National Oncology Conference—Keep the Conversation Going

Featured speaker Peter Bach, MD, MAPP, delivers the opening presentation of the ACCC National Oncology Conference.

By Amanda Patton, ACCC, Communications

From the opening presentation by featured speaker Peter Bach, MD, MAPP, to the final sessions focused on cancer survivors and the workplace and providing survivorship services on a shoestring budget—last week’s ACCC National Oncology Conference covered challenges large and small facing cancer programs and practices across the country.

Macro challenges—occurring at the health system and population health level—are well known to the oncology community. Among these are the high cost of cancer drugs and new therapies, the transformative shift in payment from volume to value, workforce shortages, reimbursement constraints, and the many issues tied to ever-increasing demands for data collection and reporting.

Micro challenges—occurring at the service line and individual provider and patient level—range from adapting delivery infrastructures to meet the evolving treatment landscape, to determining  metrics to track and how to best to communicate these to leadership, to ensuring patient access to supportive care services that remain unreimbursed, to fostering a holistic, patient-centric culture of care.

Common themes across conference sessions and conversations: Collaboration, integration, evidence-based medicine, and value.  Five key takeaways from the conference:

Cancer programs and providers must collaborate outside the box and across the care continuum.
Attendees heard first-hand from programs that are already making this work—from implementing virtual tumor boards, to engaging primary care physicians in survivorship care, to collaborating across disciplines to provide cancer prehabilitation services, and more.

There are formal & informal operational pathways to create integrated delivery networks with stakeholders for quality patient care.
Panelists in the Advancing Quality Care session agreed: to achieve a truly integrated delivery network transparency and trust between all partners is needed.

Oncology programs are increasingly turning to dynamic dashboards to demonstrate value to payers and patients.
Solutions and tools may exist outside the oncology service line. Reach out to the data analytics team or business intelligence team within your organization. Take advantage of or adapt existing resources and tools.

From personalized medicine to immuno-oncology, cancer treatment is undergoing a transformative shift.
For both providers and the patients they serve, the value proposition presented by genomic medicine is that it allows clinicians to make better therapeutic decisions.

Patients are key stakeholders in healthcare integration efforts.
“Successful integration will depend on aligned patient-centered care, patient-focused care, and patient engagement,” said ACCC President Elect Jennie Crews, MD, in the panel discussion on Advancing Quality Care.  Panelists touched on the findings included in a new ACCC white paper released at the National Oncology Conference that outlines forward-looking essential steps to ensure quality patient care in the increasingly integrated healthcare environment.

ACCC encourages members to keep the conversation going by sharing your key conference takeaways in our members-only online community ACCCExchange.

Save the date and join us in Washington, D.C., March 2-4 for the ACCC Annual Meeting: CancerScape 2016.

National Oncology Conference: Framing Issues & Finding Answers

ACCC President Steven D’Amato, BSPharm, BCOP, welcomes attendees to National Oncology Conference

by Amanda Patton, ACCC, Communications

Featured speaker Peter Bach, MD, MAPP, addressed a packed room in the opening session of the ACCC National Oncology Conference on Oct. 22, in Portland, Oregon.  Dr. Bach is Director, Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center.

Dr. Bach’s remarks centered on four prime issues challenging oncology today: the cost of cancer drugs, the need for oncology to do a better job on comparative outcomes research, the 340B drug pricing program, and the importance of incorporating end-of-life care into cancer program services.

Finding a rational way to address drug costs matters on both the macro level [in terms of the impact of healthcare costs nationally] and on the micro level at point of care when “drugs are being left at the pharmacy counter because patients can’t afford the copay,” he said.

 

Conference sessions throughout the day focused on challenges and innovative solutions that can have powerful micro- and macro-level impacts on cancer programs and providers, and the patients they serve: From “how to” sessions on benchmarking salaries, applying lean principles for staffing, establishing a virtual tumor board, distress screening, and preparing for alternative payment models, and more, to a big picture session on Advancing Quality—from Oncology Medical Homes to Integrated Delivery.  One cross-cutting takeaway message: work across disciplines and siloes—think about how to collaborate outside the box and across the care continuum.

Stay tuned for more conference highlights. Follow conference on Twitter at #ACCCNOC.

Pre-Conferences Kick Off ACCC National Oncology Conference

by Amanda Patton, ACCC, Communications

OPEN Pre-Conference attendees listen to session on biosimilars

Cancer care professionals from across the country are gathering in Portland, Oregon, this week for the ACCC 32^nd National Oncology Conference.

Yesterday’s pre-conferences set the stage with sessions on oncology pharmacy issues and a program designed for administrators new to oncology.

One hot topic under discussion at the Oncology Pharmacy Education Network (OPEN) pre-conference: Institutional Review of Biosimilars. Jim Koeller, MS, PharmD, of the University of Texas at Austin, told attendees that “nationally, what we hope to create…we’re really trying to get to is a national standard on how biosimilars should be reviewed [by institutions].”  Until that time, what can P&T Committees do to be ready for institutional review? Setting up a subcommittee or working group for biosimilars is an important first step, Koeller  said.

While biosimilars will be less expensive, they will still be costly and reimbursement for biosimilars will “take a long time to figure out,” Koeller warned.

Key takeaways for oncology pharmacists and the oncology pharmacy:

• Biosimilars are not generics: Use of biosimilars will require clinical review by a multidisciplinary team through the P&T Committee or other mechanism
• A systematic review process will be necessary, looking at product, manufacturing, and institutional factors
• Interchangeability is generally a state issue; keeping up with state laws will be essential.

A common theme across both pre-conferences: Oncology today requires multidisciplinary leadership.

“Almost everything in oncology practice is interdisciplinary,” said presenter John Hennessy, MBA, CMPE, in a New to Oncology session on Leadership and Organizational Structure. To succeed, oncology programs must have processes in place for identifying and training future leaders and aligning incentive across all team members, he said.

Stay tuned for more from the ACCC National Oncology Conference.  Follow the conference on Twitter at #ACCCNOC.

340B Mega Guidance: What Providers Need to Know

By Maureen Leddy, JD, Policy Coordinator, ACCC

On August 27, 2015, the Health Resources and Services Administration (HRSA) released the much-anticipated mega-guidance for the 340B Drug Pricing Program. The 340B program provides discounted outpatient drug pricing for specified safety-net healthcare organizations, known as covered entities. The guidance was long-requested by covered entities and drug manufacturers, both of whom seek clarity in definitions and various elements of the program. HRSA considered proposing a regulation last year, but determined it did not have rulemaking authority. Consequentially, it has now proposed guidance, which while not legally binding, does inform 340B program participants on how HRSA believes the program should operate. From the perspective of a healthcare provider seeking to avoid audit under the 340B program, HRSA’s guidance should be given significant weight.

Providers should note HRSA’s definitions of both a 340B patient and a covered entity. The guidance appears to narrow the definition of a patient, allowing 340B drug eligibility on a drug-by-drug basis, specific to the medical issue for which the patient is being treated as an outpatient at the covered entity. Previously, a covered entity could provide a patient with any necessary drugs under 340B pricing, regardless of the scope of treatment.

The guidance also proposes a new standard that a child site of a covered entity hospital must provide services with associated Medicare outpatient costs and charges, in addition to the current standard that the child site be listed on a reimbursable line of the covered entity’s Medicare cost report. HRSA also makes clear that a covered entity’s inclusion in a larger organization such as an accountable care organization, does not qualify the larger organization for the 340B program.  Finally, HRSA requests feedback on ways to demonstrate eligibility of off-site facilities.

Also notable from the provider perspective is guidance related to audit processes.  HRSA proposes a notice and hearing process for 340B audits by the agency. Covered entities found not to be in compliance may be subject to corrective action plans, and loss of eligibility in the 340B program. HRSA also tightens standards for manufacturer audits of covered entities, requiring “reasonable cause,” while failing to impose any requirement that the agency act upon manufacturer audit results.

ACCC will continue to review this 340B mega guidance leading up to the October 28, 2015 comment deadline, and welcomes member input and questions.

Defining Value in Cancer Care

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

Earlier this summer, ASCO released its much anticipated “value framework,” a proposed methodology designed to assist physicians and patients in assessing the value of different cancer treatment options. Comments on the framework were due last week, and a variety of stakeholders – including providers, patient groups, and manufacturers – provided feedback on the model.

While most would agree the framework is not yet ready for the clinical setting, it represents an important step in the broader conversation about measuring value in cancer care. As a conceptual framework, it seems to have done its job. But as ASCO points out, it is critical to consider this tool in context. The methodology contains notable limitations in data, practicality, and scope, and payers and policymakers should be cautioned that this framework is not meant to serve as a basis for reimbursement or coverage determinations.

ASCO’s approach uses randomized clinical trial data to compare new treatments with an established standard of care under two different scenarios: the advanced disease setting and the adjuvant (potentially curable) setting. A treatment receives a net health benefit (NHB) score (up to 130 points for advanced and 100 points for adjuvant) by combining a score for clinical benefit (up to 80 points), toxicity (up to 20 points), and up to 30 bonus points for quality of life measures, including palliation of symptoms and treatment-free intervals in the advanced disease setting. The NHB score is intended to demonstrate the added benefit patients may receive from a new cancer drug compared with a current standard of care.

Under the proposed framework, the clinical benefit score gives most weight to therapies that increase overall survival, followed by progression-free survival, and response rate. ASCO chose these clinical endpoints because they represent data most commonly collected and reported in clinical trials. So, for example, when survival data is not available and/or only noncomparative trials have been preformed, as is often the case with breakthrough therapies, response rate will be used to determine the effectiveness of the drug until survival data becomes available.

The combined clinical benefit, toxicity, and bonus points make up the NHB score, which is then displayed next to (and, notably, separately from) cost. Here ASCO uses drug acquisition cost, and concedes that while this is not the most complete or meaningful measure, particularly for the patient, it was the most straightforward to quantify. Of course any methodology to truly determine value should include total cost of care, including estimated costs for diagnostics, surgery, imaging, hospitalization, and provider charges. Ultimately ASCO envisions including another figure, the cost to the patient, which will have to be individualized based on the patient’s specific health benefit design. ASCO also notes the goal is that the patient will also be able to modify the importance of both clinical benefit and/or toxicity based on his or her personal values and treatment goals.

As we know, defining value is not an easy task and ASCO recognizes several limitations to this model. The first is that the NHB calculation is only valid within the context of the clinical trial, which does not allow for intertrial comparisons. Additionally, this model does not include the patient’s perspective on value, excluding critical endpoints such as quality of life and patient-reported outcomes in the calculation of NHB. We also know that the relative value of a given treatment will likely change over its lifetime; how will this conceptual framework become a practical, dynamic tool that will repopulate data and update NHB scores over time?

From the physician’s perspective, many questions remain. How exactly will this tool be used in a clinical setting? When will this conversation happen at the point of care? Who will ultimately perform the analysis, input the patient’s cost-sharing data and preferences, and present the numbers to patients? Some physicians will use the tools themselves, while others will rely on nurses, administrators, or pharmacists to perform the analytics. While ASCO is clear the proposed framework is “not meant to substitute for physician judgment or patient preference,” in current form, it may leave the patient with more questions than answers. We encourage ASCO to develop a strategy to provide the appropriate guidance, support, and education to providers to assist them in explaining these values to patients in the next iteration of this framework.

ACCC recently submitted comments on ASCO’s value framework, and we look forward to continuing to engage with ASCO and others on the challenging issue of cost and quality in the cancer care delivery system.

Ready for Some Good News?

By ACCC Communications

Prepare to be inspired.

Richard Rossi, the keynote speaker at ACCC’s 31^st National Oncology Conference in San Diego, Calif., October 8-10, 2014, will introduce meeting attendees to some of the country’s most gifted teenage researchers who are already changing the future of cancer care.

“With all negative news in healthcare, with all the stress and challenges as a cancer care professional, this will be a wonderful opportunity to hear how young people have fundamentally changed the future of medical care by their interventions,” said Rossi. He co-founded the National Academy of Future Physicians and Medical Scientists, an educational enrichment organization that honors, inspires, and motivates the nation’s most promising future physicians.

“Jack Andracka. He’s 17, but when he was 14 and sitting in his science class, he imagined a way to diagnose pancreatic cancer in stage I,” said Rossi.

According to Jack’s Wikipedia entry, the idea for his pancreatic cancer test came to him while he was in high-school biology class, drawing on the class lesson about antibodies and an article on analytical methods using carbon nanotubes he was surreptitiously reading in class at the time. Afterward, he followed up with more research using Google Search on nanotubes and cancer biochemistry, aided by free online scientific journals.

“At age 15 he contacted 200 professors asking for lab space to test his thesis. One hundred and ninety-nine turned him down,” said Rossi. Finally, he received a positive reply from Anirban Maitra, Professor of Pathology, Oncology, and Chemical and Biomolecular Engineering at Johns Hopkins School of Medicine.

The result of his project was a new dipstick-type diagnostic test for pancreatic cancer using a novel paper sensor, similar to that of the test strip for diabetes. This strip tests for the level of mesothelin, a soluble cancer biomarker, to determine whether a patient has early-stage pancreatic cancer. The test is over 90 percent accurate in detecting the presence of mesothelin.

“Jack is not an anomaly,” said Rossi. “The good news is that there are a whole bunch of young people making a huge difference in cancer research.”

And  cancer research is not the only area of oncology that’s engaging tomorrow’s leaders.

Some ACCC-member cancer programs are finding innovative ways to connect with the next generation of oncology professionals–from mentoring future oncology nurses to offering internship opportunities to tapping into the energy and enthusiasm of young volunteers in the community.

Stay tuned to ACCCBuzz for highlight’s from Rossi’s keynote talk, “The Good News About the Future of Medicine,” next Friday, October 10, 2014.

Rossi currently serves as president and executive director of the National Academy of Future Physicians and Medical Scientists. Its mission is to identify, encourage, and mentor students who wish to devote their lives to the service of humanity as physicians, medical scientists, technologists, engineers and mathematicians.

It’s not too late to attend the ACCC National Oncology Conference, learn more here.

School Is Out for the Holidays—But Cancer Programs Still Have Coding Homework

by Bonnie Kirschenbaum, MS, FASHP, FCSHP

This year, due to the federal government shutdown, the final Outpatient Prospective Payment System (OPPS) rule was released at the end of November—so cancer programs have less time than usual to prepare for changes that will go into effect on Jan. 1, 2014. Last week, ACCC held a conference call for members with analysis of the final 2014 OPPS and Physician Fee Schedule (PFS) rules. And it’s clear from the call that cancer programs have plenty of homework to do.

Here are 5 things to do for 2014, organized by OPPS payment category.

1. New drugs not yet assigned unique Healthcare Common Procedure Coding System (HCPCS) codes. When an injectable drug first comes to market and has pass-through status, it may not yet have a HCPCS code assigned to it. Instead, it will be paid for at 95% of average wholesale price (AWP) using code C9399, unclassified drugs or biologics, along with the National Drug Code (NDC) number of the drug.  Homework: This coding procedure and payment rate remains for 2014, but you must report the NDC to identify the drug.

2. New pass-through drugs with HCPCS codes. If a new drug is assigned a HCPCS code at or after FDA approval, it must be used. No payment will be made if the miscellaneous unclassified code persists in your system. Homework: Scour your files to remove and replace miscellaneous codes.

3. Specified covered outpatient drugs (SCODs) costing more than $90 per day. This reimbursement “basket” is where the majority of drug payment lies and where most drugs land once their pass-through status expires. Accurate billing is critical for these drugs. Homework: Make sure HCPCS codes, billing unit assignments, and conversions from actual dose given to billing units submitted are faultless!

4. Lower-cost packaged products costing less than $90 per day. There is no separate reimbursement for these products; payment for them is included in the bundled payment for the specific procedure or visit for which they were used. However, they must be billed as separate line items to ensure adequate payment for the bundle and, if they were administered as infusions, to ensure payment for drug administration (which is available separately from the bundle). Homework: Keep on documenting and billing for these drugs!

5. Drugs with pass-through status. The usual annual reworking of pass-through drugs resulted in 14 drugs and biologicals losing their pass-through status effective Dec. 31, 2013. Interestingly, only 9 of these products will be separately paid for in 2014, and 5 no longer will be separately reimbursed (see Table 32 in the final OPPS rule). Drugs and biologicals keeping or newly assigned pass-through status (see the list of 26 in Table 33 in the final OPPS rule) will have their pass-through payment rates reviewed on a quarterly basis with payment adjustment as needed. Homework: Several 2014 HCPCS codes have changed, as well as the status indicators which will indicate whether or not there is separate payment in 2014. Ensure that these HCPCS code changes are part of your IT systems.

Of course payments will be reduced by approximately 2% for as long as sequestration remains in effect. Counteract this by ensuring accuracy in the areas discussed above!

ACCC members can access an archived conference call and analysis of the 2014 Medicare rules here. Look for an in-depth discussion of the rules in your January/February Oncology Issues.

Bonnie Kirschenbaum, MS, FASHP, FCSHP, is a healthcare consultant and columnist, and serves on the editorial board for ACCC’s Oncology Drug Reference Guide.

New ACCC Survey Shows Sequester Impacting ALL Cancer Patients

By Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

The failed debt negotiation talks of 2011 led to the 2% across-the-board Medicare sequester that has been squeezing the oncology community since CMS implemented it in April  2013. Shortly after the sequester began, ACCC surveyed its membership across varying sites of care and found that close to 60% of respondents reported being impacted by the 2% reduction in Medicare reimbursement.  In October, when sequestration hit the six-month mark, ACCC conducted a follow-up survey of its membership to see how cancer programs were coping and if the picture painted at the start of the sequester still stood. The results of the follow-up survey highlight some interesting points about how the sequester is impacting community oncology care.

Two-thirds of survey respondents report being impacted by the sequester. Of those impacted, 84% are making adjustments to operating expenses, including reducing staff hours or not replacing staff when they resign. The follow-up survey results show the fastest growing area seeing cuts is non-revenue-generating programs, such as patient navigation services.  Reducing these services hinders the quality of care for all cancer patients since these programs help patients with financial, dietary, cultural barriers, health literacy and other needs. These programs assist all patients in a cancer program; therefore, it is not surprising that 75% of respondents said the sequester is impacting every one of their patients, even though the 2% reduction in reimbursement is applied only to Medicare claims. This is an increase of 15% from the initial survey, showing that some of the broader implications of sequestration are just beginning to surface.

Interestingly, in the follow-up survey, of those who had not yet made changes, one-quarter responded that they did not expect to make changes in the future, as compared to 14% in the earlier survey. This may be good news indicating that more cancer programs are finding ways to adjust to these reimbursement reductions without making changes to patient care.

These results show that many ACCC members are resourceful and are coming up with innovative solutions to continue to care for their patients. However, overall, the results of these surveys show that more cancer facilities are being negatively impacted as a result of the 2% cut to Medicare reimbursement through sequestration, and that the cuts have impacts far beyond Medicare patients—they  extend to all patients, to staff, and to supportive care programs. Providers are at the end of their rope—community  oncology care cannot be cut further and the sequester must be reversed to preserve patient access to the supportive care services that relieve barriers to care, increase value, and help reduce long-term costs.

Please contact your legislators to let them know how the sequester is impacting you and your patients. ACCC will continue to encourage Congress to protect patient access to care by protecting community cancer care reimbursement.

Improving the Melanoma Patient Experience

by Diane M. Otte, RN, MS, OCN

Outreach and information on skin cancer awareness and melanoma typically “heat up” as summer approaches, not as we—in most of the country—are bundling up for winter weather. Still, for community cancer programs caring for patients with melanoma, the disease knows no season.  This month ACCC is providing a new resource aimed at helping cancer programs improve the melanoma patient experience.

Those of us who have spent most of our careers in the oncology field have experienced firsthand the changes in our awareness of sun safety and skin cancer prevention. If you’re like me, you can look back to those days as a teenager when you worshipped the sun without any regard for the “bad effects.” Sunscreen? None of that. Instead, you slathered on the baby oil, used foil to enhance the effect, and even if the day was cloudy and chilly, you found a spot to indulge in sun worshipping!

How far we’ve come—in our awareness of the risk we took then and in how we can educate our children, grandchildren, friends, co-workers, and others about skin cancer—especially one of the most serious and dangerous types—melanoma! If you think about your own oncology practice, each of you could tell the story of a patient who touched you and influenced your view of this ever-increasing disease. I remember clearly a young woman in her twenties, diagnosed when pregnant with her second child. She had a two year old at home and was several months pregnant when the diagnosis was made. I don’t remember all the details of her story but I do remember the impact she had on our staff as she valiantly fought this disease…unfortunately, she lost the fight many months later.

Now, several years later, I’ve added our dermatology practice to my cancer program management responsibilities and have learned how significantly melanoma is increasing in our population—1 in 50 Americans has a lifetime risk of developing melanoma. As you look around you, my hunch is that you personally know someone who’s been diagnosed with melanoma.

ACCC’s new resource, “Melanoma: Improving the Patient Experience, Practical Strategies for Community Cancer Centers,” provides practical information that community-based oncology programs can use. The effective practices highlighted in this publication focus on a multidisciplinary approach to care, access to clinical trials, patient navigation services, supportive care, and use of clinical guidelines as well as the expertise of regional experts. Six ACCC-member cancer programs of various sizes and geographic locations share details about their programs and discuss strategies for the management of patients with melanoma as well as barriers to care. A pre/post assessment of effective practices and a checklist for use in implementing effective practices are included.

Hopefully each of us has changed our own personal sun worshipping habits and now don appropriate clothing and protection when in the sun. With this new resource, developed as part of ACCC’s Melanoma: Improving the Patient Experience project, I also challenge you to take the time to assess, within your own practice, how well you are serving your patients with melanoma and making the changes needed to educate your staff and the community around you. By working diligently to address the barriers and needs of this patient population we can make a difference.

Diane Otte, RN, MS, OCN, serves on the Advisory Board for ACCC’s Melanoma: Improving the Patient Experience project. She is Director, Cancer Center & Dermatology, Mayo Clinic Health System-Franciscan Healthcare Cancer Center, and has served on the ACCC Board of Trustees.

Cancer Care in the Age of Electronic Health Information Exchange

by Matt Farber, Director, Provider Economics and Public Policy, ACCC

The role of technology in healthcare—and the many headaches that can accompany the adoption of new technology—has been put under the microscope in recent weeks. Missteps and glitches during the roll-out of the new health insurance marketplaces’ online enrollment have some questioning broadly whether technologies designed to improve the healthcare system can actually achieve their goal.

The process may not be easy, but evidence shows that appropriate technology can improve efficiency and coordination in healthcare, whether it’s online insurance enrollment, electronic health records, or—as explored in a new white paper from ACCC—health information exchanges.

ACCC’s new white paper, “Cancer Care in the Age of Electronic Health Information Exchange,” discusses the potential impact of health information exchange on cancer care and the hurdles to adoption. It is the second white paper to come out of ACCC’s Institute for the Future of Oncology, with the first released in October.

Health information exchange describes two related concepts: the electronic sharing of health-related information among organizations, and the entities that provide services to facilitate this electronic information sharing.

“Cancer Care in the Age of Electronic Health Information Exchange” explores the current state of health information exchange adoption, the importance of HIE, and also the potential for improved quality of care and reduced costs that an HIE can provide.

The push for adoption and integration of electronic health records (EHRs) has been a first step toward realizing the capabilities and benefits of electronic health information exchange. Adoption of and engagement in HIEs, the organizations that enable electronic sharing of patient data across providers and healthcare organizations, is the next step—and in many areas of the country, this step is still out of reach.

The white paper reflects discussion and perspectives from participants in the Institute’s inaugural forum, which was held in late June 2013. Here is a snapshot of the white paper’s findings:

• HIE adoption is uneven.
• There is a lack of awareness around HIEs.
• HIE initiatives must focus on information standardization.
• HIEs can help benchmark interventions within patient populations.
• Providers must have input on the information released via patient portals.

The potential of HIEs to improve benchmarking, efficiency, and ultimately quality of care in oncology was universally agreed by participants at the Institute. However, the consensus was that many hurdles remain before the potential becomes reality.

ACCC’s Institute for the Future of Oncology addresses key topics impacting oncology now and in the future. If you would like to get involved in upcoming forums of the Institute for the Future of Oncology, please contact Matt Farber at mfarber@accc-cancer.org.