In the Know - AWIR Advocacy Newsletter - August 2018
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In the Know

AWIR Advocacy Newsletter
August 2018

Dear Member,

The AWIR government affairs team is proud to present this advocacy update as an overview of the advocacy work we have done these past months on behalf of the rheumatology community.

In the short time since AWIR has begun to focus on advocacy, we have accomplished a lot.  We have developed a number of different resources and tools to educate our members on how to begin advocating and advocacy best practices.  We are excited to showcase these resources on the new AWIR website which includes an interactive advocacy section. Looking towards the future, we are in the planning stage of hosting a reception for the Doctor’s Caucus in Washington, D.C., and are working to address gender disparity issues within rheumatology workplaces.

We look forward to continuing to empower our members through advocacy.  We hope that you will find this update helpful, and encourage you to contact our team if you have any questions or concerns.


The AWIR Advocacy Committee

Federal Spotlight

AWIR Signs onto Letters to State Insurance Commissioners

A new utilization management tool is making it harder for patients who rely on co-pay assistance to afford their medication.  Seeing heavily expanded use in 2018, health plans using accumulator adjustment programs prevent any co-pay assistance from counting towards a patient’s deductible or maximum out of pocket expenses.  


In July, AWIR signed onto comments submitted to all state insurance commissioners urging that they investigate the use of accumulator adjustment programs by insurers and PBMs in their state.  Patients with complex chronic diseases that require treatment with expensive medications depend on co-pay assistance to receive their prescribed treatment. The letter states that expensive medications, coupled with the rise of high deductible health plans, make it nearly impossible for these patients to adhere to their treatment plan.   The letter also focuses on the lack of notification, pointing out that patients either did not receive notification to the change, or that the notification was too difficult to understand.


The ACR will be releasing a policy position on accumulator adjustment programs later this year.  AWIR is encouraging its members to talk to their patients about this program. In particular AWIR suggests that members should encourage patients to talk directly to their employers, who may be implementing this program with little understanding of the impact it will have on their employees.

Panel Discusses Advocacy Highlights at AWIR National Conference

AWIR members from across the nation joined together on August 16-19 in Hilton Head, North Carolina to attend the 2018 AWIR National Conference.  During the
four day conference attendees were treated to a robust agenda filled with expert faculty speaking on a wide range of both scientific and socioeconomical issues.  Included in the agenda was an advocacy panel led by AWIR Federal Affairs Manager, Ally Lopshire.


Ally was joined by AWIR Board Members, Drs. Gwenesta Melton and Stephanie Ott, who spoke to the audience about AWIR’s recent advocacy efforts.  Ally began the panel by asking why AWIR has chosen to participate in advocacy. Dr. Ott explained that it’s important for all physicians to engage in advocacy to protect their patients and their livelihoods from unwanted policies.  As a society of female rheumatologists, it is especially important for AWIR to advocate and create their own voice within the rheumatology community.


The panel moved to Advocacy Toolkit for Busy Working Women Rheumatologists, includes helpful information on how to begin advocating, best practices in engaging with legislators, effectively using social media, and understanding the issues.  The toolkit can be found on the newly revamped AWIR website. discussing how AWIR has built a foundation for their advocacy work this past year.  Dr. Melton reviewed a number of resources and tools that AWIR has created to help its members become better advocates.  One of those resources, the


Drs. Melton and Ott walked the audience through the updated website, which now features an advocacy section.  Visitors can find descriptions of issues and AWIR’s stances, archived letters sent to federal agencies, a legislator look-up tool, and more.


The presentation concluded by talking about what AWIR hopes to accomplish in the future. This has been a successful year in advocacy so far, and AWIR hopes to build upon the momentum going into 2019 and beyond.  Members can look forward to AWIR organizing hill briefings in D.C., and advocacy training in the near future.

CMS Releases Proposed Changes to Evaluation and Management Services

CMS is proposing a number of documentation and payment changes for evaluation and management (E/M) visits that would have a large impact on rheumatologists and their practices, and could significantly reduce access to high quality care for rheumatology patients across the country.     


Most significantly, CMS is proposing to apply a single blended payment rate for level 2 through 5 office and outpatient E/M visits for both new and established patients.  This proposal would apply a single payment rate for level 2 – 5 visits for new patients and a separate single payment rate for established patients.


CMS is additionally proposing to create new add-on codes to reflect additional resources involved in primary care and certain specialty services, most significantly being an HCPCS add-on code to be billed in conjunction with a standalone office/outpatient E/M visit for certain specialists, including rheumatologists.


The proposal would also implement a 50% payment reduction for E/M visits that are furnished on the same day as a procedure or visit, currently identified on the claim by an appended modifier -25.  This means that under the new payment proposal, rheumatologists that furnish E/M visits to patients on the same day as their injection or infusion will be forced to make the patient schedule an appointment and come back on a different day for their E/M visit in order to avoid such a significant reduction in reimbursement.   


Given its potential impact on rheumatologists, AWIR is calling on its members to submit comments to CMS expressing their opposition to the proposed changes to E/M visits and urging the agency to reconsider its E/M payment proposal before it is finalized. AWIR has provided a general form letter for you to use in crafting your own personalized comments.
Submit comments and view the sample letter below.

AWIR Responds to Health and Human Services Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs 

On July 16, AWIR submitted comments to the Department of Health and Human Services in response to the request for information included in its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.


AWIR’s comments focused on addressing the proposed changes to Medicare Part B, the impact of manufacturer rebates and pharmacy benefit managers, and the provisions related to biosimilars. AWIR looks forward to working with HHS and the administration as they move forward with the plan to lower drug costs for Americans.


AWIR’s response touched on the following points:

  • AWIR strongly opposes the changes to Medicare Part B considered in the Blueprint, specifically in the form of reinstating a Competitive Acquisition Program (CAP) for Part B drugs, and moving drugs from Part B to Part D.
  • AWIR believes that the most effective solution to reforming the rebate system will ultimately hinge on implementing the most appropriate and comprehensive definition of a “rebate.”
  • In response to the Blueprint’s inquiries with respect to a fiduciary duty for PBMs, AWIR believes that imposing a fiduciary duty on PBMs is crucial to bringing a proper level of oversight to the PBM industry.
  • In response to questions regarding the utility of “gag clauses,” AWIR believes that gag clauses have no other purpose than to serve as a mechanism by which PBMs ultimately end-up costing beneficiaries more money while augmenting their profit margins, and strongly urges HHS to ban these clauses in all forms, across all federal health programs.
  • AWIR believes that the rebate system is ultimately preventing bigger drops in list prices on biosimilars as manufacturers vie for position on formularies governed by the PBMs.
  • AWIR urges HHS and the FDA to educate payers about the difference between “biosimilar” and “interchangeable” approval thresholds, and prevent mandated switching to products that are not interchangeable.
CMS Releases Request for Information on Stark Laws, Signals Willingness to Revamp Stark for Coordinated Care Efforts  

Late last month, the Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) seeking input regarding the Medicare physician self-referral law, also known as Stark law.  The RFI outlines a number of specific questions on a range of issues identified with the Stark law to help the agency better understand provider concerns, and target its regulatory efforts to address those concerns.  Released as part of CMS’s broader “Regulatory Sprint to Coordinated Care” initiative, the RFI’s goals are, in part, to help identify the Stark Law’s regulatory requirements or prohibitions that may impede coordinated care and value-based payment models, and to help CMS assess the necessity of these obstacles.


Of particular note, according to the RFI, CMS is “particularly interested in your thoughts on issues that include, but are not limited to, the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the physician self-referral law, and terminology related to alternative payment models and the physician self-referral law.”


The Stark law was originally enacted in 1992 as a way address overutilization of services by physicians who stood to profit from referring patients to facilities or entities in which they had a financial interest. More specifically, Stark law is a strict liability statute that was intended to create a bright line rule prohibiting physicians who have a financial relationship (direct or indirect) with a health care entity from referring Medicare patients for certain services unless the arrangement falls within one of the over 30 specified exceptions to the prohibition.


The exceptions outlined in the Stark regulations are extremely technical and require navigating and applying that are not well-defined or easily understood in case-specific contexts.  The complexity of the exceptions and their lack of straightforward application are particularly problematic as providers must find a way to navigate the terms and provisions or risk noncompliance.  Moreover, because Stark is a strict liability provision that holds providers liable for unintentional noncompliance, even minor technical violations can trigger the onerous penalties specified under the law.  


There is hope among physicians and health care providers that this RFI signals the start of a comprehensive reform effort lead by CMS.  AWIR will continue to provide updates as these efforts continue to move forward.


Non-Medical Switching Update  

AWIR continues to monitor non-medical switching legislation throughout the states.  Non-medical switching occurs when stable patients are switched off their medication for non-medical reasons.  


A number of states have passed or are considering legislation that protects medically stable patients from being switched off of their current prescription for non-medical reasons.  The majority of the legislation protects patients from a switch within the plan year. However, AWIR supports legislation that goes even further, grandfathering patients year-over-year.  


Highlights include:

  • Illinois’ HB4146 was signed into law by the Governor on Friday, August 24th.
  • Colorado’s HB18-1370 was postponed indefinitely in early May.
  • Maine’s non-medical switching legislation was signed into law by the Governor, but solely requires advance notification of adverse formulary changes.  
Step Therapy Update  

Step Therapy is another utilization management tool that is a priority for AWIR.  An increasing number of insurers are utilizing step therapy or fail first policies, requiring patients to try and fail one or more formulary covered medications before providing coverage for the originally prescribed non-formulary or non-preferred medication. Some patients are required by their health plans to try up to five different medications with durations lasting up to 130 days per medication.


AWIR supports legislation that gives physicians the ability to override step therapy protocols based on a patient’s medical history.


Highlights include:

  • Maine’s step therapy bill, LD 1407, was vetoed by the Governor on July 3rd.
  • In Rhode Island, one step therapy bill has passed the House and has been referred to the Senate.  Another has been recommended to be held for further study.
  • Minnesota’s step therapy bill was signed into law on May 18th.

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