Tag Archives: MACRA

What Happened in Washington This Week

By Brittney Fairman, MPS, MA, ACCC Policy Analyst

U.S. CapitolIt’s been quite a week in Washington, D.C.  Let’s recap.

On Wednesday, July 12, the Centers for Medicare & Medicaid Services (CMS) held the latest in a series of webinars explaining the agency’s proposed rule for CY 2018 updates to MACRA’s Quality Payment Program. If you missed ACCC’s webinar on the implications of this proposed rule, members can access the webinar, presentation slides, and a summary [login required].

On Thursday morning, July 13, U.S. Senate Republicans unveiled their revised draft of the Better Care Reconciliation Act of 2017 (BCRA). The updated bill is the latest effort to repeal and replace the Affordable Care Act (ACA), and we continue to have concerns about the erosion of protections for cancer patients in the exchange marketplaces. ACCC is continuing to monitor the effort on the Capitol Hill and measure the evolving legislation against ACCC’s health reform principles.

Then later that same day, the Centers for Medicare & Medicaid Services (CMS) released the proposed CY 2018 Hospital Outpatient Prospective Payment System rule and CY 2018 Physician Fee Schedule rule. ACCC is currently analyzing both rules and will provide in-depth information to members on the impact on oncology. At first glance, the proposed, significant cuts to hospitals in the 340B Program and to new outpatient facilities cause concern, particularly for small, rural cancer programs and programs in vulnerable communities without other sources of healthcare. Stay tuned for information on the date and time of an upcoming ACCC members-only webinar on these proposed rules.

Also Happening on Capitol Hill
So this week, while much of the nation’s attention has been focused on Congressional action on ACA repeal and replace, and many healthcare providers awaited CMS’s release of the proposed 2018 Medicare rules, it’s important to note that another significant piece of legislation moved forward on Capitol Hill. On July 12, the U.S. House of Representatives passed the FDA Reauthorization Act (HR 2430). This legislation includes important bills for cancer care, including the Research to Accelerate Cures and Equity (RACE) Act and reauthorization of the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. The User Fee Program plays an important role in the timely review of new drug applications and patients’ ability to access novel therapies.

The “RACE” Act is a bill which has important implications for the fight against childhood cancer. The legislation specifically updates the 2003 Pediatric Research Equity Act (PREA), which requires studies of adult drugs in adolescents during a drug’s development process.

PREA has experienced success in providing important information on a drug’s use in children in hundreds of cases; but, it has not yet been applied to pediatric cancer drugs. It is well known within the oncology community that many pediatric cancer patients are typically treated with “off-label” adult drugs. Under the RACE act, the FDA will be given authority to require a pediatric investigation into adult drugs if those drugs use molecular targeting and that same target is “substantively relevant” to the continuance of a pediatric cancer. If passed in the U.S. Senate, this act will permit clinicians to know the dosage, safety and efficacy in pediatrics and grant accurate labeling for use on children. Additionally, the RACE act will mandate that molecular targeting drugs be given an orphan designation to go through a pediatric investigation.

As summer in Washington continues to heat up, ACCC is closely monitoring legislation on Capitol Hill and performing an in-depth analysis of CMS’s proposed rules for 2018. Stay tuned for updates.


With Final MACRA Rule, CMS Increases Flexibility

By Leah Ralph, Director of Health Policy, ACCC

Healthcare costsOn Friday, October 14, the Centers for Medicare & Medicaid Services (CMS) released its final rule on the MACRA Quality Payment Program (QPP).  ACCC is conducting an in-depth analysis of the rule; however, an initial look reveals that CMS has heard the stakeholders’ message  loud and clear: Make the transition to MACRA as simple and flexible as possible. Here are some top-level highlights from the final rule:

  • Low-volume threshold exemption: the agency broadened the low-volume threshold exemption from the Merit-Based Incentive Payment System (MIPS), exempting practices with less than $30,000 in Medicare charges or fewer than 100 unique Medicare patients per year. This will exclude about one-third of physicians from having to report under the Quality Payment Program (QPP).
  • Pick your pace: CMS is allowing physicians to “pick their pace” in 2017, enabling physicians to avoid negative penalties in 2019 by reporting on some data (i.e., one quality measure) for some period of time. The takeaway: even minimal performance reporting will exempt physicians from any penalties, and opportunities for a shorter, 90-day reporting period will make providers eligible for positive adjustments. (Providers must start collecting data between January 1, 2017, and October  2, 2017, and report no later than March 31, 2018.)
  • Resource use category weighted zero in first year: MIPS has four components, and originally the resource use (cost) category was going to account for 10% of your score starting in 2017. CMS has now said this category will hold zero percent weight toward your MIPS score in the first year [in 2017, the percentages will be: 60% quality measures, 25% advancing care information (EHR use), and 15% clinical improvement activities].
  • Expanding opportunities to participate in APMs: CMS has also said it plans to expand opportunities to participate in models that qualify as “advanced alternative payment models” (APMs) in 2017 and 2018. The Center for Medicare and Medicaid Innovation (CMMI) also informed Oncology Care Model (OCM) practices on Friday, October 14, that CMS is amending the program to allow OCM practices to take two-sided risk as early as January 2017 to qualify as an advanced APM (two years earlier than the model originally allowed).

In our comments on the proposed rule, ACCC asked for increased flexibility for practices who are still building the infrastructure to meet these requirements, and a streamlining of reporting requirements as our members increasingly engage in new delivery models and navigate the path to value-based care. ACCC’s major concerns were around timeline and administrative burden – in the final rule, CMS was responsive in many ways, but ACCC will continue to work with the agency to reduce regulatory burden and make this a workable payment system for our members.

For more information, CMS launched a website for physicians that explains the program and allows you to explore and identify different measures that are most meaningful to your practice. Find a summary of the rule here. The AMA and ASCO also have great checklists on how to prepare for participation in the QPP.


ICLIO Conference: Top-Level Takeaways

By Amanda Patton, ACCC Communications

ICLIO Conf-Dr. Schwartzberg-for web

ICLIO Advisory Committee Chair Lee S. Schwartzberg, MD, FACP

The Institute for Clinical Immuno-Oncology (ICLIO) National Conference on September 30 in Philadelphia provided a window into the real-world immuno-oncology (I-O) issues facing providers, patients, and payers.

Across conference sessions some overarching themes emerged. One prevailing message:  there is an on-going need for practical, real-world education on immunotherapy, immune-related side effects, and response patterns—not just for the multidisciplinary cancer care team and allied specialties, but also for Emergency Department (ED) staff, hospitalists, and all others who connect with patients, including front desk staff.

To reduce barriers to accessing I-O, a message reiterated throughout the day was:  make immunotherapy clinical trials more widely available in the community.  Citing the Cancer Moonshot Blue Ribbon Panel Recommendation #2, which calls for a clinical trials network for immunotherapy, ICLIO Advisory Committee Chair Lee S. Schwartzberg, MD, FACP, said, “It would be a shame to limit this to [just] a few institutions. The entire community needs to be engaged,” including populations that are currently not well-represented in clinical trials, such as the elderly and underserved patient populations.

Implementing I-O: Real-World Challenges

ICLIO Conf panel-for web

Providing Community and Academic Perspectives on I-O Implementation, Panelists (L to R) Jose Lutzky, MD, FACP; Tara Gangadhar, MD; Lee S. Schwartzberg, MD, FACP

In a panel discussion on Community and Academic Perspectives on Implementing immunotherapy, Dr. Schwartzberg noted that I-O has moved out into the community “very quickly.” His own clinic’s experience tells the story.  In 2014, his clinic treated two patients with immunotherapy. To date in 2016, that number has climbed to 306 patients treated with immunotherapy.

What issues are top of mind in clinic every day? Response rate and patterns, pseudo-progression, and immune-related adverse events, said Dr. Schwartzberg.

Panelist Tara Gandahar, MD, Abramson Cancer Center, University of Pennsylvania, emphasized that “patients on immunotherapy need 24/7 access to providers who can assess issues and make a plan,” and that night coverage is of critical importance.  Patients who experience toxicity require increased monitoring both by phone and with in-person visits, she said. At the same time, it’s important to reassure patients that discontinuing therapy for toxicity does not mean they won’t see a therapeutic response.

Delivery of immunotherapy requires the involvement of multiple specialties, in particular gastroenterology and endocrinology, added panelist Jose Lutzky, MD, FACP, Mount Sinai Medical Center Comprehensive Cancer Center. Education on immunotherapy is needed for primary care providers, ED staff, ICU staff, surgeons, as well as house staff, he said.  Bringing immunotherapy to patients requires a collaborative team effort—with physicians, nurses, social workers, pharmacists, financial advocates, and others.

Building an I-O Dream Team

During a panel focused on the ideal team for successful implementation of I-O in the community, Gary Cohen, MD, Greater Baltimore Medical Center, urged that in preparing the general community for handling these agents, providers not become “complacent” in giving I-O drugs. “They must be ready for the rare side effects,” he said.

Dr. Cohen outlined the I-O dream team as including oncologists (medical, radiation, surgical), family and caregivers, nurses (especially important in terms of side effects education and monitoring), pharmacy, financial counselors/advisors, business managers, plus other medical specialists as needed such as endocrinology, GI, pulmonology, neurology, and radiology.

For smaller hospitals contemplating integrating I-O in the community setting, panelist Carole Miller, MD, St. Agnes Hospital, suggested the following six essential I-O program building blocks:

  • Multidisciplinary care
  • Shared decision-making
  • Expertise, especially regarding side effects of immunotherapy treatment
  • Patient education and support
  • Clinical trials
  • Administration buy-in and understanding of the importance of I-O.

Her cancer program has created an Immuno-Oncology Center, a separate space just outside the infusion center with I-O resources and a dedicated nursing staff.

Sigrun Hallmeyer, MD

Sigrun Hallmeyer, MD

As immunotherapy for cancer has grown, so has the size of the I-O dream team, said Sigrun Hallmeyer, MD, Cancer Specialists, SC.  Still, the “backbone” of her I-O program remains her nursing staff.  A theme throughout the conference was the critical role nurses play in educating patients on I-O side effects, monitoring and following up with patients on symptoms and side effects. Dr. Hallmeyer’s practice uses an educational sheet that nurses go through with patients when they start on immunotherapy. The practice pharmacist will not release the I-O drug unless the patient sheet on side effects is signed off on by the nurse and entered into the electronic medical record (EMR). Early detection of toxicity is the team’s goal.

Looking at the Value-Based Environment Ahead

As the healthcare system transitions to value-based reimbursement models, providers, patients, and manufacturers all confront the question of how these new payment models will impact I-O and innovation. During a panel discussion on alternative payment models (APMs) and immunotherapy, numerous concerns were raised, including the following:

  • Pathways and/or bundles: If these are mandated, how will they affect clinical advances and innovation?
  • Will the value-based environment constrain innovation?
  • How will CMMI’s Oncology Care Model (OCM) impact oncology and I-O? How might use of immunotherapy agents impact performance under the OCM? If CMS deems the model successful, it’s likely to spread rapidly to private payers, noted panelist Michael Seiden, MD, PhD.
  • How will APMs incentivize innovation? To get buy-in, APMs must reward innovation, otherwise incentives will be driven in the wrong direction, cautioned panelist Jennifer Hinkel, MSc, McGivney Global Advisors.

Pharmacy Operations & Issues

Reimbursement challenges were a central issue during a pharmacy-focused panel discussion. Whether in the academic or community setting, “immunotherapy agents are creating a lot of work in terms of getting reimbursed. It’s resource and time intensive,” said panelist Niesha Griffith, MS, RPh, FASHP, University of West Virginia Health Center.  She shared three practical steps to improve I-O reimbursement:

  1. Get approval for everything and enroll all patients in patient assistance programs.
  2. Add dedicated reimbursement staff. Patient financial advocate/support positions pay for themselves ten times over, she said.
  3. Get a seat at the table. Meet with your payers on a quarterly basis and include your pharmacy reimbursement staff in the meeting.
ICLIO Conf Edward Li-for web

Ed Li, PharmD, MPH, BCOP

Clinical issues are merging with administrative issues which is impacting the care delivery infrastructure, commented Edward Li, PharmD, MPH, BCOP, University of New England.  Looking to the future, “as we start to replace standard of care chemotherapy and move to trying to cure our patients, as we incorporate genetics and molecular testing, how will these fit into pathways?”

Panelist Nicky Dozier, PharmD, Virginia Oncology Associates, cited the growth in the number of pathways as a burden for providers. “Oncology pathways need to do more than just restrict decision making,” she said. Greater transparency is needed in terms of who has participated in the creation of the pathway, for example, were oncologists involved?

Take a deeper dive into the ICLIO National Conference by viewing the speaker slide presentations.  Visit the ICLIO website for practical resources to help the multidisciplinary team with real-world issues in implementing immunotherapy for cancer.

CMS Eases MACRA Quality Payment Program Timeline

By Leah Ralph, Director of Health Policy, ACCC

Centers_for_Medicare_and_Medicaid_Services_logoIn response to considerable pressure from industry stakeholders, medical groups and policymakers, the Centers for Medicare & Medicaid Services (CMS) announced last week that it would provide increased flexibility for practices to report out and comply with new data and performance requirements under the Quality Payment Program (QPP), created by the Medicare Access and CHIP Reauthorization Act (MACRA) passed last year.

In a blog post titled “Plans for the Quality Payment Program in 2017: Pick Your Pace,” Acting CMS Administrator Andy Slavitt lays out four pathways to compliance with the new Quality Payment Program (in order of easiest to the hardest):

  • Report some data.  Providers can avoid a negative penalty by submitting some data as required by the Quality Payment Program, including data from after January 1, 2017. CMS states this option is “designed to ensure that your system is working and that you are prepared for broader participation in 2018 and 2019.” This option allows you to avoid a negative payment adjustment in 2019.
  • Participate for only part of the calendar year. Providers may submit data as required by the Quality Payment Program for a reduced number of days (not the whole year), and the performance period could begin after January 2017. Under this option, you could still qualify for a small positive payment adjustment in 2019.
  • If you’re ready to go in 2017, participate for the full calendar year. For practices that are ready to go and choose this option, their performance period will begin January 1, 2017, and they will submit data under the Quality Payment Program for a full year. These practices will qualify for a modest positive payment adjustment in 2019. CMS expects many practices will be able to do this.
  • Participate through an Advanced Alternative Payment Model (APM).** While the three previous options would fall under the Merit-Based Incentive Payment System (MIPS) track, the fourth option allows providers who are receiving a certain percentage of Medicare payments or seeing a certain number of Medicare patients through a qualifying APM (the provider is taking two-sided or “more than nominal” risk) to participate through the Advanced APM track. These providers would qualify for a 5% incentive payment in 2019 in addition to any savings produced through the APM and would not be subject to MIPS requirements. (**Remember CMS lays out a very high bar to qualify for the APM track in the proposed rule: 90% of physicians are expected to choose MIPS).

Until 2019, physicians will see an annual 0.5% increase in payments, at which point payments will then be determined by performance in the Quality Payment Program either through MIPS or an advanced APM.

CMS has said the decision to provide leniency was in recognition of the “wide diversity of physician practices.” The agency has also said it is considering alternative start dates, shorter performance periods, increased flexibility for small or rural practices, and finding other ways for physicians to get more experience with the program requirements before being penalized.

CMS originally proposed that providers begin to report on measures outlined under the Quality Payment Program in January 2017 but that payments would not reflect that performance period until 2019. However with the new guidance from CMS, the easiest option essentially does not require real provider participation in 2017, but allows providers to test whether their systems are ready to fully participate in the future. While the details of the measures will remain unclear until a final rule is released, the Quality Payment Program will require practices to submit information on quality measures, how they use technology, and what improvement activities they are undertaking.

Through our comments to the agency in  June, ACCC advocated for increased flexibility and more time for physicians to prepare for undertaking the new requirements under the Quality Payment Program. We also asked the agency to restructure the APM requirements so that they are more achievable.

We commend CMS for releasing flexibility prior to a final rule on MACRA, which we expect to see later this fall, and ask for continued accommodations for practices that face myriad new requirements in the coming months and years.

MACRA Update—Will CMS Delay the Start Date?

By Brittney Fairman, Policy Analyst, ACCC

Calendar pages and clockLast week Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (CMS), told the Senate Finance Committee that the agency was considering “alternative start dates,” for Medicare Access and CHIP Reauthorization Act (MACRA) after receiving more than 3,000 comments on its proposed rule implementing the Quality Payment Program. The final rule is expected in November, leaving only a few months before the proposed reporting start date of January 1, 2017. Slavitt also said the agency is taking a close look at how the proposed rule would impact rural and small providers, particularly the low volume threshold that would exempt small practices from certain reporting requirements.

In our June 27 comment letter on the MACRA proposed rule, ACCC urged CMS to:

  • Delay implementation for six months to one year, to give physicians the time needed to build infrastructure and implement the Quality Payment Program effectively
  • Ensure that the agency provides adequate accommodations and protections for small group practices and solo practitioners
  • Modify the “resource use” methodology to ensure that eligible clinicians are held responsible only for the costs they can control
  • Include all Oncology Care Model (OCM) quality measures in MIPS
  • Refine the APM requirements to offer a meaningful alternative to MIPS and adopt policies to promote the availability of a wide variety of APMs and Physician-Focused Payment Models (PFPMs).

With this proposed rule, CMS aims to transition Medicare to a new physician payment program focused on quality, value, and accountability over volume. The MACRA legislation enacted by Congress outlines essentially two separate payment pathways for physicians under Medicare: The Merit-Based Incentive Payment System (MIPS), and the Alternative Payment Models (APMs). Both pathways are intended to drive the development of value-based payment. ACCC supports payment reform efforts; however, it is critical that CMS construct these pathways so that they are realistic, achievable avenues to Part B reimbursement.

ACCC will continue to keep members informed as MACRA implementation unfolds. For a deeper dive on new requirements under the Quality Payment Program, ACCC members can access the recent ACCC webinar, “MACRA CMS Proposed Rule: What You Need to Know” on demand (login required). The American Medical Association (AMA) has created a MACRA Checklist that outlines steps providers can take now to prepare, as we await the final rule.

SGR is Over: What Does it Mean for Providers?

By Maureen Leddy, Policy Coordinator, ACCC

U.S. Capitol 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.