101

Re: Omidria

In The Ophthalmologist Journal/magazine (whatever it is)

Making Cataract Surgery Child’s Play
The FDA’s first approved drop for the prevention of intraoperative miosis and reduction of postoperative pain in pediatric patients undergoing cataract surgery has arrived. But does it warrant the excitement?
M. Edward Wilson | 07/01/2021 | Longer Read

   
In children, cataracts are responsible for more visual disability than any other form of treatable blindness. In the US, more than 200,000 children are blind from unoperated cataracts, complications of cataract surgery, or the general effects of cataracts (1). The socioeconomic and quality-of-life costs associated with a lifetime of blindness stemming from untreated visually significant cataracts are huge, and estimates put the cumulative risk of cataract during the growing years as high as 1 per 1,000 (2). Fortunately, not all childhood cataracts require removal.

The complexity of cataract surgery in children demands that the surgeon has a high degree of confidence and competence. Cataract surgeons who specialize in adult surgery often lack training in the techniques specific to pediatric intraocular surgery; therefore, cases should be done by ophthalmic surgeons who perform them on a weekly or biweekly basis to ensure competency. Whenever possible, children should be referred to regional centers with significant experience (3).

Challenges of the pediatric eye
Cataract surgery in children poses several specific challenges. Anatomically, a child's eye is smaller, softer, and more flexible compared with an adult eye. Performing cataract surgery in an adult is akin to working inside a hard box, because the sclera is firm and holds its shape. Surgery in a pediatric eye, on the other hand, is more like working inside a squashed grape. The surgeon must maneuver the instruments within a tight space and use copious amounts of fluid to ensure that the eye retains its shape.

Another challenge in pediatric eyes is maintaining adequate intraoperative mydriasis – partly because of the lack of development.
Another challenge in pediatric eyes is maintaining adequate intraoperative mydriasis – partly because of the lack of development of the pupil dilator muscle. Stromal rigidity is also reduced, causing the iris to constrict in response to even mild amounts of trauma during the surgery. Such features are consistent with adult intraoperative floppy-iris syndrome. Preservative-free epinephrine may be used intraoperatively in the irrigating solution – a step that has been routine in children long before it was seen as a need in even the most unusual adult cases.


Tools for more predictable surgeries
Following the approval of Omidria (phenylephrine and ketorolac intraocular solution, 1%/0.3%; Omeros Corporation) for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative ocular pain in adult cataract surgery, the company conducted a study in pediatric patients (4); I was an investigator. It was not possible to use a control arm that did not include treatment (in other words, no additive to the BSS) in this patient population; therefore, we randomized subjects to phenylephrine plus ketorolac or phenylephrine alone. As a result, we were also able to evaluate the effect of the nonsteroidal anti-inflammatory agent (ketorolac) on pain. Because the use of phenylephrine is off-label in pediatric cataract surgery, the manufacturer provided both the phenylephrine plus ketorolac product and the phenylephrine for the purposes of the study.

The multicenter, double-masked Phase 3 registration trial was conducted at 17 US sites to compare the safety of phenylephrine and ketorolac 1.0%/0.3% (PE/K 1.0%/0.3%) with phenylephrine 1.0% (PE 1.0%) in children undergoing cataract surgery who were aged from birth to three years old – a notoriously difficult age group for surgery. We also measured intraoperative pupil diameter and postoperative pain. The safety endpoints were evaluated up to 90 days postoperatively. A masked central reader looking at surgical videos measured change in pupil diameter from immediately prior to incision to wound closure. Postoperative pain was measured using the Alder Hey Triage Pain Score at 3, 6, 9, and 24 hours following wound closure. The parent/caregiver recorded the results.

It is important to note that this study was powered to assess safety only given that the FDA indicated that efficacy could be extrapolated from the prior pivotal trial results that were the basis for FDA approval in the adult population. Consistent with the primary objective of assessing safety, enrollment was limited to 78 patients of whom 72 patients were ultimately randomized; no notable changes in vital signs or ophthalmological complications were observed in either group. The mean change in pupil diameter was similar between PE/K 1.0%/0.3% and PE 1.0% (mean difference in AUC -0.071; P = .599). Despite the study design’s relatively limited sample size, the postoperative ocular pain scores and overall mean scores were lower in the PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P = 0.029 and 0.021, respectively).

In short, the study demonstrated that PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. And showed that postoperative pain levels were lower in the PE/K 1.0%/0.3% group. The results of which were published in the Journal of Cataract and Refractive Surgery (4).


Addressing a moving target
Removing the cataract in a pediatric eye is only part of the procedure; a child’s eye is still growing, so implant choice is critically important. Indeed, the growing eye represents a moving target – with the surgeon attempting to predict the development of the eye’s future refractive error.

When the cataract is removed, so too is an essential regulator of refractive error in the growing eye.
When an adult has cataract surgery, refractive error is corrected at the same time, making cataract surgery a truly refractive procedure. In a pediatric eye, it is the opposite. When the cataract is removed, so too is an essential regulator of refractive error in the growing eye. The lens is replaced with an implant that does not change, thereby derailing the process of emmetropization. And that’s why the procedure is only performed when absolutely necessary.

To summarize, pediatric cataract surgery is exceedingly challenging but not impossible. In such cases, it is helpful to remove the unknowns and create a process for as much of the surgery as possible to ensure a good outcome. With Omidria now FDA-approved for preventing intraoperative miosis and reducing postoperative ocular pain in children, pediatric surgeons can have added confidence and greater predictability of outcomes while performing these complex procedures.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

102

Re: Omidria

Implications for Omidria and NOPAIN

STAT
Biden nominates West Virginia’s Rahul Gupta as drug czar

Former West Virginia health commissioner and current March of Dimes executive Rahul Gupta has been picked as President Biden's nominee for director of the Office of National Drug Control Policy. The agency oversees drug-related policy and informs decisions made by other related agencies including the the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration. The pick, which was first reported by the Washington Post, comes as opioid overdose deaths are rising alongside a related increase in HIV/AIDS and hepatitis C cases. As West Virginia health commissioner, Gupta had firsthand experience with the addiction crisis and related rise in infectious disease, but was involved in controversy surrounding his treatment of a well-known needle exchange in Charleston.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

103

Re: Omidria

2022 Proposed rule is out and there is one mention of Omidria, which is code 66984

A stakeholder nominated CPT codes 66982 through 66986 as potentially misvalued, as  they have not been valued in the non-facility/office setting. This stakeholder did not submit  other details or reasoning to support their nomination. We note that some of these cataract related procedures were initially reviewed and valued in CY 2020 PFS final rule (84 FR 62751),  and that presently, additional codes in this family are scheduled to be reviewed and valued in this  CY 2022 PFS proposed rule (we refer readers to section II.E. of this proposed rule, Valuation of  Specific Codes). The highest utilization of these cataract codes are CPT code 66982  (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage  procedure), manual or mechanical technique (e.g., irrigation and aspiration or  phacoemulsification), complex, requiring devices or techniques not generally used in routine  cataract surgery (e.g., iris expansion device, suture support for intraocular lens, or primary  posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage;
without endoscopic cyclophotocoagulation) and CPT code 66984 (Extracapsular cataract  removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical  technique (e.g., irrigation and aspiration or phacoemulsification); without endoscopic  cyclophotocoagulation). In 2018 and 2019, these services were almost all performed in the ASC  facility setting, but based on 2020 claims, the most common setting appears to have shifted to the  hospital inpatient or hospital outpatient facility setting. There is no case presented here that  constitutes a misvaluation of CPT codes 66982 to 66986, and therefore, we are not inclined to  put this code family forward as potentially misvalued for CY 2022; however, we welcome  additional comment, including any analysis or studies demonstrating that one or more of these  codes meet the criteria listed above under “Identification and Review of Potentially Misvalued  Services,” particularly in regard to any changes in the resources to providing a service, or are  otherwise potentially misvalued.
TABLE 7: Stakeholders’ Nominations of CPT Codes as Potentially Misvalued for CY 2022
CPT..... CPT Descriptor
22551 Neck spine fuse&remov bel c2
49436 Embedded ip cath exit-site
55880 Abltj mal prst8 tiss hifu
59200 Insert cervical dilator (PE supply)
66982 to 66986 Cataract codes

I think this changes nothing for Omidria but will check with Greg.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

104

Re: Omidria

I have been studying the document (I have a copy but I do not have the link and I wasted a lot of time trying to get one, so I gave up). There are other references to the cataract lens replacement, but they do not seem relevant. I have also asked Greg whether anything has changed because of the CMS document.

But I believe this document is more about the Doctor's fees schedules for different procedures, and NOT drug reimbursement.

Usually, Omidria is in the CMS document about the Proposed and Official RULES for ASCs (the non-hospital surgical centers where the procedures are usually performed in).

The document for that should happen, if I recall correctly about 1 week before the end of this month. Now is earlier than usual and this document has no mention at all about Omidria (which is good).

From prior things I have heard, I don't think that CMS pays for Omidria in hospitals... but i am not sure. This document suggests that the number of lens replacements are increasing in hospitals, but that is the only useful thing I noticed.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

105

Re: Omidria

the 2022 Proposed Rule is out
https://www.cms.gov/newsroom/fact-sheet … cal-center

I have not gone through it  yet. Will report back when I do.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

106

Re: Omidria

This sound like it could be about Omidria. It was posted elsehwere out of context.

CMS proposes that beginning on or after January 1, 2022, a non-opioid pain management drug or biological that functions as a surgical supply in the ASC setting would be eligible for separate payment when it is FDA approved and indicated for pain management or as an analgesic, and with a per day cost above the OPPS/ASC drug packaging threshold. Accordingly, CMS is proposing to continue separate payment in the ASC setting in CY 2022 for the two products currently receiving separate payment under this policy since they meet the proposed criteria.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

107

Re: Omidria

Finally got it, here:
https://public-inspection.federalregist … -15496.pdf

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

108

Re: Omidria

The most important thing is that Omidia will be reimbursed in the ASC in 2022.
That is in the material below, also other things related but not crucial now. I have yet to search the rest of the document. Maybe later I will have more. The CMS document may be responsible for the rise in OMER price. espcially  because there is something in there that will allow a pitch to be made to allow Omidria separate payment in the Hospital setting, not just the ASCs.

In the CY 2021 OPPS/ASC final rule with comment period (85 FR 85896 to 85899), we
continued the policy to pay separately at ASP plus 6 percent for non-opioid pain management
drugs that function as surgical supplies in the performance of surgical procedures when they are
furnished in the ASC setting and to continue to package payment for non-opioid pain
management drugs that function as surgical supplies in the performance of surgical procedures in
the hospital outpatient department setting for CY 2021. For CY 2021, only two drug products
met the criteria as non-opioid pain management drugs that function as surgical supplies in the
ASC setting, and thus receive separate payment under the ASC payment system. These drugs are
Exparel and Omidria.

(2) CY 2022 Evaluation of Payments for Opioids and Non-Opioid Alternatives for Pain
Management and Comment Solicitation on Extending the Policy to the OPPS
As noted in the background above, over the past several years we have reviewed
non-opioid alternatives and evaluated the impact of our packaging policies on access to these
products. In our previous evaluations, we used currently available data to analyze the payment
and utilization patterns associated with specific non-opioid alternatives, including drugs that
function as a supply, nerve blocks, and neuromodulation products, to determine whether our
packaging policies may have reduced the use of non-opioid alternatives. In the CY 2021
OPPS/ASC final rule with comment period (85 FR 85896 to 85899), we stated that we would
continue to analyze the issue of access to non-opioid pain management alternatives in the HOPD
and the ASC settings as part of any reviews we conduct under section 1833(t)(22)(A)(ii), with a
specific focus on whether there is evidence that our current payment policies are creating access
barriers for other non-opioid pain management alternatives for which there is evidence-based
support that these products help to deter or avoid prescription opioid use and opioid use disorder.
For CY 2022, we conducted a subsequent review of payments for opioids and non-opioid
alternatives as authorized by section 1833(t)(22)(A)(ii). We analyzed utilization patterns in both
the HOPD and ASC settings for multiple non-opioid pain management drugs, including the two
drugs that are receiving separate payment when furnished in the ASC setting under our current
policy for CY 2021: Exparel and Omidria. The results of our CY 2022 review were similar to
the results of our reviews in previous years. Generally, utilization of non-opioid pain
management drugs continued to increase year after year in the HOPD setting, where payment for
these non-opioid alternatives is packaged with the payment for the associated surgical procedure.
In the ASC setting, where Exparel and Omidria are separately paid, we also saw utilization
increases for these two drugs. However, in the ASC setting, the rate of increase in utilization is
much more substantial than in the HOPD setting. In particular, in the HOPD setting where
payment for Exparel is packaged, utilization of Exparel increased from 19.7 million units in 2019
to 21.8 million units in 2020, whereas utilization of Exparel increased from 1.5 million units in
2019 to 3.3 million units in 2020 in the ASC setting, where Exparel is separately paid. We note
that a number of reasons could explain this discrepancy other than our policy to pay separately
for Exparel under the ASC payment system, including evolving clinical practice in the ASC
setting, which could increase the number of surgeries performed in ASCs for which Exparel is an
appropriate pain management drug.
We have consistently explained, including as recently as in the CY 2021 OPPS/ASC final
rule with comment period (85 FR 85894), that our packaging policies support our strategic goal
of using larger payment bundles in the OPPS to maximize hospitals' incentives to provide care in
the most efficient manner. For example, where there are a variety of devices, drugs, items, and
supplies that could be used to furnish a service, some of which are more costly than others,
packaging encourages hospitals to use the most cost-efficient item that meets the patient's needs,
rather than to routinely use a more expensive item, which may occur if separate payment is
provided for the item. We have not found conclusive evidence to support the notion that the
OPPS packaging policy, under which non-opioid drugs and biologicals are packaged when they
function as a supply in a surgical procedure, has created financial incentives to use opioids
instead of evidence-based non-opioid alternatives for pain management. For example, we have
not observed decreased utilization of non-opioid alternatives for pain management in the HOPD
setting. Therefore, for CY 2022, we are proposing to continue to package payment for nonopioid pain management drugs that function as surgical supplies in the performance of surgical
procedures in the hospital outpatient department setting.
As explained earlier in this section, while packaging encourages efficiency and is a
fundamental component of a prospective payment system, where there is an overriding policy
objective to reduce disincentives for use of non-opioid products to the extent possible, we
believe it may be appropriate to establish payment that reduces disincentives for use of nonopioid drugs and biologicals for pain management when there is evidence that use of those
products reduces unnecessary opioid use. For these reasons, we are soliciting comment as to
whether we should expand our current policy that only applies in the ASC setting—to pay
separately at ASP plus 6 percent for non-opioid pain management drugs that function as surgical
supplies in the performance of surgical procedures when they are furnished in the ASC setting—
to the HOPD setting. We are interested in learning from stakeholders whether similar
disincentives for the use of non-opioid pain management drugs and biologicals identified in the
ASC setting exist in the HOPD setting. Previously, in the CY 2019 OPPS/ASC final rule with
comment period (83 FR 59067), we identified several disincentives that were unique to the ASC
setting compared to the HOPD setting, including the fact that ASCs tend to provide specialized
care and a more limited range of services in comparison to hospital outpatient departments. Also,
ASCs are paid, in aggregate, approximately 55 percent of the OPPS rate. Therefore, fluctuations
in payment rates for specific services may affect these providers more acutely than hospital
outpatient departments; and ASCs may be less likely to choose to furnish non-opioid
postsurgical pain management treatments, which are typically more expensive than opioids, as a
result. Additionally, we are seeking comment on what evidence supports the expansion of this
policy to the HOPD setting, including the clinical benefit that Medicare beneficiaries may
receive from the availability of separate or modified payment for these products in the HOPD
setting.
Finally, we are seeking comment on if we should treat products the same depending on
the setting, ASC or HOPD. For example, we are seeking comment on whether products should
have the same eligibility requirements to qualify for revised payment in the ASC and the HOPD
settings. We are additionally seeking comment on how the additional comment solicitations
described below, which refer to the ASC setting, could also be applied to the HOPD setting.
(3) Proposed Criteria for Eligibility for Separate Payment under the ASC Payment System for
Non-Opioid Pain Management Drugs and Biologicals that Function as Surgical Supplies
As described in section 1833(t)(22)(A)(i) of the Act, the Secretary shall conduct a review
of payments for opioids and evidence-based non-opioid alternatives for pain management with a
goal of ensuring that there are not financial incentives to use opioids instead of non-opioid
alternatives. In any future reviews the Secretary may determine appropriate to conduct under
section 1833(t)(22)(A)(ii) of the Act, we believe it is important to establish the evidence-base for
non-opioid alternatives for pain management when evaluating whether current payment policies
result in an incentive for providers to use opioids instead of such evidence-based non-opioid
alternatives for pain management. Accordingly, for CY 2022 and subsequent years, we are
proposing two criteria that non-opioid pain management drugs and biologicals would be required
to meet to be eligible for a payment revision under the ASC payment system in accordance with
section 1833(t)(22)(C). The proposed criteria are intended to identify non-opioid pain
management drugs and biologicals that function as supplies in surgical procedures for which
revised payment under the ASC payment system would be appropriate.
Specifically, for CY 2022, we are proposing the following criteria that non-opioid pain
management drugs and biologicals would be required to meet to be eligible for separate payment
under the ASC payment system in accordance with section 1833(t)(22)(C):
Criterion 1: FDA Approval and Indication for Pain Management or Analgesia
We propose that the drug or biological product must be safe and effective, as determined
by the FDA. We propose that the drug must be approved under a new drug application under
section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), generic drug application
under an abbreviated new drug application under section 505(j), or, in the case of a biological
product, be licensed under section 351 of the Public Health Service Act. We further propose that
the drug or biological must also have an FDA-approved indication for pain management or
analgesia. We believe FDA approval is an appropriate requirement for a drug or biological to be
eligible for this policy because the FDA reviews drugs and biologicals for safety and
effectiveness, which would allow us to identify safe and effective non-opioid products to which
this separate payment policy should apply. Given that the FDA has an existing and detailed
review process already in place to review drugs and biologicals, we believe it would be
appropriate and administratively efficient to utilize FDA approval as a requirement to ensure that
the drugs and biologicals approved under this policy are generally safe and effective for
beneficiaries. We believe the vast majority of drugs and biologicals on the market have
undergone FDA review and approval, and we do not anticipate this criterion would prevent
otherwise eligible drugs or biologicals from qualifying. In addition, section 1833(t)(22)(C) of the
Act, our current policy, and our proposed policy all focus on pain management products.
Specifically, section 1833(t)(22)(C) of the Act refers to reviews of opioid and evidence-based
non opioid products for pain management. Therefore, we propose to require an FDA-approved
indication for pain management or analgesia for a drug or biological to qualify as a pain
management product. The FDA approval process would allow us to confirm that a drug or
biological is, in fact, a non-opioid. Drugs and biologicals that are approved as opioids or opioid
agonists, or that receive an opioid-related approval from the FDA would not be eligible for
separate payment under this policy.
Criterion 2: Cost of the Product
Currently, under the OPPS, drugs that are not policy-packaged are subject to the drug
packaging threshold. In accordance with section 1833(t)(16)(B) of the Act, the threshold for
establishing separate APCs for payment of drugs and biologicals was set at $50 per
administration during CYs 2005 and 2006. We set the packaging threshold for establishing
separate APCs for drugs and biologicals through annual notice and comment rulemaking. (Please
see section V.B.1.a. of this proposed rule for additional details on the drug packaging threshold
policy). The proposed per-day drug packaging threshold for CY 2022 is $130.
As our second criterion, we are proposing that a drug or biological would only be eligible
for a payment revision under the ASC payment system in accordance with section
1833(t)(22)(C) if its per-day cost exceeds the drug packaging threshold described in section
V.B.1.a. of this rule. We believe this is an appropriate requirement because we believe that not
all non-opioid alternative treatments are equally disincentivized by our packaging policies. In
particular, the cost of non-opioid drugs and biologicals below the packaging threshold of $130
per day does not generally have a significant impact on the overall procedure costs, and we
believe use of these drugs and biologicals is unlikely to be disincentivized by CMS packaging
policies. However, when the per-day cost of the drug is above the drug packaging threshold, the
cost of these drugs or biologicals generally has a significant impact on the overall procedure
costs. Section 1833(t)(22)(A)(i) of the Act discusses financial incentives to use opioids instead of
non-opioid alternative treatments. As such, we do not believe non-opioid pain management drugs
that are lower in cost are generally disincentivized by our packaging policies, as their cost is
more easily absorbed into the payment for the primary procedure in which they are used when
compared to drugs and biologicals above the threshold. We are proposing to use the existing
OPPS drug packaging threshold as it is familiar to stakeholders and its application to drugs and
biologicals under this policy creates uniformity across the OPPS and ASC payment systems.
Therefore, CMS is proposing that drugs and biologicals would be required to have a per-day cost
that exceeds the drug packaging threshold that CMS sets annually through notice and comment
rulemaking.
We also believe the use of this threshold as an eligibility criterion for drugs under
consideration for a payment revision under this policy is appropriate, as it conforms with the
broader goals of the OPPS and ASC payment systems. Like other prospective payment systems,
the OPPS relies on the concept of averaging to establish a payment rate for services. The
payment may be more or less than the estimated cost of providing a specific service or a bundle
of specific services for a particular beneficiary. The OPPS packages payments for multiple
interrelated items and services into a single payment to create incentives for hospitals to furnish
services most efficiently and to manage their resources with maximum flexibility. Our packaging
policies, including the drug packaging threshold, support our strategic goal of using larger
payment bundles to maximize hospitals’ incentives to provide care in the most efficient manner.
Packaging payments into larger payment bundles promotes the predictability and accuracy of
payment for services over time. For the reasons mentioned above, we believe it to be appropriate
to package drugs under consideration for this policy which fall below the OPPS drug packaging
threshold.
We propose that non-opioid drugs and biologicals currently receiving transitional drug
pass-through status in the OPPS would not be candidates for this policy as they are already paid
separately under the OPPS and ASC payment system. Please see section V.A., Proposed OPPS
Transitional Pass-Through Payment for Additional Costs of Drugs, Biologicals, and
Radiopharmaceuticals, of this proposed rule for additional details on transitional pass-through
payments for drugs and biologicals. We propose that once transitional drug pass-through status
expires, the non-opioid drug or biological may qualify for separate payment under the ASC
payment system if it meets the proposed eligibility requirements.
We seek comment on whether there are any other non-opioid drug or biological products
that would meet the proposed criteria if finalized.
(4) Proposed Regulation Text Changes
We propose to codify our proposed criteria for separate payment for qualifying nonopioid pain management drugs and biologicals that function as surgical supplies in the regulation
text for the ASC payment system in a new § 416.174. In particular, we propose to provide in a
new § 416.174(a)(1) that non-opioid pain management drugs or biologicals that function as a
supply in a surgical procedure are eligible for separate payment if they are approved under a new
drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA),
generic drug application under an abbreviated new drug application under section 505(j), or, in
the case of a biological product, are licensed under section 351 of the Public Health Service Act.
Section 416.174(a)(1) would also provide that the drug or biological must have an FDAapproved indication for pain management or analgesia. New § 416.174(a)(2) would require that
the per-day cost of the drug or biological must exceed the OPPS drug packaging threshold set
annually through notice and comment rulemaking.
We also propose to amend § 416.164(b)(6) to provide that non-opioid pain management
drugs and biologicals that function as a supply when used in a surgical procedure as determined
by CMS under § 416.174 are ancillary items that are integral to a covered surgical procedure and
for which separate payment is allowed. We also propose to amend § 416.171(b)(1) to provide
that the payment rate for non-opioid pain management drugs and biologicals that function as a
supply when used in a surgical procedure as determined by CMS under § 416.174 are paid an
amount derived from the payment rate for the equivalent item or service under the OPPS, and if
such a payment amount is unavailable, are contractor priced.
(5) Eligibility for Separate Payment in CY 2022 for Exparel, Omidria, and Other Non-Opioid
Products for Pain Management
As discussed in the CY 2021 OPPS/ASC final rule with comment period, there are two
products receiving separate payment in the ASC setting under our current policy to pay
separately for non-opioid pain management treatments that function as surgical supplies when
furnished in the ASC setting (85 FR 86171). These two products are Exparel (HCPCS Code
C9290, Injection, bupivacaine liposome, 1 mg) and Omidria (HCPCS Code J1097,
phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml).
Based on the current information available to us, as we explain below, we are proposing that
both products would be eligible for separate payment in CY 2022 under our proposed policy. We
have included our initial evaluation of these two products below.
(a) Eligibility for Separate Payment in CY 2022 for Exparel under the Proposed Eligibility
Criteria
We are proposing that Exparel would continue to receive separate payment in the ASC
setting as a non-opioid pain management drug that functions as a surgical supply for CY 2022.
Based on CMS’s internal review, we believe Exparel meets criterion 1. Exparel was approved by
the FDA with a New Drug Application (NDA #022496) on 10/28/2011.2
Exparel’s FDAapproved indication is “in patients 6 years of age and older for single-dose infiltration to produce
postsurgical local analgesia (1). In adults as an interscalene brachial plexus nerve block to
2
Exparel. FDA Letter. 28 October 2011.
https://www.accessdata.fda.gov/drugsatf … 00ltr.pdf.
produce postsurgical regional analgesia”.3
No component of Exparel is opioid-based.
Accordingly, we propose that Exparel meets criterion one.
As discussed in section (3) above, for criterion two we are proposing that a drug or
biological would only be eligible for separate payment under this policy if its per-day cost
exceeds the drug packaging threshold described in section V.B.1.a. of this rule. The proposed per
day cost threshold for CY 2022 is $130. Using the methodology described at V.B.1.a., the per
day cost of Exparel exceeds the $130 per day cost threshold. Therefore, we propose that Exparel
meets criterion two.
Therefore, we are proposing that Exparel meets criteria one and two, and should receive
separate payment under the ASC payment system for CY 2022.
(b) Eligibility for Separate Payment for Omidria in CY 2022 under the Proposed Eligibility
Criteria
We are proposing that Omidria would continue to receive separate payment in the ASC
setting as a non-opioid pain management drug that functions as a surgical supply for CY 2022.
Based on our internal review, we believe Omidria would meet criterion one. Omidria was
approved by the FDA with a New Drug Application (NDA #205388) on 5/30/2014.4
Additionally, Omidria’s FDA-approved indication is as “an alpha 1-adrenergic receptor agonist
and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing
intraoperative miosis; Reducing postoperative pain”.5
No component of Omidria is opioid-based.
Therefore, we propose that Omidria would meet proposed criterion one.
Using the methodology described at V.B.1.a., the per day cost of Omidria exceeds the
$130 per day cost threshold. Therefore, we propose that Omidria meets criterion two.
3
Exparel. FDA Package Insert. 22 March 2021.
https://www.accessdata.fda.gov/drugsatf … 35lbl.pdf.
4
Omidria. FDA Letter. 30 May 2014.
https://www.accessdata.fda.gov/drugsatf … 00ltr.pdf.
5
Omidria. FDA Package Insert. 08 December 2017.
https://www.accessdata.fda.gov/drugsatf … 06lbl.pdf.
Therefore, we are proposing that Omidria meets criteria one and two, and should receive separate
payment under the ASC payment system for CY 2022.
(6) Comment Solicitation on Policy Modifications and Potential Additional Criteria for Revised
Payment for Non-Opioid Pain Management Treatments
In addition to the proposed eligibility criteria above, we are also soliciting comment on
potential policy modifications and additional criteria that may help further align this policy with
the intent of section 1833(t)(22) of the Act. Below we discuss potential additional criteria. We
note that, depending on the public comments we receive and our continued consideration of
these potential criteria, we may adopt these criteria as part of our final policy and include them in
the final regulation text; accordingly, we are providing substantial details, explanations, and
considerations about these potential criteria. We welcome input from stakeholders on these and
any additional policy modifications or criteria they believe would enhance our proposed policy.
We are also soliciting comment on other barriers to access to non-opioid pain management
products that may exist, and to what extent our policies under the OPPS or ASC payment system
could be modified to address these barriers.
(a) Utilization of the Product
We have historically used utilization as a metric to determine whether a change in our
payment policy was necessary to determine whether our policies create a disincentive to use nonopioid alternatives. For example, as previously discussed, Exparel’s decreasing utilization in the
ASC setting caused us to propose to pay separately for non-opioid pain management drugs that
function as surgical supplies in the ASC setting. We have used currently available claims data in
prior years to analyze the payment and utilization patterns associated with specific non-opioid
alternatives to determine whether our packaging policies may have reduced the use of non-opioid
alternatives. We believe that higher utilization may be a potential indicator that the packaged
payment is not causing an access to care issue and that the payment rate for the primary
procedure adequately reflects the cost of the drug or biological. We also believe decreased
utilization could potentially indicate that our packaging policy is discouraging use of drug or
biological and that providers are choosing less expensive treatments. We note that it is difficult
to attribute product-specific changes in utilization to our packaging policies alone. Nonetheless,
while we acknowledge certain limitations of utilization data, we believe analyzing utilization
either on a product-specific basis or on a broader basis could be an important criterion in
determining whether separate payment is warranted for a non-opioid pain management
alternative.
Therefore, we are soliciting comment on whether specific evidence of reduced utilization
should be part of our evaluation and determination of whether a non-opioid pain management
product should qualify for modified payment. This data may help to demonstrate that our
packaging policies are causing an access issue for these products. Additionally, we realize that
new products to the market may not have utilization data available, or reliable utilization data
may be difficult to obtain for some products; therefore, we are also requesting comment on
whether utilization data requirements should vary based on the newness of a product or its FDA
marketing approval date.
(b) FDA Indication for Pain Management or Analgesia for the Drug or Biological Product
As previously discussed, section 1833(t)(22)(A) of the Act specifically refers to reviews
of opioid and evidence-based non opioid products for pain management. We believe the majority
of drugs and biologicals that would meet the requirements of our proposed policy would already
have FDA approval as a pain management drug or as an analgesic. However, we acknowledge
there may be other non-opioid products that would benefit from inclusion under this policy, but
do not have a specific FDA-approved indication for pain management or analgesia, and would
not satisfy criterion 1. Therefore, we are soliciting comment on whether we should allow certain
FDA-approved drugs and biologicals to be eligible for separate payment under this policy
without a specific FDA-approved indication for pain management or as an analgesic drug. In lieu
of an FDA indication for pain management or analgesia, we are seeking comment on whether it
would be appropriate to approve a product for inclusion under this policy if the painmanagement or analgesia attributes of the drug or biological are recognized by a medical
compendium. Similarly, we are seeking comment as to whether we should consider specialty
society or national organization (such as a national surgery organization) recommendations of
non-opioid pain management products that function as surgical supplies and reduce opioid use in
the ASC setting, as evidence that a product meets criterion one, where a drug or biological does
not have an FDA indication for pain management or analgesia.
(c) Peer-reviewed Literature Requirement Comment Solicitation
We note that section 1833(t)(22)(B) requires the Secretary to focus on covered OPD
services (or groups of services) assigned to a comprehensive ambulatory payment classification,
ambulatory payment classifications that primarily include surgical services, and other services
determined by the Secretary that generally involve treatment for pain management. We are also
soliciting comment as to whether we should only adopt a payment revision to drugs and
biologicals that function as surgical supplies in the ASC setting when those products have
evidence in peer reviewed literature supporting that the product actually decreases opioid. We
believe this may be appropriate to ensure Medicare payment policies would not financially
incentivize use of opioids rather than evidence-based non-opioid alternative treatments, as
required by section 1833(t)(22)(A)(iii) of the Act. Specifically, we are seeking comment as to
whether the drug or biological’s use in a surgical procedure as a non-opioid pain management
product should be supported by peer-reviewed literature demonstrating a clinically significant
decrease in opioid usage compared to the standard of care, and we are seeking comment on
whether such decreases in opioid usage should be sustained decreases that continue into the postoperative period.
Additionally, we are seeking input from commenters as to what they believe the
requirements for peer-reviewed literature requirements should be. For example, we are seeking
stakeholder feedback as to whether peer-reviewed literature should demonstrate that use of the
drug or biological results in at least one, or several, of the following: decreased post-operative
opioid use following surgery; decreased opioid misuse following surgery; or decreased opioid
use disorder and dependency following surgery.
Additionally, we ask stakeholders if specific thresholds are necessary to determine
whether these decreases are statistically and clinically significant and whether the decreases
should simply be measured against placebo or the standard of care. We also request information
on how stakeholders would define the standard of care in these circumstances. When evaluating
literature, we would expect to examine the study methods, sample size, limitations, possible
conflicts of interest, patient populations studied, and how the evidence supports the conclusion
that the product can serve as a non-opioid pain management product and provide a clinically
significant reduction in opioid use that continues into the post-operative period. However, we
welcome input from stakeholders about additional aspects of these studies that they believe CMS
should focus on for this potential criterion. Additionally, we would expect to use our discretion
to assess whether the submitted studies meet these criteria, as well as for clinical applicability,
literature integrity, and potential biases in consultation with our clinical advisors.
In order to provide stakeholders with some examples of what supporting evidence CMS
may consider for this potential criterion, we believe it would be helpful for CMS to receive
literature demonstrating that use of a non-opioid drug or biological results in a statistically and
clinically significant decreased day supply of outpatient opioids prescribed after surgery
discharge compared to the generally accepted standard of care, or a statistically and clinically
significant decreased morphine milligram equivalents (MME) per opioid dose prescribed after
surgery discharge compared to the generally accepted standard of care. We would consider the
generally accepted standard of care to include pain management therapy a patient would receive
in the absence of the non-opioid alternative, such as the use of localized analgesia and/or an
opioid. As previously discussed, we would then expect the use of a non-opioid pain management
drug or biological to result in a decline in opioids used compared to the pain management
therapy a patient would receive in the absence of the non-opioid alternative. We would expect
this decline in opioids to include a decreased number of opioids received by a patient
intraoperatively, post-operatively, and most significantly at discharge. We are soliciting
comment on additional examples or measures that would be beneficial for CMS to take into
consideration. Additionally, we are seeking comment on whether we should require a specific
objective measure for this criterion. We also seek input on how to assess whether changes are
statistically and clinically significant. We request comment on whether stakeholders believe
evidence of statistical significance should be sufficient, or whether stakeholders believe the
literature should also demonstrate clinically significant differences between treatment groups as
well.
(d) Alternative Payment Mechanisms for Non-Opioid Drugs and Biologicals
As previously discussed, for CY 2022, we are proposing to pay separately at ASP plus 6
percent for non-opioid pain management drugs and biologicals that function as surgical supplies
in the performance of surgical procedures when they are furnished in the ASC setting and meet
our other proposed criteria. Section 1833(t)(22)(A)(iii) requires the Secretary to consider the
extent to which revisions payments (such as the creation of additional groups of covered OPD
services to classify separately those procedures that utilize opioids and non-opioid alternatives
for pain management) would reduce payment incentives to use opioids instead of non-opioid
alternatives for pain management. Accordingly, separate payment is not the only possible
revision that may be appropriate. We seek comment on additional payment mechanisms that may
be appropriate aside from separate payment. For instance, we request feedback from stakeholders
as to whether a single, flat add-on payment, or separate APC assignment, for products or
procedures that use a product that meets eligibility criteria would be preferable to separate
payment. We note that any revisions the Secretary determines appropriate under section
1833(t)(22)(C) must be applied in a budget neutral manner under section 1833(t)(9)(B). We also
seek input from stakeholders on any other innovative payment mechanisms for eligible nonopioid drugs and biologicals for pain management.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

109

Re: Omidria

I congratulated Greg and his people to get this done, on your behalf and made some point about how easy it is to show that Omidria is not used because of being bundled in the hospital out patient setting. He said they have made these arguments before and he will respond to CMS's request for comments. If they can convince CMS it will be a big help because about 35% of procedures are as an outpatient, and that is rising. Omidria gets almost none of these, judging from totla revenue when there is no reimbursement in ASCs.

Plus residents and interns train in hospital so it is good to get them using Omidria from the very start.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

110

Re: Omidria

In the PR announcing the Proposed Rules
https://www.cms.gov/newsroom/fact-sheet … cal-center
they covered the Omidria case, but not by name.

Payment for Non-Opioid Products Under Section 6082 of the SUPPORT Act

The law requires that the Secretary must review payments under the OPPS and ASC for opioids and evidence-based non-opioid alternatives for pain management to ensure there are not financial incentives to use opioids instead of non-opioid alternatives. For CY 2022, CMS is proposing to modify its current policy, adopted under section 1833(t)(22)(A) and section 1833(i)(8), as added by section 6082(a) and (b), respectively, of the SUPPORT Act, to provide for separate or modified payment for non-opioid pain management drugs and biologicals that function as supplies in the ASC setting when those products meet certain criteria, as determined by CMS.

CMS proposes that beginning on or after January 1, 2022, a non-opioid pain management drug or biological that functions as a surgical supply in the ASC setting would be eligible for separate payment when it is FDA approved and indicated for pain management or as an analgesic, and with a per day cost above the OPPS/ASC drug packaging threshold. Accordingly, CMS is proposing to continue separate payment in the ASC setting in CY 2022 for the two products currently receiving separate payment under this policy since they meet the proposed criteria.

CMS is soliciting comment on establishing an application process, through which an external party could submit an application for separate payment for a non-opioid pain management drug or biological that functions as a surgical supply.

In addition, CMS is soliciting comment on several additional criteria that could be implemented through future rulemaking, such as the presence of peer-reviewed literature that demonstrates a clinically significant decrease in opioid use for the surgical procedure and post-operative period.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

111

Re: Omidria

More Congress people signed onto NOPAIN lately.

Sen. Manchin (D WV) is key in getting NO PAIN passed.

They are paying him plenty in the infrastructure Bill:

http://twitter.com/energydems/status/14 … 87428?s=21
GREAT NEWS: The abandoned mine cleanup provisions included in Chairman @Sen_JoeManchin’s bipartisan Energy Infrastructure Act would create 1,730 jobs & generate $4.3 billion in economic output over 15 years in West Virginia, according to a new report.

Hope he wants more...like NOPAIN in the same Bill or an earlier one.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

112

Re: Omidria

Greg wrote back, as usual, he's careful to not divulge anything new.

Thanks, Alan — will pass along to the team.
As you would imagine, we plan to make the case that lack of reimbursement in the HOPDs has limited utilization.  This case we have made before and is in the public record.  Can’t predict CMS’ response. I was, though, impressed by their thoughtful and detailed handling of the non-opioid exclusion.

And, since I want to get some useful information about the size of the OPPS (Hospital Out Patient) market, I replied with some questions.

Thanks for the reply, Greg.
I have been wondering whether you had made your argument to CMS after Section 6082 of the SUPPORT Act was passed (see below).

Can you please tell me whether Omidria had Separate Reimbursement in the OPPS during the initial Pass-Through period immediately after approval?

Did it have separate payment at any other time, or has it been bundled since the end of initial Pass-Through?

I find the potential exciting if CMS is now honest and thoughtful. Being reimbursed in the hospital setting should also increase the future ASC revenue, given the surgical residents getting trained in hospitals.
Best...
Alan

Payment for Non-Opioid Products Under Section 6082 of the SUPPORT Act

The law requires that the Secretary must review payments under the OPPS and ASC for opioids and evidence-based non-opioid alternatives for pain management to ensure there are not financial incentives to use opioids instead of non-opioid alternatives.

I hope he will write back so I can try to do some rough modeling on future revenues.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

113

Re: Omidria

I got the June Omidria Symphony channel check data for revenue. I t was a nice improvement and te second highest month ever. I have copied the image to FB so it can serve as a host for putting it here.

https://scontent.fpac1-2.fna.fbcdn.net/v/t39.30808-6/223221753_1914518145390094_3532009377113979115_n.jpg?_nc_cat=100&ccb=1-3&_nc_sid=730e14&_nc_ohc=-kfOuJns5c0AX8mEmzK&_nc_ht=scontent.fpac1-2.fna&oh=7302126aec1f279061dade9193550d64&oe=60FEFC74

As I have explained each time I write about the Symphony data, it is not tracking everything and I need to apply a correction factor to try to predict quarterly revenue. It is complicated because the correction factors change as the source of the reveue changes, I think. A higher % at the VA or in hospital interacts with whether or not there is separate reimbursement. So we can't be confident about whatever I come up with.

I am going to work on this now but it looks like it should be the 2nd best Q, ever...

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

114

Re: Omidria

I have done the comparison in a different, simpler way.

In Q3'20 Omeros reported $34.8 million gross revenue but they took a reserve of ~$8M for returns related to bundling.
The SYM# for those 3 months were 24.9M.

In Q2'21 the SYM# is 23.3, which is 6.4257% less.
Using that on the $34.8M revenue in Q3'20, I project Q2'21 Omidria Revenue to be $32.56 million.

I would round down to $32 million because the deals with the corporate multi-site ASCs probably requires additional discounts from Omeros. Of course, we don't know whether Omeros is supplying them directly and bypassing the SYM channel checks. If THAT is the case, then it could be $33M.

Bottom line is that it will be a good number and reduce the cash burn for the Q to around $20M or less, leaving something like $80M in the kitty (unless they made more narsoplimab in the period than I am guessing).

I am estimating expenses to be higher than Q1 because more narso-related staff are probably hired and burning cash without revenue, and there may have been another batch of narso made (and the cost of this is an unknown, but I am guessing a few $M.

You should look the trend in the chart of revenue.
It indicates that the period without reimbursement recover to the trendline and continues climbing. Q3 should be a record Q ($37M?) and if the trend continues we should hit close to $40M in q4. That sets 2023 up to have Omidria revenue at about $175M or a bit more.

If OMER gets full separate payment in OutPatients, then add about a 20% increase for that in 2022, maybe a 25% increase in 2024 and a 30% increase in 2025 compared to what it will be at the status quo. OPPS makes up abut 35% of lens replacements and we have almost no sales there now because it is bundled and hospitals will not foot the bill.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

115

Re: Omidria

Alan Robert Ross wrote:

That sets 2023 up to have Omidria revenue at about $75M or a bit more.

????

116

Re: Omidria

Thanks
Fixed it to $175M.

Of course, narso revenues should be higher than that by then.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

117

Re: Omidria

:thumbsup:

118

Re: Omidria

A lawfirm article about the 2002 Proposed Rule confirming the separate reimbursement for Omidria and other issues.

https://www.jdsupra.com/legalnews/2022- … e-5073768/

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

119

Re: Omidria

I assume you meant 2022, not 2002. No doubt Omidria becoming a larger source of funds for Omeros will be a good thing. But I fail to see how Omeros can turn itself into a company the size of Pfizer, for instance, so as to be able to carry on so many concurrent trials as to the rich pipeline. I’m thinking like Jim lately; it’ll be our daughter who enjoys Omeros stock profits.

120

Re: Omidria

Well PFE already has $billions in vaccine revenue.
OMER is not likely to become another PFE, Avi. It is more likely to some day become a PART of PFE.

If the Market continues to go higher and higher, forever, your grandchildren may not see the high in Omeros.
If inflation goes higher and higher along with stocks the buying power of higher priced Omeros stock may bog down. The future always has potential and risks.

I could potentially be happy enough to sell at $50 or $100 because there is a limit to the amount of money I need and I'd prefer to not be at risk... but govt. and stupid people apparently always put our future well-being at risk, because it certainly isn't THEIR priorities.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

121

Re: Omidria

Personally, I prefer 100 over 50. It would be twice as helpful as 50.....

122

Re: Omidria

And if it is $100 by yearend because of good CV19 results, EUA application and Narso HSCT approval, will you then hold out for $250?
Or $500?

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.