For the first time, the Ministry of Health regulates the work of the exception committees in the health funds, which are actually the last resort for patients who need life-saving drugs that are not included in the health basket.
The Exception Committees are the last resort, and sometimes the only one, for patients who need a drug that is not in the drug basket.
Each of the health funds operates its own committee, but these committees operate without the supervision and control of the Ministry of Health and without uniform principles.
Salah Abu Al Kayan.
do not want to give the medicine,
Over the years, the State Comptroller, as well as a report by the Ministry of Health itself from 2019, pointed to a series of required corrections in these committees - starting with the fact that their work is not transparent, and ending with long waiting times for approvals.
Now, a circular published recently by the Deputy Director for Supervision of the Health Insurance Funds at the Ministry of Health regulates the work of the exception committees. According to the circular, a schedule will be established for processing applications (up to two months at the most), there will be an obligation to report to the Ministry of Health on the scope of the applications, and guiding principles for the operation of the committees will be established .
However, there is no solution to the transparency problem in the circular, so patients who are considering contacting the committee cannot know if another patient received the same treatment they need.
"No reply"
A case that can illustrate the necessity of regulating the committees is the story of 4-year-old Saleh from the Negev, who has Duchenne syndrome, a severe and incurable muscular dystrophy.
His mother, Mania Abu Al-Qian, has been waiting for more than six months for approval for a drug called "Axondis", which delays the deterioration of the disease and prevents the progression of disability in the children with the syndrome.
With the help of the family doctor and with the help of the "Small Steps" association for Duchenne patients, the family applied to the Exceptions Committee - and was refused, even though two other patients in the same fund are being treated with the drug.
"My child has a developmental delay, and to this day we have not received the treatment," Mania says, "I sent all the forms already in December and called several times to ask what was new. They kept telling me in two days, three days, next week, and they don't answer anything. No want to give the medicine.
"It is a treatment that calms his illness. He needs to receive the medicine. They keep asking me at Schneider Hospital if he has already received it, and I said no. It is an expensive medicine, it costs NIS 2 million a year. Where do I get such an amount every year?"
Response in a reasonable time
According to the draft of the new procedure, the Exceptions Committee will be obliged to hold a hearing within a "reasonable time" that does not exceed 60 days for non-urgent cases, and within a few days in the case of medical urgency.
For the first time, it was also determined that a reasoned decision would be given in case of rejection.
Shmulik ben Ya'akov,
Contrary to the situation today, where the procedure is sometimes done in front of a doctor who submitted the application for the patient, according to the procedure the committee will have to inform the applicant himself of the receipt of the application within three days, and if additional documents or completions are required - it will have to update within five days.
In addition to this, the applicant will be given advance notice of the date of the hearing, of his right to a hearing and of his right to be present or a representative on his behalf at the hearing.
His right to receive a detailed decision within seven days, or by phone in case of urgency, will also be enshrined.
Another interesting guideline is that economic considerations should not be taken into account and priority should be given to income support recipients, because this would result in "the only ones who will be able to benefit from the actual treatments".
Medical considerations for examining the application will be the patient's medical condition, alternative treatments that are available to him and whether they helped him up to the time of the application, the therapeutic alternatives in the health basket and the degree of medical foundation that the requested medicine has.
The registration of the drug or certain experimental stages will not be a threshold condition for the discussion.
In addition, the funds will be obliged to publish and inform the insured about the very existence of the exception committees and the ways of contacting them, and to send reports to the Ministry of Health about the extent of referrals and the approvals given.
Not for exceptions
In 2021, 2,846 applications were submitted to the Exception Committees of the HMOs (see table).
According to estimates, the cost of the drugs financed by the funds reached about NIS 300 million.
For comparison, the budget for the annual addition to the medicine basket was NIS 500 million in recent years, so in practice it is a "mini medicine basket" and on a central route no less than the official medicine basket, at least from a budgetary point of view.
An official at the health insurance funds told "Israel Hayom" that it would have been appropriate for the Ministry of Health to establish one central committee and budget for it: "You cannot call a body that approves 60% of requests an 'exceptions committee'. The exceptions are those whose request was not approved. There should be a national exception committee because it is not It is true that each cash register will consider for itself."
Shmulik Ben-Yaakov, chairman of the Association for Patient Rights, explains that "the Exceptions Committees only deal with those difficult cases where patients need life-saving or life-prolonging drugs.
For a decade we have been seeking to establish a procedure for their operation.
One of the biggest problems is that the public does not know what is approved and what is not.
"As soon as doctors know which drugs have been approved, they will be able to get an idea in which cases their patients can be submitted to the committee. As they publish every year which drugs have entered the health basket, here we are expanding the basket and it makes sense to publish it in a transparent and clear manner. This is the responsibility of the Ministry of Health."
Another issue that the association wants to correct is providing representation to the applicant.
"All the funds have public representatives, and it should be required that they also sit on the committees. It is important that there is no representation just for the interest of the fund or for economic considerations."
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