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:

1. 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.
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.
3. 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 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.

King v. Burwell: Federal Health Insurance Subsidies Upheld for Patients

By Maureen Leddy, JD, Policy Coordinator, ACCC

On June 25, the Supreme Court issued their decision in the highly watched King v. Burwell case, ruling that the more than 6 million people currently purchasing insurance through a federal exchange can continue to access subsidies. At issue was the legality of federal subsidies for those in states that opted not to create a state health insurance exchange. Without these subsidies, the Court felt that the insurance markets would have essentially collapsed in the 34 states with federally run marketplaces, with the majority of those accessing subsidies unable to afford coverage when faced with full premium costs and, as a result, costs rising exponentially for those remaining in the market. Specifically, the court said: “[t]he combination of no tax credits and an ineffective coverage requirement could well push a State’s individual insurance market into a death spiral.”

A different decision in King would have likely created much disruption in the marketplace for both patients and providers. According to Kaiser Family Foundation, more than 6 million Americans might have lost subsidies, and faced an average premium increase of 287%. RAND estimated the number of insured Americans would have declined by 9.6 million. The healthy insured may have elected to discontinue coverage, leaving high-cost patients to constitute the majority of the insurance pool. Cancer patients might have been faced with paying unsubsidized and substantially increased premiums, which for some may have been unattainable.

Overturning subsidies would have also placed providers in the precarious position of caring for patients that became uninsured. The financial and ethical implications of treating newly uninsured patients are great. While providers may have chosen not to terminate patients undergoing a course of treatment regardless of a change in insurance status out of ethical obligation, the financial result would have been challenging, particularly for those community-based practices that lacked programs for low-income patients. For hospital-based providers, the financial implications would also have been great, undermining provisions in the Affordable Care Act that reduced Disproportionate Share Hospital (DSH) Medicare payments in exchange for a substantially reduced uninsured population. In short, without current federal subsidies in place, the mechanisms for providing and funding care for millions of Americans would have needed to be revisited. With a lack of agreement in Congress on the best approach to renewed healthcare reform, providers would have faced a great deal of uncertainty.

With a 6-3 decision, Justice Roberts’ Court concluded that “Congress passed the Affordable Care Act to improve health insurance markets, not destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”

Post updated 6/26/2015

HRSA Releases 340B Proposed Rule

By Maureen Leddy, JD, Policy Coordinator, ACCC

A proposed rule regarding 340B pricing enforcement was published in the Federal Register on June 17. The proposed rule responds to a mandate in the Affordable Care Act, which required the Health Resources and Services Administration (HRSA) to provide for imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge 340B-covered entities. The rule also provides a methodology for ceiling price calculation.

While not addressing more controversial aspects of the 340B program, such as patient definition, hospital eligibility criteria, and contract pharmacy arrangements, the rule does provide some important clarifications. Codification of the ceiling price calculation would provide 340B-covered entities with needed clarity in ensuring appropriate pricing. The rule would also impose a civil monetary penalty of up to $5,000 per instance of knowing and intentional overcharge of a covered entity, regardless of whether the order is placed with a manufacturer, wholesaler, authorized distributor or agent.

ACCC continues to closely watch for developments related to 340B, including expected release this summer of HRSA’s “mega-guidance,” anticipated to clarify several issues for which the agency does not believe it has rulemaking authority. HRSA has also indicated that it intends to release another rule on the administrative dispute resolution process in the near future. Stay tuned.

USP Chapter 800–Round Two

By Maureen Leddy, JD, Policy Coordinator, ACCC

Recently, ACCC submitted comments on the U.S. Pharmacopeia (USP) draft Chapter <800>, proposed standards for handling hazardous drugs in healthcare settings. The comments are in response to USP’s latest draft of Chapter <800>.

As you likely recall, USP released a first draft of Chapter <800> in March 2014. In response to comments by ACCC and other stakeholder groups, USP issued a revised Chapter <800> draft in December 2014.

In responding to the initial draft, ACCC and other stakeholder groups expressed concern about the difficulties providers would face implementing the proposed Chapter <800> standards, in large part due to the financial investment they would require. Many, including ACCC, anticipated that if USP Chapter <800> was adopted as first drafted, some cancer facilities would no longer be able to offer compounding services to patients or might even close altogether.

ACCC is pleased that USP’s revised Chapter <800> draft provides more flexibility, but concerns remain. We continue to request additional pathways to comply with the new USP standards and to ask for more clarity on specific requirements. ACCC supports USP’s ultimate goal of ensuring healthcare worker safety; however, we believe that in several instances there are more cost-efficient protective measures that would provide more certain safety enhancements.

USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP standards, such as Chapter <800>, are generally adopted by states and enforced by state Boards of Pharmacy or other regulatory entities. USP has indicated that the earliest likely effective date for Chapter <800> is August 2016; however, the many structural and procedural changes in the current draft would make compliance by that date a stretch for oncology programs.

The ACCC policy team is watching closely for a further revised or final draft of Chapter <800>; we will keep you posted.

Growing Momentum Around 340B

By Leah Ralph, Manager, Provider Economics & Public Policy, ACCC

Once again attention is focusing on the 340B Drug Pricing Program. With policymakers – and a variety of stakeholders – increasingly clamoring for more clarity and with some calling for more restrictions, HRSA has struggled with its authority to issue regulations on certain topics, including patient definition, hospital eligibility criteria, and contract pharmacy arrangements.

Last week, it looked like policymakers might address the issue legislatively, attempting to insert last-minute language into the House Energy and Commerce Committee-led effort, 21^st Century Cures legislation, that would “overhaul” the program and include many of the issues HRSA has attempted to address in regulations and guidance. However, the Committee ran out of time to find consensus on the comprehensive 340B reform plan, and the language ultimately did not make it into HR 6, the bill that passed out of committee last week.

In keeping with the growing momentum, last week MedPAC also released a report on the 340B Program at the request of Congress. The report provides an overview of the program and evaluates the trend in program growth and spending since its inception. This report could be used to set the stage for future reforms.

Perhaps most important, following HRSA’s withdrawal of its “mega-rule” last fall due to a court ruling against the agency’s treatment of orphan drugs under the program, HRSA recently submitted “mega-guidance” to OMB for review. While language is not yet public, we expect the guidance to cover topics where HRSA does not believe it has the rule-making authority, including patient definition, hospital eligibility, contract pharmacy, and audits. While OMB typically has up to 90 days to review submissions, the agency is not required to take the whole period, and we may see guidance published as early as June.

ACCC continues to follow the 340B dialogue closely, and looks forward to seeing clear, comprehensive rules and definitions to ensure compliance and the long-term viability of the program. For more, see the ACCC position statement.

 

Oncology Care Model: Updates from CMS

By Maureen Leddy, JD, Policy Coordinator, ACCC

As the clock ticks down to the May 7 deadline for CMMI Oncology Care Model (OCM) provider Letters of Intent (LOIs), some ACCC members may still be on the fence about submitting an LOI. CMS introduced the Oncology Care Model—the agency’s first specialty-specific alternative payment model—back in February. Those physician practices selected for OCM participation will begin receiving reimbursement for chemotherapy treatment episodes of care under the Oncology Care Model in spring 2016.

Since the introduction of the OCM, ACCC members have raised numerous questions as they weigh whether to apply for participation. In general, these questions have focused on three main issues: performance benchmarking methodology, payer collaboration, and the financial feasibility of achieving the practice transformation requirements. CMS has responded to some of these concerns, but we hope the agency will continue to provide clarity as the LOI submission period closes and our members prepare final applications for the June 18 deadline. Read on for a summary of CMS’s responses on these three key issues.

Performance Benchmarking Methodology

The initial Request for Applications (RFA) from CMS generated questions about the benchmarking methodology used to calculate a provider’s baseline or target price for specific episodes of care. Providers raised concerns about outliers with extremely high costs of care. CMS has responded that it will use Winsorization, resetting the outlying episode to a specific percentile within the provider’s total average care costs. Providers also raised concerns about how an already lean practice may benefit from OCM participation, where the benchmark for performance is based on the specific practice’s past performance. CMS has responded that the baseline period will likely be a three-year period beginning in 2012. The agency believes that this will help account for any very recent practice improvements. CMS has also indicated that the baseline for the entire five-year model will remain that same three-year period, ensuring practices that quickly adopt performance targets are not penalized in later years.

Payer Collaboration

In CMS’s applicant scoring methodology, participation with other payers (i.e., in addition to Medicare) will represent 30 points out of 100, a signal that the agency highly values the expansion of the OCM beyond Medicare. CMS has announced that 48 payers have submitted LOIs, and providers have raised concerns about whether to apply if no payer will be participating in their region. CMS has indicated that while it is an advantage for provider practices to partner with other payers, it is possible for a practice to be selected to participate in the OCM with only Medicare. There have also been indications that once the list of providers submitting LOIs is made public, there may be opportunity for payers to expand their participation regions.

Financial Feasibility

ACCC members have also raised concerns about whether the $160 per beneficiary per month fee is sufficient to achieve all of the practice transformations called for in the OCM. CMS has noted that other payers are expected to provide enhanced payments, which can also be used for the infrastructure changes called for in the OCM. For patients that do not fall within the OCM, practices may also continue to bill for chronic care management and transitional care management. CMS believes that this will provide sufficient revenue to support the required infrastructure changes. However, ACCC welcomes further feedback from members.

As we enter the post-SGR era, ACCC will be working to keep members informed on alternative payment model initiatives. We are pleased to hear that several members will apply to participate in the CMMI Oncology Care Model, and will continue to provide updates on this and other relevant alternative payment models as details become available.

Questions or comments on the OCM? Contact us at ocm@accc-cancer.org or visit our Oncology Care Model Resource Center.