AUTOIMMUNE, INFUSION SERVICES LIMITED

Whether you're a patient or medical professional, you need to read this and take action. Medicare and Medicaid furnished a plan to adjust financial reimbursements to health care providers making it near impossible for them to stay open. The "Most Favored Nation" (MFN) rule recently released by the administration, allows foreign countries to determine the cost of Part B medications. Since U.S. doctors are not allowed to purchase medicines internationally, unless drug companies lower prices in the U.S., small physician practices will fail or stop offering certain treatments such as rheumatological infusions. If your doctor doesn’t have access to purchase the medication at the low international price, Medicare/Medicaid will not reimburse the physician. MFN is mandatory for all providers participating in the Medicare program. There are limited exemptions for payable Medicare Part B drugs based on reasonable costs.

What does this mean? It means you may have to drive to the hospital to get treatment and only if you have what they consider a life threatening condition. Your doctor will not be able to afford the high price for what is needed to perform the service. Doctors will more than likely opt out of Medicare for these services or close and go work for someone else.

HOW CAN I HELP? Comment on this rule directly to the government! Voice your opposition. Visit: federalregister.gov. Communicate directly with your legislators. The Coalition of State Rheumatology Organizations (CSRO) encourages you to voice your concerns urging to delay the rule so they have time to dialogue the new policy with CMS (Centers for Medicare & Medicaid Services). CSRO has an Advocacy tab with an Action Center selection on their website to make it easy to respond to U.S. Senators and Representatives. Go to: csro.info.

Keep reading, it gets worse. Medicare pays more than twice as much for medications as other nations. Why do they have to pay more, you ask? Because the Average Sales Price (ASP) is calculated using only the prices the manufactures charge to certain U.S. based purchasers, plus a mandated 6 percent add-on. This encourages a higher price on drugs. The more expensive the drug the better the extra 6 percent looks to the manufacturer and the "cash back" to the payers. How do you get the lower drug price if there is no other drug like it on the market? Why are lower prices given to hospitals and not smaller practices?

This new reimbursement approach appears to be intended to remove or eliminate benefits for a small practice provider who has no other choice but to pay a higher price for the drug or not offer the service. If pharmaceutical manufacturers don’t change their pricing policy to allow smaller practices to purchase the drugs at the lower price, then hospitals will likely be the only ones who can purchase these drugs. Medicare is offering benefits to patients in its new rule by offering prescription drug rebates to help patients save, but how is this going to help the patient if there only option for treatment is to go to the hospital. After all, aren’t hospital cost the most expensive for the payer (Medicare/Medicaid)? This is not ideal for patients, providers, or medical advancement.

What doctors are saying. Infusion practices like Birmingham Rheumatology may be forced to shut down if this rule takes effect. Doctors such as Greg Eudy, M.D. (Rheumatology Specialist in Birmingham, AL), who provides his patients with personalized treatment, can no longer afford his staff, the infusion nurse, and pay for IV infusion supplies needed. According to Dr. Eudy, “This will be a hard hit if we are forced to stop doing infusions for Medicare patients. We would seek alternatives for our patients through large, hospital-like infusion centers or through home injections, where available. However, home injections, under current rules, will likely lead to VERY HIGH out of pocket expenses for Medicare patients. Furthermore, it is doubtful that other infusion centers or practices will be able to assume infusion care for Medicare patients under this new rule.”.

The following is a letter from Dr. Eudy to his U.S. Senator.

PLEASE do something urgently help to avoid an access to care crisis WITHIN the Covid pandemic crisis! I am a practicing Rheumatologist, and I am writing to urge you to oppose the Most Favored Nation (MFN) interim final rule recently issued by CMS. The Model is set to go into effect on January 1, just over a month after it was proposed - and almost a month before the comment period on the rule even closes. The message I infer from this manner of doing things is, "we won't be listening to you, anyway." This level of disrespect is frankly unamerican.

CMS has explicitly admitted that a portion of the savings will come from lost utilization due to beneficiaries losing or forgoing access. I can testify that this WILL BE THE CASE. As a matter of fact, I, along with all of the other Rheumatology practices in the Birmingham metro area, have ALREADY canceled these treatments for Medicare patients starting January 1. Maybe a real life story will help: A gentleman who has been under my care for 2 years now visited me yesterday. He recounted his life before I appropriately diagnosed him with a debilitating autoimmune disease. He was "strung out" on opioid medications, in chronic pain, with an extremely low quality of life. Once he was appropriately diagnosed and treated with an intravenous biologic infusion in my office, he immediately started having pain relief. He discontinued all opioid pain medications and now states, "you gave me my life back." Yesterday I had to tell him I will not be able to offer this treatment to him next month. I was the one who had to tell him. Not CMS. Not a drug company. Not an irresponsible, bully administration. I had to tell him. It was heartbreaking.

If patients, like the above mentioned gentleman, with rheumatoid arthritis or other autoimmune diseases are forced to abandon their treatments, control of their disease will be lost. This means that systemic inflammation can irreversibly damage joints, internal organs, and accelerate cardiovascular disease. Furthermore, uncontrolled inflammation will increase their risk of the so-called cytokine storm associated with the most severe and deadly Covid-19 cases. And, by the way, the emerging novel Covid-19 vaccines will not be here to rescue them. Patients with immune compromising conditions who take immune suppressing medications we prescribe were excluded from the vaccine trials. We can not responsibly endorse the vaccine for them at this time, as it has not been tested for safety IN PATIENTS LIKE THEM.

In an unprecedented move, this Most Favored Nation model requires mandatory countrywide participation with just over a month of prior notice. Under the new reimbursement scheme many offices will be underwater on already purchased drugs. An Oncology colleague of mine stated this morning, "If this rule goes into effect, effective and innovative cancer care for Medicare patients will come to a halt on January 1."

For me to continue offering care to patients, I HAVE TO remain fiscally responsible. I am a professional medical practice, but also a small business. The rule allows practices to apply for financial hardship exclusions only AFTER they have failed. For a small business like mine, it does not work that way. You can not invite my business to fail and then later determine I will be exempt. Believe me, a business that is already operating on a 6% margin (AFTER sequestration is removed), is a business that CAN NOT afford to spend more than what comes in.

As a matter of principle, I understand the desire to see medication prices reduced in our healthcare system. I would hope that reasonable, testable, solutions could be developed that are fair to all parties involved, and DO NOT reduce access to care, as this rule will most certainly do.

For these reasons I hope you will join me in opposing the Most Favored Nation policy.

Sincerely,
Greg E Eudy, MD
Take action today. The sooner the better. We could see a domino effect where smaller clinics close and the only alternative is the hospital. We have till January 1st to respond. "Many rheumatology practices have already started to curtail ordering Part B medications for Medicare patients because of the potential losses starting in January, which means, many patients will be without treatment as early as the first week of January.", said CSRO.

Action Links:
federalregister.gov | csro.info

Video Interview with Dr. Eudy

Author: Jennie Welter

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