CANCERSCAPE Session to Demystify Site-Neutral Payment Policy
By Amanda Patton, ACCC Communications
In recent months MedPAC, the Centers for Medicare & Medicaid Services (CMS), Congress, and the GAO have ramped up attention on the impact of consolidation and integration, shifts in sites of service, and how unequal payment rates across settings of care are affecting Medicare costs.
Adding to the controversy (and confusion) around site-neutral payment as a solution to reducing the Medicare “spend” is the recently passed Bipartisan Budget Act of 2015 at Section 603, “Treatment of Off-Campus Outpatient Departments of a Provider.”
Although the issues surrounding site neutral payment policy are complex, “Section 603 is pretty straight forward,” says Ronald Barkley, MS, JD, of the CCBD Group. “It’s the downstream unintended consequences that cancer programs need to understand.” In a session at the upcoming ACCC Annual National meeting in Washington, D.C., March 2-4, Barkley will demystify site neutral payment policies, lay out pros and cons, and provide a realistic assessment of the potential impact of Section 603. Attendees will leave with a 360-degree understanding of the issues and a “knowledge base to work from” going forward, Barkley said.
Site-neutral payment policies have the potential to affect revenue and budgeting, strategic planning, pro forma development, and 340B Drug Program participation. Thus, a thorough understanding of Section 603 is critical for today’s cancer program leadership.
Time is of the essence, according to Barkley. “There is a window of opportunity to take your message to CMS before [the agency] translates the [Section 603] legislation into regulation.”
Attend the ACCC 42nd Annual Meeting, CANCERSCAPE, from March 2—4, 2016, in Washington, D.C., and gain strategic insight into key drivers of change impacting our evolving oncology care delivery system in sessions focused on Policy, Value, and Quality. Learn more here. Want to discuss this issue with your elected representatives on Capitol Hill? See what’s planned for ACCC Capitol Hill Day on March 2.
ACCC Advocacy Update
By Leah Ralph, Director, Health Policy, ACCC
Congress closed out 2015 with a bang, passing a number of large, end-of-year spending bills to keep the government funded through 2016 and several provisions that will impact ACCC members.
The omnibus appropriations bill (H.R. 2029) boosted NIH funding by 6.6 percent to $32.1 billion, the largest increase NIH has seen in 12 years. A separate package of Medicare provisions, the Patient Access and Medicare Protection Act (S. 2425) passed just before Congress adjourned for the year. This legislation created a blanket hardship exemption for meaningful use penalties in 2015, making it easier for the Centers for Medicare & Medicaid Services (CMS) to review and process hardship exemption requests. (To apply for an exemption, physicians must apply by March 15, 2016, and hospitals by April 1, 2016.)
The Medicare bill also froze payment rates to freestanding radiation therapy centers at 2016 levels for two years, CY2017 and CY2018. It is important to note that the Medicare bill ultimately did not include a provision that would have exempted “under construction” off-campus outpatient facilities from an earlier law (the Bipartisan Budget Act of 2015) that reduced Medicare payments to newly built or acquired hospital outpatient departments.
Before year-end President Obama signed both H.R. 2029 and S. 2425 into law.
As attention shifts toward elections in 2016, with divergent views on the future course of the nation’s healthcare policies, we are sure to see even more movement on policies that will impact the provision of quality cancer care. Make your New Year’s resolution today to join us for ACCC Capitol Hill Day March 2, 2016. Learn more and register here.
An Easy—and Empowering—New Year’s Resolution
By Leah Ralph, Director, Health Policy, ACCC
New Year’s resolutions are the very definition of trope: a common or overused theme. But they don’t have to be. Today I’m asking you to set aside the old standbys of weight loss or more exercise and look at the bigger picture—specifically what you can do to improve the lives of the cancer patients you treat each and every day.
Last year ACCC mobilized members from 23 states and held over 80 meetings with legislators on Capitol Hill about issues of importance to the oncology community. We effected real change. Shortly after our ACCC Hill Day visits, Congress passed a permanent repeal to the Sustainable Growth Rate (SGR) formula, guaranteeing predictable physician payment rates and setting in motion a wave of Medicare reimbursement reforms. Our voices made a difference!
This year, we’re growing our annual Capitol Hill Day program and making some exciting changes: more comprehensive training, more face time with legislators, and, most important a greater focus on helping you tell your community’s story—the one that your legislators most want to hear. What’s going on in your home town? What’s keeping you up at night? What are the stressors that are having a negative impact on your cancer patients?
So whether you’ve attended a previous ACCC Capitol Hill Day or you’re an “advocacy newbie,” here are three solid reasons to make the ACCC 2016 Capitol Hill Day your New Year’s Resolution:
- More comprehensive training. The ACCC policy team will host webinars and conference calls to prepare for your congressional meetings. We’re planning a comprehensive training and reception for Tuesday, March 1, plus an additional advocacy review on the morning of Hill Day, Wednesday, March 2.
- More face-time with legislators. Gather for lunch with your ACCC colleagues and congressional members to discuss key issues that impact your program, such as reimbursement for supportive care services, drug costs, staffing shortages, and how excessive data collection and reporting is cutting into the time you can spend on direct patient care.
- Less focus on specific bill numbers. You don’t need to be a “policy expert” or familiar with specific legislation in 2016. It’s a chance to share YOUR STORY so lawmakers understand how policy impacts oncology care in YOUR COMMUNITY. (Now, if you want bill numbers, we’ll have those too.)
Policymakers rely on healthcare providers—not policy staff—to provide real-world perspectives on policy issues that matter. As the leading national multi-site, multidisciplinary organization, ACCC is uniquely positioned to serve as a resource. This is our value to legislators. The diversity and sophistication of our membership requires a nuanced, balanced approach to policy challenges—and we stand ready to offer insights on how cancer care is delivered today.
As our experts, we invite you to come to Washington, D.C., to do what you do best. Talk about your programs, your processes, and most importantly your patients. Our annual Capitol Hill day is an important and rewarding opportunity to advocate for policy change. Resolve to attend ACCC Capitol Hill Day 2016, and help to put the voice of the cancer care team and cancer patient at the center of policy decisions. Learn more at accc-cancer.org/HillDay.
Key Takeaways from NCCN Summit on Value, Access, & Cost of Cancer Care
By Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC
On September 11, 2015, the National Comprehensive Cancer Network (NCCN) convened healthcare experts for a policy summit on “Value, Access, and Cost of Cancer Care.” ACCC policy staff was in attendance, along with a host of provider and patient organizations. The summit explored methods to achieve optimum cancer patient care while considering rising care costs, and NCCN’s work groups on Value, Access and Cost also reported their findings. Some key takeaways follow.
Views on Value
The discussion on value centered on appropriate measures for value from the patient, provider, and payer perspectives. Panelists generally agreed that a broader view of healthcare is necessary to assess value. This includes consideration of the continuum of care, rather than just a specific episode of care. The full cost burden of cancer care on patients must also be addressed, and may include employment, caregiver, and housing and transportation issues.
Access Issues
Panelists explored access issues, focusing on the growing demand for cancer care services and its impact on access. Health exchange plans were identified as a source of disparate care, in that enrollees choose plans based on cost and then, upon cancer diagnosis, are faced with inadequate provider networks and prescription drug coverage. The discussion also touched on recent legislation driving providers to value-based reimbursement, and projected impacts on patient access to academic cancer centers. For the employer-insured population, one panelist commented on a shift to contracts with specific hospitals for second opinion and potential treatment of specific malignancies.
Cost Control
Among potential methods for curbing costs, panelists cited caution in use of high-cost diagnostics, treatments and therapies; avoidance of hospitalizations and emergency room use; and increased emphasis on palliative and end-of-life care. The panel noted that savings in provider care costs are possible, particularly through increased care planning and patient navigator uptake.
In discussing the cost of anti-cancer therapies, panelists pointed out that oncology is unique in that there is currently maximum use of generics with little opportunity for shifting to lower-cost prescription drugs until the further introduction of biosimilars. While drug costs make up just 15% of cancer care costs, they represent the fastest rising cost in cancer care. The panel acknowledged the challenges to containing prescription drug costs, and noted that some pharmacy benefit managers (PBMs) are looking to employ an indication-based formula for drug pricing, reimbursing for drugs by value and differentiating claims by condition. In the context of biologics, greater approval and high usage rates of biosimilars will be important to cost containment in the coming years.
The policy team at ACCC will continue to engage in this discussion of rising cancer costs and challenges in patient access to care.
Continue the Conversation
Join ACCC in Portland, Oregon, Oct. 21-23, at the 32nd National Oncology Conference and continue the conversation in sessions that will explore issues of value, cost, and patient access to care including:
Patient Access and the Cost of Cancer Care Across Specialties
Peter B. Bach, MD, MAPP, Center for Health Policy and Outcomes,
Memorial Sloan Kettering Cancer Center
What Will It Take? Must-Haves for Alternative Payment Models
Erich Mounce, MSHA, The West Clinic, PC
Palliative Care Models: Solutions for Programs of All Sizes
Moderator: Michael Kolodziej, MD, FACP, Aetna; Amy J. Berman, BS, RN, The John A. Hartford Foundation;
Sibel Blau, MD, Northwest Medical Specialties; and Brad Smith, Aspire Health
The full conference agenda and registration information is available here.
Proposed 2016 Medicare Rules
By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC
The Centers for Medicare & Medicaid Services (CMS) 2016 proposed rules are out, and, not surprisingly, we continue to see the agency push outpatient payments toward more bundled services and move full steam ahead to tie Medicare payments at large to quality and value in the coming year.
2016 HOPPS Proposed Rule
Generally speaking, the proposed Hospital Outpatient Prospective Payment System (OPPS) rule includes few surprises, most notably CMS is proposing a -2% across-the-board reduction to compensate for “excessive” packaged payments for laboratory services in CY14. The rule also includes nine new comprehensive ambulatory payment classifications (C-APCs) to add to the 25 introduced last year and proposes consolidation and restructuring of nine APC clinical families. Importantly, CMS will continue to reimburse drugs at ASP+6% in the hospital outpatient department. The agency also provides some flexibility on the “two-midnight” rule. Currently the rule requires that a beneficiary to remain in the hospital for longer than two midnights in order for the stay to be reimbursed as an inpatient stay. Under the proposed rule, CMS would recognize some shorter stays as inpatient, and would evaluate on a “case-by-case” basis.
2016 PFS Proposed Rule
The proposed Physician Fee Schedule (PFS) rule was released later than expected this year, perhaps due to slightly more contentious provisions. The good news – perhaps – is that, as proposed, the 2016 PFS would have no (0%) impact on Medicare payments in hematology/oncology. However, on the radiation oncology side the news is not so good. If all of the proposals in the rule are finalized, radiation oncology will face an estimated -3% cut and freestanding radiation therapy centers will see a -9% cut due to a combination of new code values and a change in assumption involving the overall use of linear accelerators. CMS also indicates how it will treat biosimilars for the purposes of Part B reimbursement, proposing to assign the same HCPCS code to all biosimilars that reference the same innovator drug. These would be paid based on their volume-weighted ASP+6% of the reference product’s ASP. If no ASP data is available, biosimilars would be reimbursed at 100% of their wholesale acquisition cost.
Under the PFS, CMS also proposes to create two new CPT codes for advanced care planning services, one to start the conversation with a patient and the other for continued discussion. The rule also begins the phasing out of the PQRS (the 2018 payment adjustment will be the last); adjustments for quality reporting will now be made under the new Merit-Based Incentive Program (MIPS), created by the legislation that repealed the Medicare Sustainable Growth Rate (SGR). CMS seeks comments on MIPS on issues like the definition of clinical practice improvement activities, how to define a physician-focused payment model, and more.
ACCC will be submitting comments on both rules, due August 31 and September 8, respectively. On Tuesday, July 21, 4:00-5:00 PM EST, ACCC is hosting a members-only conference call with a full rundown of both proposed rules. Stayed tuned.
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, 21st 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.
SGR is Over: What Does it Mean for Providers?
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.
Stay tuned.
SGR Repeal: Are We There Yet?
By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC
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.
ACCCBuzz 
leave a comment