Implications of Hemophilia A with Bundled Ortho Surgery Pricing in the ASC

Hemophilia A and B are rare, inherited bleeding disorders that occur owing to mutations in the factor VIII or factor IX gene, respectively. Each of these clotting factors plays a role in the intrinsic pathway of blood coagulation. The Factor VIII is quite expensive and rarely used in the ASC setting.

The prevalence of hemophilia A is approximately 1 in 5000 male live births and that of hemophilia B is about 1 in 30,000 male live births. So, the conditions aren't mainstream by any means. Factor replacement is essential when planning surgery in ANY setting, but in the ASC, one has to wonder if the case is appropriate in the ASC, and if so, how is the factor replacement paid for?

And, with orthopedic cases, complications may still occur due to suboptimal dosing of factor therapy, poor medication adherence, or the development of inhibitors (antibodies that target factor VIII or factor IX). As a result, patients with hemophilia may develop orthopaedic manifestations such as hemarthrosis. Repeated bleeding into the joints, most commonly the ankle, elbow, and knee, leads to cartilage damage and degenerative articular changes, potentially leading to severe osteoarthritis.

Hemophilic arthropathy has been found to be present in approximately 90% of hemophilia patients by the third decade of life. By their 5th and 6th decades, they need knee replacements. Prior to that, they may need other elective procedures such as arthroscopic synovectomy, osteotomy, arthrodesis, arthroplasty, and revision arthroplasty may be considered in select patients.

My concern in the case of bundled pricing and transparency is that this condition presents a big, giant question mark in terms of cost predictability. As cost containment tactics are being deployed algorithmically, and not by adequately trained, knowledgeable medical personnel, the contingencies of Factor replacement, its costs, risks and complexity could be "unaddressed" and thereby create problems in bundled and transparent case rates in ASCs when exceptions arise to "normal" bundled case rates absent these complexities. Surgery in patients with hemophilia is challenging given the high risk of bleeding and infection.

1. So for starters (here she goes, I know, don't roll your eyes back at me!), the cases should not be counted among the normal, non-hemophilia surgical outcome stats. They are outliers through and through. They should be counted but not reported in the same report as post-op infections, either. Place them in their own report categories.
2. The cases should also not be priced as "normal" bundled case rates if the factor replacement is accounted for in case costs. The replacement factor should be a carve out, priced separately.
3. Care should also be taken in coding so that the exception to reported outcomes of total joint arthroplasty for hemophilic arthropathy is highlighted as an exception, and not rolled in to other totals.
4. In both local cases and cases involving medical travel, the standardized preoperative, intraoperative, and postoperative protocols must be adjusted, as well.

In pricing the case costs, consider this example protocol:

• Eloctate 4500 units twice weekly until surgery to protect against bleeding.
• Ten days before surgery, the patient completes a pharmacokinetic (PK) study using antihemophilic factor recombinant (Kogenate) 5000 units (±10%).
• The hematology team (absent in an ASC setting) then creates an individualized plan for the dosing and frequency of factor VIII infusions to assure adequate hemostasis during and after the procedure.
• Finally, the patient may be advised to stop all over-the-counter nonsteroidal anti-inflammatory drugs and vitamins 7 days before surgery per standard protocol.

Okay, so if you are a biller reading this without adequate medical background, and you've been tasked to come up with a bundled price, I could write the above in Greek, which would then look like this to you:

• Eloctate 4500 μον?δε? δ?ο φορ?? την εβδομ?δα μ?χρι τη χειρουργικ? επ?μβαση για προστασ?α απ? αιμορραγ?α.
• Δ?κα ημ?ρε? πριν απ? τη χειρουργικ? επ?μβαση, ο ασθεν?? ολοκλ?ρωσε μια φαρμακοκινητικ? μελ?τη (PK) χρησιμοποι?ντα? αντι-υδρ?φιλο παρ?γοντα ανασυνδυασμ?νο (Kogenate) 5000 μον?δε? (± 10%).
• Η ομ?δα αιματολογ?α? (απουσι?ζει σε μια ρ?θμιση ASC) στη συν?χεια δημιουργε? ?να εξατομικευμ?νο σχ?διο για τη δοσολογ?α και τη συχν?τητα των εγχ?σεων του παρ?γοντα VIII για να εξασφαλιστε? επαρκ?? αιμ?σταση κατ? τη δι?ρκεια και μετ? τη διαδικασ?α.
• Τ?λο?, μπορε? να συμβουλευτε? τον ασθεν? να σταματ?σει ?λα τα μη στεροειδ? αντιφλεγμον?δη φ?ρμακα και τι? βιταμ?νε? χωρ?? συνταγ? 7 ημ?ρε? πριν απ? τη χειρουργικ? επ?μβαση αν? πρ?τυπο πρωτ?κολλο.
• Eloctate 4500 monádes dyo forés tin evdomáda méchri ti cheirourgikí epémvasi gia prostasía apó aimorragía.
• Déka iméres prin apó ti cheirourgikí epémvasi, o asthenís oloklírose mia farmakokinitikí meléti (PK) chrisimopoióntas anti-ydrófilo parágonta anasyndyasméno (Kogenate) 5000 monádes (± 10%).
• I omáda aimatologías (apousiázei se mia rythmisi ASC) sti synécheia dimiourgeí éna exatomikevméno schédio gia ti dosología kai ti sychnótita ton enchyseon tou parágonta VIII gia na exasfalisteí eparkís aimóstasi katá ti diárkeia kai metá ti diadikasía.
• Télos, boreí na symvoulefteí ton asthení na stamatísei óla ta mi steroeidí antiflegmonódi fármaka kai tis vitamínes chorís syntagí 7 iméres prin apó ti cheirourgikí epémvasi aná prótypo protókollo.

So there, wasn't that easy? There's a reason why we don't have many bundled prices built around the nation. The competency isn't there that's adequate to mitigate errors and financial risks. No more than the competency to read and interpret Greek or Chinese or Hindi or Thai!

Then comes the course of care at the ASC:

Immediately before surgery, the patients are often given a preoperative dose of antihemophilic factor recombinant (Kogenate) 5000 units (±10%). The hematologist consulting on the case may recommend that pharmacologic venous thromboembolic event (VTE) prophylaxis should not be given as the risk for bleeding was greater than the risk for either a deep venous thrombosis (DVT) or fatal pulmonary embolism. So that medication is redacted from the costs.

The use of intermittent pneumatic compression devices (IPCDs) may be necessary perioperatively and postoperatively. Intraoperatively, an additional dose of Kogenate was available in case of unexpected or excessive bleeding. Each of these changes and equipment costs may impact the case costs, proportionately. If the ASC is licensed for 23 hours service, postoperatively, the they recommend measuring the factor VIII activity level, and a regimen of Kogenate 5000 units every 8 hours for the first 24 hours after surgery. So in 23 hour stay, that's on the ASC.

On the day of surgery, the patient receives 2 grams of intravenous (IV) cefazolin, 160 mg of IV gentamicin, and 1 gram of IV tranexamic acid before incision. These may not be your standard orders, so costs must again be adjusted to compensate.

Once the capsule was closed in a watertight manner, 1 gram of intra-articular tranexamic acid (TXA) was injected into the joint for topical hemostasis. Don't forget to price this! After the surgery, the compressive dressings, a knee immobilizer, and IPCDs are then applied. If you don't use these frequently, these too, are outlier costs.

This is one reason why when I develop international and domestic patient redirection programs that include medical travel, I become very dubious of "facilitators" who lack medical training and bundled price developers without adequate medical knowledge. And if you've seen some of the curricula for "certifications" for medical tourism facilitators, you'll know immediately why my disdain is so pronounced for these "2-3 day wonder" certification courses. People who were a cashier at the grocery store can be certified by the certifiers out there, who themselves lack this knowledge, so they sure as heck don't teach it to anyone else! But some of them attempt to charge the providers upwards of 30% of the case price to coordinate care as a layperson who is totally incompetent to manage this.

Then there are the homebound discharge orders.

On the first day after surgery (postoperative day 1), Kogenate 5000 units infusion frequency may be anticipated to be changed to once every 12 hours and titrated based on recorded factor VIII trough levels. The dose of the Kogenate infusion may be titrated to maintain a factor VIII level of greater than 80% 3 days postoperatively and greater than 50% for the remainder of the in-patient hospitalization.

Since these cases require more intensive observation, I don't recommend they be done in the ASC setting, but what about small critical access hospitals that don't have an ICU or a hematologist on regular staff?

Discharge is possible once the patient exhibits a stable hemoglobin level, postoperative hemostasis looks good, and adequate factor VIII levels can be consistently obtained.

At discharge, the infusion protocol usually skips nonsteroidal anti-inflammatory drugs for pain control due to their anti-platelet effect.

Summary points

1. Knees, ankles and elbows are most commonly affected to OA in hemophilia patients.
2. For most patients with hemophilia, the preferred means of postoperative venous thromboembolic event prophylaxis in patients with hemophilia is IPCDs and nonpharmacologic prophylaxis. These tools are different than standard orthopedic and podiatric cases, so they need to be priced differently.
3. Consider declining these cases under a bundled priced case rate in an outpatient setting. It isn't only the replacement factor that'll get you in trouble. There's longer stay, more nursing care, higher infection and complications risks, other drugs, supplies and protocols to be followed.

Hope that helps you! Questions? AskMariaTodd? | 800 727 4160