Category Archives: In and Around Washington, DC

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).

CMS Finalizes CY2018 OPPS & PFS Rules

By Blair Burnett, ACCC Policy Analyst

Bipartisan healthcare talks may have stalled in Congress as tax reform takes center stage, but the Centers for Medicare & Medicaid Services (CMS) finalized the CY 2018 Hospital Outpatient Prospective Payment Systems (OPPS) and Physician Fee Schedule (PFS) rules last week, bringing big changes to Medicare reimbursement in 2018. For highlights, read on.

2018 OUTPATIENT PROSPECTIVE PAYMENT SYSTEM HIGHLIGHTS
Overall, in 2018, CMS will increase OPPS payment rates by 1.35 percent.

340B – Most notably, the 2018 OPPS rule finalized substantial cuts to Part B drug reimbursement for 340B hospitals. Starting January 1, 2018, 340B entities will be paid Average Sales Price (ASP) minus 22.5 percent, instead of ASP plus 6 percent, for separately payable drugs that were acquired under the 340B Program, excluding drugs on pass-through status and vaccines. Most 340B entities are included in this reduction; however, for 2018 there are exemptions for rural sole community hospitals (SCHs), PPS-exempt cancer hospitals, and children’s hospitals. In the final rule, the agency reserves the right to revisit these exemptions in 2019. Drugs not purchased under the 340B Drug Pricing Program will continue to be paid at ASP plus 6 percent.

Early estimates suggest that this cut will produce $1.6 billion in savings which will be redistributed through a 3.2 percent increase in payment for non-drug items and services across all hospitals.

Operationally, CMS will also require the use of a modifier to identify whether a drug was purchased under the 340B Drug Pricing Program. One modifier will be required for hospitals that are subject to the payment reduction and another modifier for hospitals who are exempt from the payment reduction but still acquire drugs under the 340B Program.

ACCC and many other stakeholder groups advocated strongly against this proposal and hoped for a more constructive policy conversation about real reforms to the 340B program. Several hospital groups, including the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), and America’s Essential Hospitals, are considering a lawsuit to stop CMS from finalizing these reductions.

Drug Packaging – Under the prospective payment system, CMS has continually put forward policies that move OPPS toward bundled payments. In 2015, CMS conditionally packaged payment for ancillary services assigned to an APC group with a geographic mean cost of $100 or less, but excluded low-cost drug administration services. In 2018, CMS is finalizing its policy to conditionally package payment for low-cost drug administration services.

In 2018, CMS also extends non-enforcement of direct supervision requirements for outpatient therapeutic services for Critical Access Hospitals (CAHs) and rural hospitals with 100 or fewer beds in 2018 and 2019. Additionally, the agency is making changes to the date-of-service policy (i.e., the “14-day rule”) so that, in general, labs can bill Medicare directly for advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests.

2018 MEDICARE PHYSICIAN FEE SCHEDULE HIGHLIGHTS
Overall, in 2018, CMS will increase physician payment rates by 0.41% with no combined impact on hematology/oncology and an estimated 1% increase for radiation oncology and radiation therapy centers.

Payment Rates for Non-excepted Off-campus Provider-Based Hospital Departments – CMS is finalizing a reduction to payment rates for services provided at non-excepted off-campus hospital outpatient provider-based departments (i.e., off-campus facilities that began billing under OPPS after Nov. 2, 2015). Payment rates for services provided at these facilities will change from 50 percent of the OPPS rate to 40 percent of the OPPS rate. The agency states that this payment decrease is meant to “level the playing field” between hospitals and physician practices by promoting “greater payment alignment.”

Biosimilars – In a reversal of agency policy, CMS also finalizes a policy that each biosimilar product will receive its own unique reimbursement code. This is a departure from a policy in the CY 2017 OPPS Final Rule requiring that biosimilar products that rely on a common reference product be grouped into the same payment calculation for determining a single ASP payment limit.

Telehealth Services Expansion – In the 2018 PFS, CMS significantly expands telehealth services, adding numerous codes to the telehealth services list – including new codes for visits to determine low dose computed tomography eligibility, interactive complexity, health-risk assessments, care planning for chronic care management, and psychotherapy for crisis. To reduce the administrative burden for providers, CMS is also finalizes a proposal that will not require reporting a telehealth modifier on future telehealth claims.

Additionally, CMS finalizes that practitioners will be required to begin reporting consultation of appropriate use criteria (AUCs) beginning in 2020.

ACCC members are invited to join us for a webinar on Wednesday, November 29, 2017 from 3-4 PM EST, for an in-depth analysis of how these final 2018 payment rules may impact your cancer program or practice. Learn more and register.

Are We There Yet? Approaching a Bipartisan Compromise on Healthcare

By Blair Burnett, ACCC Policy Analyst

U.S. CapitolAfter a flurry of activity on healthcare over the past couple of months, a bipartisan proposal may be making gains in Congress. The highlights:

October 12, 2017 – The Trump Administration released an executive order that laid the groundwork for big changes to the Affordable Care Act (ACA) marketplaces including less comprehensive plans offered through associations of small employers as well as a push for increased use of short-term medical coverage. This could essentially create an alternative insurance market that would not have to comply with many of the consumer protections created under the ACA, and would likely attract healthier, less costly consumers, which would drive up premiums in the current exchanges. Later that evening, the Administration announced it would immediately end cost-sharing reduction (CSR) payments used to subsidize healthcare costs for low-income individuals on the exchanges. The legal battle around CSRs has been playing out in the courts since 2014, with some arguing that the payments are illegal because they were not appropriated by Congress. Analysis from the Congressional Budget Office (CBO) predicts large premium increases for exchange plans in 2018 and beyond, as insurers attempt to cover the loss of the CSR payments and some consider leaving the marketplaces all together.

October 17, 2017 – The following week, Chairman and Ranking Member of the Senate Health, Education, Labor, and Pensions Committee (HELP), Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), announced a bipartisan bill designed to provide temporary stability in the marketplaces.

Key tenets of the Alexander-Murray proposal include:

  • Continued Funding for CSR Payments: CSRs would continue to be funded through 2019. For states where insurance regulators are pressing individual insurers to decline this payment, no funding would be issued.
  • Restoration of ACA Enrollment Funding: Any state participating in an exchange would see restoration of over $100 million in outreach and enrollment funding through 2019. This proposal also seeks transparency with open enrollment advertising and outreach with a mandated reporting timeline.
  • Preexisting Conditions & Essential Health Benefits Coverage Requirements: Under this bipartisan proposal, insurers would not be able to waive the ACA preexisting conditions or ten Essential Health Benefits (EHBs), which became coverage requirements under the ACA, as previous ACA reform/replace bills have sought to do.
  • Section 1332 Waivers Support: This proposal would streamline the waiver process and make it easier for states to acquire and maintain 1332 waivers. These allow states to implement their own health insurance programs as long as they meet thresholds for coverage and affordability that are similar to those achieved under the ACA.

Despite early support among both Democrats and Republicans in the Senate and pushing healthcare reform forward, last week President Trump signaled a singular focus on tax reform while meeting with Congressional leadership, suggesting there may not be a clear path forward. The Alexander-Murray proposal would also likely face an up-hill battle in the House where Majority Leadership is still focused on ACA repeal and replace. On October 25, the Congressional Budget Office (CBO) released an initial impact analysis of this proposal citing a deficit reduction of nearly $4 billion through 2027. Even with that news, the likelihood of this bill to move on its own appears slim; the most likely pathway for this proposal to become law, if at all, will be tacking it on to a “must pass” end of year funding bill.

Regardless of how – or when – the short-term stabilization package moves, the Administration’s announcement to end the CSR payments has already made an impact. Early estimates show that premiums for a silver-level plan in 2018 will increase 34%, higher than the average 25% increase we saw in 2017, and not all enrollees will qualify for the premium tax credits used to offset these market increases.[1] Without CSR payments, insurers will also likely continue to exit ACA exchanges in many states, leading to states with fewer options and an unstable market overall. For cancer patients, and those battling chronic illnesses, efforts by the Administration to loosen regulatory requirements around comprehensive coverage and decisions to end critical funding streams to assist insurers in providing meaningful coverage for the costliest consumers is particularly troubling and will mean higher cost plans and fewer options.

And, amid all this uncertainty, Open Enrollment season is upon us. The Enrollment Period for ACA Exchanges has been scaled back to 45 days under the current administration, and will occur from November 1 through December 15, 2017.

ACCC will continue to monitor any legislative progress of the bipartisan market stabilization bill and continue to advocate for comprehensive, affordable insurance options for all cancer patients. For more on what ACCC needs to see in any ACA reform proposal, see our Health Reform Principles for Cancer Patients.


[1] avalere.com/expertise/managed-care/insights/silver-exchange-premiums-rise-34-on-average-in-2018

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.

CMS Proposed 2018 Medicare Rules: What Lies Ahead?

By Leah Ralph, Director of Health Policy, ACCC, and Blair Burnett, Policy Analyst, ACCC

Healthcare costsHere in Washington, D.C., as we count down the days remaining in the Congressional August recess, the Centers for Medicare & Medicaid Services (CMS) has reminded us that big changes in healthcare are not limited to the political brinkmanship of ACA repeal. On July 13, 2017, the agency released its CY 2018 proposed Hospital Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) rules. The proposed OPPS rule was the big news this year, signaling major changes may be in store for hospital reimbursement in 2018. The agency is proposing significant reduction in payment for drugs purchased under the 340B Drug Pricing Program and for 2018, CMS is proposing further reimbursement reductions for new off-campus provider-based departments (PBDs).

Holy OPPS!
The 340B Drug Pricing Program, created in 1992, requires drug manufacturers to provide outpatient drugs at a discounted price to eligible healthcare facilities who are generally providing care to a certain percentage of indigent patients. While the 340B program has grown, and reform has been widely debated by policymakers over the past decade, CMS’ rule proposes to fundamentally alter the way providers will get reimbursed for drugs purchased through the program. It’s worth noting though that 340B oversight is under the jurisdiction of the Health Resources & Services Administration (HRSA), an agency of the U.S Department of Health and Human Services, and not under CMS purview.

For 2018, under the OPPS CMS proposes to reduce Medicare reimbursement for separately payable drugs without pass-through status purchased through the 340B Program from average sale price (ASP) plus six percent to ASP minus 22.5 percent. Further, because CMS cannot currently identify 340B drugs in Medicare OPPS claims data, CMS also proposes to require that hospitals submitting claims for separately payable drugs not acquired through the 340B program use a modifier on the claim to be reimbursed at ASP plus six percent.

Medicare’s HOP Panel Weighs In
ACCC continues to work through the details of the proposal and meet with policymakers and other stakeholders to put forward meaningful, workable solutions for reforming the 340B program. Most recently, on August 21, ACCC and other stakeholders testified at Medicare’s Advisory Panel on Hospital Outpatient Payment (HOP) meeting, outlining the deleterious impact this proposal would have on cancer programs participating in the 340B program. (ACCC also testified against the agency’s proposal to related to packaging Level 1 and 2 drug administration services, more on this below.) At the conclusion of the meeting, the HOP Panel voted to recommend to CMS that the agency drop the current proposal to cut 340B payments.

To learn more about CMS’ proposal and ACCC advocacy efforts, join us in Nashville, Oct. 18-20 at the 34th ACCC National Oncology Conference.

And There’s More
Another significant proposed change relates to packaging of drug administration services. Currently CMS excludes packaging of low-cost drug administration services (i.e., costing less than or equal to $100) from the ancillary services packaging policy. For 2018, the agency is proposing to package Level 1 and 2 drug administration services when these services are performed with another separately payable service, but pay for them separately when performed alone. CMS believes that this “conditional” packaging of drug administration services will promote equitable payment between physician offices and hospital outpatient departments. ACCC disagrees with the agency’s rationale and will be urging CMS not to finalize this policy.

Opportunity to Comment on 14-Day Rule
In the 2018 proposed OPPS rule, CMS is also soliciting comments on the “14-Day Rule.”  This is a policy that determines when a hospital may bill Medicare for a clinical diagnostic laboratory test versus when the laboratory performing the test may bill Medicare directly. CMS is considering potential modifications to the “14-Day Rule” that would allow labs to bill Medicare directly for molecular pathology tests and advanced diagnostic laboratory tests. ACCC played an active role in requesting that this policy be reopened for public comment.

Moving to the Proposed 2018 PFS Rule: CMS Proposes Change to Site-Neutral Payment
For 2018, CMS is proposing to further reduce reimbursement for non-excepted off-campus provider-based departments (PBDs). [Notably, this provision is included in the PFS proposed rule, despite impacting facilities traditionally billing under the OPPS, because in 2017, the PFS was the “applicable payment system” for these non-excepted PBDs and CMS reimbursed them under the PFS at non-facility rates.] Read on for details.

In the 2018 PFS  rule, CMS  proposes to significantly change last year’s site-neutral payment policy and further reduce reimbursement for non-excepted off-campus provider-based departments (PBDs). In general, these are entities that began billing Medicare as an off-campus PBD after November 2015.  For these non-excepted PBDs, the agency is proposing to decrease payment from 50% to 25% of OPPS rates. The agency is basing this proposed rate reduction on a comparison of payment rates for clinic and office visits under both payment systems (i.e., the OPPS and PFS). CMS expressed concern that paying 50% of the OPPS rate might result in payments for items and services that are greater than would otherwise be paid to physician offices under the PFS. Early analysis by ACCC, however, shows that reimbursement at 25% of OPPS will be well below PFS rates for certain services.

Of note: In the proposed rule, CMS does not address whether the payment reduction for drugs acquired under the 340B Program or the modifier for drugs not acquired under that program would apply to these non-excepted office-campus provider-based departments

More on the 2018 Proposed PFS Rule
While, overall, the Physician Fee Schedule was fairly quiet this year, one notable provision is CMS’ approach to payment for biosimilars. For 2018, the agency is proposing to continue its approach (from 2016) that biosimilars will generally share a single HCPCS code and that these products will be grouped into the same payment calculation for the purposes of determining a single ASP payment limit. While CMS isn’t officially opening this policy for comments, the agency requests feedback on how this already-implemented policy will impact the ability to create a competitive marketplace and encourage innovation in the biosimilars market.

Big Picture
Overall, CMS estimates that OPPS payments will increase by nearly two percent next year (except for the impact of the 340B proposal), while under the proposed PFS, payment rates will see no change for hematology/oncology and a one percent increase for radiation oncology in 2018.

Let Us Hear From You
CMS is taking comments on both the OPPS and PFS CY 2018 Proposed Rules through Sept. 11, 2017, and, importantly, also seeking open-ended comments from the public on policies that would maintain flexibility and efficiencies in the Medicare program while reducing unnecessary burdens for clinicians and patients. ACCC is busy drafting its comments and we want to hear from you. Please contact Leah Ralph, Health Policy Director, at lralph@accc-cancer.org with your input. We also encourage you to submit comments directly to CMS at regulations.gov.

 

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].

House Subcommittee Hearing Focuses on HRSA’s Oversight of 340B

by Blair Burnett, Policy Analyst, ACCC

U.S. CapitolThis week, the U.S. House of Representatives Subcommittee on Oversight and Investigations, of the Energy and Commerce Committee, chaired by Rep. Tim Murphy (R-PA), held a hearing titled, “Examining HRSA’s Oversight of the 340B Drug Pricing Program.” Health Resources and Services Administration (HRSA) is the agency within the U.S. Department of Health and Human Services that currently oversees the 340B Drug Pricing Program. The program’s inception in 1992 sought to provide discounted outpatient drugs to “covered entities” (DSH facilities, rural referral centers, freestanding cancer centers, non-profit hospitals, etc.) who provide a certain level of care to Medicaid and low-income Medicare patients, allowing covered entities to stretch scarce federal resources to provide affordable prescription drug coverage to all patients.

The hearing, convened on Tuesday, July 18, addressed how HRSA’s oversight can improve review of eligible healthcare facilities utilizing the program in the face of continued expansion of facilities that qualify. As of October 2016, there are 12,168 covered entities utilizing the 340B Drug Pricing Program, and this number has quadrupled since 2011. The hearing also sought to explore how HRSA can be more transparent with 340B Drug Pricing Program reporting, calling attention to gaps in current data collection efforts.

Witnesses who testified at the hearing included:

  • Krista M. Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, U.S. Department of Health and Human Services;
  • Debbie Draper, Director, Health Care, Government Accountability Office (GAO); and,
  • Erin Bliss, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General (OIG), U.S. Department of Health and Human Services.

Both the office of the GAO and HHS OIG have done significant work with the 340B Drug Pricing Program, and the witness testimony spoke to the recommendations both have made to HRSA. Both offices have also repeatedly reviewed HRSA’s regulatory capabilities with the 340B Drug Pricing Program and stated the need for more robust oversight. Based upon witness testimony and member questioning, key takeaways include:

  • Possible bipartisan legislation efforts that seek to grant HRSA more oversight of the 340B Drug Pricing Program.
  • Increased transparency from HRSA on 340B Drug Pricing Program costs and rules.
    Multiple members called for insight into how covered entities are utilizing any savings accrued from the 340B Drug Pricing Program. Within the current oversight from HRSA, there are no guidelines on how covered entities utilize or report 340B Drug Pricing Program savings.
  • Additional hearings to examine the 340B Drug Pricing Program within the subcommittee bringing in physicians and hospital executives to ask healthcare facilities how they are utilizing savings acquired from the 340B Drug Pricing Program.

Notably, this hearing convened shortly after the July 13 release of the Centers for Medicare & Medicaid Services (CMS) proposed 2018 Outpatient Prospective Payment System (OPPS) rule, which calls for a drastic reduction in Medicare Part B payments for outpatient drugs to all covered entities utilizing the 340B Drug Pricing Program from average sale price (ASP) plus 6 percent to ASP minus 22.5 percent in an effort to reign in the program. Rep. DeGette (D-CO), Rep. Schakowsky (D-IL), and Rep. Pallone (D-NJ) voiced concern over this proposal and called for bipartisan support to make meaningful reforms to the 340B Drug Pricing Program to ensure HRSA oversight is effective in aligning transparency as well as improved facility and overall data audits.

As policymakers continue to shine the light on the 340B program, over the next several weeks ACCC will continue to monitor efforts to reform the program and evaluate the impact the OPPS proposal will have on ACCC membership. Along with other stakeholders and coalition partners, we will be forcefully advocating for policies that are in the best interest of all community-based providers and their patients.


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.