By Maureen Leddy, JD, Policy Coordinator, ACCC
On May 21, the House Energy and Commerce Committee advanced its 21st Century Cures legislation, HR 6, by a unanimous vote of 51-0. The Committee has publicly pledged that HR 6 will be taken up on the House floor sometime in June, with the goal of final passage in the House by the end of the year. The Cures legislation represents a tremendous step toward advancing research in the field of oncology and healthcare, as well as improving the process for bringing new technologies into oncology programs nationwide. ACCC supports these efforts and continues to watch carefully. Read on for background and an analysis of key provisions in the current draft.
21st Century Cures: The Road to Passage
A year ago the House Energy and Commerce Committee, led by Chairman Upton (R-MI) and Representative DeGette (D-CO), issued a call to action on the 21st Century Cures initiative. The focus was to be the discovery, development, and delivery of life-saving drugs and devices to patients. Through a series of hearings and meetings with stakeholders and government officials, the Committee developed draft legislation, originally circulated in January 2015. The most recent draft incorporates the input of multiple stakeholders and represents a collaborative effort toward developing a better pathway to bring new therapies to patients.
Importantly, the prospects in the Senate, at least for 2015, remain uncertain. The Senate Health, Education, Labor and Pensions Committee (HELP) has been conducting a similar effort toward producing draft legislation focused on new drug and device development. The HELP Committee released a white paper in January 2015 that focused on barriers to development and delivery of new drugs and devices to patients, and examined potential solutions within FDA and NIH. On April 28, the Committee held a hearing, “Continuing America’s Leadership: The Future of Medical Innovation for Patients,” its third hearing on development and delivery of new treatments. While we are encouraged by these efforts, Chairman Lamar Alexander (R-TN) has indicated that the Senate may not develop its own legislative draft language until early 2016.
HR 6: Where Was Consensus Reached?
Despite uncertainty around the Senate’s parallel effort, HR 6 represents an extraordinary collaborative effort toward improving the pathway for disease treatment development. Exactly what did they agree to that will impact ACCC members and their patients?
- NIH Funding
ACCC was pleased to see provisions included that would significantly advance NIH biomedical research. Provisions supporting high-risk breakthrough research and facilitating clinical trial and health data sharing would spur the development and use of new cancer treatment technologies. The establishment of a 21st Century Cures Council, consisting of representatives from NIH, FDA, CMS, industry, insurers, patients, providers, as well as academic researchers, would allow for continued collaboration by this wide range of stakeholders. This council is tasked with setting a strategic agenda for cures development, identifying gaps in innovation and proposing recommendations, and identifying opportunities for collaboration in the U.S. and abroad.
- Drug Development Tools and Precision Medicine
HR 6 follows President Obama’s January announcement of the research-focused Precision Medicine Initiative, clarifying terms and the development of precision drugs and biologics, and requiring guidance documents. The bill defines “biomarker” and requires establishment of a framework for development of biomarkers, including a taxonomy for biomarker classification. The FDA would be required to define “precision drug or biological product” as well as issue guidance on development of biomarkers to inform prescribing decisions. The legislation would also establish a pathway for accelerated drug approval through use of surrogate endpoints.
The field of oncology is witnessing a tremendous growth in the number of molecular biomarkers, as well as diagnostic tests. These improvements in classification of biomarkers as well as clear guidance on prescribing are key to the adoption of these new technologies in cancer care programs.
- Clinical Trials
The option to participate in clinical trials is critical to cancer patients that do not respond to standard treatments. HR 6 would advance federal clinical trial participation, requiring NIH to standardize patient inclusion and exclusion information. It would also require the creation of a scientific research sharing system for federally funded trials. 21st Century Cures would also promote clinical trials by eliminating regulatory duplication through harmonization of HHS and FDA Human Subject Regulations. The legislation modernizes provisions and streamlines the review process to account for trials conducted at multiple sites.
ACCC is pleased that consensus was reached on these and other key provisions regarding research and development of innovative cures. We will continue to monitor this legislation as it reaches the House floor, and watch the Senate for parallel legislation. Stay tuned.
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.
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.
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.
By Maureen Leddy, Policy Coordinator, ACCC
On April 14, 2015, after years of uncertainty and 17 short-term “doc fix” patches to prevent severe annual cuts to physician payments, Congress approved H.R. 2, Medicare Access and CHIP Reauthorization Act (MACRA). This bipartisan, bicameral compromise finally puts an end to the sustainable growth rate (SGR) formula. MACRA provides physicians with the predictability in payments needed to continue to provide high-quality cancer care, while transitioning over a 10-year period to a new dual Medicare reimbursement system.
What’s in Store?
Under MACRA physicians must eventually participate in a Merit-Based Incentive Payment System (MIPS) or an Alternative Payment Model System. Through June 2015, MACRA calls for Medicare physician reimbursement at the rate set by last year’s “doc fix” patch. Then, for five years, through 2019, annual 0.5% increases to payment rates are established.
In 2020, a second five-year phase begins during which reimbursement rates remain flat. During this second phase, providers will need to transition to the Merit-Based or Alternative Payment Model Systems. Ultimately MACRA encourages providers to participate in Alternative Payment Model Systems through higher incentive payments; beginning in 2026, physicians will receive automatic payment updates of 0.75% if participating in an APM, and 0.25% if participating in MIPS, with an opportunity to receive additional bonus payments based on performance. Payments under the MIPS will be subject to positive or negative adjustments based on the following performance criteria:
- quality of care
- resource use
- clinical practice improvement activities
- use of electronic health records (EHR) technology.
During the second five-year phase through 2024, providers participating in an Alternative Payment Model will be eligible for annual lump-sum bonuses equaling 5% of the prior year’s payments upon achieving specified targets in transitioning from fee-for-service payments. Providers participating in MIPS will be eligible during this second five-year period for additional positive adjustments in rates for exceptional performance.
Payment Model Technical Advisory Committee
MACRA encourages the development of Alternative Payment Models applicable to specialties and small practices, as well as models that align private and state-based payers. The legislation calls for creation of a Payment Model Technical Advisory Committee that will recommend additional Alternative Payment Models to CMS. CMMI’s recently launched Oncology Care Model (OCM) already provides one venue for many cancer providers to participate in an Alternative Payment Model. Visit ACCC’s Oncology Care Model Resource Center for answers to providers’ questions on eligibility, reimbursement, and key considerations for participation in this new payment model, plus links to application forms and CMMI OCM materials.
Going forward, ACCC will be vigilantly monitoring the Payment Model Technical Advisory Committee recommendations for other Alternative Payment Models that may be relevant to oncology practices.
ACCC looks forward to working with our members to effectively implement the bill and transition towards a new future for physician reimbursement.
On Wednesday, April 22, ACCC is hosting a members-only conference call with presenter Dan Todd, former Senior Health Counsel, Senate Finance Committee, and a primary author of MACRA, that will provide an in-depth look at what MACRA means for oncology providers and the future of physician reimbursement. ACCC members can access call-in information here.
As ACCC members know, last week brought unprecedented momentum on an issue physicians and Congress have been struggling with for over a decade: repealing the sustainable growth rate (SGR). Just days before the current SGR “patch” expired, the House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act, legislation that would permanently replace the SGR formula with stable Medicare payment updates and encourage physicians to increasingly participate in alternative payment models. The bill builds on last year’s bipartisan, bicameral compromise that ultimately hit roadblocks when legislators struggled to find a way to pay for it.
The Senate was expected to take up the House bill, but on March 27, the chamber recessed for two weeks, leaving a very small window to consider the bill when they return on April 13.
Senate Majority Leader Mitch McConnell has said the bill should move “very quickly” when the chamber comes back into session, and there is “every reason” to believe the bill will pass.
Meanwhile, the current “patch” expired March 31, and CMS has indicated that it will hold claims for two weeks, or 10 business days, through April 14.
We’re in the homestretch; we’re closer to a permanent fix to the SGR than we have ever been before. But are we there yet? Not quite. Now is the time to contact your Senators, and urge them to support passage of H.R. 2, to ensure that physicians have the predictable, appropriate payments they need to continue to provide high-quality cancer care.
Stay tuned. And make your voice heard. Contact your Senators today.
On Thursday, March 26, the U.S. House of Representatives passed H.R. 2, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.
Unfortunately, the Senate announced late Thursday evening that they will not consider the SGR repeal bill until they return from recess on April 13, 2015. CMS has indicated it will hold claims for two weeks, through April 14.
ACCC urges members to contact your Senators in the next two weeks and ask them to support a permanent repeal of the SGR.
On March 26, by a vote of 392-37 the U.S. House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.
Rep. Michael C. Burgess, MD, (R-Texas), the bill’s primary sponsor, said in a statement, “This is the work of a collaborative body. . . .It is time to end the SGR. Let us never speak of this issue again.”
On March 25, the White House expressed support for the bill.
The Senate is expected to vote on the bill March 27, before Congress recesses for two weeks.
ACCC urges members to contact your Senators and ask them to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!
by Leah Ralph, Manager, Provider Economics and Public Policy, ACCC
With another SGR deadline looming, leaders in the U.S. Senate and House are coming close to striking a bipartisan, bicameral deal to finally replace the broken Medicare Sustainable Growth Rate (SGR) formula.
On March 24, bipartisan leaders of the House Energy and Commerce and House Ways and Means Committees introduced H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), to permanently replace Medicare’s Sustainable Growth Rate (SGR). The agreement builds upon H.R. 1470, introduced last week.
H.R. 2 would create an improved physician payment system that rewards quality, efficiency, and innovation and put an end to the cycle of annual “doc fix” crises that have created uncertainty for millions of Medicare providers and beneficiaries for over a decade. As you well know, physicians need the assurance of predictable, appropriate payments in order to plan for the future and invest in the personnel and technologies that are essential to providing high-quality cancer care.
This is historic momentum on an issue that has plagued providers—and Congress— for years. This year’s compromise builds on last year’s efforts, and the window to get this bill across the finish line is narrowing. Join us in urging Congress to continue to work together to pass responsible legislation that appropriately reimburses patient care.
Contact your member of Congress to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!
by Amanda Patton, ACCC Communications
March 23 marked the five-year anniversary of President Obama’s signing of the Affordable Care Act into law. Over the last five years, nearly 16.4 million Americans have gained health coverage under the ACA.
Last week, at ACCC’s Annual Meeting, CANCERSCAPE, in Arlington, Va., panelists Steven D’Amato, BSPharm, BCOP, executive director, New England Cancer Specialists; Wendy Andrews, BS, practice manager, Hematology/Oncology at the University of Arizona Cancer Center; and George Dahlman, executive vice president, Federal Affairs & Operations, National Patient Advocate Foundation, explored the impact of the ACA from the patient advocate and provider perspective, sharing the view from the frontlines of care delivery and patient advocacy. The discussion was moderated by ACCC Executive Director Christian Downs, JD, MHA.
One challenge panelists identified is meeting the increased demand for services driven by growing numbers of insured patients.
“In Maine we have an exchange, Maine Community Health Options. It’s been so successful that the challenge is having adequate staff to manage the program,” said Steven D’Amato. “The big challenge will be the workforce challenge as we have more insured patients.”
Wendy Andrews, who is a practice manager, noted that Arizona has expanded Medicaid, which has moved many patients from self-pay to Medicaid. While they are seeing more patients with insurance, these patients all tend to be underinsured.
Another challenge expressed by each of the panelists is the pressing need to help patients understand their insurance coverage and, especially, their out-of-pocket costs.
During the first year of the Marketplace in Arizona, those trying to help consumers with plan selection often had a lack of knowledge [about coverage] and patients were “actually given the wrong information,” Ms. Andrews said. Now, in the Marketplace’s second year, this problem continues.
From the patient advocate’s perspective, George Dahlman finds that the Marketplace experience is exposing consumers’ education gaps. “We have 200 case workers that help patients with insurance problems and copay programs. [This is exposing] the biggest education gaps for consumers. Most people look at the insurance premiums—not what’s included in the benefits program” when purchasing coverage.
Andrews agreed, finding that “ninety percent of all patients really, truly do not understand their insurance benefits.”
Providers and patient advocate organizations alike are challenged to help educate consumers about their coverage. “These are complicated insurance products, and you’re educating two patient populations: previously insured and those who’ve never had insurance before. It’s a brave new world for consumers,” said Dahlman. Patients need information about whether they can keep their current providers when considering insurance options, and what their out-of-pocket costs will be.
“In our practice, it’s essential that patients meet with a financial advocate first,” said D’Amato. Wendy Andrews agreed. “We pre-register all of our patients and verify their benefits.” Her practice requires that patients also verify that they’ve made premium payments. As a result, the front-end administrative burden for providers has increased.
Finally, the panel touched on the impact of narrow networks within marketplace plans. In a rural state, like Maine, “you always worry about access,” said D’Amato. “Creation of narrow networks creates inconvenience for patients.” In Arizona, Andrews said,“the problem we see the most is lack of providers being available in all the plans. What does a patient do when there isn’t a provider in their plan and they have to travel long distances [for care]?”
In summary, the panelists’ described three key challenges post-ACA implementation:
- Access challenges, i.e., having enough providers to meet increased patient demand; narrow networks potentially limiting patient access to providers
- Education challenges, i.e., increased need to help patients, both previously insured and those who are newly insured, understand their coverage and out-of-pocket costs, and
- Front-end administrative burdens, i.e., verifying coverage, understanding patients’ insurance plan coverage, and helping identify resources for underinsured patients.
by Amanda Patton, ACCC Communications
On Tuesday, March 17, at ACCC’s Annual Meeting, Ron Kline, MD, Medical Officer with the Center for Medicare and Medicaid Innovation (CMMI), and Kavita Patel, MD, MS, of the Brookings Institution helped bring a little more clarity to CMMI’s Medicare’s Oncology Care Model (OCM).
The OCM has been developed by CMMI to test new payment and service delivery models, as part of its overarching triple aim of better care, smarter spending, and healthier people. OCM goals center on care coordination; appropriateness of care; and access for beneficiaries going through chemotherapy, Dr. Kline said. Learn more here.
In his overview of the five-year pilot, Dr. Kline pointed to the multi-payer nature of the OCM. “Payers are encouraged to work as part of the model. The point is to leverage the OCM to bring in more and more payers and patients to this model.”
Finally, he stressed the OCM is not intended to be a one-size-fits-all model.
“Part of the point of OCM is that we don’t have all the right answers for all the parts of the country…and the best way to move forward is to learn best practices [through the model].”
CMMI plans to hold webinars, site visits, and meetings at ASCO and elsewhere to share OCM best practices, he said.
So, What’s Everyone Asking?
According to Dr. Patel, the top OCM hot topics are:
# 1 Eligibility. CMMI wants the OCM to “include everyone as much as possible as long as we adhere to the principles of the OCM, attribute, and benchmark appropriately,” said Dr. Kline.
“ACCC is exactly the audience the Oncology Care Model is tailored for—those providing ongoing services for cancer care,” said Dr. Patel.
#2 If you have a practice, can only some providers participate? The short answer is, if you participate, anyone in the practice who is prescribing chemotherapy would be automatically included in the OCM. This includes NPs or PAs who might be prescribing. Simply put: It’s an inclusive model.
#3 Data requirements. Participants need the administrative and technological resources to support these.
For those contemplating OCM participation Patel suggests the following steps:
- Evaluate what infrastructure investment you will need to make.
- Perform a serious “gut check” with providers on what OCM participation will mean.
- Consider how you’ll get all those involved in the OCM to understand the model’s total cost of care framework. (This last item is likely the biggest organizational hurdle, Patel said.)
- Finally, consider the staffing requirements for participation.
What components will be needed for OCM success? Dr. Patel identified three:
- Bringing on primary care physicians
- Learning how to do robust data exchange inside the practice, e.g., having an EMR able to deliver clinicians what they need at point of service
- Being able to predict which patients in your population will need more intensive services (risk stratify).
Perhaps it’s not surprising that even during the OCM discussion, the SGR made a cameo appearance. Dr. Patel noted that details of an SGR fix currently being negotiated on Capitol Hill will likely include some provisions that will force doctors to enter into alternative payment models in the next five years.
ACCC’s 41st Annual Meeting, CANCERSCAPE, kicked off on March 16 with Capitol Hill Day. ACCC members from across the country fanned out across the Capitol for more than 70 scheduled meetings with legislators and key staff members from both the House and Senate.
With the current Sustainable Growth Rate (SGR) patch set to expire March 31, the timing was ripe for these advocates to speak up for a permanent fix to the SGR.
First time ACCC Hill Day participant Linda Gascoyne, patient advocate for medical oncology, East Maine Medical Center in Brewer, Maine, spent the day with the Maine delegation that met with Senator Susan Collins on Monday, afternoon. “I found her [Senator Collins] to be very empathetic as she listened and learned about what we were asking [from Congress],” Ms. Gascoyne said. In addition to the SGR, the Maine delegation talked with Senator Collins about the need for federal oral parity legislation and elimination of the prompt pay discount from the ASP calculation.
Donna Sulsenti, practice manager, South Shore Hematology Oncology and president of HOMNY was part of the New York delegation that had visits with four congressional offices. “It was extremely interesting speaking about issues with our legislators and getting something accomplished,” she said. She also finds it “satisfying to know that ACCC is working for us.”
Another first time ACCC Hill Day participant Monica Cfarku, nurse manager, Oregon Health & Science University, Knight Cancer Institute, said she “learned a lot” from her meetings with hill staff. In turn, she found staff engaged on the issues and interested in learning from her. “I felt like I offered them a different perspective as someone on the frontline of care delivery.” In fact, staff from a congressional office invited her to return later in the week to share more of her perspective.
Stay tuned for more from ACCC’s Annual Meeting, Cancerscape underway in Arlington, Va. Follow us on Twitter at #cancerscape15.