USP Chapter <800> — Readiness is All

By Amanda Patton, ACCC, Communications

ThinkstockPhotos-180686516Last week, on February 1, the United States Pharmacopeial Convention (USP) announced publication of the new standard general chapter, <800> Hazardous Drugs – Handling in Healthcare Settings. USP approved an extended official implementation date of July 1, 2018. This gives healthcare facilities a little more than two years to conform to the standard’s requirements.

With Chapter 800, for the first time a USP standard addresses hazardous drug administration, bringing nurses—and not just pharmacists—under its purview. The standard covers all medications specified in the National Institute for Occupational Safety and Health (NIOSH) list of antineoplastic and other hazardous drugs.

“If there is chemotherapy in your organization, then it applies to you. So you better know about USP 800,” says Martha Polovich, PhD, RN, AOCN, Assistant Professor, Georgia State University. “It applies to all healthcare personnel and all entities in which these drugs are present.” In a session on March 4 at the ACCC Annual Meeting, CANCERSCAPE, Dr. Polovich will provide an in-depth look at final USP Chapter 800, what cancer programs need to know about compliance, and why time is of the essence. Dr. Polovich served on the expert panel that helped to write Chapter 800.

Although the implementation is July 2018, “You can’t wait until early 2018 and expect to meet the standard,” Dr. Polovich warns. While some organizations are already in compliance, it may take others that long to get up to speed, according to Dr. Polovich. Some will need to make capital improvements. And because Chapter 800 requires the use of closed-system transfer devices (CSTD) for hazardous drug administration, some will need to acquire CSTD and ensure that staff is fully trained.

USP 800 is an enforceable standard meaning that state boards of pharmacy and other regulatory entities may require compliance with the new standard.

Readiness is All

What should healthcare facilities be doing to prepare for compliance? As a first step, Dr. Polovich suggests a baseline assessment to find out where the organization is not meeting the standard. Using the baseline assessment results, organizations can then prioritize next steps. For example, if major capital improvements are needed, ensure that these are added into the budget planning cycle. Another key piece is identifying a champion who will be responsible for the organization’s safe handling program and be in charge of USP 800 compliance, she says. This individual should be an expert who is knowledgeable about hazardous drug management and prevention of exposure to hazardous drugs. Healthcare facilities also need to identify the drugs in their organization that should be handled as hazardous.

Join us at the ACCC Annual Meeting to hear from Dr. Polovich and other thought leaders on issues impacting quality oncology care delivery today and tomorrow. View the meeting agenda and learn more here.

Getting Engaged

One in an occasional blog series on topics from Oncology Issues, the journal of the Association of Community Cancer Centers.

by Susan van der Sommen, MHA, CMPE, FACHE, ACCC Editorial Committee Chair

ThinkstockPhotos-484468581When first hearing of a cancer diagnosis, I imagine a patient’s mind spinning with a cyclone-like ferocity … Am I going to die? How will I tell my family? What about all of my plans? It’s cancer … of course I am going to die … but how soon? Suddenly, life spins out of control.

Engaging patients in their care can dramatically reduce anxiety by giving back some control. Of course they can’t control the diagnosis, but they can control how they face it – on their terms, with their beliefs, wishes, and desires at the forefront of every decision.

In a recent Oncology Issues article, “Talk to Me: Improve Patient Engagement; Improve Your Cancer Program,” author Chad Schaeffer, MS, FACHE, lays the foundation for developing strategies to connect patients and the decision-making process relating to their care. Improved patient engagement can alleviate some of patients’ burden in feeling as if they are hapless victims of heinous misfortune and allow them to regain some semblance of control over their future. Schaeffer is executive director at the Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, WV.

Defining patient engagement in simple, broad terms as “the ongoing and mutually beneficial interaction between patient and providers,” he notes that putting the patients’ needs and aspirations first will improve engagement and, ultimately, satisfaction for all.

What are the goals?

Patients’ treatment goals vary and are individualistic. Some desire to extend life at any cost; others prefer quality over quantity. Many want as little disruption to their daily lives as possible. As Schaeffer points out, evening and weekend hours, though not always pleasing to cancer center staff and physicians, will allow some patients and caregivers the flexibility to carry on with their routine (work, childcare, etc.) while receiving treatment and care at a time that is convenient.

Are we meeting your needs?

Cancer center physicians often struggle with the difficult conversations regarding the “end of life,” resulting, as Schaeffer points out, in decisions that may not coincide with a patient’s wishes. According to an end-of-life study at Stanford University, family members whose loved one died in an “institutional setting” reported poor symptom management, lack of physician communication and patient engagement, and a dearth of emotional support for loved ones and caregivers. Conversely, those who passed with home hospice services reported a considerably higher degree of satisfaction with regard to unmet needs and physician engagement.

Is there something you aren’t telling me?

In addition to reviewing Press Ganey and CGCAHPS surveys, the leaders at the Bassett Cancer Institute in upstate New York have instituted a process where they can – in real time – monitor patient satisfaction. Throughout the course of their treatment, patients are offered a tablet on which they answer a few questions about their care. Questions are flagged so that when a patient expresses dissatisfaction, a member of the leadership team can address the patient’s concern during his or her visit. It gives both the patient and staff an opportunity to more effectively understand what drives patient satisfaction while giving patients an active voice in their care.

Engaging patients from the outset of their diagnosis and throughout their care is critical to their satisfaction and ultimately, as Schaeffer points out, a more effective, patient-centered cancer treatment center.

Patient–centered care is a key focus of the upcoming ACCC Annual Meeting, CANCERSCAPE, March 2-4, in Washington, D.C. Learn more here.

Read the current edition of Oncology Issues here.

ACCC member Susan van der Sommen, MHA, CMPE, FACHE, is Executive Director, DSRIP, Bassett Healthcare Network. She currently serves as chair of the ACCC Editorial Committee.

February 4 World Cancer Day

WCD_LOGO_4CBy Susan van der Sommen, MHA, CMPE, Chair, ACCC Editorial Committee

A primary goal of World Cancer Day 2016 is to get people all around the world talking about cancer. Today that goal is being realized as, individually and collectively, we reflect on the global impact of this disease.

The numbers are daunting:

8.2 million – the number of people who die from cancer worldwide each year

19.3 million – the projected number of new cancer cases worldwide by the year 2025

11.5 million – the projected number of deaths worldwide from cancer in 2025

These numbers make the call to action clear, and the campaign message from the Union for International Cancer Control (UICC) for World Cancer Day 2016 is empowering: “We Can. I Can.

As individuals, families, cancer care providers, and healthcare organizations across the globe observe World Cancer Day, the Association of Community Cancer Centers (ACCC) salutes its membership of more than 20,000 oncology professionals from 2,000 hospitals and practices nationwide who work on the frontlines of cancer care delivery. Medical oncologists, radiation oncologists, oncology nurses, radiation therapists, dosimetrists, pharmacists, social workers, administrators, practice managers, cancer registrars, patient navigators, financial advocates, dietitians, office and clerical staff, and allied healthcare professionals—individually and through their organizations, these men and women, along with the patients they serve—face each day with a “We Can. I Can.” attitude.

On World Cancer Day 2016, the Association of Community Cancer Centers joins in the UICC call to action. Through educational efforts such as the ACCC Financial Advocacy Network, ACCC works to support our members’ “We Can. I Can.” efforts to ensure patient access to quality care and reduce of the burden of cancer.

Learn more about World Cancer Day  here.

 

Collision Ahead? Precision Medicine & Cost

By Amanda Patton, ACCC, Communications

meetings-AM2016-brochure-190x246As researchers and clinicians continue to advance our understanding of the genomic and molecular underpinnings of an increasing number of cancers, oncology finds itself at the “perfect intersection of precision medicine and genomics and concerns about cost,” says Kavita Patel, MD, MS, a Senior Fellow at the Brookings Institution and a primary care physician at Johns Hopkins Medicine.

On March 3 at the ACCC Annual Meeting, Cancerscape, Dr. Patel will provide perspective on whether these forces are on an inevitable collision course—or if there may be a way forward to realize precision medicine’s potential to ultimately reduce costs.

Value  =  ?

A core tenet of healthcare reform is transition to a value-based healthcare system. But, as the oncology community is well aware, different stakeholders have different perceptions of “value.”

“Value to some means reduced costs,” says Dr. Patel. “Others define value as reduced costs with increased quality. Arguably precision medicine is the ultimate in value-based care; it aligns the patients’ needs with the most targeted care, however it might have an increased individual cost.”

“Oncology is one of the few areas in medicine where we actually commonly use precision medicine. For example, for lung cancer we routinely send out tissue for targeted genomic screening and have therapies based on the results,”  says Dr. Patel. The challenge is that science continues to outpace policy.

As oncology transitions to value-based payment models, “the members of the same community that brought us precision medicine—cancer clinicians and researchers—must be the ones who define value in precision medicine,” says Dr. Patel.

Population health must be a part of the value discussion, she says. “We have to do a better job of looking at outcomes and metrics and how we are doing with our patients.” Looking ahead, every oncology practice or cancer center will need to be measuring and demonstrating their impact on population health and patient outcomes. Somehow oncology will have to bring  precision medicine’s individualized approach to treatment into alignment with population health value.

The cancer community must have a voice in the value conversation, Patel stresses, “because it’s important that the people who deliver care in real-time be the people who help define value.”

You’re invited to be part of that conversation. Join us at the ACCC Annual Meeting, Cancerscape, March 2-4, in Washington, D.C. Learn more here.

CANCERSCAPE Session to Demystify Site-Neutral Payment Policy

By Amanda Patton, ACCC Communications

meetings-AM2016-brochure-190x246In recent months MedPAC, the Centers for Medicare & Medicaid Services (CMS), Congress, and the GAO have ramped up attention on the impact of consolidation and integration, shifts in sites of service, and how unequal payment rates across settings of care are affecting Medicare costs.

Adding to the controversy (and confusion) around site-neutral payment as a solution to reducing the Medicare “spend” is the recently passed Bipartisan Budget Act of 2015 at Section 603, “Treatment of Off-Campus Outpatient Departments of a Provider.”

Although the issues surrounding site neutral payment policy are complex, “Section 603 is pretty straight forward,” says Ronald Barkley, MS, JD, of the CCBD Group. “It’s the downstream unintended consequences that cancer programs need to understand.” In a session at the upcoming ACCC Annual National meeting in Washington, D.C., March 2-4, Barkley will demystify site neutral payment policies, lay out pros and cons, and provide a realistic assessment of the potential impact of Section 603. Attendees will leave with a 360-degree understanding of the issues and a “knowledge base to work from” going forward, Barkley said.

Site-neutral payment policies have the potential to affect revenue and budgeting, strategic planning, pro forma development, and 340B Drug Program participation. Thus, a thorough understanding of Section 603 is critical for today’s cancer program leadership.

Time is of the essence, according to Barkley. “There is a window of opportunity to take your message to CMS before [the agency] translates the [Section 603] legislation into regulation.”

Attend the ACCC 42nd Annual Meeting, CANCERSCAPE, from March 2—4, 2016, in Washington, D.C., and gain strategic insight into key drivers of change impacting our evolving oncology care delivery system in sessions focused on Policy, Value, and Quality. Learn more here.  Want to discuss this issue with your elected representatives on Capitol Hill? See what’s planned for ACCC Capitol Hill Day on March 2.

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Originally posted to ACCCBuzz on January 28, 2016.

Why ICD-10 Codes Must Tell Your Patient’s Story

By Amanda Patton, ACCC Communications

meetings-AM2016-brochure-190x246We’re four months post ICD-10 implementation and some are comparing the transition to Y2K—a lot of sound and fury over what ultimately turned out to be a relatively calm transition.

If you think it’s all smooth sailing from here on out, think again. “ICD-10 is nothing like Y2K,” says Cindy Parman, CPC, CPC-H, RCC, Principal, Coding Strategies, Inc. “Moving to ICD-10 is more like having a baby. Once the baby’s arrived the work begins.”

In a session on Friday, March 4 at the ACCC 42nd Annual Meeting, CANCERSCAPE, Parman will be sharing tips for cancer programs to take stock of their ICD-10 transition.

Post implementation, what ICD-10 pain points is Parman seeing in oncology programs?

· Coding errors.  These may be coder mistakes or they may stem from insufficient documentation in the medical record—for example, physicians not providing enough information.
· Productivity.  Working with ICD-10 is taking coders longer because there is more information to sift through and coders may have to go back to physicians with questions.
· Reimbursement issues.  Insurance payers are taking an opportunity to tighten up qualifications for reimbursement. Some ICD-9 codes may have been reimbursed in the past, where the corresponding ICD-10 code will not result in payment. Even smooth transitions to ICD-10 don’t necessarily mean that cancer programs are coding correctly, Parman warns.

“It’s important for cancer programs to understand that ICD-10 is a patient classification system,” says Parman. Used appropriately, the code set will generate the data that tells the patient’s story and ensure that providers are getting credit for all of the care that is being provided. But when codes are missed that story is incomplete.

New payment models will be driven by ICD-10 codes, and capturing all the care provided for patients is critical, Parman says. “The data that cancer programs are collecting today will be used by the Centers for Medicare & Medicaid Services (CMS) to develop future alternative payment models (APMs). If the codes used do not reflect the full scope of services provided, cancer programs won’t be able to go back later and say ‘we left these codes off.’ ”

During her meeting session, Parman will discuss the potential for mining ICD-10 data to measure quality, safety and efficiency, among other indicators. But, she points out, “You can’t mine data you don’t have.”

Join us at the ACCC 42nd Annual Meeting, CANCERSCAPE, from March 2—4, 2016, in Washington, D.C., and gain strategic insight into three key drivers of change impacting our evolving oncology care delivery system: policy, value, and quality. Full session and speaker information available here.

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Originally posted to ACCCBuzz on January 26, 2016.

Required Reading: “Advancing Immuno-Oncology in the Community Setting”

Lee-Schwartzberg-220x209By Lee Schwartzberg, MD, FACP
Chair, Institute for Clinical Immuno-Oncology, Advisory Committee

Along with their copies copy of the January/February Oncology Issues, ACCC members will receive “Advancing Immuno-Oncology in the Community Setting,” the inaugural white paper from the Institute for Clinical Immuno-Oncology (ICLIO), an institute of the Association of Community Cancer Centers (ACCC).

As members of the oncology community well know, the last five years have brought us thrilling advances in immunotherapy. We’ve seen the introduction of checkpoint inhibitors and vaccines that are unleashing the power of an individual’s immune system to fight cancer. In the past few months, we’ve witnessed a surge of new FDA indications for immunotherapy agents in a number of disease sites, including melanoma, lung cancer, and renal cell carcinoma.

Immuno-oncology is now emerging as the fourth pillar of cancer treatment. It is a new field, bringing new promise and new challenges for patients, providers, and payers.

As Chair of the ICLIO Advisory Committee, I urge you to take a few minutes to explore the ICLIO white paper. Whatever your role in cancer care delivery, you’ll benefit from learning about the resources ICLIO offers today and those planned for tomorrow. Here are three reasons to learn about ICLIO:

  1. The immunotherapy momentum continues to build. There is a robust pipeline of new immunotherapies in development, as well as emerging combination therapies. Staying up-to-date on advances in this new field is imperative—for your cancer program and your patients.
  2. Empowered, informed patients and their families will be asking about (and for) these new immunotherapy options.
  3. The challenges of integrating new therapies occur on many fronts—clinical, administrative, programmatic—and across disciplines. ICLIO brings a multidisciplinary approach to addressing these challenges with practical resources that help build a bridge from bench to bedside so that eligible patients in the community can access these new therapies and receive care in an evidence-based way.

For more, explore ICLIO resources online at accc-iclio.org and learn about future ICLIO initiatives. Take advantage of our upcoming ICLIO webinars in January:

Immunotherapies for the Treatment of Metastatic Renal Cell Carcinoma (mRCC)
January 15, 2016
12 pm, ET

Navigating Patient Assistance Programs for Immunotherapy Treatment
January 21, 2106
12 pm, ET

Coordination of Care for Immunotherapy Patient
January 27, 2016
12:30 pm, ET

Learn more and register for the webinars here. Join our community centered on transformative care!

ACCC Advocacy Update

By Leah Ralph, Director, Health Policy, ACCC

U.S. Capitol Congress closed out 2015 with a bang, passing a number of large, end-of-year spending bills to keep the government funded through 2016 and several provisions that will impact ACCC members.

The omnibus appropriations bill (H.R. 2029) boosted NIH funding by 6.6 percent to $32.1 billion, the largest increase NIH has seen in 12 years. A separate package of Medicare provisions, the Patient Access and Medicare Protection Act (S. 2425) passed just before Congress adjourned for the year. This legislation created a blanket hardship exemption for meaningful use penalties in 2015, making it easier for the Centers for Medicare & Medicaid Services (CMS) to review and process hardship exemption requests. (To apply for an exemption, physicians must apply by March 15, 2016, and hospitals by April 1, 2016.)

The Medicare bill also froze payment rates to freestanding radiation therapy centers at 2016 levels for two years, CY2017 and CY2018. It is important to note that the Medicare bill ultimately did not include a provision that would have exempted “under construction” off-campus outpatient facilities from an earlier law (the Bipartisan Budget Act of 2015) that reduced Medicare payments to newly built or acquired hospital outpatient departments.

Before year-end President Obama signed both H.R. 2029 and S. 2425 into law.

As attention shifts toward elections in 2016, with divergent views on the future course of the nation’s healthcare policies, we are sure to see even more movement on policies that will impact the provision of quality cancer care. Make your New Year’s resolution today to join us for ACCC Capitol Hill Day March 2, 2016. Learn more and register here.

An Easy—and Empowering—New Year’s Resolution

By Leah Ralph, Director, Health Policy, ACCC

Working-Federal-Government-FeaturedNew Year’s resolutions are the very definition of trope: a common or overused theme. But they don’t have to be. Today I’m asking you to set aside the old standbys of weight loss or more exercise and look at the bigger picture—specifically what you can do to improve the lives of the cancer patients you treat each and every day.

Last year ACCC mobilized members from 23 states and held over 80 meetings with legislators on Capitol Hill about issues of importance to the oncology community. We effected real change. Shortly after our ACCC Hill Day visits, Congress passed a permanent repeal to the Sustainable Growth Rate (SGR) formula, guaranteeing predictable physician payment rates and setting in motion a wave of Medicare reimbursement reforms. Our voices made a difference!

This year, we’re growing our annual Capitol Hill Day program and making some exciting changes: more comprehensive training, more face time with legislators, and, most important a greater focus on helping you tell your community’s story—the one that your legislators most want to hear. What’s going on in your home town? What’s keeping you up at night? What are the stressors that are having a negative impact on your cancer patients?

So whether you’ve attended a previous ACCC Capitol Hill Day or you’re an “advocacy newbie,” here are three solid reasons to make the ACCC 2016 Capitol Hill Day your New Year’s Resolution:

  1. More comprehensive training. The ACCC policy team will host webinars and conference calls to prepare for your congressional meetings. We’re planning a comprehensive training and reception for Tuesday, March 1, plus an additional advocacy review on the morning of Hill Day, Wednesday, March 2.
  2. More face-time with legislators. Gather for lunch with your ACCC colleagues and congressional members to discuss key issues that impact your program, such as reimbursement for supportive care services, drug costs, staffing shortages, and how excessive data collection and reporting is cutting into the time you can spend on direct patient care.
  3. Less focus on specific bill numbers. You don’t need to be a “policy expert” or familiar with specific legislation in 2016. It’s a chance to share YOUR STORY so lawmakers understand how policy impacts oncology care in YOUR COMMUNITY. (Now, if you want bill numbers, we’ll have those too.)

Policymakers rely on healthcare providers—not policy staff—to provide real-world perspectives on policy issues that matter. As the leading national multi-site, multidisciplinary organization, ACCC is uniquely positioned to serve as a resource. This is our value to legislators. The diversity and sophistication of our membership requires a nuanced, balanced approach to policy challenges—and we stand ready to offer insights on how cancer care is delivered today.

As our experts, we invite you to come to Washington, D.C., to do what you do best. Talk about your programs, your processes, and most importantly your patients. Our annual Capitol Hill day is an important and rewarding opportunity to advocate for policy change. Resolve to attend ACCC Capitol Hill Day 2016, and help to put the voice of the cancer care team and cancer patient at the center of policy decisions. Learn more at accc-cancer.org/HillDay.

ACCC Comments on Proposed 340B Guidance

Hooked on creditBy Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC

On October 27, 2015, the Association of Community Cancer Centers (ACCC) submitted comments on the Health Resources and Services Administration (HRSA) “mega-guidance” on the 340B Drug Pricing Program. ACCC supports HRSA’s effort to provide more clarity in the program and we commend HRSA for taking this important step amid legal challenges and Congressional pressure. But just how far the guidance will go remains unclear. While HRSA’s guidance does not have the strength of a rulemaking, it does inform 340B participants how the agency believes the program should operate, and we can expect it will be used as a basis for future audits. It remains to be seen whether Congress will codify the guidance or move any other legislation related to 340B.

HRSA’s guidance largely focuses on laying out a narrower definition of a patient under the program. Essentially the guidance proposes to significantly strengthen the relationship between the 340B covered entity (CE) and patient in order for that patient to qualify for 340B discounted drugs. The CE would now need to provide much more comprehensive service to a patient in order to receive a 340B drug discount.

Specifically HRSA proposes a six-prong test to determine patient eligibility:

  1. The patient must have received a healthcare service from a registered CE.
  2. The healthcare service is provided by a CE-associated provider (employed by or an independent contractor of that CE).
  3. The drug prescription is a result of the service provided by the CE and, importantly, the service is not limited to the dispensing or infusion of a drug.
  4. The service is consistent with the CE’s grant or contract (typically for grantees only).
  5. The prescription is the result of an outpatient service, determined by how the CE bills the payer.
  6. The CE maintains access to auditable health records, demonstrating a provider-to-patient relationship and that the CE is responsible for that patient’s care.

So what does this mean for cancer care? This guidance will likely have significant implications for referrals and follow-up care, limiting the ability of cancer patients to move between sites of care. For example, under the guidance, when a patient sees a physician at a non-340B site as a referral or follow up to care, even though the patient’s care originated at a CE, that patient would no longer be eligible to receive a 340B discount. Further, under the guidance, if a community practice physician (i.e., a non-CE-physician)—potentially without the infrastructure or resources to provide certain oncology services—sends patients to a CE for an infusion, that patient would not be eligible for 340B drug pricing. This is because the guidance stipulates that the service the CE provides cannot be limited to the infusion or dispensing of a drug.

In our comments to HRSA, ACCC weighed in on the potential unintended consequences and administrative burden this revised patient definition may present for CEs. We urge the agency to consider the complexity of today’s multi-site cancer care infrastructure and to ensure that cancer patients retain access to appropriate, quality cancer care. Further, in order to qualify for 340B drug pricing, a CE must provide associated healthcare services to a referred patient beyond just dispensing or the infusion of a drug. ACCC urges HRSA to coordinate with the Centers for Medicare & Medicaid Services (CMS) to ensure CEs understand what constitutes a healthcare service for purposes of 340B drug pricing. ACCC also urges HRSA to clarify any specific requirements regarding the content of a CE’s patient records in order to demonstrate a provider-to-patient relationship for purposes of the 340B program. Finally, ACCC notes the multitude of new administrative and accountability requirements for CEs, and encourages HRSA to work with stakeholders to collect data on the financial and operational impact of these new requirements.

The agency may issue final guidance sometime in the following months. ACCC will be monitoring closely. Stayed tuned.