January 6, 2025, Dark Report reviews 2024 and cites a July 2024 op ed in STAT about the DOJ's retrograde attitude toward pharma-supporting genetic testing for drug eligibility. I asked Chat GPT 4 whether a 2022 AO and a 2024 AO were contradictory. Both find, I guess, that genetic testing support was potentially illegal, but, in those AO scenarios, allowable (low risk).
In between the 2022 AO and 2024 AO was a legal case where Ultragenyx was forced to pay $6M. Ouch. Here.
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The two OIG opinions (OIG 22-06 and OIG 24-12) are not inherently contradictory but reflect distinct interpretations based on the specific circumstances of each genetic testing arrangement. Here's an analysis:
Key Similarities:
- Anti-Kickback Statute and Beneficiary Inducements CMP: Both opinions recognize that the arrangements would generate prohibited remuneration under the Federal Anti-Kickback Statute and Beneficiary Inducements CMP if intent to induce referrals existed.
- Favorable Ruling: Both opinions ultimately conclude that, given the safeguards in place, the risk of fraud and abuse is sufficiently low, and the OIG will not impose sanctions.
Key Differences:
Purpose of the Genetic Testing:
OIG 22-06 (2022):
- The testing was intended for a disease where genetic predisposition information (e.g., identifying hereditary versus non-hereditary forms) might inform monitoring and early diagnosis.
- The genetic test results do not directly dictate the prescription of the medications involved (Medications A and B), which are approved for both hereditary and acquired disease forms. There was no direct nexus between testing and prescribing these medications.
OIG 24-12 (2024):
- The testing focused on identifying specific subtypes of a rare genetic condition (linked to kidney stones and chronic kidney disease) to inform treatment decisions, including the potential use of a specific drug manufactured by the requestor.
- Although the drug is not prescribed for all patients with the subtype, its approval is narrowly tied to one subtype, creating a more direct potential link between testing and prescribing.
Safeguards to Mitigate Fraud:
- Both opinions emphasize safeguards (e.g., strict eligibility criteria, prohibition of data sharing with sales teams, independent healthcare professional decision-making). However:
- OIG 22-06: Relies heavily on the fact that genetic testing has no direct bearing on medication prescription decisions. The medication is approved for all disease forms regardless of genetic findings, which weakens any incentive for inappropriate referrals.
- OIG 24-12: Acknowledges a closer nexus between the testing and potential drug use but justifies its favorable ruling due to stringent measures like non-branded educational efforts, no prescriber or patient identification shared with the manufacturer, and the ultra-rare nature of the condition.
Perceived Risks:
- OIG 22-06: Highlights the minimal risk of overutilization because the testing is narrowly targeted and cannot independently diagnose or justify treatment.
- OIG 24-12: Accepts a potentially higher risk because the testing is more closely tied to identifying eligibility for a specific treatment. However, it concludes that the safeguards sufficiently address these risks.
Conclusion:
While OIG 22-06 involves genetic testing with less direct ties to prescribing decisions, OIG 24-12 involves an arrangement where testing outcomes could more explicitly inform treatment with the manufacturer’s drug. These distinctions in purpose and risk management likely explain why the OIG reached similar outcomes despite slightly different risk profiles.
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OK, so I fed Chat GPT the DOJ report on the $6M fine in 2023 to ULTRAGENYX and I got this.
https://www.statnews.com/2024/07/25/sponsored-genetic-testing-rare-diseases-doj-impediment/
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To fit the 2023 Ultragenyx legal case into the paradigm of the 2022 and 2024 OIG advisory opinions, we can compare and contrast the legal and factual underpinnings of all three situations. This analysis demonstrates why the Ultragenyx arrangement fell afoul of the law, while the other two arrangements received favorable OIG opinions.
Key Points of Comparison
- Safeguards Against Inducements and Overutilization:
2022 AO and 2024 AO: Both advisory opinions emphasized strong safeguards against using the testing program as a tool to drive prescriptions or referrals. Specifically:
- De-identified Data: Neither the manufacturer nor the sales force received identifiable information about patients or providers who used the testing programs.
- No Ties to Sales Activities: Data was used only for operational purposes, not for marketing or sales targeting.
- Objective Clinical Criteria: Testing was based on narrow eligibility criteria and did not require the prescription of the drug in question.
Ultragenyx Case: In contrast, Ultragenyx:
- Paid for test results that included identifiable information about providers and patients (e.g., HCP names, patient de-identified IDs, test results).
- Used this data for marketing purposes, directing sales representatives to target HCPs and follow up on positive test results.
- Actively linked the testing program to potential prescriptions of Crysvita, undermining the objectivity of treatment decisions.
- Link Between Testing and Treatment Decisions:
2022 AO: The genetic test results had no direct bearing on whether a drug was prescribed, as the medications were approved for all forms of the disease. This lack of direct connection mitigated concerns about improper inducements.
2024 AO: While the genetic test could identify patients eligible for a specific drug, the advisory opinion emphasized safeguards ensuring independence of prescribing decisions:
- Providers were not incentivized or required to prescribe the drug.
- Requestor did not receive data on prescribers or patients, eliminating potential influence over prescribing patterns.
Ultragenyx Case: Here, the genetic testing program was explicitly tied to inducing prescriptions:
- A positive genetic test was often required for insurers to approve Crysvita prescriptions, creating a direct link between testing and drug utilization.
- Ultragenyx’s use of test result data for marketing targeted HCPs and patients, leading to allegations of kickbacks.
- Remuneration and Kickbacks:
2022 AO and 2024 AO: Both advisory opinions acknowledged that the free testing programs constituted "remuneration" under the Federal Anti-Kickback Statute but concluded that the safeguards reduced fraud and abuse risks:
- Free testing was unconditionally provided, with no obligation to use the manufacturer’s products.
- The arrangements were structured to benefit public health (e.g., earlier diagnosis of rare diseases) without inducing improper referrals.
Ultragenyx Case: Ultragenyx’s actions were deemed kickbacks because:
- The free testing was allegedly used as a tool to induce HCPs to prescribe Crysvita.
- Paying the lab for test results created a financial incentive to refer patients and HCPs to Ultragenyx, violating the False Claims Act.
- Data Usage and Sales Practices:
2022 AO and 2024 AO: Both opinions strictly limited data usage:
- Data was de-identified and could not be used for sales or marketing.
- Sales representatives were prohibited from accessing or acting on testing data.
Ultragenyx Case: Ultragenyx explicitly used testing data to target HCPs and promote Crysvita, undermining the independence of medical decision-making.
Fitting the Ultragenyx Case into the Paradigm
The 2023 Ultragenyx settlement demonstrates what happens when safeguards, like those emphasized in the 2022 and 2024 AOs, are absent or disregarded. The lack of firewalls between genetic testing programs and marketing activities, coupled with direct links between testing and prescriptions, transformed Ultragenyx’s program into a kickback scheme.
- Lessons from Ultragenyx: Both AOs show how to design a testing program that aligns with the law:
- Ensure testing programs are focused on patient benefit, not sales generation.
- Keep data de-identified and prohibit its use for marketing or targeting prescribers.
- Maintain strict separation between testing services and prescribing incentives.
In contrast, Ultragenyx blurred the line between diagnostics and marketing, resulting in False Claims Act liability. This case reinforces the importance of maintaining clear ethical and legal boundaries in such arrangements.
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I fed Chat GPT the 2024 OP ED in STAT. Dr Kakkis is CEO of Ultragenyx.
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Dr. Emil Kakkis’s op-ed is a passionate defense of the role of sponsored genetic testing programs in the rare disease landscape. It reflects frustration with the DOJ’s enforcement action against Ultragenyx, but it also downplays key factors that led to the $6 million settlement. Here's an analysis of his arguments and their fairness in light of the DOJ case and the two OIG advisory opinions:
Fair Points:
The Importance of Genetic Testing for Rare Diseases:
- Dr. Kakkis correctly highlights the diagnostic challenges faced by rare disease patients, including the lengthy and costly diagnostic odyssey.
- Genetic testing can indeed provide life-changing insights, leading to faster diagnoses, targeted treatments, and informed decision-making.
Failure of Insurance to Cover Testing:
- His criticism of insurers for not covering genetic testing is valid. This gap often leaves pharmaceutical companies and patients to shoulder the financial burden.
Clinical Autonomy in Prescribing Decisions:
- He emphasizes that doctors retained full discretion over whether to prescribe Crysvita, and in some cases, the testing led to discontinuation of unnecessary treatment—a point that underscores the potential value of such programs.
Broader Benefits of Genetic Testing:
- Beyond prescribing decisions, genetic testing can guide enrollment in clinical trials, genetic counseling, and other care pathways, reinforcing its importance.
Unfair or Oversimplified Points:
Minimizing the Role of Kickbacks:
- Dr. Kakkis asserts that there were "no kickbacks or false claims," but the DOJ settlement involved admissions of conduct that align with legal definitions of kickbacks:
- Sharing Test Results for Marketing: Ultragenyx paid the lab for test results, including HCP names and test outcomes, and used this information to target HCPs for marketing Crysvita. This direct link between sponsored testing and marketing undermines his claim of a clean separation between diagnosis and drug promotion.
- Dr. Kakkis asserts that there were "no kickbacks or false claims," but the DOJ settlement involved admissions of conduct that align with legal definitions of kickbacks:
Ignoring the Lack of Safeguards:
- The Ultragenyx program lacked the robust safeguards seen in the 2022 and 2024 OIG opinions, such as de-identified data and prohibitions on sales force access. These omissions heightened the risk of undue influence on prescribing decisions, which the DOJ deemed improper.
Overlooking the DOJ’s Focus on the Lab Relationship:
- The DOJ’s case heavily criticized the payments to the lab for Results Reports, which it viewed as inducing referrals. This is a significant distinction from the OIG-approved programs, where such direct financial arrangements and identifiable data sharing were absent.
Framing the DOJ’s Actions as Medically Harmful:
- While it’s true that DOJ enforcement could create a chilling effect on sponsored testing programs, Dr. Kakkis’s claim that the DOJ is "thwarting" medical progress oversimplifies the situation. The DOJ is targeting improper financial relationships that could distort treatment decisions, not the concept of sponsored testing itself.
Key Subtleties the Op-Ed Misses:
The Fine Line Between Low-Risk and High-Risk Arrangements:
- The OIG advisory opinions showed that sponsored genetic testing programs can exist within legal guardrails if they are carefully designed to prevent marketing and prescribing incentives.
- Ultragenyx’s program failed to adhere to these principles, crossing into what the DOJ saw as kickbacks.
The DOJ’s Emphasis on Intent and Context:
- The DOJ’s issue wasn’t with sponsored testing per se but with how the program was structured and its intent to promote Crysvita prescriptions. This distinction is critical and is missing from the op-ed.
The Role of Corporate Responsibility:
- The op-ed frames Ultragenyx as a victim of overzealous enforcement but avoids addressing the company’s responsibility to ensure its programs comply with federal laws, especially as guidance evolved post-2022.
Is the Op-Ed Fair-Handed?
The op-ed makes valid points about the challenges faced by rare disease patients and the potential benefits of genetic testing. However, it is not entirely fair-handed because it:
- Fails to acknowledge the specific flaws in Ultragenyx’s program that led to DOJ action.
- Mischaracterizes DOJ enforcement as a blanket attack on all sponsored testing rather than a targeted response to improper practices.
- Omits the critical legal and ethical nuances that separate compliant programs from those deemed kickbacks.
Dr. Kakkis’s frustration is understandable, but his op-ed would have been more balanced if it had acknowledged the lessons from the Ultragenyx case and the need for more robust safeguards in sponsored testing programs. By aligning with the principles outlined in the OIG advisory opinions, sponsored testing can advance rare disease diagnosis without raising red flags for regulators.
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