Tag Archives: CMS

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.

 

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.

CMS 2017 OPPS & MPFS Final Rules: Top-Level Takeaways

By Leah Ralph, Director of Health Policy, ACCC

Centers_for_Medicare_and_Medicaid_Services_logoThis week the Centers for Medicare & Medicaid Services (CMS) released the final CY 2017 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) rules. ACCC is currently analyzing the rules and will hold a webinar for members with more in-depth information in the coming weeks. Below are some key highlights.

Outpatient Prospective Payment Systems CY 2017 Final Rule

CMS estimates that the policies in the final rule will increase OPPS payments by 1.7% in 2017. The big news: in the final rule, the agency goes forward with the site-neutral payment provision for new off-campus provider based departments (PBDs):

  • Newly built or acquired off-campus PBDs: CMS finalized its proposal to no longer allow new off-campus PBDs (that were not billing under OPPS as of November 2, 2015) to bill under OPPS beginning January 1, 2017. CMS is finalizing the Medicare Physician Fee Schedule (MPFS) as the applicable payment system, but is also establishing new MPFS rates specifically so that hospitals can be paid directly for these new (what CMS is calling “non-excepted”) items and services. Hospitals will be paid under the MPFS at these new rates, which will be billed on the institutional claim and must be billed with a new claim line modifier “PN” to indicate that an item or service is non-excepted. For 2017, the payment rate for these new services will generally be 50% of the OPPS rate (with some exceptions, including payment for separately payable drugs, which will not be reduced). Packaging and certain other OPPS policies will continue to apply. Important: CMS specifically notes that items and services provided at new off-campus PBDs will continue to be reported on the hospital cost report and therefore eligible for 340B drug discounts if the parent hospital is a 340B eligible hospital. Find discussion of the impact of this policy on 340B discounts on pages 648-649 of the final rule.
  • Existing off-campus PBDs: CMS largely backed off its proposal to limit the expansion of outpatient items and services that can be billed under OPPS for existing off-campus provider-based facilities. PBDs that were billing under OPPS prior to November 2, 2015, can continue to bill for those services under OPPS—and expand those services beyond the 19 clinical families CMS had originally defined in the proposed rule. However, CMS has said that these facilities must remain at the same physical address to continue to bill under OPPS unless it is an extraordinary circumstance, such as a natural disaster. This may be short lived though as CMS also indicated it will continue to look at this and that the agency is “interested in what data…could be collected that would allow us to implement a limitation on service expansion” for these exempted facilities.
  • Packaging Policies:
    • CMS is finalizing its proposal to create 25 additional C-APCs, which are primarily major surgery APCs within the various existing C-APC clinical families.
    • The agency is finalizing its proposal to base packaging on a claim, rather than on date of service, so that services that are provided during a hospital stay that spans more than one day are packaged.
    • CMS finalized the expansion of a policy that excludes molecular pathology tests from CMS’ laboratory packaging policy to other Advanced Diagnostic Laboratory Tests (ADLTs).

Physician Fee Schedule CY 2017 Final Rule

The CY 2017 Medicare Physician Fee Schedule final rule focuses on policies aimed at improving pay for primary care, chronic care management, mental health care, and diabetes prevention. The rule’s provisions are expected to have a neutral impact on hematology/oncology, radiation oncology, and radiation therapy centers, and a -1% impact on radiology. Select cancer-related provisions include:

  • Payment for Mammography Services: CMS finalized a new coding framework based on new CPT coding for mammography services. The coding revision reflects use of current technology used in furnishing these services, including a transition from film to digital imaging equipment and elimination of separate coding for computer-aided detection services. CMS is maintaining current valuation for the technical component of mammography services in order to implement coding and payment changes over several years.
  • Medicare Telehealth Services: CMS finalized the addition of several codes to the list of services eligible to be furnished via telehealth, including: advance care planning services, end-stage renal disease related services for dialysis, and critical care consultations furnished via telehealth using new Medicare G-codes. CMS is also finalizing payment policies related to the use of a new place of service code specifically designed to report services furnished via telehealth.
  • Appropriate Use Criteria for Advanced Imaging Services: The Protecting Access to Medicare Act (PAMA) of 2014 established a new program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services under fee-for-service Medicare. As a component of the Medicare AUC program, CMS finalized the first eight priority clinical areas, which include cancer of the lung (primary or metastatic, suspected or diagnosed). CMS also finalized the clinical decision support mechanism (CDSM) application to allow for preliminary or full qualification; the deadline for the first round of applications is March 1, 2017.

View fact sheets for both rules here: OPPS and PFS.

 

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.

 

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.

ACCC Asked: Congress Listened

By Leah Ralph, Director of Health Policy, ACCC

time for actionToday 242 members of Congress joined in a bipartisan letter to CMS Acting Administrator Andy Slavitt urging the agency to withdraw its proposed Medicare Part B Drug Payment Model.  The effort was spearheaded by House Ways and Means Committee Member and Budget Committee Chairman Tom Price, MD (R-GA), House Energy and Commerce Committee Member John Shimkus (R-IL), and House Ways and Means Committee Charles Boustany Jr., MD (R-LA).

You asked and Congress listened.  Last week, hundreds of ACCC members reached out to their legislators asking that they sign on to the Congressional letter to CMS.  ACCC thanks its membership from 2,000 cancer programs and practices across the country for speaking up and telling their legislators about the detrimental impact this proposed rule would have on their patients and providers.

But the question remains: Will CMS listen?

May 9 is the deadline for comments to CMS on this misguided proposal. ACCC will be submitting comments to the agency and urges its members to send comments as well.

Learn more about ACCC advocacy efforts on this issue here.

ACCC Annual Meeting: Five Key Takeaways

by Amanda Patton, ACCC Communications

ACCC 42nd Annual MeetingNearly 500 oncology professionals gathered in Washington, D.C., last week for the 42nd ACCC Annual Meeting, CANCERSCAPE. Throughout sessions centered on policy, value, and quality, attendees heard a recurrent message: Your experience, perspective, and input on the issues of value-based care, quality measures, and outcomes are essential as the healthcare system and oncology transition to the new world of alternative payment models and value-based care.

From ACCC Capitol Hill Day last Wednesday throughout the meeting sessions, attendees were urged to educate policymakers and payers about the real-world processes involved in delivering quality cancer care.

In the meeting’s opening session, Congressman Rick Nolan (MN-D)  called out the vital role ACCC members can play in helping educate legislators and policymakers, “No one can articulate need, challenges, potential to ultimately cure cancer [better] than the people in this room today,” he said.

Can precision medicine be reconciled with value-based care? “Absolutely” said Kavita Patel, MD, MS, of the Brookings Institution.  Oncology already delivers personalized (or precision) medicine through targeted therapies for some cancers, she pointed out. Communicating about the oncology care process so that policymakers understand real-world cancer care delivery is imperative, Patel said. Part of that conversation should aim to help policymakers understand the demanding intuitive thought process that is part of today’s oncology care, along with the tremendous amount of information cancer care providers must keep up with given the pace and variety of emerging therapies. “It’s not writing prescriptions,” she said.

Five Key CANCERSCAPE Takeaways

High-level meeting takeaways that interconnect value, policy, and quality include:

  1. Alignment. For value and quality measures to work in oncology, alignment among payers, providers, and patients is essential.
  2. Put your data to work. Cancer programs and practices are finding ways to harness their data to improve quality patient-centered care and reduce costs. In a presentation on Collaboration Across Specialties to Improve Care and Curb Costs, Matthew Manning, MD,  from Cone Health demonstrated how his program used data to identify “hotspotters,” assess gaps in care, improve outcomes, and reduce costs.
  3. Communicate. Support conversations across silos and among stakeholders. Engage with patients to understand their goals of care and to define value and quality. While value frameworks are generic, “all patients are different” agreed panelists in a Town Hall discussion on Value Framework Tools.
  4. Be proactive. Don’t wait until USP Chapter 800 goes into effect to assess your facilities readiness. Don’t wait until HRSA issues its final 340B mega-regulation. Take steps today to assess your program’s compliance. “Be prepared” was also the message in a Biosimilars Update from Nisha Pherwani, PharmD, BCOP, clinical director of Oncology, Cardinal Health. She urged attendees to:
    • Understand the FDA approval process for biosimilars
    • Provide a concise review to your P&T committee
    • Review the FDA guidances on biosimilars
    • Stay tuned for more on how interchangeability will impact regulations.
  5. Speak up. Oncology providers can best articulate the care they provide and the issues impacting care delivery. Leadership in oncology has to step forward to help define quality and value and inform policy. Work with ACCC to make your voice heard.

This week’s CMS release of a proposed rule designed to test new Medicare Part B drug payment models makes clear the critical need for the oncology community stay on top of what is happening among policymakers in Washington, D.C.  ACCC has voiced strong opposition to CMS’s proposal. Among other concerns, ACCC points to the lack of opportunity for stakeholder input on the development of this proposal.

ACCC urges its members speak up and ask Congress to stop the CMS Medicare Part B Drug Payment Model.  Click here to contact your legislators.

Annual Meeting Highlight: Medicare Update & What to Expect in 2016

By Amanda Patton, ACCC Communications

ACCC 42nd Annual Meeting-ConwayAt the ACCC 42nd Annual Meeting last week, Lindsay Conway of The Advisory Board Company updated attendees on Medicare payments and what to expect in 2016.  Not surprisingly, her presentation touched on issues related to the meeting’s central themes of policy, quality, and value.

Two examples of the forward momentum in quality this year will be “testing” new oncology quality measures through PCHQR Quality Reporting Measures and CAHPS for Cancer Care.  Field testing for the CAHPS for Cancer Care is wrapping up, Conway said, and we can expect to see the CAHPS trademark on three oncology-specific surveys this summer.  Specifically, we will see a survey for surgical oncology, a survey for radiation oncology, and a medical oncology survey. Each survey will consist of about 85 questions and will likely reflect five CAPHS domains, including:

  1. Effective Communication
  2. Shared Decision Making
  3. Enabling Patient Self-Management
  4. Technical Communication
  5. Access

Looking ahead, Conway noted that new policies are supporting population health goals while also slowly moving forward with payment for value. As examples, she cited recent Medicare policies related to biosimilars, advance care planning, and lung cancer screening.

As cancer programs plan strategically for the future, Conway suggests keeping an eye on the following:

  • Payment equalization—which is gaining momentum
  • Progression of site-neutral payment policies
  • Physician practice acquisition—the equation is becoming increasingly complex from both the hospital and the physician practice perspectives
  • Alternative payment models (APMs), in particular the Center for Medicare and Medicaid Innovation (CMMI) Oncology Care Model.

The CMS OCM initiative, which will pilot a value-based reimbursement model in oncology, is on everyone’s radar screen, as the oncology community awaits the agency’s announcement of practices selected for participation. Conway acknowledged that the OCM model is complex and that many questions remain about how CMMI will implement the model.

The ultimate benefit for those participating in the OCM will not be financial, according to Conway. The benefits for participants will be strategic, e.g., new data sets, benchmarks, more data about the patients being served, the opportunity to develop competencies in operating in a risk-based environment, and having a voice in the development of new risk-based models in oncology.

2016 Medicare Payment Rules Finalized

Centers_for_Medicare_and_Medicaid_Services_logoBy Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC

The Centers for Medicare & Medicaid Services (CMS) on Oct. 30, 2015, released the final 2016 Physician Fee Schedule and Outpatient Prospective Payment System rules. With the exception of radiation therapy codes, the final rules align quite a bit with the proposed rules. A preliminary summary is included below. Stay tuned for detailed summaries and analysis on an upcoming ACCC members-only conference call on these 2016 final rules.

Highlights of 2016 PFS Final Rule

Radiation Oncology

In a noteworthy departure from the proposed 2016 PFS rule, CMS did not finalize new radiation therapy treatment payment codes. CMS responded to concerns expressed by ACCC and other stakeholder groups and delayed implementation of new radiation oncology codes, continuing use of current G-codes and values for 2016. However, the agency did finalize its proposal to increase the linear accelerator equipment utilization rate assumption from 50 percent to 70 percent over two years. CMS continues to seek empirical data on costs and usage of capital equipment, including linear accelerators.

Advance Care Planning

For 2016, CMS finalizes its proposal to establish separate payment for advance care planning services, consistent with the recommendations of the American Medical Association and other stakeholders, including ACCC. These new codes compensate providers for shared decision-making conversations at various stages of a patient’s illness.

Biosimilars

For 2016, CMS finalized its proposal to include all biosimilars of a reference biological product within the same billing and payment code. ACCC had commented against this proposal, raising concerns regarding traceability and administrative burdens expected with the use of a single code. While ACCC supports efforts to increase patient access to biologics, ACCC maintains that a system must be in place to track the specific biosimilar product used for each patient.

“Incident To”

CMS finalized its proposal to clarify requirements for billing for “incident to” services. CMS now formally requires that the physician or practitioner billing for “incident to” services must have directly supervised the auxiliary personnel providing these services. Addressing stakeholder concerns about the treating physician’s supervisory role in “incident to” services, the final rule clarifies that the supervising physician need not be the treating physician for billing purposes.

Highlights of 2016 OPPS Final Rule

CMS finalized its proposed cut in hospital outpatient payment rates of – 0.3 percent. Within this calculated –0.3 percent rate update is a –2 percent cut, applied due to the agency’s calculation of excess packaged payment for laboratory services in 2014. As a result of this year’s rate cut due to miscalculations in packaging policies, ACCC urged CMS to proceed cautiously with any additional packaging proposals to ensure future negative adjustments would not be necessary. However, CMS finalized its proposal to expand conditionally packaged services to include three new APCs: level 4 minor procedures, and level 3 and 4 pathology services. CMS notes that packaging of these services is consistent with the agency’s overall packaging policy.

Advance Care Planning

ACCC had also advocated for separate payment under advance care planning codes in the hospital outpatient setting. The 2016 OPPS final rule calls for conditionally packaging payment for these services, permitting separate payment in the hospital outpatient setting in limited circumstances.

Biosimilars

In the 2016 OPPS final rule, CMS finalized its proposals to pay biosimilars based on ASP+ 6% of the reference biologic product, and to allow biosimilars to be eligible for pass-through status. ACCC supported these proposals, noting that providing equivalent payment rates in the physician office and outpatient setting for biosimilars removes incentives to select one setting over another.

Two-Midnight Rule

CMS also finalized proposed changes to its two-midnight rule regarding hospitalization payment status. CMS will now allow certain patients not expected to meet the two-midnight stay requirement for inpatient status to still be classified as inpatient. CMS indicates that qualifying patients are those that require inpatient hospital care, as determined by the admitting physician and supported by the medical record, despite the expectation that their stay will last less than two midnights.

ACCC continues to analyze the 2016 payment rules and will update its members in the coming weeks.

 

ACCC Responds to CMS on Proposed 2016 PFS Rule

By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

Centers_for_Medicare_and_Medicaid_Services_logoOn September 8th, ACCC submitted comments on CMS’ proposed 2016 Physician Fee Schedule rule. This year, the proposed PFS was released later than usual and contained a number of provisions that ACCC will be watching closely in the coming months.

Read on for a quick roundup of major provisions and ACCC recommendations to CMS:

Radiation Oncology Cuts

CMS proposes several significant changes to payment for radiation oncology procedures that would collectively result in drastic cuts for radiation oncology providers – an estimated 3% for radiation oncology and 9% for freestanding radiation therapy centers. CMS is proposing payment rates for new CPT codes that would effectively reduce Medicare reimbursement for IMRT and other radiation treatment delivery services. The agency also proposes to remove several essential direct practice expense inputs from the new radiation treatment delivery codes, including the on-boarding imaging equipment that is essential to providing safe and accurate radiation treatment. Finally, CMS proposes to adjust the equipment utilization rate assumption for the linear accelerator used in image guidance from 50% of available time to 70% of available time over two years, reducing reimbursement for services that make use of that equipment.

In our comments, ACCC expressed significant concern to CMS that these deep, simultaneous cuts in radiation oncology reimbursement will have the effect of forcing some cancer care providers, particularly those operating in rural and underserved areas, to close their doors. ACCC urges CMS to take the necessary steps to mitigate this threat, for example, by not implementing the proposed increase in the equipment utilization rate. ACCC will be monitoring this closely and stands ready to work with CMS to find ways to implement any appropriate changes over a period sufficient to allow providers to absorb the changes while not compromising access to critical radiation oncology services.

 Biosimilar Reimbursement

CMS proposes a payment methodology for biosimilar products in which all biosimilars with the same reference product would be assigned a single HCPCS code and reimbursed based on the volume-weighted average sales price (ASP) for all products under the code plus 6% of the reference product’s ASP.

ACCC asks CMS not to finalize this proposal. We expressed concern that assigning multiple biosimilar products a single HCPCS code would create new and unnecessary administrative burdens for physicians and other providers when treating patients with biosimilar products, as they would not only need to enter the HCPCS code into the medical record, as they do now, but also the specific biosimilar therapy used for the patient. Additionally, this approach could significantly impede effective tracking of safety information and other information about the patient experience with specific biosimilar products—after these enter the market. We urge CMS to promote effective tracing of safety information and to minimize administrative burdens on providers who prescribe biosimilars.

 Advance Care Planning

CMS proposes to establish payment rates for the two CPT codes adopted by the AMA CPT Editorial Panel to describe advance care planning services. ACCC strongly supports this proposal and asks that the payment rates for these services adequately reflect the cost to physicians of providing advance care planning.

As ACCC believes advance care planning services are equally important in the hospital outpatient setting, where they also take substantial time and resources and contribute significantly to the quality of patient care. In our comments to the proposed 2016 Outpatient Prospective Payment System rule, we urged CMS to pay separately for these two CPT codes in the outpatient setting as well.

Chronic Care Management

CMS recognizes that Medicare’s payment rates for the CPT codes for transitional care management (TCM) and chronic care management (CCM) do not fully account for the cognitive work that primary care physicians and other practitioners perform in managing and delivering care, particularly to chronically ill beneficiaries. CMS identifies add-on codes as one potential means of establishing payment rates that appropriately value the additional time and intensity of physicians’ cognitive work often involved in delivering care management services. ACCC encourages CMS to develop such codes, and to work with ACCC and other provider organizations to ensure that any new add-on codes are structured and valued appropriately.

ACCC also has concerns related to CMS’ proposal for chronic care management in the 2016 OPPS proposed rule. On the hospital outpatient side, CMS is proposing to permit only one hospital to bill for CCM services during a calendar month. ACCC points out to CMS that because cancer care is highly multidisciplinary, it can be difficult to agree upon who should be the designated CCM physician, and we are concerned that CMS’ rules for these services already make it very difficult for hospitals to seek payment for them. We urge CMS to continue to consult with hospitals and physicians on the best way to determine which entities should bill for these services.

“Incident To” Services

CMS proposes to require that the physician or other provider who bills for an “incident to” service must also be the physician or other provider who directly supervises the auxiliary personnel in providing that service. If CMS were to finalize this proposal, ACCC urges the agency to provide education to physicians and other providers on the revised requirement to ensure providers do not experience unwarranted disruption in billing for appropriate “incident to” services.

CMS is expected to finalize the 2016 Physician Fee Schedule rule in late October. Stay tuned, as ACCC will keep members updated as CMS revises and finalizes these important proposals.