Deadline 12/31/18 – Opportunity to Comment on CMS Proposed Part B Drug Plan

The Centers for Medicare and Medicaid Services (CMS) published an Advance Notice of Proposed Rulemaking with Comment (ANPRM) on October 30, 2018. The ANPRM provides for 60 days of comment before an actual proposed rule is released. The actual proposed rule when issued should provide for at least another 60 days of comment. The ANPRM solicits public comments on potential options to test the use of an International Pricing Index (IPI) Model for separately payable Part B drugs and biologics. CMS is considering issuing a proposed rule in the spring of 2019 on the IPI Model. The potential IPI Model would start in the spring of 2020 and operate for five years, until the spring of 2025.

Comments are due by 5 p.m. EST on December 31, 2018. The link to comment is on page four of this document and enter this file code for the rule: CMS-5528-ANPRN.

Ask Your Lawmakers to Protect Access to Part B Therapies

From the American College of Rheumatology

In a significant and dangerous departure from previous policy, the Centers for Medicare and Medicaid Services (CMS) will begin adjusting Part B drug reimbursements to physicians based on their performance in the Merit-based Incentive Payment System (MIPS) beginning in 2018. Unless lawmakers act swiftly to reverse this policy, some rheumatology providers will see significant payment cuts and may be forced to stop administering vital Part B drug therapies.

We need Congress to act immediately to reverse this policy and ensure Medicare patients have access to the Part B drug treatments and in-office services they need. Please write your lawmakers and ask them to take immediate legislative action to prevent payment adjustments from being applied to Part B drug payments to physicians under MIPS.

Take Action Now

Take Action (September 2017)

Physicians across the country are concerned about  keeping the Centers for Medicare & Medicaid Services from imposing quality-program penalties and bonuses on Part B drug payments.

Across the country, physicians are urging Congress to oppose this proposal, which could compel some solo-practice physicians to limit the Part B drug-related services they offer.

Representative Erik Paulsen (R-MN) is working to preserve access to Part B drugs by sending a letter to Health and Human Services Secretary Tom Price, MD, that expresses concerns regarding a proposal to include Part B drugs in the application of Medicare payment adjustments under the new Merit-based Incentive Payment System (MIPS).

The Centers for Medicare and Medicaid Services (CMS) is proposing that it apply positive and negative payment adjustments required under MIPS to these Part B drug reimbursements. This is a significant departure from previous policy as none of the MIPS legacy programs, including Meaningful Use (MU), the Physicians Quality Reporting System (PQRS) and the Value-based Modifier (VBM), applied related adjustments to reimbursement for drugs. These are essentially pass through payments for the cost of acquiring these drugs so applying either bonus or penalty adjustments to them would be inappropriate.

This proposal could negatively impact patient access to critical treatments. In addition, many physician organizations do not believe that Congress intended for CMS to apply MIPS bonuses and penalties to Part B drug reimbursements when it enacted the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015.

The Paulsen letter urges CMS to reevaluate its interpretation of the MACRA statute to ensure your patients have access to all the services and treatments they need. Physicians can make a difference by contacting their Congressional Representatives and Senators  to join in the effort.

What you can do:

  1. Ask your representative in the US Congress to sign Representative Erik Paulsen’s letter calling for U.S. Health and Human Services Secretary Tom Price, MD, to exempt Part B drug payments from penalties.
  2. Ask your representative in the US Congress to help ensure access to compounded office-use treatments.
    Physicians can aid the effort to preserve patients’ access to compounded, office-use antibiotics and antivirals. A bipartisan proposal in the U.S. House of Representatives would let traditional compounding pharmacies distribute these drugs without a patient-specific prescription in states that allow office-use compounding.
  3. Ask your representative in the US Congress to support the Preserving Patient Access to Compounded Medications Act from Reps. Morgan Griffith, R-Va., and  Henry Cuellar, D-Texas.

Click here to look up your Congressional representative and access their online email form, address and phone number.

MED limit removed from HCA opioid policy

August 23, 2017

Update to new HCA opioid policy:

On August 23, 2017, the Health Care Authority sent a message through GovDelivery to providers explaining the new HCA opioid policy, which will go into effect for Medicaid on October 1, 2017. This communication included provisions for a 90 MED dose limit in most circumstances. We have decided to remove the 90 MED dose limit from the policy for now, for the reasons described below.

We did extensive review and discussion with stakeholders before releasing the policy. However, after broader release, it was brought to our attention that there were situations where the 90 MED limit could put a patient at risk of under-treatment. These include patients leaving the hospital after certain kinds of surgery or trauma, who may need short-term use of very high doses; and patients on chronic low-level opioids or opioid replacement therapy who have an acute pain problem and may need short-term escalation above 90 MED due to medication tolerance. The exception processes in the policy would not have worked well for these patients and their providers.

Creating a suitable process that takes these situations into account will take time. We want to make sure we arrive at the correct process, taking all possibilities into account. Rather than delay implementing the policy until this work can be done, we have decided to proceed with the other elements of the policy on October 1 as planned, but we have removed the 90 MED limit. This change also removes the need for peer-to-peer review.

We remain committed to addressing issues around dose escalation for opioids, and we believe 90 MED is an appropriate limit in most circumstances. We will work with stakeholders to explore the best process for achieving this.

We appreciate your engagement with this process. We believe this policy will be an important tool to address the opioid crisis and protect the safety of Washington Apple Health clients.

If you are a patient looking for information about current opioid prescribing guidelines in the State of Washington, we recommend you go to this page of the Washington State Department of Health website.  Please do not call the WRA office, as we are not the appropriate agency to answer your questions. 

New opioid clinical policy (effective October 1, 2017)

Washington State Healthcare Authority Announcement:

Healthcare providers should be aware that on October 1, 2017, a new Washington State Health Care Authority (HCA) clinical policy pertaining to opioid prescriptions takes effect for Apple Health (Medicaid), both through managed care organizations and fee-for-service.

We’re writing to make you aware of the policy and to ask you to “save the date” for a one-hour webinar about the policy. The webinar will be offered twice in September. (see below for details)

New policy helps combat opioid crisis
As you are certainly aware, opioid use disorder (misuse and addiction) is a public health crisis in Washington State and across the country.

In October 2016, Governor Inslee issued Executive Order 16-09, marshalling the state’s resources to combat this crisis. These efforts include preventing opioid use disorder as well as treating it.

HCA’s opioid clinical policy is a prevention and patient safety tool. The focus is on acute prescriptions and on the transition from acute to chronic use, since these are critical to reducing long-term opioid use and the risk of developing opioid use disorder.

Medical organizations support
HCA coordinated with the Washington State Medical Association, Washington State Hospital Association, health plan partners, and others in developing the policy, which aligns with recommendations of the Centers for Disease Control, the Washington State Agency Medical Directors Group, and the Bree Collaborative around safe and appropriate opioid prescribing.

Summary of policy requirements
Risk of long-term opioid use goes up with every day’s supply on the initial prescription, and with every refill. By prescribing the lowest effective dose for the shortest time needed, you can help prevent opioid use disorder.

The policy limits the quantity of opioids that can be prescribed to opiate naïve patients for non-cancer pain. The limits for new opioid prescriptions will be:
• No more than 18 doses (approximately a 3-day supply) for patients age 20 or younger.
• No more than 42 doses (approximately a 7-day supply) for patients age 21 or older.
• You can override these limits if you feel this is medically necessary, by typing “Exempt” in the text of the prescription.

At the point of transition from acute to chronic opioid treatment—defined as six weeks of therapy—the policy requires that you attest that you are following best practices for opioid prescribing.

These are listed on the HCA Chronic Opioid Attestation form, which will soon be available online, and include actions such as:
• Checking the Prescription Monitoring Program.
• Informing the patient about the risks of opioid use, and using a pain contract.

Documentation of these practices should be in the chart, but you are not required to submit supporting materials.

For both acute and chronic prescribing, doses are limited to 90 MED per day, except for exemption situations, or if a peer-to-peer consultation confirms medical necessity.

Patients who are undergoing active cancer treatment or who are in hospice, palliative care, or end-of-life care are exempt from these restrictions.

Patients who are already on chronic opioids will be grandfathered under the policy, and will not be subject to these limits or to prior authorization.

Important step
The opioid clinical policy is an important step in helping children and adults in Washington avoid opioid use disorder, and supporting safe and effective use of opioids.

I appreciate your engagement with this effort to lower the effects of the opioid crisis in our state.


Daniel S. Lessler, MD
Chief Medical Officer
Health Care Authority

Read the full policy
The full policy is available online at the HCA website.

Online resources available soon

Informational materials about the policy will be available soon, including:
• An online Q&A for providers and pharmacists.
• Detailed scenarios to explain how the policy would be applied in different situations.
• A patient handout.

These materials will be available on the HCA website by the end of August.

About the Health Care Authority (HCA)
The Washington State Health Care Authority purchases health care for more than 2 million Washington residents through Apple Health (Medicaid) and the Public Employees Benefits Board (PEBB) Program. As the largest health care purchaser in the state, we lead the effort to transform health care, helping ensure Washington residents have access to better health and better care at a lower cost.

For more information, visit the HCA website, where you’ll also find contact information.


If you are a patient looking for information about current opioid prescribing guidelines in the State of Washington, we recommend you go to this page of the Washington State Department of Health website.  Please do not call the WRA office, as we are not the appropriate agency to answer your questions. 

Advocacy-Related Requests for WRA Members

Adam Cooper from ACR at WRA mtng 9-18-16
Adam Cooper, Senior Director, Government Affairs at the American College of Rheumatology, participated in the Advocacy Panel on Sunday, Sept. 18 at the WRA’s Annual Conference.

Adam Cooper, Senior Director, Government Affairs, American College of Rheumatology, attended our 2016 WRA Annual Conference and asked us to pass on these advocacy-related requests to our members:

1. We are asking members to join or renew their AMA memberships this year so we can continue to be at the table:

All rheumatologists are encouraged to join or renew membership with the American Medical Association (AMA). It is critically important that the voice of our specialty be heard at the AMA and we keep our seat at the table that impacts our profession and our practice. You can join or renew at

We also need your help to continue to grow the voice of rheumatology in the AMA House of Delegates. If you are already an AMA member, it is very important that you review your information and cast your ballot for the ACR, which tells the AMA you want to be counted for rheumatology. You can cast your specialty ballot vote here.

2. We are asking all ACR and ARHP members in the United States to help with a contribution to RheumPAC in any amount.  We are looking for higher levels of participation, not necessarily higher dollar amounts.  Investments in RheumPAC for 2016 can be made here.  If anyone needs help making their donation they can reach out.

3. If any members from Washington State would like to go to an event for their member(s) of Congress and take a RheumPAC check, they can reach out to me.  More than likely we can make it happen and help them identify local events, where they can get one-on-one time to talk issues with their representatives in Washington.

Contact info for Adam:

Adam Cooper, MS
Senior Director, Government Affairs
American College of Rheumatology
2200 Lake Boulevard NE
Atlanta, Georgia 30319 | (404) 633-3777 |

WRA Advocacy News – June 2016

State Updates

Washington Out-of-Pocket Costs Taskforce Selected

The July 1st deadline is approaching to convene the first Out-of-Pocket Costs Taskforce meeting that was created by Senate Bill 6569 this past spring.

Joanna Lindsay from the Arthritis Foundation, and Stephanie Simpson of the Bleeding Disorders Foundation of Washington were selected to serve on the Task Force.

SB 6569 was an initiative that passed into law by a veto override vote during a special session to study the high out-of-pocket costs for patients. WRA legislative staff will continue to monitor the task force and will update WRA membership as necessary.

Patient Out-of-Pocket Costs Taskforce

Advocacy Tips: Preparing to Engage an Elected Official

As the WRA provides opportunities for advocacy, it is important that the individual advocate prepare for future engagement with policymakers. To help, the WRA government relations team has provided some helpful advocacy tips to consider:

  • DO YOUR HOMEWORK! Know exactly what you want to say and carefully review your messages.
  • If possible, compile information about the impact of specific healthcare issues on the elected officials district or state.
  • DO NOT compile a long list of statistics: your elected officials will not remember them and they will lose their impact.
  • Prepare a few dramatic numbers or anecdotes to illustrate your points.
  • To encourage policymakers to support a specific issue effecting rheumatology, present materials that clearly articulate your position.
  • Know the counter-arguments and be ready to respectfully answer any questions or disagreements.

State Roundup: Priority Legislation that Passed Around the U.S.

Washington had several pieces of priority legislation this legislative cycle that align among Rheumatology advocates around the country.  Step Therapy, Biosimilars and Prior Authorization have been at the forefront in patient access issues around the country.

  • 2016 State Priority Successes:
    • Step Therapy: Indiana, West Virginia, Illinois, Kansas, New York, Missouri.
    • Biosimilars: Kentucky, Missouri, Rhode Island, Arizona, Hawaii, Connecticut, Idaho, Oregon.
    • Prior Authorization: Ohio, New Hampshire.

Federal Updates

Part B Stakeholders Testify before Congress

Coalition of State Rheumatology Organizations (CSRO) National Advocacy Chair, Dr. Michael Schweitz, testified before the Subcommittee on Health in opposition to the recent Medicare Part B Demo proposed by CMS.

The hearing, “The Obama Administration’s Medicare Drug Experiment: The Patient and Doctor Perspective,” brought together stakeholders that would be adversely affected by the change in reimbursement for Part B drugs.

Watch the video

Bipartisan Step Therapy Letter Delivered to CMS

Congressmen Leonard Lance (R-NJ) and Scott Peters (D-CA) have sparked debate on step therapy by sending a letter to CMS. Both expressed their concerns about the barrier the adverse rule has had on patients and physicians.

The letter asks the CMS, who oversees the Medicare program, to ensure step therapy protocols are open and transparent, do not create a barrier to access and do not take prescribing power out of the hands of physicians.

Read the letter

Other Federal News Stories of Interest

Price, Shimkus, Boustany Respond to CMS’s Dismissal of Concerns Regarding the Proposed Medicare Part B Drug Payment Model

AMA Blasts Medicare Part B Drug Price Plan

Medicare’s Slavitt: MACRA Will Help Doctors, But Input Is Needed

WRA Advocacy News – April 2016

State Updates

Senate Bill 6569 (Out-of-Pocket Task Force)

SB 6569 was an initiative that passed into law by a veto override vote during a special session that adjourned in March to end the two-year legislative cycle (2015-2016). The bill creates a task force to study the high out-of-pocket costs for patients.

Task force members will be required to study the following issues associated with high out-of-pocket costs:

  • Evaluate factors contributing to the high out-of-pocket costs for patients.
  • Consider patient treatment adherence and the impacts on chronic illness and acute disease.
  • Discuss the impact when patients cannot maintain access to their prescription drugs and the implications of adverse health impacts.
  • Consider the impact of the factors on affordability of health care coverage.

Recommendations by the task force are required to be submitted to the appropriate committees by December 2016. WRA’s legislative staff will monitor scheduled task force hearings and provide updates as necessary.

Senate Bill 5935 (Biological Products)

SB 5935 authorizes a biological product to be substituted in the place of another biological product. Before allowing pharmacist to make the switch, they must adhere to the following:

  • Prescription must be marked “substitution permitted.”
  • The substitute product has to be lower than the wholesale price of the original biologic.
  • Pharmacist must notify the prescriber and inform the patient of the substitution.

The bill took effect on July 24, 2015.

Other State News Stories of Interest

M.D. Phone Home: New Legislation Expands Telemedicine in Washington
New law fights “doc-shopping” by addicts
Washington Legislature: What passed, died and was revived
State revokes, suspends licenses, certifications, registrations of health care providers

Federal Updates

Medicare Part B Sparks Opposition

Centers for Medicare and Medicaid Services (CMS) recently proposed a new payment structure for Medicare Part B drugs, leaving Rheumatologist and other physicians across the country with serious concerns about access to care for their patients. The new plan looks to reduce the reimbursement of Part B drugs from ASP + 6% to ASP +2.5% and a fixed $16.80 per day. To combat the measure, opponents have been publically engaged as over 300 groups have already sent letters urging House and Senate leadership to advise CMS to rethink their position.

WRA has been tracking the issue on an ongoing basis and will look to provide resources for rheumatologists and their practices to oppose the Part B model. WRA will also be providing comments to CMS during their open comment period which ends on May 9.

FDA Approves Biosimilar to Remicade

The U.S. Food and Drug Administration have approved Inflectra (infliximab-dyyb) for multiple indications. The biosimilar can be prescribed by a health care professional for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and crohn’s disease. This is the second biosimilar to be approved by the FDA.

Other Federal News Stories of Interest

The HIPAA Audits are Coming, The HIPAA Audits are Coming
Report Offers a Mixed View of Health Care Law Costs
CMS finalizes mental health and substance use disorder parity rule for Medicaid and CHIP
FDA Issues Draft Guidance for Labeling Biosimilars