on for some key conference takeaways.
Immunotherapy is a completely different therapy.
From the clinical perspective, there is the need to understand differences in patients’ responses to immuno-oncology (I-O) therapy, to understand how to manage toxicities, and to educate all members of the multidisciplinary care team, the broader provider community, and patients and caregivers.
In a panel on Immuno-Oncology Applications, Sigrun Hallmeyer, MD, Oncology Specialists, SC, described her experience with implementing immunotherapy in the community setting. “This is really a completely different therapy,” she said. “What happens to patients in terms of side effects is unpredictable. . . . You can have twenty patients with no side effects and the twenty-first patient will have every side effect.”
Despite the challenge of understanding toxicities, Hallmeyer said, “What we are seeing in our community practice mirrors what is happening in clinical trials in terms of efficacy and side effects. . . . This is no longer a niche therapy for one or two tumor types.”
“We need to think in broad terms about educating other providers about immunotherapy toxicities,” said panelist Lee Schwartzberg, MD, The West Clinic, PC. Immunotherapy and toxicity profiles should be discussed in providers’ multidisciplinary conferences and during tumor boards, he said.
Panelist Gordana Vlahovic, MD, MHS, Duke University Medical Center, has been proactive in teaching residents at her program about toxicity profiles. The promise of these therapies is fueling demand, she said. “My practice has referrals from 45 states. Immunotherapy is something that people usually ask for.”
Dr. Hallmeyer agreed. “My patients are educated and well informed. They’ve known about these drugs. There was huge anticipation from the patient perspective and also from physicians.”
Advances in immunotherapy are accelerating more rapidly than the healthcare system’s ability to integrate them, particularly in terms of coverage and reimbursement, panelists agreed. It can take months for new drugs to be assigned J codes. In the meantime, payers may put a “hold” on drug claims, essentially putting the claim in limbo—neither denied or approved. Without a denial, patients cannot apply to patient assistance programs for help.
These are costly therapies, and “insurance and payment for these agents is a huge issue,” said Dr. Hallmeyer. Listen to a podcast of the Immuno-Oncology Applications session here.
Immunotherapy from the payer perspective.
Any discussion of new cancer therapies today must include cost and issues of financial toxicity—for the health system as a whole, for cancer programs and practices, and for patients. “It’s impossible not to be enthusiastic about the topic of today’s discussion,” said Michael Kolodziej, MD, Aetna, “but that doesn’t mean it’s easy.” From the payers’ perspective immunotherapy presents a problem that requires collaborative effort—the critical need to understand the patient population that responds to I-O. “We need to get the right treatment to the right patient at the right time, and we need you [providers] to help us figure it out,” he said.
Over the next two years, a number of immunotherapy drugs are likely to be approved for new indications, increasing the financial challenges, said panelist Michael Seiden, MD, PhD, McKesson Specialty Health. Listen to a podcast of the Payer Directions session here.
Immunotherapy comes with unique administrative challenges.
Three core administrative challenges in I-O implementation were spotlighted by Niesha Griffith, MS, RPh, FASHP, The Arthur G. James Cancer Hospital, The Ohio State University, in a panel discussion on tackling I-O integration challenges:
- Managing the deluge of immunotherapy information for patients and staff
- Ensuring appropriate triage of patients
- Managing reimbursement and patient financial support
Reinforcing the need for provider and staff education on immunotherapy, Griffith cited the critical issue of patients needing emergent care. “Everyone in the practice needs to understand that immunotherapy patients need to be treated differently when they go to the emergency department.”
“Education about I-O toxicities is critical,” commented panelist Steven D’Amato, BSPharm, BCOP, New England Cancer Specialists. “It’s especially important in order to avoid emergency department admissions and unintended downstream costs.”
In tackling the reimbursement and financial issues related to I-O therapies, Griffith said, “I can’t say enough about the importance of financial advocate support.” A key to success at her program has been adding dedicated reimbursement specialists to the pharmacy department.
Using patient assistance programs for immunotherapy agents is essential, she said. And to do this effectively, reimbursement specialists and the clinical team must work together. Administrative staff needs information from and communication with the clinical team to help patients access these therapies. “Financial advocates need to know everything about these new agents,” Griffith said.
While physicians are excited by these new therapies, in private practice it’s essential to have processes and efficiencies in place, especially on the back-end, to ensure reimbursement for I-O therapies, said panelist Spencer Green, MS, MBA (HA), Bozeman Deaconess Cancer Center. “Smaller cancer programs need access to experts to help think through the challenges of implementing new immunotherapy agents,” he said. Listen to a podcast of this session here.
I-O care coordination requires consistent, strong communication before, during, between, and after treatments.
Attendees got a bird’s-eye view from the frontlines of I-O implementation from panelists Catherine Schott, RN, BSN, CCRC, Wheaton Franciscan Healthcare; Jennifer Diehl, RN, Moffitt Cancer Center; and Gary Cohen, MD, Greater Baltimore Medical Center. Ms. Schott offered three essentials for care coordination of I-O patients:
- Begin care coordination early
- Encourage early reporting of adverse events
- Encourage compliance and long-term follow-up visits
Providers and staff—including office staff answering phone lines—need to be well educated about potential adverse events, said Ms. Schott. Educating patients and their families is equally important. She emphasized three key steps in care coordination of patients on I-O therapy:
- Conducting ongoing patient and caregiver education
- Providing wallet cards or symptoms logs for patients
- Encouraging accurate reporting of adverse events.
Schott stressed the importance of good communication during, between, and after treatment. “It’s important to know there may be late occurring side effects,” she said. “As more patients are treated with immunotherapy agents, we need to be vigilant about late occurring side effects.”
“For immunotherapy patients, it’s important to know who to call 24/7,” said panelist Jennifer Diehl. “Other providers may not be familiar with I-O agents, side effects, and treatments.”
Provider-to-provider communication is essential, said Dr. Cohen. Treating patients with these new immunotherapy agents is very different from “our experience in treating cancer patients with traditional chemotherapy or other modalities,” he said. Assessment of patients is very different. With immunotherapy progressive disease may not always be due to metastasis. Toxicities are different. “With immunotherapy we have to teach our radiation oncologists, our endocrinologists about how immunotherapy agents work.”
Immuno-oncology indications are rapidly evolving.
The conference’s closing session featured Timothy Kuzel, MD, FACP, Northwestern University, discussing evolving I-O indications in renal cell carcinoma and melanoma, and Renato G. Martins, MD, MPH, Seattle Cancer Care Alliance, presenting on evolving immunotherapy indications for lung cancer. “We believe very strongly that molecular profiling is a key component of improvement of care in non-small cell lung cancer,” said Dr. Martins. Listen to a podcast of Dr. Martins’ presentation here.
Learn more from the ICLIO Conference: Access session podcasts and view presentations here.
The Institute for Clinical Immuno-Oncology is a hub of I-O information and resources for the entire multidisciplinary cancer care team—both clinical and non-clinical program staff. Access webinars, articles, and join the ICLIO community: Transform care today!
The Association of Community Cancer Centers (ACCC) established the Institute for Clinical Immuno-Oncology (ICLIO) to empower multidisciplinary cancer care teams to advance application of immuno-oncology by providing comprehensive I-O resources.
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.
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.
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.
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.
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.
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.
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.