Category Archives: Healthcare Reform

2018 Quality Payment Program Rule Highlights

By Blair Burnett, ACCC Policy Analyst

On Thursday, Nov. 2, 2017, the Centers for Medicare & Medicaid Services released the 2018 final rule for the second year of the Medicare Access & CHIP Reauthorization Act (MACRA) Quality Payment Program (QPP). While we were disappointed by some policies in the 2018 rule, in general, the final rule signals a continued commitment to increased flexibility and reduced administrative burden for clinicians.

Starting in 2019, Medicare-participating clinicians will have to choose whether they will participate in the new QPP through one of two tracks: the fee-for-service based Merit-Based Incentive Payment System (MIPS) or through an Advanced Alternative Payment Model (APM). Clinicians should be reporting measures now (in 2017) for payment adjustments that will occur in 2019. If you are not aware of your obligations under the QPP, be sure to familiarize yourself as soon as possible – most clinicians should be reporting on three MIPS categories (quality measures, advancing care information, and clinical practice improvement activities) now for changes that are coming in 2019.

The final rule that outlines the QPP program in 2018 significantly reduces the number of providers subject to scoring under the MIPS track of the QPP. In 2018, any clinician with less than $90,000 in Medicare Part B allowed charges or fewer than 200 Part B beneficiaries will be exempt from MIPS reporting (previously this “low-volume threshold” was $30,000 in Part B charges and 100 Part B patients). With these changes, it is estimated that 123,000 providers will be excluded from MIPS scoring. CMS is also expanding access to reporting under the Advanced Alternative Payment Model (APM) track of the QPP. Clinicians who are participating in the Medicare Shared Savings Program (MSSP) Track 1+ as well as the Next Generation ACO Model and the Comprehensive Primary Care Plus (CPC+) program will all now qualify for QPP reporting as an advanced APM. CMS estimates that about 185,000 to 250,000 clinicians will now be eligible for reporting under an advanced APM, creating more competition within the MIPS track. CMS also expanded the option of reporting as virtual groups for physicians in groups of 10 or fewer and added bonus opportunities for small practices and clinicians treating complex patients.

CMS also eases reporting requirements around electronic health record (EHR) use, allowing MIPS-eligible physicians to be able to use 2014 or 2015 editions of certified EHR technology to meet the Advancing Care Information (ACI) category. Additionally, clinicians across the U.S. who were significantly affected by Hurricanes Harvey, Irma, and/or Maria are eligible to apply for an ACI hardship exception. These affected clinicians are eligible to apply for reweighting of the MIPS reporting requirements for quality, cost, and improvement activities categories for the 2018 performance period. The deadline to apply for both exemptions is December 31, 2017.

Despite these flexibilities, ACCC is disappointed to see that CMS has moved up the timeline to hold clinicians accountable for the cost of care they provide. Originally CMS had proposed that the cost category under MIPS be weighted at zero in 2018, however the final rule requires that cost account for 10% of the MIPS score in 2018. Additionally, despite opposition from ACCC and many stakeholders, CMS also finalized that Part B drug revenue will be subject to the MIPS adjustment, which is not what we believe Congress intended and breaks from past precedent in CMS policies.

We expect QPP participation and requirements will continue to evolve in the coming years, but be sure to prepare yourself now – these changes to Medicare reimbursement are around the corner.

ACCC members are invited to join us for a webinar on Wednesday, December 6, 2017, from 3-4 PM EST, for an in-depth analysis of the CY 2018 QPP final rule and how these changes may impact providers and their cancer program or practice. Learn more and register (log in required).

ACCC Comments to CMS on Quality Payment Program Proposed Rule

By Blair Burnett, ACCC Policy Analyst

On August 21, 2017, ACCC submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s proposed 2018 updates to the Quality Payment Program (QPP), a two-track value-based reimbursement system created by the Medicare Access and CHIP Reauthorization Act (MACRA). The two tracks in which eligible clinicians can opt to participate are the enhanced fee-for-service based Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs), which require clinicians to take on more than nominal risk.

Under the QPP, 2017 performance will affect Medicare payments for all eligible clinicians in 2019. While many ACCC members have said they’re somewhat familiar with the program, others don’t feel quite as prepared to meet the specific program requirements.

In our comment letter, ACCC asked CMS for continued flexibility and additional clarity on how the MIPS adjustment will be applied in 2018. ACCC requested that:

  • CMS should continue to offer clinicians maximum flexibility in participating in the QPP, including through broad availability of alternative reporting options such as virtual groups, facility-based scoring, and MIPS APM reporting and scoring.

ACCC urges CMS to continue expanding the use of flexible reporting options that allow clinicians in diverse practices and communities across the country to participate in the QPP. Many ACCC practices are also currently participating in MIPS APMs, such as the Oncology Care Model (OCM), that do not currently qualify for the Advanced APM incentive outlined in the current proposal. ACCC advocates for more flexibility in what qualifies as an advanced APM and a continued flexible approach to allow clinicians to participate in the QPP to the best of their ability and in a manner that reflects the nature and priories of their practice and their patients.

  • CMS should finalize the increase in the low-volume threshold to $90,000 in Part B allowed charges and 200 Part B beneficiaries and clarify that the $90,000 threshold does not include the cost of drugs billed directly by clinicians.

ACCC supports increasing the threshold that exempts clinicians from the QPP based on a low revenue and patient volume because it allows practices with tighter resources to still successfully participate without fear of lower performance scores. We also ask CMS to clarify that the cost of the drugs billed directly by clinicians under Part B will not count towards the revenue threshold.

  • CMS should finalize its proposal to assign a weight of 0% to the cost performance category for CY 2018 and carefully implement the cost score in the future so that clinicians are assessed and scored against their peers and only for the costs of care for which they are responsible.

ACCC supports CMS’ proposal to delay scoring clinicians on cost for 2018 and urges CMS not to impose cost of care payment adjustments without accurate methodology. When considering how to assess cost under MIPS, we hope that CMS will: ensure fair beneficiary attribution for overall cost measures, establish narrowly tailored episode-based measures, apply its discretion  to reweight performance categories, and recognize the variable nature of costs through appropriate risk and specialty adjustments and exclusion of outliers.

  • Importantly, CMS should clarify that MIPS payment adjustments will not apply to Part B payments for drugs billed directly by clinicians.

ACCC strongly opposes applying the MIPS payment adjustment to Part B payments for drugs and urges CMS to clarify that the adjustment will not apply to drug payments. We are concerned that the application of MIPS adjustments to Part B drug payments would represent an unjustified change in agency policy, create incentives for clinicians to focus on cost of treatment rather than whether it is clinically appropriate, and create new barriers to access for patients.  

ACCC will update our membership when we see a final rule from CMS. Read our full comments.

ACA Repeal Efforts Stalled in Washington

by Blair Burnett, Policy Analyst, ACCC

U.S. Capitol

Despite much debate, healthcare reform remains in flux in Washington after a round of critical votes in the U.S. Senate this week. In the latest effort to repeal the Affordable Care Act (ACA), on Tuesday, July 25, the U.S. Senate voted 51-50, with Vice President Mike Pence breaking the tie vote, for a motion to proceed, which set up a process allowing for open debate and amendments to the AHCA, the House version of ACA repeal, on the Senate floor.

On Tuesday evening, the U.S. Senate brought to the floor their latest version of the Better Care Reconciliation Act (BCRA) with the added Cruz Amendment, allowing for sale of low-cost insurance plans if insurance policies that comply with the “essential services” provision of the ACA are also sold. The bill needed 60 votes to pass, but only received 43.

Debate continued Wednesday, July 26, and the U.S. Senate brought a repeal only bill to the floor, the Obamacare Repeal Reconciliation Act (ORRA), without language of a replacement effort. The vote, 45-55, showcased the lack of support among either party to vote for healthcare reform without actionable legislation.

As of Thursday, July 27, Senators were still in debate, bringing various amendments to floor for a vote. Late Thursday evening, a “skinny bill” was brought forth, that sought to roll back both the individual and employer mandate from the ACA. The text of this bill was not made available for public review, but besides repeal of the individual and employer mandate, left much of the ACA in place. When brought to a vote in the U.S. Senate, the bill failed, with a 49-51 vote in dissension of passage.

CBO estimates stated that the number of individuals insured would have decreased by 16 million by 2026 if the “skinny bill” were to pass and continue to become formal legislation. In the same time frame, the CBO estimates stated the federal deficit would have decreased by $142 billion, and premiums would have increased by an average of 20 percent.

For now, ACA repeal efforts and larger healthcare reform has stalled. More changes are certain to come from the Hill in the coming months as bipartisan healthcare reform legislation is expected to be drafted. Based upon the four pillars of ACCC’s health reform principles, a “skinny repeal” of the ACA would likely have destabilized current insurance markets, and placed increased burdens on cancer patients, specifically, elderly, low-income Americans accessing insurance in the individual and non-group markets. This week, ACCC joined over 30 other provider and patient groups to advocate against a skinny repeal of the ACA bill.

Senate Social Media Campaign - Skinny Repeal 7-27-17
As new legislation is brought forth, ACCC will continue to monitor and analyze impacts healthcare reform will have on cancer patients across the country.


ACCC members can gain an in-depth understanding of how CMS’ proposed CY 2018 Medicare rules will impact oncology by participating in ACCC’s August 9 webinar, “CMS Proposed 2018 OPPS & PFS Rules: What You Need to Know.” Learn more [member log-in required].

Update from Capitol Hill

By Brittney Fairman, MPS, MA, ACCC Policy Analyst

U.S. CapitolAt the end of last week, it was anticipated that the U.S. Senate would hold a vote on the Senate Republicans’ revised version of the Better Care Reconciliation Act (BCRA) today, Tuesday, July 18. However, over the weekend,  Senator John McCain (R-AZ) underwent an emergency surgery and Senate Majority Leader Mitch McConnell (R-KY) announced that the vote on BCRA would be postponed until Senator McCain’s return to Washington, D.C. With two Senators, Rand Paul (R-KY) and Susan Collins (R-ME), already openly opposed to voting ‘Yes’ on BCRA—Senator McCain’s absence would have put the Republican Senators’ vote on the bill at risk.

In order to continue the repeal and replace of the Affordable Care Act (ACA), Senate Republicans would need at least 50 of the 52 Senate Republicans to vote in favor of BCRA.

On Monday evening, the bill took another turn when Senator Mike Lee (R-UT) and Senator Jerry Moran (R-KS) jointly announced their opposition of a motion to proceed on the revised healthcare bill. These two additional defections on Senator McConnell’s bill means the Senate Majority does not currently have the votes to even begin debate on the legislation to repeal and replace the Affordable Care Act (ACA).

So at this point, the future of BCRA remains uncertain. On Monday evening, Majority Leader McConnell stated, “Regretfully, it is now apparent that the effort to repeal and immediately replace the failure of Obamacare will not be successful.” President Trump has suggested the Senate Majority move forward in repealing the ACA without immediate replacement.  In this scenario, the Senate would vote in the coming days on a bill which would delay the ACA’s repeal for two years as Republicans work on individual bills to dismantle the current healthcare law.

ACCC will continue to monitor the Senate’s actions and keep ACCC members posted with the latest updates.

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.

 

ACA Repeal & Replace Update: Senate Republicans Put Their Cards on the Table

By Brittney Fairman, MA, MPS, Policy Analyst, ACCC

U.S. CapitolLast Thursday, June 22, Senate Republicans publicly unveiled their discussion draft legislation titled, the Better Care Reconciliation Act—their version of the House’s recently passed American Health Care Act (AHCA) (H.R. 1628). Neither bill was drafted under regular order, as Republicans try to maintain steam in pushing forward with the repeal and replacement of the Affordable Care Act (ACA). Unfortunately, for multiple stakeholders, including many of those within the cancer care community, it is questionable how much the Republican Caucus sought patient and provider feedback to incorporate into their bills.

Although there was much speculation that the Senate version of the AHCA would undergo an entire re-write, the legislation released last week represents more of a fine-tuning of the House AHCA bill. Much of the Senate draft’s language reflects that found within the AHCA. The Senate bill contains various tax cuts for mostly high-income Americans; maintains the elimination of the individual and employer mandates; proposes less generous premium subsidies for those with lower household incomes; holds onto the AHCA’s similarly deep cuts to the Medicaid program—phasing out the expansion over three years and transitioning to a capped financing structure which essentially re-shapes the program’s funding; changes state adjustment-of-age bands by allowing insurers to increase the ACA’s ratio from allowing insurers to charge up to three times more for older individuals to permitting insurers to charge up to five time more; and still allows states to apply for waivers to overhaul their insurance markets (including the option of ending the essential health benefit requirement and potentially reinstating annual and lifetime coverage gaps).

There are, however, several notable changes within the “draft” Better Care Reconciliation Act signaling some improvement from the House bill. This Senate version would require insurers to cover people with pre-existing conditions and ban them from charging higher premiums because of their health history. But there is a caveat—there would not be an essential health benefit (EHB) requirement. This means that insurers would be able to offer less comprehensive policies that may or may not cover a patient’s treatment for pre-existing condition(s). Additionally, for individuals with household incomes between 100 percent and 200 percent of the federal poverty (FPL), authorized funding for cost-sharing reductions (CSR) payments would continue until 2020.

On Monday, June 26, the nonpartisan Congressional Budget Office (CBO) released a CBO score for the Senate legislation that finds the bill would result in 22 million more uninsured Americans by 2026, relative to the number under current law. This is slightly fewer than the increase in the number of uninsured estimated for the House-passed AHCA legislation.  According to the CBO score under the Better Care Reconciliation Act, by 2026 an estimated 49 million people will be uninsured, compared to the 28 million who will be uninsured that year under the current law.

A vote on the Senate bill is expected this week, leaving Senators with a relatively short window for reviewing the bill and also leaving stakeholders limited time to weigh in on the bill’s negative consequences for healthcare.

In a statement, the Association of Community Cancer Centers (ACCC) has expressed deep disappointment in the Senate’s draft legislation both in terms of policy and process, noting that the bill violates ACCC’s health reform principles.  ACCC believes this bill would be devastating for cancer patients and their families, and urges lawmakers to vote against the Better Care Reconciliation Act of 2017.  ACCC members can contact their Senators here.


Editor’s note: This post was updated on 6/26/17 to reflect release of the CBO score for the Better Care Reconciliation Act of 2017.

ACCC Expresses Serious Concern Over the AHCA

By Leah Ralph, Director of Health Policy, ACCC

U.S. CapitolOn May 4, 2017, the U.S. House of Representatives narrowly passed the American Health Care Act (AHCA), a bill that would repeal and replace key portions of the Affordable Care Act (ACA). The bill now heads to the Senate, where it faces significant concerns over the projected decrease in coverage and increase in cost, and will likely undergo a substantial re-write.

While the bill faces uncertainty, the Association of Community Cancer Centers (ACCC) remains very concerned about the impact the AHCA, as currently written, would have on cancer patients’ ability to access comprehensive, affordable health insurance coverage. The bill violates a number of ACCC’s health reform principles, which were central to our recent advocacy efforts on Capitol Hill.

Previous Congressional Budget Office (CBO) reports estimate that 24 million more Americans will be left without coverage under the AHCA, while disproportionately increasing out-of-pocket costs for elderly, low-income Americans in the individual and non-group markets. Recent amendments to the bill also weaken protections for patients with pre-existing conditions, like cancer, and the requirement that insurers cover defined Essential Health Benefits, such as cancer screenings. The current legislation also effectively rolls back the Medicaid expansion and proposes to fundamentally restructure the Medicaid program, inevitably shifting costs to the states and squeezing Medicaid benefits for low-income cancer patients across the country.

ACCC will continue to work with Congress to advocate for meaningful health reform policies that protect patient access to appropriate, affordable health insurance coverage and decrease costs for the patient and the healthcare system.

ACCC urges its membership to contact their Senators opposing the bill as currently written.

Going the Distance: What We Heard at the OCM Workshop

By Leah Ralph, DIrector of Health Policy, ACCC

ACCC-OCM-CollaborativeWe are now 10 months into the groundbreaking Center for Medicare and Medicaid Innovation (CMMI) Oncology Care Model (OCM). Just a few weeks ago during the ACCC 43rd Annual Meeting, a number of OCM practices came together to share updates, pain points and successes, and to collaborate on innovative approaches to meeting OCM requirements during ACCC’s OCM Workshop.

Shaping Up
Participation in the OCM has been likened to “training for a marathon,” requiring cancer programs to do an honest self-assessment of their financial and operational capabilities, and double down on their investment in workflows, staffing, and data collection—all while trying to reduce costs and meet a number of beneficiary-level reporting requirements. EHRs (electronic health records) play a critical role in these efforts, and practices are finding that much of the quality and clinical data CMS is asking for is not readily accessible, requiring time-consuming chart abstraction and manual reporting. In addition to data analytics, other major challenges include:

  • increased staffing needs,
  • investment in IT systems, and
  • clinician education and engagement.

Some practices have hired full-time patient care coordinators—similar to research coordinators for clinical trials—to manage OCM requirements, including identifying and tracking patients, coordinating episodes and required measures, and billing the Monthly Enhanced Oncology Services (MEOS) payments.

While there is agreement that the OCM’s policy goals—improving care quality and reducing costs—are the right ones, operationalizing the program has proven to be far more complex than originally anticipated. Even by CMS. And, like all major payment reform initiatives, course corrections will be needed along the way.

Some Pain, Some Gain
Despite challenges, ACCC OCM Workshop participants are also finding that the OCM’s  “practice transformation” requirements are strengthening their programs. Many have taken a “good, hard look” at palliative care and pain documentation, care coordination, and end-of-life conversations. Others have implemented social work and dietitian services that they were not previously able to make available to patients. While many cancer programs were engaged in these activities in some form before the OCM, participation in CMMI’s demonstration program has made these components robust and consistent, improving patient care. One practice called it an “awesome byproduct” of the program.

Another byproduct? Practices are also finding that the OCM is creating an imperative for the C-suite to make certain investments and providing leverage with EHR vendors; requests that were previously considered optimization items are now considered “must haves” to meet OCM requirements.

Dealing with Data
Last month OCM practices faced their first big data reporting deadline and they also received their first feedback reports following the first episode of care, breaking out cost per episode and comparing performance to other OCM practices. These data came in a format that was not easy to interpret, and required several practices to outsource the data analysis and interpretation. With the feedback reports practices are seeing their spending on OCM patients, and getting a sense of how they may fare with performance-based payments down the road, but practices won’t see reconciliations against target prices until early 2018.

Watchful Waiting
Where OCM practices succeed and struggle carry important implications for all cancer programs and the transition to value-based care. As one practice put it, the OCM is “the pebble in the pond for us.” We should all be watching the ripples closely. And taking notes.

To learn more about the ACCC OCM Collaborative, visit  accc-cancer.org/OCM. All OCM participating programs are invited to join our online community at ocmcollaborative.org to hear what else your colleagues are saying.

 

Drug Pricing in the Crosshairs

by Amanda Patton, ACCC Communications

Drug pricing reform is in the news again this week as the Medicare Payment Advisory Commission (MedPAC) voted unanimously April 6 in support of the Commission’s multi-part Part B recommendations that include a Drug Value Program (DVP) with elements that align with President Trump’s interest in requiring drug companies to bid for government business.

ACCC17-Cancerscape“Despite Trump’s outreach to industry leaders and declaration of support for reducing drug prices, any attempt at price reform will be hard fought,” Jessica Turgon, MBA, ECG Management Consultants, told attendees last week at the ACCC 43rd Annual Meeting, CANCERSCAPE. The “how” of executing drug pricing reform will be “impressive,” Turgon said. She outlined five possible reform scenarios for lowering U.S. drug costs. The unknown: which reforms will the Administration stick to the most?

  1. Importing cheaper drugs from other countries in an effort to reduce average domestic drug prices. Pro: This might force drug companies to lower prices domestically. Con: It could result in higher drug prices worldwide.
  1. Increasing availability of generic drugs by requiring the FDA to speed up the approval process for generic versions of drugs. There is a similar option being put forward to hamper or make illegal the practice of “pay to delay,” which slows generic drug advancement. In fact, one study found that “pay to delay” has cost U.S. consumers $14 billion by keeping brand name drugs as the sole source product when cheaper, generic versions were available.
  1. Allowing Medicare to negotiate for drug prices using its leverage as the largest healthcare payer to achieve lower drug prices. This would require legislation or possibly execution through the regulatory process. However, the Congressional Budget Office has indicated this option would not have that great of an impact on federal spending, Turgon said.
  1. Increasing the use of value-based drug purchasing, i.e., paying for drugs based on the outcomes they achieved (i.e., treatment effectiveness) and not on a flat fee or other standard pricing approach. If this were integrated into protocols or pathways, it’s not clear how the financial results would be quantified, Turgon noted. However, as last year’s proposed Medicare Part B experiment showed, the impact would be very hard on providers.
  1. Scaling back the scope of the 340B Drug Pricing Program, for example, by revising the definition of a covered entity. The program remains in MedPAC’s crosshairs, Turgon warned. In FY 2013, covered entities saved $3.8 billion on outpatient drugs through the program; the number of 340B covered entity sites grew to 16,500 in 2013, a rise of nearly 8,000 sites from 2008. Turgon’s take-home message for cancer programs: Ask yourselves, “If I had to operate without my 340B program what would my cancer program, hospital, or health system look like?” Would it would likely have a significant impact on your health system overall? Is 340B funding “everything else” [e.g., services that are currently not-reimbursed, such as patient navigation] at your hospital right now?

Add to the mix, MedPAC’s recommendations for reducing spending in Medicare Part B. (Spending has gone up 9% every year since 2009, Turgon noted, which is not sustainable.) Briefly put, MedPAC’s recommendations fall into two track recommendations:

Track 1: Improve the average sales price (ASP) system.

  • Require drug makers to report ASP data and increase penalties for non-compliance.
  • Reduce WAC (wholesale acquisition cost), cut the add-on payment from 6 percent to 3 percent.
  • Require drug makers to give Medicare a rebate when the ASP price for a product exceeds an inflation benchmark.
  • Require the Centers for Medicare & Medicaid Services (CMS) to implement a common billing code for a reference biologic and its biosimilars.

Track 2: Establish a Drug Value Program

For this voluntary program, Medicare would contract with private vendors to negotiate prices for Part B drugs using tools like a formulary. The Drug Value Program vendor would negotiate directly with drug manufacturers. Providers would purchase all DVP products at the price negotiated by their DVP vendor. Medicare would reimburse providers for the DVP-negotiated price AND reimburse DVPs an administrative fee with a shared savings opportunity.

What Cancer Programs Can Do Now

What seems certain is President’s Trump continued interest in drug pricing reform. How (or if) reform is executed remains to be seen. MedPAC serves in an advisory role to Congress on Medicare issues—and whether Congress will consider MedPAC’s recommended changes to Part B is also uncertain. In the face of the many uncertainties surrounding drug pricing reform, cancer programs can still take proactive steps to address the rising cost of drugs, Turgon said. To do so, she suggested that cancer programs:

  • Develop and adhere to clinical pathways and protocols.
  • Determine the availability of evidence-based alternatives that are cheaper and comparable to high-priced drugs, and remove the higher-priced drugs from your formulary or tighten guidelines around use.
  • Deploy clinical pharmacists to educate prescribers about high drug prices.
  • Hold cost-of-care conversations with patients.
  • Reduce waste associated with high-cost drugs.
  • Keep negotiating with GPOs and wholesalers.
  • Identify signs of increases in drug prices as close to real-time as possible to avoid delays in taking action to minimize financial impact.
  • Keep the lowest possible inventory of high-cost drugs.
  • Keep communication lines open with senior administrators so they stay informed of the impact on the drug budget.

Final takeway: “Run your hospital-based cancer program as a private practice and know where your costs are,” Turgon advised.

Next Steps for Value Frameworks?

by Amanda Patton, ACCC Communications

ACCC17-Value Framework Panel (2)The mantra of “moving from volume to value” is ubiquitous in healthcare today.  So what do cancer programs need to know about evolving value frameworks in oncology? Attendees at the ACCC 43rd Annual Meeting, CANCERSCAPE, in Washington, D.C., heard real-time updates on two of the leading frameworks—ASCO’s work-in-progress Value Framework  and NCCN’s Evidence Blocks™.

Both value frameworks aim to be tools used in support of patient―physician shared decision-making according to panelists Stephen Grubbs, MD, FASCO, Vice President of Clinical Affairs, American Society of Clinical Oncology, and Robert Carlson, MD, CEO, National Comprehensive Cancer Network.

ASCO’s Value Framework was not built on drug pricing, but to have a discussion with a patient on potential financial toxicity and the benefit of the treatment in the context of how much the treatment will cost the patient, explained Dr. Grubbs. ASCO’s framework uses three primary parameters to calculate value: clinical benefit, toxicities of treatment, and cost. “Our goal at ASCO is to develop a tool that could be customized with information for each individual patient,” said Dr. Grubbs.

After receiving more than 400 comments on its original Value Framework draft, ASCO published a revised version in May 2016.  Grubbs made clear, however, that ASCO’s framework is still a work in progress. “It’s not yet ready for use,” he stressed.

In 2017 ASCO is working on improving the framework methodology, Dr. Grubbs explained, noting that a current weakness is that the framework is set up to compare a randomized clinical trial between two different treatments.  “If I have a treatment where I use drug A versus drug B, and than I have a trial that compares drug B to drug C—how do I compare drug A to drug C?” Work is underway at ASCO to address cross-trial comparisons and also to “anchor the net health benefit score in some meaningful way,” Grubbs shared. Finally, ASCO will continue work with patient advocates and patients to identify endpoints that are meaningful for patients.

On the other hand, NCCN’s Evidence Blocks are operationalized. NCCN’s goal was to create a “flexible value system that could be used to develop each patient’s equation for what is valuable,” said Robert Carlson, MD, CEO, National Comprehensive Cancer Network. NCCN Evidence Blocks are built on five metrics:

  • Effectiveness (efficacy)
  • Safety (adverse events, toxicities)
  • Data quality
  • Data consistency
  • Affordability

The Evidence Blocks are presented in a graphic format so that a user can look for “30 different options in about 4 or 5 seconds and come up with regimens that would be optimal for a specific circumstance,” Dr. Carlson said.

Like ASCO, NCCN intends the Evidence Blocks to support a patient-centered approach to integrating a value discussion into everyday practice. “We look at Evidence Blocks as a conversation starter, not an answer,” Carlson said.  “We don’t tell the patient, because the Evidence Block looks like this, this is what you should do. It’s a question of what’s most important to them.”

Currently, 33 of the NCCN guidelines have Evidence Blocks associated with them. By the end of 2018 all of the NCCN guidelines that have systemic therapies should have Evidence Blocks, according to Carlson. NCCN also intends to expand the Evidence Blocks into other treatment modalities. “We are now starting to look at other modalities, radiation oncology, surgical oncology, and diagnostics . . . in terms of the same sort of scales,” he said.

Rounding out the discussion, panelist Ali McBride, PharmD, MS, BCPS, The University of Arizona Cancer Center added perspective on the cost/value discussion as it may unfold on the frontlines of care. “Many patients may not be able to afford the 20% copay cost for IV therapy, let alone the out of pocket cost for many oral therapies,” he said. “We have to spend a lot of time detailing out those costs for patients, and if they can’t afford it, we have to say, then what’s our next step in that guideline pathway?”

All three panelists noted the need for financial transparency for patients and providers as one component of the value discussion.

In closing, panel moderator Christian Downs, JD, MHA, Executive Director, ACCC, asked panelists to consider what the value framework discussion might look like 10 years down the road.

Acknowledging the difficulty of making any predictions about the future shape of the oncology value discussion, Dr. Carlson envisions technology playing a pivotal role. “My own expectation and hope is that within a decade we will have computer-based systems that patients are able to interact with directly and help define and discover their own value system,” he said. Such a system would enable patients to indicate if they were more concerned with neurotoxicity or cardiotoxicity, for example. Plus the system would also have the capacity to query payers so that patients could know the financial impact of their therapy.

Big data (if the promise is realized) may change the face of value frameworks, noted Dr. Grubbs.  The potential of extensive real-world databases will bring “much more information on what happens to patients outside the narrow clinical trial that has the best, the most robust patients. . . [and extend to] what happens in the real-world. . . . if we had a big data system that had all this information about what happened to everybody and you could really home in on what happens to a 75-year-old person who was not in the clinical trial and have the cost data, you might come up with a very different looking value [framework] from what we’re showing you here today.”

Finally, as value frameworks continue to evolve, community cancer programs and practices have an important role to play, panelists agreed.  “There’s a huge reservoir of expertise and experience in community oncology, and we’d love to tap that, to learn from that. [One of the] ways you can help us, is to continually give us feedback in terms of whether we have it right or wrong. . . . talk to us,” Dr. Carlson said.

Dr. Grubbs concurred, adding that community oncologists are key to making value frameworks functional. “When you see this come out, please make comments back to ASCO on how to make this better, because nobody is going to get this right…right from the beginning.”