Innovations in Oncology Management

PART 2 OF A SERIES

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Oral Chemotherapy Access Legislation: Impact on Oncology Practices and Their Patients

n the past decade, there has been an explosion in the number STAKEHOLDER PERSPECTIVE of available oral therapies for patients with cancer. In contrast to conventional intravenous (IV) chemotherapies, many of The Impact of Oral the new oral oncology drugs target specific biologic processes in 1 Chemotherapy Access cancer cells and block cancer cell growth. In addition to their B:8.375” Legislation ................................... 6 specificity, which may translate into reduced toxicity and side efT:8.125” fects, oral agents are convenient, especially for patients who An Interview with Mary Kruczynski S:7.625” travel long distances to reach their treatment facility.1 This trend Director of Policy Analysis, Community toward oral anticancer therapies is accelerating; 25% to 30% of Oncology Alliance, Washington, DC the drugs in manufacturers’ oncology pipelines are now oral medications. In recent years, oral anticancer drugs have become the standard of care for several types of cancer, including metastatic Conversely, oral chemotherapy medications are acquired from melanoma, non–small-cell lung cancer, and renal cell carcinoma.2 a pharmacy and are self-administered. As a result, they are usually covered under the health insurer’s pharmacy benefit.3 Many The Need for Oral Chemotherapy Access Legislation US payers have been slow to adjust to this increase in oral an- payers have placed oral oncology drugs on the specialty tiers of ticancer therapies.1 Traditional IV chemotherapy agents, admin- their drug formularies. For specialty drugs, patients must often pay istered in the outpatient setting, are usually covered under health a percentage of the drug cost, referred to as coinsurance, rather insurers’ medical benefit, and patients often pay a flat copayment than a flat amount per prescription.4 that covers the drug as well as the cost of administration. Patients’ Coinsurance percentages vary from one benefit design to anannual out-of-pocket (OOP) costs for these IV medications are other, and the same health plan may offer multiple coverage opoften capped under their medical benefit.1 tions. Regardless of the design, however, the patient’s cost burden

Editor’s Note Welcome to Innovations in Oncology Management, a news- depending on their diagnosis, may need an oral therapeutic regletter series for oncology practice administrators, administrative imen, which often falls under a health insurer’s pharmacy benstaff, advanced practice clinicians, and oncology pharmacists. efit. For these specialty drugs, patients’ coinsurance payments The series provides concise, up-to-date information on current may pose a burden, and state legislatures throughout the United issues that are impacting the business of oncology. Our first States are taking steps to limit patients’ out-of-pocket costs. newsletter explored patient financial support services; this The article featured in this issue—Oral Chemotherapy second issue of the newsletter focuses on oral chemotherapy Access Legislation: Impact on Oncology Practices and Their access legislation and its impact on oncology practices and their Patients—provides the current landscape of oral chemotherapy patients. access legislation, and, in a special interview, Mary Kruczynski In the last decade, the number of available oral therapies for of the Community Oncology Alliance shares her insights on the patients with cancer has exploded, and oral anticancer drugs impact of oral chemotherapy access legislation. We hope you have become the standard of care for several typesfoundation of cancer. of enjoy this valuable resource, and that it helps oncology practices Patients, Science, and Innovation are the everything More are living cancerinthan ever before, and, better servetotheir patients. we do.patients At Celgene, wewith believe an unwavering commitment

medical innovation, from discovery to development. Our passion is relentless—and we are just getting started. Supported by funding from Celgene Corporation and Celgene Patient Support. Manufacturer did not influence content.

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Innovations in Oncology Management

PART 2 OF A SERIES

http://innovationsinoncologymanagement.com

Oral Chemotherapy Access Legislation: Impact on Oncology Practices and Their Patients

n the past decade, there has been an explosion in the number of available oral therapies for patients with cancer. In contrast to conventional intravenous (IV) chemotherapies, many of the new oral oncology drugs target specific biologic processes in cancer cells and block cancer cell growth.1 In addition to their specificity, which may translate into reduced toxicity and side effects, oral agents are convenient, especially for patients who travel long distances to reach their treatment facility.1 This trend toward oral anticancer therapies is accelerating; 25% to 30% of the drugs in manufacturers’ oncology pipelines are now oral medications. In recent years, oral anticancer drugs have become the standard of care for several types of cancer, including metastatic melanoma, non–small-cell lung cancer, and renal cell carcinoma.2

The Need for Oral Chemotherapy Access Legislation

US payers have been slow to adjust to this increase in oral anticancer therapies.1 Traditional IV chemotherapy agents, administered in the outpatient setting, are usually covered under health insurers’ medical benefit, and patients often pay a flat copayment that covers the drug as well as the cost of administration. Patients’ annual out-of-pocket (OOP) costs for these IV medications are often capped under their medical benefit.1

STAKEHOLDER PERSPECTIVE The Impact of Oral Chemotherapy Access Legislation.................................... 6 An Interview with Mary Kruczynski Director of Policy Analysis, Community Oncology Alliance, Washington, DC

Conversely, oral chemotherapy medications are acquired from a pharmacy and are self-administered. As a result, they are usually covered under the health insurer’s pharmacy benefit.3 Many payers have placed oral oncology drugs on the specialty tiers of their drug formularies. For specialty drugs, patients must often pay a percentage of the drug cost, referred to as coinsurance, rather than a flat amount per prescription.4 Coinsurance percentages vary from one benefit design to another, and the same health plan may offer multiple coverage options. Regardless of the design, however, the patient’s cost burden

Editor’s Note Welcome to Innovations in Oncology Management, a news letter series for oncology practice administrators, administrative staff, advanced practice clinicians, and oncology pharmacists. The series provides concise, up-to-date information on current issues that are impacting the business of oncology. Our first newsletter explored patient financial support services; this second issue of the newsletter focuses on oral chemotherapy access legislation and its impact on oncology practices and their patients. In the last decade, the number of available oral therapies for patients with cancer has exploded, and oral anticancer drugs have become the standard of care for several types of cancer. More patients are living with cancer than ever before, and,

Supported by funding from Celgene Corporation and Celgene Patient Support. Manufacturer did not influence content.

depending on their diagnosis, may need an oral therapeutic regimen, which often falls under a health insurer’s pharmacy benefit. For these specialty drugs, patients’ coinsurance payments may pose a burden, and state legislatures throughout the United States are taking steps to limit patients’ out-of-pocket costs. The article featured in this issue—Oral Chemotherapy Access Legislation: Impact on Oncology Practices and Their Patients—provides the current landscape of oral chemotherapy access legislation, and, in a special interview, Mary Kruczynski of the Community Oncology Alliance shares her insights on the impact of oral chemotherapy access legislation. We hope you enjoy this valuable resource, and that it helps oncology practices better serve their patients.

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Vice President/Group Publisher Russell Hennessy rhennessy@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton Copyeditor Jessica Cheng Editorial Assistant Cara Guglielmon Production Manager Cara Nicolini The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Jr Digital Media Specialist Charles Easton IV Web Content Manager Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Alyson Bruni Jini Gopalaswamy Project Manager Deanna Martinez Project Coordinator Mike Kodada IT Manager Kashif Javaid Administrative Services Team Leader Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

EDITOR’S NOTE Welcome to Innovations in Oncology Management ™.......................................1

FEATURE Oral Chemotherapy Access Legislation: Impact on Oncology Practices and Their Patients............................................................................ 1

STAKEHOLDER PERSPECTIVE The Impact of Oral Chemotherapy Access Legislation An Interview with Mary Kruczynski, Director of Policy Analysis, Community Oncology Alliance, Washington, DC........................................... 6

MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care that patients with cancer deserve, providers must master the ever-changing business of oncology. Innovations in Oncology Management ™ offers process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—including patient financial support services, health policy legislation, and emerging payment models.

Innovations in Oncology Management ™ is published by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Innovations in Oncology Management is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Innovations in Oncology Management do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Innovations in Oncology Management should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/ or damage to persons or property arising out of or related to any use of the material mentioned in this publication. POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Innovations in Oncology Management, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881.

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can be substantial––up to 50% of the drug cost in some cases. Furthermore, some benefit designs do not have an annual OOP limit, adding to the patient’s cost burden.1 Because many of these oral oncology drugs cost $100,000 or more annually, patients may be responsible for large coinsurance payments.5 As a result of these factors, many state legislatures have enacted oral chemotherapy access—or oral parity— legislation.

States Adopting Oral Chemotherapy Access Legislation

Many states have passed laws within the last 6 years requiring health insurers to provide coverage for oral anticancer drugs that is equivalent to the coverage provided for traditional IV chemotherapy agents under medical benefit plans (Figure).6 In recent years, a steady stream of states has ratified oral chemotherapy access legislation, beginning with Oregon in 2008 (Table 1).6 Of the 7 states that have passed oral chemotherapy access legislation in 2014 (Table 1), the Maine, Wisconsin, and Georgia statutes have all taken effect, but apply to policies, plans, and contracts that will be continued, renewed, or executed on or

after January 1, 2015. The Arizona statute, which became law on April 30, 2014, applies to policies, plans, and contracts issued, delivered, or renewed on or after January 1, 2016.7 The Missouri oral chemotherapy access law, which becomes effective on January 1, 2015, caps monthly OOP costs at $75. In addition, the Kentucky law, which was signed in mid-April 2014, will take effect on January 1, 2015.7 In Ohio, the most recent state to approve oral chemotherapy access, legislation passed on September 17, 2014, and will take effect on January 1, 2015.8 Oral chemotherapy access legislation is currently pending in several other states, including North Carolina, New Hampshire, and Pennsylvania.6,7 In North Carolina, legislation passed in the House of Representatives and is pending in the Senate Health Care Committee. However, the current bill has a cap of $300 monthly on each oral anticancer medication, and efforts are under way to amend the existing legislation to provide for an OOP cap of $100 per medication.9 In Pennsylvania, legislation passed in the House of Representatives on October 7, 2014, and was referred to the Senate Banking and Insurance Committee, where it is currently pending action.10

Figure States That Have Enacted Oral Chemotherapy Access Laws as of October 2014

States that have oral chemotherapy access laws

INNOVATIONS IN ONCOLOGY MANAGEMENT u 5

tates That Have Enacted Parity Laws for Oral Table 1 S Chemotherapy as of October 2014 Year State 2008

Oregon

2009

Indiana, Iowa, Hawaii, District of Columbia

2010

Vermont, Connecticut, Kansas, Colorado, Minnesota

2011

Illinois, New Mexico, Texas, New York, Washington

2012

New Jersey, Virginia, Maryland, Nebraska, Delaware, Louisiana

2013

Massachusetts, Oklahoma, Utah, Nevada, Florida, Rhode Island, California

2014

Maine, Missouri, Wisconsin, Kentucky, Georgia, Arizona, Ohio

Caps for Orally Administered Table 2 P atient Out-of-Pocket Anticancer Drugs6 Cap amount per State prescription, $ Florida

Missouri

Kentucky, Louisiana, Nevada, Ohio, Oklahoma, Wisconsin

100

California, Georgia

200

Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Minnesota, New Jersey, New Mexico, New York, Oregon, Rhode Island, Texas, Utah, Vermont, Virginia, Washington

No cap

Variance in State Oral Chemotherapy Access Legislation

Oral chemotherapy access laws vary from state to state, and practice administrators should familiarize themselves with specific coverage stipulations in the state in which their practice is based. Most but not all states have a stipulation that prevents health insurers from raising patient cost-sharing for IV chemotherapy agents to achieve parity with oral drugs.6 Although the specific language may vary to some degree, the intent of these clauses is the same. For example, Texas Stat §1369.204 states that “a health benefit plan insurer may not reclassify anticancer medications or increase a coinsurance, copayment, deductible, or other out-of pocket expense imposed on anticancer medications to achieve compliance….”11 Ten states have instituted caps on the maximum copayment amount that insured patients are required to pay per prescription. In keeping with the legislation, these caps apply equally to orally and intravenously administered chemotherapy agents. The OOP caps vary from state to state, and range from $50 to $200.

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Table 2 shows the OOP patient spending caps for the 10 states with this requirement in their oral chemotherapy access legislation.6

Pending Federal Legislation

Oral chemotherapy access laws pertain only to state-regulated, private, individual, or group insurance plans that cover chemotherapy agents. These laws do not apply to Medicare beneficiaries or patients covered by self-insured plans in which the employer assumes the financial risk for providing healthcare benefits to its employees. Both of these are exempt from state law by the federal Employee Retirement Income Security Act of 1974 (ERISA).12 The federal government, rather than individual states, has jurisdiction over insurance regulation for the approximately 131 million Americans covered under Medicare and self-insured plans.13 Efforts are under way to implement oral chemotherapy access legislation at the national level to protect individuals who are covered by Medicare and self-insured plans. On April 26, 2013, Rep Brian Higgins (D, New York) introduced H.R. 1801, the Cancer Drug Coverage Parity Act, which had 64 bipartisan cosponsors at the time this article was written. Similar to existing state oral chemotherapy access laws, the legislation seeks to amend ERISA, the Public Health Service Act, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans (including selfinsured entities) to provide for coverage of oral anticancer drugs on terms no less favorable than the coverage provided for anticancer medications administered by a healthcare provider.14 Furthermore, health insurers covered under the law would not be able to increase the patient OOP costs for IV medica-

Ten states have instituted caps on the maximum copayment amount that insured patients are required to pay per prescription. In keeping with the legislation, these caps apply equally to orally and intravenously administered chemotherapy agents. tions in order to comply with the law. The pending H.R. 1801 legislation, however, does not mandate patient OOP spending caps, but states that deductibles, copayments, and coinsurance of oral anticancer therapies should not exceed deductibles, copayments, and coinsurance of chemotherapy agents that are administered by healthcare providers. In addition, the law would not restrict insurers’ ability to require prior authorization or other utilization controls before approving coverage for chemotherapy drugs.14

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Similarly, Sen Al Franken (D, Minnesota) introduced the Cancer Treatment Parity Act (S. 1879) to the Senate on December 19, 2013. The language of S. 1879 is very similar to that of H.R. 1801.15

Conclusion

The majority of first-line anticancer chemotherapy agents have historically been administered intravenously to patients in the physician’s office. In recent years, however, pharmaceutical manufacturers have developed a number of oral chemotherapy agents that can be taken at home. Today, oral chemotherapy drugs comprise more than 25% of the medications in the oncology development pipeline, indicating a growing role of oral chemotherapy agents for the treatment of patients with cancer.2

Although specific state laws vary, all seek to equalize patient sharing for intravenously and orally administered anticancer drugs. Efforts are under way in the House and the Senate to enact similar federal legislation. Medications that are administered intravenously are typically covered under a health plan’s medical benefit. Orally administered chemotherapy agents, however, are typically covered under a health plan’s pharmacy benefit, often resulting in higher OOP costs for patients. About two thirds of states have enacted legislation restricting the OOP cost disparity between IV and oral chemotherapy agents, including 7 thus far in 2014. Although specific state laws vary, all seek to equalize patient sharing for intravenously and orally administered anticancer drugs. Efforts are under way in the House and the Senate to enact similar federal legislation. Because the OOP burden of paying for cancer treatment can be substantial for patients with cancer, oncology practice administrators, financial counselors, and others are advised to keep abreast of state and federal legislation that may affect their patients’ ability to pay for their medications. u

References

1. Andrews M. Some states mandate better coverage of oral cancer drugs. Kaiser Health News. www.kaiserhealthnews.org/Features/Insuring-Your-Health/2012/ cancer-drugs-by-pill-instead-of-IV-Michelle-Andrews-051512.aspx?p=1. Published May 14, 2012. Accessed November 7, 2014. 2. Ness S. Current oncology pipeline trends. Specialty Pharmacy Times. www. specialtypharmacytimes.com/publications/specialty-pharmacy-times/2013/ May_June-2013/Current-Oncology-Pipeline-Trends. Published May 29, 2013. Accessed November 7, 2014. 3. Council for Affordable Health Insurance. Policy trends: a closer look at the oral chemotherapy parity mandate. www.cahi.org/cahi_contents/resources/

KEY POINTS ➤ There has been an explosion recently in the number of oral anticancer therapies, but US payers have been slow to adjust to this increase. ➤ Many payers have placed oral anticancer drugs on the specialty tiers of their drug formularies; as a result, patients pay a substantial percentage of the drug cost. ➤ Because coinsurance payments for oral oncology drugs are high, a number of states have enacted oral parity legislation. ➤ Ten states have instituted caps on the maximum copayment amount that insured patients are required to pay per prescription; these caps apply equally to orally and intravenously administered anticancer drugs. ➤ Oral chemotherapy access laws do not apply to Medicare beneficiaries or patients covered by self-insured plans, and efforts are under way to implement oral parity laws for individuals who are covered by Medicare and self-insured plans. pdf/PolicyTrendsOralChemoOct2012.pdf. Published October 2012. Accessed November 7, 2014. 4. Fitch KV, Iwasaki K, Pyenson BS. Parity for oral and intravenous/injected cancer drugs. Milliman. www.milliman.com/uploadedFiles/insight/research/ health-rr/parity-oral-intravenous-injected.pdf. Published January 25, 2012. Accessed September 9, 2014. 5. Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121:4439-4442. 6. International Myeloma Foundation. Oral chemotherapy legislative landscape – September 2014. http://myeloma.org/ArticlePage.action?articleId=3708. Accessed November 7, 2014. 7. Stephan GM. Update on parity laws for chemotherapy. Insurance Compliance Corner. www.insurancecompliancecorner.com/update-on-parity-laws-forchemotherapy-2. Published May 6, 2014. Accessed September 9, 2014. 8. Legiscan. Ohio Senate Bill 99. http://legiscan.com/OH/drafts/SB99/2013. Accessed September 9, 2014. 9. American Cancer Society Cancer Action Network. North Carolina action center: oral chemotherapy parity. http://acscan.org/action/nc/campaigns/oral_ chemotherapy_parity/. Accessed September 9, 2014. 10. Pennsylvania General Assembly. Bill information. www.legis.state.pa.us/cf docs/billInfo/billInfo.cfm?sYear=2013&sInd=0&body=H&type=B&bn= 2471. Accessed November 4, 2014. 11. International Myeloma Foundation. Texas’s oral anticancer treatment access law: what clinicians need to know. http://myeloma.org/pdfs/StateFactSheets/ IMF/TX_Oral_Anticancer_Treatment_Law_Fact_Sheet.pdf. Accessed September 9, 2014. 12. Self-Insured Institute of America. Self-insured group health plans. www.siia. org/i4a/pages/Index.cfm?pageID=4546. Accessed September 9, 2014. 13. Alliance for Health Reform. ERISA regulation of health plans: fact sheet. www.allhealth.org/briefingmaterials/erisaregulationofhealthplans-114.pdf. Updated March 6, 2003. Accessed November 7, 2014. 14. H.R.1801.IH. Cancer Drug Coverage Parity Act of 2013. http://thomas.loc. gov/cgi-bin/query/z?c113:H.R.1801:. Accessed November 7, 2014. 15. S.1879. Cancer Treatment Parity Act of 2013. https://beta.congress.gov/ bill/113th-congress/senate-bill/1879. Accessed September 9, 2014.

INNOVATIONS IN ONCOLOGY MANAGEMENT u 7

STAKEHOLDER PERSPECTIVE

The Impact of Oral Chemotherapy Access Legislation An Interview with Mary Kruczynski Director of Policy Analysis, Community Oncology Alliance, Washington, DC

n today’s competitive and challenging oncology practice environment, savvy practice administrators keep abreast of health policy issues that may impact their practice’s ability to care for patients. The affordability of oncology drugs remains a concern for many patients with cancer. Out-of-pocket costs for chemotherapy and other oncology-related medications average $4800 annually compared with $450 for medications for other medical conditions.1 In an effort to help mitigate the cost of cancer treatment for patients, approximately two thirds of state legislatures in the United States have passed oral chemotherapy access legislation, which limits the maximum copayments that can be charged for oral drugs to the same levels that are charged for intravenous (IV) chemotherapy drugs.

Depending on their insurance benefit design, most patients are unaware that their out-ofpocket costs for oral medications, which are usually covered under their insurer’s pharmacy benefit, can far exceed what they would pay for IV drugs, which are typically covered under the medical benefit. To explore the impact of oral chemotherapy access legislation, Innovations in Oncology Management™ conducted an interview with Mary Kruczynski, who currently serves as the Director of Policy Analysis for the Community Oncology Alliance (COA), where she reviews and comments on significant federally proposed legislation, as well as oncology-related issues raised at the state level. Ms Kruczynski has been with COA since its inception and shares her knowledge with cancer

8 u NOVEMBER 2014

care delivery teams across the United States on legislative matters, healthcare reform law, coordinated patient care models, and oral oncology drugs.

Q: How would you describe the issue of oral chemotherapy access, or oral parity, as it is often referred to? Why is legislation needed to address the issue? Mary Kruczynski: Equal access to cancer drugs is an issue of fairness and patient protection. Patients don’t know how much drugs will cost them until the drugs are prescribed. Depending on their insurance benefit design, most patients are unaware that their out-ofpocket costs for oral medications, which are usually covered under their insurer’s pharmacy benefit, can far exceed what they would pay for IV drugs, which are typically covered under the medical benefit. As more and more oral chemotherapy drugs become available, the patient burden would only become greater in the absence of this legislation.

Q: A total of 34 state legislatures have enacted legislation, many in the past 12 months. When legislation first takes effect, what is the awareness at the practice level? MK: Oncology practices are very busy, and their primary focus is caring for their patients. Most of the time, they are unaware of newly enacted legislation and rely on others to inform them of recent policy developments.

Q: How are oncology practices and patients made aware of the legislation? MK: There are a number of advocacy groups that help to disseminate the information. In keeping with our mission, COA is active in explaining the legislation to community-based practices. We send out notices to our membership and have frequent conference calls with our broad network of oncology practice administrators where we keep them aware of important developments in the policy arena. We also engage clinical and administrative stakeholders through state oncology societies. We educate our members about the details of their state law and explain what to do if insurers are not complying with the legislation.

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KEY POINTS ➤ Several states have developed policies that limit the maximum copayment of oral chemotherapy to the amount charged for intravenous chemotherapy drugs. ➤ Busy oncology practices rely on organizations for information on newly enacted legislation. It will take time to increase the community’s level of awareness. ➤ The Community Oncology Alliance and other advocacy groups educate patients and communitybased practices on the oral chemotherapy access legislation. ➤ Enacted oral chemotherapy access legislation has been beneficial to privately insured patients and oncology practices in several states. ➤ The newer legislation, compared with that enacted in 2008 and 2009, promotes fairness in setting premiums for oral and intravenous chemotherapy.

Q: What is the status of the oral chemotherapy access legislation that has been proposed at the federal level? Why is it important? MK: Bills have been proposed in both the House and the Senate, but right now it does not appear that further action is imminent. A national oral chemotherapy access law is impor tant, because it would offer protection to all insured patients, including those with Medicare coverage who comprise a large proportion of patients with cancer. Right now, the state laws only apply to privately insured patients. In addition, the state laws have different languages and requirements. If a federal law were passed, it would apply equally to everyone.

Oral chemotherapy access legislation promotes quality by enabling oncology practices to prescribe the most clinically appropriate chemotherapeutic agents, with the goal of striving for the best possible outcomes for the patient.

Q: In states that have enacted oral chemotherapy access legislation, what have been the effects on practices and patients? MK: Clearly, the laws have had a positive effect on privately insured patients, because they often lower patients’ out-ofpocket expenses for oral chemotherapy medications. Of course, the legislation has also been beneficial to oncology practices, because oncologists can prescribe treatment based on clinical value rather than cost. As a result, practices and patients are no longer put in the position to choose between a more expensive treatment that may be a better therapeutic option and a less expensive, older treatment that may not work as well or may have more side effects.

Q: Are you aware of any unintended consequences of the legislation? MK: When the first few states passed legislation in 2008 and 2009, some insurers raised IV copays to match oral copays. Since then, the laws have been amended to eliminate this loophole and newer legislation does not allow this practice. There were concerns that the laws might result in increased rates for all commercially insured members, but, so far, there hasn’t been any evidence that premiums have increased in states that have enacted oral chemotherapy access legislation.

QQ: What do you foresee in the future?

MK: Ultimately, I believe that federal legislation will be enacted, but likely as part of a broader package rather than as a stand-alone bill. When we look at the bigger picture, providing equal access to oral and IV chemotherapy aligns with the goals of integrated value-based care delivery, which is epitomized by the oncology patient-centered medical home. The oncology medical homes emphasize a team-based, patient-focused approach to delivering quality cancer care that is coordinated and efficient. Oral chemotherapy access legislation promotes quality by enabling oncology practices to prescribe the most clinically appropriate chemotherapeutic agents, with the goal of striving for the best possible outcomes for the patient. In my view, it is an important component of the larger effort to deliver quality, coordinated cancer care with the central focus on the patient and his or her entire medical condition. u

Reference

1. Fromer M. IOM workshop explores growing problems in patient access to cancer drugs. ASCO Post. 2014;5.

INNOVATIONS IN ONCOLOGY MANAGEMENT u 9

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