Editorial

Dr Jim Cowan: Is “clinically appropriate” a new way for health insurers to deny care?

This undefined term ‘clinically appropriate’ has been added 13 times to an amended version of a telemedicine bill… In every one of these situations the defined and accepted term ‘medically necessary’ has been replaced by ‘clinically appropriate’… The words ‘clinical necessity’ have no widely-accepted definition in the world of health insurance and are not based on medical science…

Rhode Island News: Dr Jim Cowan: Is “clinically appropriate” a new way for health insurers to deny care?

February 8, 2021, 9:52 am

By Jim Cowan MD MPH

In the near future you may find that your health insurance company refuses to cover a medically necessary service because it’s not ‘clinically appropriate’. Your health insurance company tells you, “Yes, we agree the care your doctor wants to give you is medically necessary but we don’t think it’s ‘clinically appropriate’, so we’re not going to pay for it. Sorry, but we can do this because the words ‘clinically appropriate’ were in a telemedicine bill, S0004A, sponsored by Senators Miller, Goldin, Valverde, Goodwin, Felag, Coyne, Burke, Cano, Seveney, Lawson, and Kallman.”

Rhode Island health insurance companies are on public record as saying, “…determining what is clinically appropriate is not used to restrict access or to limit the use of telemedicine services” (OHIC Payment and Care Delivery Advisory Committee Telemedicine Subcommittee. Recommendations Report December 2020. p11). This telemedicine bill does exactly the opposite of what insurance companies said in December. It lets insurance companies deny payment because they alone determine a medically necessary service is clinically inappropriate.

This is a problem.

So what’s the reason for using the words ‘clinically appropriate’ in a health care bill?

None. At least, none that’s good for patients.

The American Medical Association makes this crystal-clear when it defines ‘medically necessary’ as ‘health care services that a prudent physician would provide to a patient… in a manner that is… clinically appropriate in terms of type, frequency, extent, site and duration…”

This definition of “Medically necessary” requires the clinical appropriateness of a service be considered, along with the service being safe, effective, and within local standards of good care. The widely-accepted definition used by the federal Centers for Medicare and Medicaid Services (CMS) that’s been the basis for insurers’ coverage decisions since the start of Medicare in 1966 also embraces the type, frequency, extent, site and duration of medical services delivered to patients.

Thus medically necessary care is clinically appropriate. This makes it impossible for care to be medically necessary and at the same time not clinically appropriate. This is so obvious you might say “It’s a no brainer.”

But not if you’re a health insurance company because the phrase ‘clinically appropriate’ could be used to justify denial of payment for care you need if it makes its way into S0004A currently to be considered by the Senate Health and Human Services Committee chaired by Senator Josh Miller this Thursday, February 11th.

Here’s the key language in the current draft of a telemedicine bill (S-0004-A) which includes this language:

A health insurer shall not exclude a healthcare service for coverage… so long as such healthcare services are clinically appropriate…

Federal and state law requires insurers to cover all medically necessary services. The use of the term ‘clinically appropriate’ here gives insurers a way to deny care for medically necessary services they’d otherwise have to pay for.

The situation is both Orwellian and Kafka-esque.

It’s Orwellian because the phrase ‘clinically appropriate’ is not defined in the bill (or officially anywhere else for that matter), leaving the insurance company to say, as The Party says in Orwell’s novel “1984”, this word means what I say it means, and if I say it means something else tomorrow then it means something else tomorrow.

It’s Kafka-esque because treatment that’s medically necessary is already, by definition, clinically appropriate. Care that is medically necessary but not clinically appropriate cannot logically exist. Yet if this bill becomes law, in the unreal world of Rhode Island health insurance,  payment will be denied for medically necessary services.

It’s quite an accomplishment to write a sentence that would make both Orwell and Kafka proud.

This undefined term ‘clinically appropriate’ has been added 13 times to an amended version of a telemedicine bill (S-0004-A) introduced by Senators Miller, Goldin, Valverde and Goodwin affecting where you can get telemedicine service, if it must be pre-authorized, if it will be paid for by insurance, and if the payment will differ from one setting to another.

In every one of these situations the defined and accepted term ‘medically necessary’  has been replaced by ‘clinically appropriate’. Medical necessity uses widely-accepted medical science to define care that’s effective, safe, necessary and meets local standards of care when it’s used to treat your condition’. The words ‘clinical necessity’ have no widely-accepted definition in the world of health insurance and are not based on medical science.

If this bill passes into law with the words ‘clinically appropriate’ in it, health insurance companies will be able to question and deny payment for telemedicine services that are medically necessary. This is a very bad idea for patients and doctors.

But there’s an even greater concern. If this phrase ‘clinically necessary’ becomes law in this telemedicine bill, ‘clinically appropriate’ will find its way into future bills that attempt to ‘save the Affordable Care Act (ACA)’ from Republican sabotage. These future bills promise to copy the language of the Affordable Care Act, also known as Obamacare, into Rhode Island General Law. One risk is that important parts of the ACA will be left out of Rhode Island bills. Another risk is that insurer-friendly language such as ‘clinically appropriate’ replaces ‘medically necessity’ language in the text of the ACA.

For example, the ACA prohibition of annual and lifetime caps on insurance coverage was left out of RI legislation recently passed to protect ACA “essential benefits” (S0005A). This is a disaster for patients with serious long-term illnesses where expensive treatments and drugs are needed to keep them alive year after year. They will be insured by an insurance company that says to them at some point, “You’ve reached your cap, the limit of what we have to pay, so yes, you’re insured by us but, actually, we don’t have to pay for your medically necessary care any more.”

This is the reason Obamacare outlawed annual and lifetime caps on health insurance payments. The omission of lifetime caps in Rhode Island would sentence the sickest patients to bankruptcy, worsening illness, and premature death.

So ‘saving the ACA’ becomes a way to let insurance cap what’s paid to seriously sick patients. Hardly a step forward. Think of “clinically appropriate” as another threat to good patient care.

Now is the time to call or email members of the Senate Health and Human Services Committee and ask them to amend this bill by removing all reference to ‘clinically appropriate’ and ‘clinical appropriateness’ on the ground that this term is a barrier to good patient care.

Here are the email addresses and phone numbers of the Senate Health and Human Services Committee:

Also, you can testify against this bill at the Health and Human Services Committee which meets this Thursday February 11th. It’s a virtual meeting.  Here’s the Agenda and details on how to submit written or verbal testimony. Note that written testimony must be submitted by 2 pm on Thursday, and requests to give verbal testimony by 4 pm on Wednesday

Also helpful would be calls to the sponsors of this bill: Senators Miller, Goldin, Valverde, Goodwin, Felag, Coyne, Burke, Cano, Seveney, Lawson, Kallman with the same message: “The phrase ‘clinically necessary’ is a threat to good patient care bill in the telemedicine bill S-0004-A. As written it will let insurance companies deny payment for care that’s medically necessary and this phrase should be removed.”

If your own senator is not listed above you can still call them and ask them to vote against any health care bill that comes to the floor of the Senate including the phrase ‘clinically appropriate” or similar language.

Contact info for all senators is listed at the end of this article.


Warning: What follows is wonkish… but intriguing.

A quest for examples, the history behind S0004A, and how a desire for quality care mis-directs from the truth.

Give Us Some Examples:

Maybe we’re missing something here, although common sense suggests it’s hard to think of a medical service that is necessary but is not ‘clinically appropriate’, whatever that really means.

But let’s be fair. Perhaps there are some very good reasons to include the term ‘clinical appropriateness’ in health care bills. It would be helpful if the sponsors of ‘clinically appropriate’ language in the telemedicine bill could share their thinking with us, or, even better, if they provided examples of services of medically necessary services that are not clinically appropriate.

They could start with the CMS and AMA definitions of ‘medically necessary’ and go on to give examples of medically necessary care that was not ‘clinically appropriate’. A few good examples in the major areas of health care such as medicine, surgery, pediatrics, women’s health and behavioral health would go a long way to justifying their sponsorship of this language. They might even convince us it was actually a good idea to deny payment for medically necessary care because it wasn’t deemed clinically necessary by a health insurance company.

On the other hand, if the sponsors of this bill can’t give examples of medically necessary but clinically inappropriate care then this language should not be used in this telemedicine bill or in any other health care legislation in Rhode Island.

If no examples are forthcoming it’s reasonable to assume ‘clinically appropriate’ has some other purpose. Perhaps denial of payment using terms that are not rooted in accepted science and standards of care?

History: What does Medically Necessary really mean?

For many years, health insurance companies have paid for services that everyone agrees are ‘medically necessary’. Most of the time this works well because it forces insurers to pay for services delivered in ways that science suggests will help the patient. But how can you tell if a particular service is medically necessary?

It’s easy. Medically necessary services, according to the federal Centers for Medicare and Medicaid Services (CMS), are ‘proper and needed for the diagnosis or treatment of your medical condition’ and ‘meet the standards of good medical practice in the local area’ and ‘aren’t mainly for the convenience of you and your doctor’.

What CMS says is pretty straightforward, right? You’ve got a problem, science says there are effective and safe ways to fix it, so it’s necessary for you, and your insurer pays for it. But who says the science is there to justify your care? Certainly not your insurance company.

CMS is advised by an independent committee of doctors, scientists, patients and others using medical science to say what existing and new services are effective and safe. Because of this, the term ‘medically necessary’ is widely accepted by all health insurers and medical professionals as the best way to decide what health insurance should cover.

Health insurers provide long detailed lists, based on good evidence, of the medically necessary services they cover and when they should be used. These lists include hundreds, even thousands of tests, treatments, and guess what? These lists are pretty much the same, which is what you’d expect because they’re based on science.

Take a look for yourself. Lists of medically necessary services and when and how they should be used can be found here:

Misdirection: We Need This To Monitor The Quality of Care

Sponsors of this bill might argue ‘clinically necessary’ language is needed to monitor the quality of care. This is wrong.

First, quality of care is already monitored and reported by law, and second, this quality monitoring is done based on a body of knowledge captured with the existing phrase ‘medically necessary’ which, as mentioned, includes the language and concept of ‘clinically appropriate’’ as well as consideration of how care is provided, for example face-to-face or by telemedicine. Accreditation by the National Committee on Quality Assurance is required if a health insurer is to stay in business in the US. (http://www.ncqa.org). Insurers have to demonstrate their insured members are getting high quality care. (Members are what insurance companies call patients.)

This is done by asking the simple question, “For these members that needed a medically necessary service, how many actually got it at the right time, right place, right methods, and by the right provider?” This measure of quality includes all of the “Who, what, when, where and why?” of medical practice.

So what’s the need for the words ‘clinically appropriate’ in a Rhode Island health care bill on the grounds that it’s needed to measure quality?

Once again, the answer is None. This phrase adds no value in the measurement of quality but could be used to deny payment for medically necessary care.

The organization to establish measures of quality in telemedicine is the NCQA. They establish and interpret standards of care delivery. For telemedicine, NCQA will do this on a national stage, using the accepted language of medical necessity, after consultation with many stakeholders. Once NCQA telemedicine measures are in place, NCQA will share comparisons of performance across the country, allowing interpretation of local results with national benchmarks.

Quality measurement and improvement does not justify the use of ‘clinically appropriate’ language in Rhode Island health legislation.

Here’s a bit more history of how this ‘clinically appropriate’ language got into the current telemedicine bill over the objections of providers and patient advocates. It reveals who will really benefit from ‘clinical appropriateness’.

In June 2020 Governor Raimondo asked the Office of the Health Insurance Commissioner (OHIC) to convene an Advisory Group of health care providers, insurers and others to make recommendations for the use of telemedicine during and after the COVID pandemic. When this advisory group met there was serious opposition from advocates to the phrase ‘clinically appropriate’ when OHIC pushed for it in a draft telemedicine bill. The final report says:

Stakeholders were concerned that the determination of what is clinically appropriate in the process of making payment policy would not be transparent or fair. Several suggested that OHIC should convene a group, inclusive of community providers, to set policy for what is a clinically appropriate telemedicine service… Insurers heard these concerns and noted that determining what is clinically appropriate is not used to restrict access or to limit the use of telemedicine services; instead, it is used to ensure that inappropriate care is not being delivered or paid for.” (OHIC Payment and Care Delivery Advisory Committee Telemedicine Subcommittee. Recommendations Report December 2020. p11)

The stakeholders questioning the ‘clinically appropriate’ language were patient advocates and health care professionals who treat patients. The proposed group to study the use of ‘clinical appropriateness’ was never convened. Perhaps OHIC thought it was a bad idea to let patients and community providers decide how telemedicine care should be delivered in Rhode Island. Also note that insurers assumed they would be determining what care was clinically appropriate, indicating how they would use this language if it became law.

Despite the disagreement over the undefined ambiguous ‘clinically appropriate” this language appears thirteen times in the current bill. It’s unclear if OHIC or someone else asked for this language but the sponsors of the bill, Senators Miller, Goldin, Valverde, Goodwin, Felag, Coyne, Burke, Cano, Seveney, Lawson and Kallman decided to include it. What is clear is that it benefits insurers, not patients. This is clear because insurers were the ones defending it in the advisory group, opposing representatives of patients and providers. What’s also clear is that this language will not help assess or improve quality in any way that’s not already done using the term ‘medical necessity’.

What ‘clinical appropriateness’ will do, if this language passes into law, has nothing to do with quality. It will be a legal way for insurers to interfere with and even deny payment for medically necessary care.

Now is the time to call or email members of the Senate Health and Human Services Committee and ask them to amend this bill by removing all reference to ‘clinically appropriate’ and ‘clinical appropriateness’ on the ground that this term is a barrier to good patient care.

Here are the email addresses and phone numbers of the Senate Health and Human Services
Committee:

Also, you can testify against this bill at the Health and Human Services Committee which meets this Thursday February 11th. It’s a virtual meeting. Here’s the Agenda and details on how to submit written or verbal testimony. Note that written testimony must be submitted by 2pm on Thursday, and requests to give verbal testimony by 4 pm on Wednesday

Also helpful would be calls to the sponsors of this bill: Senators Miller, Goldin, Valverde, Goodwin, Felag, Coyne, Burke, Cano, Seveney, Lawson, Kallman with the same message:

“The phrase ‘clinically necessary’ is a threat to good patient care bill in the telemedicine bill S0004A. As written it will let insurance companies deny payment for care that’s medically necessary and this phrase should be removed.”

If your own senator is not listed above you can still call them and ask them to vote against any health care bill that comes to the floor of the Senate including the phrase ‘clinically appropriate” or similar language.

Contact info for all Rhode Island State Senators:

  1. Senator Maryellen Goodwin ([email protected] (401) 276-5507)
  2. Senator Ana Quezada ([email protected] (401) 680-5515)
  3. Senator Gayle Goldin ([email protected] (401) 276-5568)
  4. Senator Dominick Ruggerio ([email protected] (401) 222-6655)
  5. Senator Samuel Bell ([email protected] (401) 680-0725)
  6. Senator Tiara Mack ([email protected] (401) 288-1288)
  7. Senator Frank Ciccone III ([email protected] (401) 275-0949)
  8. Senator Sandra Cano ([email protected] (401) 276-5561)
  9. Senator John Burke ([email protected] (401) 374-4721)
  10. Senator Walter Felag Jr ([email protected] (401) 245-7521)
  11. Senator james Seveney ([email protected] (401) 683-3046)
  12. Senator Louis DiPalma ([email protected] (401) 847-8540)
  13. Senator Dawn Euer ([email protected] (401) 276-5589)
  14. Senator Valarie Lawson ([email protected] (401) 222-6655)
  15. Senator Meghan Kallman ([email protected] (401) 648-9422)
  16. Senator Jonathon Acosta ([email protected] (401) 305-0545)
  17. Senator Thomas Paolino ([email protected] (401) 726-3177)
  18. Senator Cynthia Mendes ([email protected] (401) 688-0399)
  19. Senator Ryan Pearson ([email protected] (401) 276-5568)
  20. Senator Roger Picard ([email protected] (401)769-4902)
  21. Senator Gordon Rogers ([email protected] (401) 222-2708)
  22. Senator Stephen Archambault ([email protected] (401) 276-5589)
  23. Senator Jessica de la Cruz ([email protected] (401) 222-2708)
  24. Senator Melissa Murray ([email protected] (401) 222-6655)
  25. Senator Frank Lombardo, III ([email protected] (401) 270-1379)
  26. Senator Frank Lombardi ([email protected] (401) 453-3900)
  27. Senator Hanna Gallo ([email protected] (401) 276-5568)
  28. Senator Joshua Miller ([email protected] (401)-276-5582)
  29. Senator Michael McCaffrey ([email protected] (401) 739-7576)
  30. Senator Jeanine Calkin ([email protected] (401) 921-6682)
  31. Senator Kendra Anderson ([email protected] (401) 287-2809)
  32. Senator Cynthia Armour Coyne ([email protected] (401) 222-6655)
  33. Senator Leonidas Raptakis ([email protected] (401) 229-4146)
  34. Senator Elaine Morgan ([email protected] (401) 222-2708)
  35. Senator Bridget Valverde ([email protected] (401) 276-5589)
  36. Senator Alana DiMario ([email protected] (401) 626-2405)
  37. Senator Susan Sosnowski [email protected] (401) 783-7704)
  38. Senator Dennis Algiere ([email protected] (401) 222-2708)