COA Speaks Out Against PBM Restrictions of Medication Access

CVS Caremark®, one of the leading pharmacy benefit managers (PBMs) in the United States, recently made a decision to restrict patient access to physician dispensing of medication directly to patients at their clinic or at a physician-owned pharmacy by designating all physician practices to be “out-of-network,” as of January 1, 2017. The Community Oncology Alliance (COA), a nonprofit organization dedicated to advocating for oncology practices and the patients they serve, has been one of the first to criticize this plan.

Studies evaluating physician dispensing have demonstrated that the practice increases medication adherence and improves patient outcomes, particularly for patients taking oncology medications.1 However, other research has suggested that physician dispensing of drugs may also increase overall health care expenditures.2 Other concerns with the practice that have been cited include medication safety concerns and the potential for conflicts of interest,3 athough COA disagrees with this assessment. 

In a press release from the organization, COA president Bruce Gould, MD, said, “New actions by PBMs, such as CVS Caremark, would set cancer care back immensely…If the planned PBM restrictions are implemented, then patients needing oral therapies will find their access to drugs limited and their care fragmented.”4

Ricky Newton

In August 2016, COA released a white paper entitled, “Pharmacy Benefit Managers’ Attack on Physician Dispensing and Impact on Patient Care.”1 In the white paper, COA pointed to the fact that CVS Health Corporation, the owner of CVS Caremark, operates a chain of retail, mail-order, and specialty pharmacies and thus has a conflict of interest inherent in restricting the ability of competing independent providers to dispense medications.4

To understand how restricting physician dispensing can impact patient outcomes, Journal of Clinical Pathways spoke with Ricky Newton, CPA, the director of financial services and operations at COA. Mr Newton helps to lead the Community Oncology Pharmacy Association (COPA), a COA initiative that has brought together community oncology clinics dispensing oral cancer drugs and ancillary therapies. He discussed COA’s concerns about PBM restrictions and proposed some potential ways in which PBMs can work with providers to lower costs while preserving patient access.


First, can you describe why COA believes physician dispensing to be a valuable way of helping patients to achieve better outcomes? 

As cancer treatment shifts from physician-administered chemotherapy infusions to oral cancer drugs, being able to dispense these complex, potentially toxic specialty drugs is essential to effective, coordinated cancer care. Providing these drugs at the point-of-care provides greater assurance that patients will receive their drugs, be instructed on how to take them, and communicate any medication issues with their providers. 

What are some of the chief concerns COA has about PBMs’ aims to restrict physician dispensing, and why do you think those changes might be detrimental to patient health? 

Requiring patients with cancer to get their drugs from mail-order prescriptions from PBMs limits access to treatment, disrupts care management, and increases the cost of care—all of which affect patient outcomes and prognosis. More specifically, it:

•    limits and delays patient access to chemotherapy drugs and treatment by as much as three weeks;

•    disrupts the coordination of care, such as the infusions, radiation, and laboratory testing, which is frequently prescribed in conjunction with oral therapies;

•    disrupts care management including the opportunity for physicians to monitor for adverse events, compliance, tolerance, and efficacy; and

•    increases cost to the patient by limiting split-filling, which avoids drug waste, as well as access to Patient Assistance Programs and co-payment cards.

All of these effects can increase stress and have a disastrous impact on patients fighting a life-threatening illness.

How might these changes affect community practices participating in the Centers for Medicare & Medicaid Services (CMS) Oncology Care Model or their ability to meet goals outlined in the soon-to-be implemented Medicare Access & CHIP Reauthorization Act (MACRA)?

The clear and overarching trend in health care generally, and for Medicare oncology patients specifically, is towards integration and coordination of care that solidifies the physician as the primary clinician responsible for patient outcomes. 

This trend is evidenced recently by CMS’s new Oncology Care Model,5 which focuses explicitly on physician-led care and contemplates physician dispensing of drugs billed and delivered under Medicare Part D, the type of “physician dispensing” that CVS Caremark is wrongly proposing to consider as “out-of-network.” It will also absolutely impact MACRA and the implementation of proposed changes such as the Merit-Based Incentive Payment System and Advanced Alternative Payment Models. Any hasty action aimed at limiting patient access to physician dispensing is immensely problematic for patients, providers, and these initiatives.

COA has requested that CVS Caremark delay the initiation of their new program. Should they fail to do so, what action is COA prepared to take, and have you received much support from other health care stakeholders in the industry? 

CVS Caremark should delay implementation of this change until a more thorough examination of its justification and impact on patient care can take place. The decision to begin implementation on January 1, 2017, is arbitrary and not being driven by any legal change or mandated deadline. They have been credentialing, contracting, and paying for in-office dispensing as “in-network” Medicare Part D providers for over a decade! They should not rush through with this change. For the sake of patients, it is critical that we all have a better understanding of the impact that this change will have on patient care before it becomes a reality.

COA and its member practices remain committed to attempting to resolve this issue in good faith on behalf of cancer patients and their providers, and are willing to continue good-faith dialogue with CVS Caremark aimed at reaching an acceptable resolution. 

That said, as the White Paper notes, currently, the only PBM that has stated its intention to restrict patient access to physician dispensing is CVS Caremark.1 Earlier this month, COA submitted an appeal to CVS Caremark to delay or cancel their proposed action, and we have had subsequent discussions with them on this issue. 

Our appeals have stated that if CVS Caremark does not reverse its position, or the January 1, 2017, implementation date is not postponed, COA, on behalf of patients and the community oncology providers it represents, would have no choice but to take affirmative action to prevent CVS Caremark from implementing the change. This could include, but is not limited to, pursuing legal, legislative, and regulatory remedies. 

The White Paper states that CVS Caremark and other PBMs are putting profits over patients. Do you think there are other means by which these organizations can reduce costs to the health care system while preserving patient access?

As the front-line providers for the majority of Americans with cancer, we understand better than anyone the realities and problems of the increasing cost of cancer care. COA is totally committed to transforming the payment for cancer care but only with a focus on quality cancer care delivery that places patients first. We welcome CVS Caremark to join us in these efforts, as numerous others, including public and private payers, employers, and providers of all shapes and sizes, have. For example, we could work together on supporting new care delivery models such as the Oncology Medical Home model of care, which emphasizes high-quality and coordinated cancer care with positive patient outcomes.6 This proposed change is completely opposite the integrated health care system and is proven to work. Pharmacies in practices are also achieving oncology specialty pharmacy accreditation through the Accreditation Commission for Health Care (ACHC), which sets high quality standards on behalf of oncology patient care. 

Can you tell us about some of the issues COA has taken on in order to advocate for community practices and their patients? 

For nearly 15 years, COA has built a national grassroots network of community oncology practices to advocate for public policies that benefit patients. Individuals from all levels of the cancer care delivery team—oncologists, hematologists, pharmacists, mid-level providers, oncology nurses, patients, and survivors—volunteer their time on a regular basis to lead COA and serve on its committees.

COA members are regularly in Washington, DC and have testified before both chambers of Congress, helping to shape key, bipartisan legislation that impacts community oncology. Currently, COA is working to advance cancer care payment reform acts in the House of Representatives and the Senate;7 support the Oncology Care Model;8 fight the disastrous Medicare Part B experiment;9 introduce increased transparency and accountability to the 340B program;10 and more.

References:

1.    Community Oncology Alliance. Pharmacy benefit managers’ attack on physician dispensing and impact on patient care: Case study of CVS Caremark’s efforts to restrict access to cancer care. http://bit.ly/2cUEusW. Published August 30, 2016. Accessed September 22, 2016. 

2.    Kaiser B, Schmid C. Does physician dispensing increase drug expenditures? Empirical Evidence from Switzerland. Health Econ. 2016;25(1):71-90.

3.    Grissinger M. Good intentions, uncertain outcomes: Physician dispensing in offices and clinics. Pharmacy and Therapeutics. 2015;40(10):620-695.

4.    Pharmacy benefit managers improperly reinterpret Medicare rules for financial gain [press release]. Community Oncology Alliance. August 30, 2016.

5.    Oncology Care Model. Centers for Medicare & Medicaid Services website. http://bit.ly/2crhynD. Updated September 21, 2016. Accessed September 22, 2016.

6.    Oncology Medical Home. Oncology Medical Home website. http://bit.ly/2d35Dw1. Accessed September 22, 2016.

7.    COA supports new oncology payment reform bill by Senators Cornyn and Carper [press release]. Washington, DC: Community Oncology Alliance Press Releases; July 14, 2016. http://bit.ly/2coOY1H. Accessed September 22, 2016. 

8.    COA Announces Major Support Initiative for CMS Oncology Care Model [press release]. Washington, DC: Community Oncology Alliance Press Releases; August 2, 2016. http://bit.ly/2d4aICu. Accessed September 22, 2016.

9.    Stop the Medicare experiment on cancer care! Cancer Experiment website. http://www.cancerexperiment.com/index.php. Accessed September 22, 2016.

10.    Who benefits from 340B? It’s not always the patient. Air X 340: Alliance for Integrity and Reform website. Accessed September 22, 2016.