ChatGPT Weighs In: Changing CGP Barriers at CMS to Benefit Patients

I am working to assist an organization that wants to improve CMS policy for cancer patients.  Generally, lung cancer patients need to have "comprehensive genomic testing," or CGP, which is a panel of 200 or more oncogenes to help direct the patient's therapy.  Sadly, half the time patients do not get this testing.   There are several policy reasons for this.

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ChatGPT

I understand your situation. Addressing policy issues for comprehensive genomic testing for lung cancer patients is a crucial and commendable effort. Here are several potential policy issues that might explain why only half of the patients are receiving this testing:

Cost and Reimbursement Policies: Comprehensive genomic testing can be expensive, and if the insurance policies, including Medicare and Medicaid, don't cover or only partially cover the cost of the test, patients might not be able to afford it.

1. Guideline and Approval Issues: If CGP isn't widely accepted or incorporated into official treatment guidelines or if it isn't FDA-approved, it may not be routinely offered to patients or covered by insurance.
2. Physician Awareness and Education: Some clinicians might not be aware of the benefits of CGP or how to interpret the results, which may prevent them from recommending the test.
3. Laboratory Infrastructure and Capacity: Some facilities might not have the necessary laboratory infrastructure or the capacity to perform CGP.
4. Policy on Off-label Drug Use: CGP can identify mutations that could potentially be targeted by drugs approved for other indications (off-label use). However, some insurance policies don't cover off-label drug use, which might discourage CGP.
5. Inequalities in Access: There might be disparities in access to CGP based on socio-economic status, geographical location, race, or other factors.
6. Data Privacy and Ethical Concerns: Some patients might refuse CGP due to concerns about genetic data privacy, potential discrimination, or ethical considerations. Clear policy guidelines need to be in place to address these issues.

Addressing these policy issues could involve advocating for change at various levels:

1. Healthcare Systems: Increase awareness of the benefits of CGP among healthcare providers, update clinical guidelines to incorporate CGP, and improve lab infrastructure.
2. Insurance Companies: Advocate for coverage of CGP and targeted therapies for off-label use.
3. Government: Advocate for legislation that requires insurance coverage for CGP, enforces genetic data privacy, and addresses health disparities. It may also be beneficial to involve patient advocacy groups in these efforts.
4. Education: Improve education on the benefits of CGP for clinicians and patients.

I hope this helps and I wish you the best in your efforts to improve access to comprehensive genomic testing for lung cancer patients!

User

Thank you!  Here are some specific policy concerns.

1.  Treating physician must order the test. CMS has a regulation, 42 CFR 410.31, that says the person ordering the test must be the treating physician who is managing the patient's illness.   (This wording is specifically meant to exclude the pathologist or radiologist).   This blocks the pathologist from ordering the CGP test, and some stakeholders thinks CMS should update this regulation.  However, the barrier and burden to getting CMS to update such a regulation is very high.

2.  Pathologist can order some tests, but only minor ones.  There is a pathologist ordering exception, but it is very limited.  CMS says a pathologist may order a test "necessary to complete a case."  CMS provides only one example, the pathologist sees like TB bacteria and orders a TB stain.  This is a trivial $10 expense, and it's not clear that CMS would belive the pathologist must order a $4000 CGP test to complete a case.   

3.  Standing orders.   There are some CMS rules around "standing orders" but they have traditionally been applied to simpler scenarios, such as ordering glucose 4 times a day while the patient is in hospital to monitor their blood sugar.   That is a 'Standing order."   Having a standing order in a hospital that all incoming cancer patients should have a $4000 CGP test, well, one or two hospitals may have adopted such a brave approach, but very few hospitals see that as a realistic meaning of "standing order."    

Giving these three policy barriers, how could we move forward? Treating physician must order; Pathologist can order [within very very limited scope], or instituational standing orders for costly test.

ChatGPT

Indeed, the policy barriers you've outlined pose challenges to increasing the accessibility of comprehensive genomic testing (CGP) for cancer patients. Here are a few potential strategies to navigate these issues:

1. Develop a Collaborative Model: Encourage a model of care where pathologists work more closely with treating physicians to ensure the latter order the CGP when appropriate. Educational initiatives could be set up to increase treating physicians' awareness of the benefits of CGP, and regular meetings or consultations could be organized between treating physicians and pathologists.
2. Advocate for Policy Changes: While changing CMS regulations is difficult, sustained advocacy can lead to eventual success. Efforts could be targeted towards expanding the role of pathologists in ordering tests, as well as broadening the interpretation of 'necessary to complete a case.' Advocacy campaigns should highlight the importance of CGP in determining appropriate therapies and improving patient outcomes.
3. Utilize Standing Orders Strategically: Standing orders could be applied for patients who meet certain criteria indicating high likelihood of benefit from CGP. For instance, all patients with a specific type or stage of cancer could be automatically recommended for CGP under a standing order. This narrower approach may be more palatable to hospitals and CMS, given the cost implications of a broader standing order policy.
4. Promote Research: Encourage and fund research demonstrating the benefits and cost-effectiveness of CGP. This evidence could be invaluable in making a case to CMS and insurance companies for more flexible policies around ordering CGP.
5. Leverage Technology: Digital health tools could be used to alert treating physicians when CGP might be beneficial for a patient, based on their specific diagnosis, stage of disease, etc. These tools could also provide physicians with information on how to interpret the results of CGP.
6. Partner with Patient Advocacy Groups: These groups can help apply pressure on policymakers and increase public awareness of the issue.

The key here is persistence, and to keep building a compelling body of evidence that demonstrates the value and necessity of CGP in treating lung cancer. This is a multi-faceted issue and will likely require a multi-pronged approach to effectively address.

User

How would the CMS agency likely respond to clarifying the rules or expanding the rules to be more friendly to CGP?  Personally, I am skeptical that CMS officials would be easy to talk to, or listen with an open mind, or actually move proactively forward.   

ChatGPT

Indeed, getting a bureaucratic institution like the Centers for Medicare & Medicaid Services (CMS) to change its policies can be a difficult process, but not an impossible one. Your skepticism is understandable, as the process often involves substantial time, effort, and evidence to convince these agencies to make a change.

CMS is fundamentally a public organization, driven by the mandate to provide effective and efficient healthcare services to the eligible population while balancing cost implications. They generally respond to changes when there's a clear evidence base that supports the efficacy, cost-effectiveness, and necessity of the proposed changes.

Here are some strategies that could potentially prompt a positive response from CMS:

Evidence-Based Approach: CMS typically requires robust clinical evidence demonstrating that a proposed change would lead to improved patient outcomes. This includes randomized clinical trials, observational studies, and cost-effectiveness analyses. A concerted effort to compile and present this evidence in a persuasive way will be important.

1. Stakeholder Support: Gathering support from a broad range of stakeholders, including patient advocacy groups, healthcare providers, and other health agencies, can amplify your voice and lend credibility to your argument. The more consensus there is among these groups about the importance of CGP, the more likely CMS is to take notice.
2. Public Comment Periods: During rulemaking periods, CMS opens up for public comments where suggestions and criticisms about proposed rules are heard. These are opportunities to submit formal comments and to encourage other stakeholders to do the same.
3. Pilot Programs: CMS might be more open to changes if they can first be tested on a small scale. If a pilot program could be established that demonstrates the benefits of more liberal CGP ordering, CMS might be more likely to consider policy changes.
4. Legislative Advocacy: CMS is bound by the laws that Congress enacts. If efforts to directly change CMS policy are unsuccessful, you could potentially advocate for legislative changes that would require CMS to modify their policies.
5. Continued Engagement: Regular communication with CMS officials to discuss your concerns, share new evidence, and maintain an open dialogue can build relationships and understanding over time.

Remember, policy change often requires persistence and time. Even if initial efforts are not successful, continued advocacy and the accumulation of evidence can eventually lead to change.

EXTRA

As we work to coordinate with other stakeholders and then bring these requests for changes to CMS, what are the biggest mistakes we could make (the "watch-outs").  How can we then mitigate those risks.

ChatGPT

As you embark on this journey to coordinate changes with CMS, it's essential to plan carefully and avoid potential pitfalls. Here are some common mistakes to watch out for and strategies to mitigate those risks:

Lack of Clear and Consistent Messaging: Miscommunication can undermine your campaign. Ensure that all stakeholders are on the same page and convey a consistent, unified message. Use clear, concise language that non-experts can understand. Mitigate this risk by having frequent meetings and updates with all stakeholders.

Not Enough Supporting Evidence: CMS will require substantial evidence of the benefits and cost-effectiveness of CGP. Not having enough data to back up your arguments will weaken your case. Mitigate this risk by proactively investing in research or leveraging existing literature and studies to strengthen your proposal.

Neglecting to Build Broad Support: If you only involve a few organizations or focus only on patient advocacy groups without engaging other stakeholders (like medical societies or pharmaceutical companies), CMS may not see the request as representative of a broader consensus. Mitigate this risk by actively reaching out to a wide range of stakeholders.

Ignoring the Cost Factor: While patient care is crucial, CMS also has to consider cost-effectiveness. Ignoring the financial implications of more widespread CGP testing could lead to a quick dismissal of your proposal. Mitigate this risk by conducting or sourcing cost-effectiveness analyses and demonstrating the potential long-term cost savings of early and precise intervention.

Overlooking the Bureaucratic Process: CMS, like any government agency, has specific procedures for changing regulations. If these processes are not followed precisely, your proposal could be dismissed on procedural grounds. Mitigate this risk by thoroughly understanding the policy change process or working with experts who do.

Underestimating Timeline: Policy change often takes longer than expected. If you underestimate the time required, you may not allocate sufficient resources to the effort, leading to burnout or loss of momentum. Mitigate this by developing a realistic timeline, having persistent follow-ups, and securing adequate resources.

Failure to Engage CMS Early: CMS should not be the last to hear about your proposal. Engage with them early and often, allowing them to provide feedback and direction to your efforts. Mitigate this by making CMS a part of your dialogue right from the early stages.

By anticipating these potential pitfalls and developing strategies to address them, you can greatly enhance your chances of successfully bringing about the policy changes you seek.