Friday, September 15, 2023

Chat Explains what a CMS "SAD" Drug List Is

 I fed Chat GPT a Self Administered Drug Exclusion List (a CMS document) and here's the answer.

This document appears to be an article or informational document related to the Medicare program in the United States. It provides information and guidelines regarding the coverage of outpatient prescription drugs under the Medicare program.

The document discusses the criteria used to determine whether a drug or biological is usually self-administered by patients, and if so, whether it is excluded from payment. It also outlines the evidentiary criteria and presumptions used in this determination. The document contains a list of specific drugs and their exclusion status based on these guidelines, with details such as generic and brand names, exclusion effective dates, and reasons for exclusion.

Additionally, the document discusses the use of modifiers for drugs with multiple routes of administration and provides information about coding and billing procedures related to these drugs.

Overall, this document serves as a reference for healthcare providers and contractors participating in the Medicare program to understand the coverage and payment rules for outpatient prescription drugs.


How many drugs are mentioned?


There are a total of 142 drugs mentioned in the document. These drugs are listed with their respective codes and additional information related to their administration and coverage status.

How does Medicare decide if something belongs on this list of drugs, or not?



Medicare uses a specific process to determine which drugs are included on its list of covered drugs, known as the Medicare formulary. This process is governed by guidelines and regulations established by the Centers for Medicare & Medicaid Services (CMS). Here are the key steps in how Medicare decides if a drug belongs on its list:

FDA Approval: In most cases, for a drug to be considered for inclusion on the Medicare formulary, it must first receive approval from the U.S. Food and Drug Administration (FDA). The FDA evaluates drugs for safety and efficacy before they can be marketed in the United States.

Drug Classes and Categories: Medicare organizes drugs into classes and categories based on their therapeutic use. These categories help determine which drugs are interchangeable with each other. Within each category, Medicare looks for drugs that provide clinically significant benefits over others.

Formulary Committees: Medicare contracts with private insurance companies to administer its prescription drug plans (Part D plans). These insurance companies have Pharmacy and Therapeutics (P&T) Committees consisting of healthcare professionals, pharmacists, and other experts. These committees review and evaluate drugs within specific categories.

Clinical Guidelines and Evidence: P&T Committees consider clinical guidelines, medical literature, and scientific evidence to assess the safety and effectiveness of drugs. They may consider factors like clinical trial data, real-world outcomes, and patient preferences.

Cost Considerations: While Medicare primarily focuses on the clinical effectiveness of drugs, cost-effectiveness is also considered. Insurance companies negotiate with drug manufacturers to obtain favorable pricing for drugs that will be included on the formulary.

Patient Access and Availability: Medicare aims to ensure that beneficiaries have access to necessary medications. They consider factors like patient needs and the availability of alternative treatments.

Public Input: CMS and Part D plan sponsors often seek public input on proposed formulary changes. This can include input from healthcare professionals, patient advocacy groups, and the general public.

Periodic Reviews: Medicare conducts regular reviews of the formulary to make updates and changes as new drugs become available, clinical guidelines evolve, or when there are changes in drug pricing and market dynamics.

Exceptions and Appeals: In some cases, a beneficiary may need a drug that is not on the formulary. There is a process for requesting exceptions or appealing coverage decisions.

It's important to note that the specific criteria and processes may vary slightly among different Medicare Part D prescription drug plans, but they all adhere to the general principles outlined above. The goal of Medicare's formulary is to balance clinical effectiveness, cost-efficiency, and patient access to ensure that beneficiaries receive appropriate and affordable medications.




The news article highlights a specific case involving Medicare policy changes related to self-administered drugs (SADs) and their significant financial implications for patients. The key points in the article are as follows:

Patient's Situation: George Beitzel, an 84-year-old retiree with Crohn's disease and Parkinson's disease, had been receiving injections of ustekinumab (Stelara) at a clinic every 2 months for 5 years. Medicare had previously covered the cost of these injections under Part B, which covers drugs administered in medical settings.

Policy Change: On October 15, 2021, Medicare quietly changed its policy regarding Stelara. It reclassified Stelara as a "SAD" or self-administered drug, even though Beitzel was unable to self-administer due to his Parkinson's disease. This policy change meant that Medicare would no longer cover the drug when administered in an outpatient setting.

Financial Impact: Beitzel was unaware of this policy change, and he continued to receive injections at the clinic for another 7 months. As a result, he now faces a bill of $43,543.47 for each injection he received after the policy change, totaling as much as $176,000. He received numerous letters from Medicare denying his appeals.

Lack of Notice: What's particularly distressing is that Medicare did not require providers to give advance notice to beneficiaries about the change in coverage status, leaving patients to discover the change only when they received large bills months later.

Legal Action: Beitzel and another patient filed a class-action lawsuit against the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra through the Center for Medicare Advocacy (CMA). They are seeking relief for the financial burden caused by the policy change and requesting an injunction to require proper notice and modifications to the program for those who cannot self-administer SADs.

Impact on Other Patients: The article mentions that this policy change doesn't only affect Stelara but also potentially thousands of Medicare beneficiaries who are facing similar unexpected financial burdens due to the reclassification of drugs as SADs.

Safety Concerns: Beitzel emphasizes the danger posed by Medicare's actions, as patients who cannot self-administer are left with limited options, high costs, and the risk of discontinuing necessary treatments.

This news article illustrates how changes in Medicare policy, particularly the reclassification of drugs as self-administered, can have profound and unexpected financial consequences for patients. It also highlights the importance of clear communication and notice to beneficiaries when such policy changes occur, especially when patients may not be able to self-administer due to medical conditions. The legal action taken in response to these changes underscores the potential impact on a broader group of patients facing similar challenges.

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