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For ophthalmology practices, drug prices continue to be an issue for patients, and step-therapy and pre-authorization are responses to increasing drug costs, which exceed any other component of healthcare. While inflation is less than 2% per year, name brand drug price increases reach double digits year after year, according to George A. Williams, MD, president of the American

That leaves industry leaders to wonder why. The argument has always been that it is expensive to develop drugs, to innovate and invest in necessary research, said Dr. Williams. who also is chairman of ophthalmology at 

“Although true, the real relationship between marketing and administrative costs for pharmaceutical companies compared with what they spend on research is approximately two to one,” he said. “Worldwide and during the past decade, there has been a static relationship between research investment and sales, averaging around 15% to 18%.”

 approves about 200 new drugs every year, with only 15 to 50 classified as new molecular entities, or NMEs. The FDA says that NMEs contain active moieties that have not been approved by the FDA previously, either as a single ingredient drug or as part of a combination product.

“Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA,” according to the FDA website.

New battles taking place in fight to control drug costs

One reason for this gap could be the U.S. patent system, Dr. Williams said. Experts have argued that drug prices keep increasing because pharmaceutical companies are running out of new agents that can command premium prices. One detailed analysis reveals that as some higher-end drugs come off-patent, manufacturers have responded by increasing the price of drugs that remain on patent.

“The system is set up to generate profits, not research and innovation,” Dr. Williams said. The majority of the costs are attributable to a relatively small number of drugs, he explained. “For Medicare Part B and Part D-where glaucoma patients live-the per capita growth rate for drug cost is 10% per year. Profit margins for the top 25 drug makers are robust, and these companies have consistently doubled the profit margins of all other companies in the Fortune 500,” Dr. Williams said. “There appears to be bipartisan support for addressing this issue.”

Pre-authorization, familiar to all physicians and ophthalmology practices, can involve drugs, devices or surgery. It is granted about 90% of the time, but it is still an impediment to patients’ access. This has piqued the interest of Congress, and the AAO has been advocating for standardization with follow-through in the pre-authorization environment. Step-therapy

“Step-therapy, a potential game-changer in the drug space, comes from the 

Centers for Medicare and Medicaid Services

 decision to allow Medicare Advantage (MA) plans the option of implementing step-therapy across all Part B drugs, including off-label compounded treatments,” Dr. Williams said.

Many questions remain, however, such as: What constitutes a trial or treatment failure? How much vision does the patient have to lose (or not gain)? What happens with the fellow eye?

“These questions create access issues for patients,” Dr. Williams said. “The Academy has been involved in step-therapy for years and will continue to speak to policy makers about the need for consistent, patient-centered coverage policies.”

There remains significant variation in coverage, however, and only 16% of drug indications are covered by all plans, Dr. Williams noted.

A comprehensive analysis indicates that less than half of drug indications are covered by 75% or more of commercial carriers. Prescribing protocols are consistent with the FDA label barely half of the time; they are more restrictive a third of the time; and 5% of the time there is no coverage even when FDA approved, according to Dr. Williams. The AAO has written to the CMS expressing concern about the impact this has on patients’ access to care, Dr Williams noted.

 report, may incentivize payers to deny access to services and payment in order to increase the profit of these private companies.

In fact, 75% of the denials the MA plans implement that are appealed are reversed, but only 1% of the denials were actually appealed.

The OIG concluded that “this is especially burdensome for beneficiaries with urgent health conditions.” This issue is likely to become more significant with the continuing expansion of MA. In 2018, 35% of Medicare beneficiaries were in Medicare Advantage with some states as high as 60%, Dr. Williams said.

Drug availability, pricing negatively affect the practice of glaucoma

One possible solution is to have Americans pay what other countries pay. “In the United States, we pay approximately 80% more for all drugs-in the retina space, it is substantially more.” Dr. Williams said.

“With Medicare part D, patients pay the first $415. Medicare pays 75% of the next 3,800. After that, patients go into the donut hole.”

The ever growing gross-to-net rebate bubble is the difference between the manufacturer’s list price and the net price, after negotiated rebates and discounts decided by pharmacy benefit managers (PBMs). Last year, it was $166 billion.

“This can produce perverse incentives for drug companies to raise prices and increase discounts, because PBMs are paid by insurers based on the amounts they negotiate for each discount,” Dr. Williams concluded. “These discounts are supposed to be shared with either the insurance provider or with the patient-but it turns out they are not, and our patients pay co-pays on the inflated price. This rebate bubble has exploded in recent years, from $59 billion in 2012 to $126 billion currently.”


	p: 248/288-2280  e: George.Williams@beaumont.edu
	This article was adapted from Dr. Williams’ presentation at the 2019 American Glaucoma Society annual meeting. Dr. Williams has no other financial disclosures related to this report.

Articles

Escalating prices continue to be an issue for patients. They also hamper treatment options for physicians.

New battles taking shape in fight to control drug costs

This article was reviewed by George A. Williams, MD


	
	For ophthalmology practices, drug prices continue to be an issue for patients, and step-therapy and pre-authorization are responses to increasing drug costs, which exceed any other component of healthcare.
	
	While inflation is less than 2% per year, name brand drug price increases reach double digits year after year, according to George A. Williams, MD, president of the American Academy of Ophthalmology.
	That leaves industry leaders to wonder why.
	
	The argument has always been that it is expensive to develop drugs, to innovate and invest in necessary research, said Dr. Williams. who also is chairman of ophthalmology at Oakland University. “Although true, the real relationship between marketing and administrative costs for pharmaceutical companies compared with what they spend on research is approximately two to one,” he said. “Worldwide and during the past decade, there has been a static relationship between research investment and sales, averaging around 15% to 18%.”
	
	


	The FDA approves about 200 new drugs every year, with only 15 to 50 classified as new molecular entities, or NMEs. The FDA says that NMEs contain active moieties that have not been approved by the FDA previously, either as a single ingredient drug or as part of a combination product.
	
	“Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA,” according to the FDA website.
	
	One reason for this gap could be the U.S. patent system, Dr. Williams said.
	
	Experts have argued that drug prices keep increasing because pharmaceutical companies are running out of new agents that can command premium prices. One detailed analysis reveals that as some higher-end drugs come off-patent, manufacturers have responded by increasing the price of drugs that remain on patent. 
	
	“The system is set up to generate profits, not research and innovation,” Dr. Williams said. 
	
	The majority of the costs are attributable to a relatively small number of drugs, he explained.
	
	“For Medicare Part B and Part D-where glaucoma patients live-the per capita growth rate for drug cost is 10% per year. Profit margins for the top 25 drug makers are robust, and these companies have consistently doubled the profit margins of all other companies in the Fortune 500,” Dr. Williams said.  “There appears to be bipartisan support for addressing this issue.”
	
	

Reimbursment remains a hurdle for teleglaucoma in United States 


	Pre-authorization, familiar to all physicians and ophthalmology practices, can involve drugs, devices or surgery. It is granted about 90% of the time, but it is still an impediment to patients’ access. This has piqued the interest of Congress, and the AAO has been advocating for standardization with follow-through in the pre-authorization environment.
	
	


	“Step-therapy, a potential game-changer in the drug space, comes from the Centers for Medicare and Medicaid Services decision to allow Medicare Advantage (MA) plans the option of implementing step-therapy across all Part B drugs, including off-label compounded treatments,” Dr. Williams said.
	
	Many questions remain, however, such as: What constitutes a trial or treatment failure? How much vision does the patient have to lose (or not gain)? What happens with the fellow eye?
	“These questions create access issues for patients,” Dr. Williams said. “The Academy has been involved in step-therapy for years and will continue to speak to policy makers about the need for consistent, patient-centered coverage policies.”
	
	There remains significant variation in coverage, however, and only 16% of drug indications are covered by all plans, Dr. Williams noted.
	
	


	
	A comprehensive analysis indicates that less than half of drug indications are covered by 75% or more of commercial carriers. Prescribing protocols are consistent with the FDA label barely half of the time; they are more restrictive a third of the time; and 5% of the time there is no coverage even when FDA approved, according to Dr. Williams.
	
	The AAO has written to the CMS expressing concern about the impact this has on patients’ access to care, Dr Williams noted. Changes to MA, according to a recent Office of the Inspector General report, may incentivize payers to deny access to services and payment in order to increase the profit of these private companies. In fact, 75% of the denials the MA plans implement that are appealed are reversed, but only 1% of the denials were actually appealed.
	
	The OIG concluded that “this is especially burdensome for beneficiaries with urgent health conditions.” This issue is likely to become more significant with the continuing expansion of MA. In 2018, 35% of Medicare beneficiaries were in Medicare Advantage with some states as high as 60%, Dr. Williams said.
	
	

Lack of Medicare coverage leads to less eyeglass use, study finds


	One possible solution is to have Americans pay what other countries pay.
	
	“In the United States, we pay approximately 80% more for all drugs-in the retina space, it is substantially more.” Dr. Williams said. “With Medicare part D, patients pay the first $415. Medicare pays 75% of the next 3,800. After that, patients go into the donut hole.”
	
	The ever growing gross-to-net rebate bubble is the difference between the manufacturer’s list price and the net price, after negotiated rebates and discounts decided by pharmacy benefit managers (PBMs). Last year, it was $166 billion.
	
	“This can produce perverse incentives for drug companies to raise  prices and increase discounts, because PBMs are paid by insurers based on the amounts they negotiate for each discount,” Dr. Williams concluded. “These discounts are supposed to be shared with either the insurance provider or with the patient-but it turns out they are not, and our patients pay co-pays on the inflated price. This rebate bubble has exploded in recent years, from $59 billion in 2012 to $126 billion currently.”
	
	


	p: 248/288-2280 
	e: George.Williams@beaumont.edu
	

This article was adapted from Dr. Williams’ presentation at the 2019 American Glaucoma Society annual meeting. Dr. Williams has no other financial disclosures related to this report.

New battles taking place in fight to control drug costs 

Reimbursement for telehealth initiatives remains an uncertainty in the United States today, with capitated systems at the forefront in initial teleglaucoma applications.

Worldwide, healthcare systems are implementing models of teleglaucoma care. Clarifying reimbursement considerations, however, is necessary for greater strides toward U.S. adoption, according to 

, assistant professor of ophthalmology at 

. Dr. Rathi noted some examples for consideration.

University of Alberta’s teleglaucoma program

 consists of a remote or in-house pathway, he noted. Patients on the remote pathway visit a local ophthalmologist or optometrist who collects standardized history, examination, and imaging findings.

The eye-care provider securely transmits the information to a remote glaucoma specialist who delivers an electronic recommendation to the referring clinician. The in-house program is a tertiary-care referral center in Edmonton.

These individuals see an ophthalmic technician who obtains the history, exam, and imaging, according to Dr. Rathi. A glaucoma specialist reviews the data and sends a report to the referring provider. The program seeks to reduce the time patients spend in the clinic, and wait to have a glaucoma evaluation. In Canada, Medicare reimburses at two-thirds of the conventional in-person fee for these consultations.

, the patient sees a local optometrist who sends the history, exam findings, and imaging to the remote ophthalmologist. Dr. Rathi said that the specialist video conferences with the patient and the local provider to deliver the recommendations.

Australia Medicare reimburses clinicians if there is a live audio-video component to the encounter and the patient is located at least 15 kilometers away from the consulting ophthalmologist or resides in a care facility for indigenous Australians.

“Initially, there was no reimbursement for the local referring optometrist,” Dr. Rathi said, “After Medicare implemented reimbursement covering technical costs for the referring physician, the program had a 3.5-fold increase in utilization during the next 12 months.”

the mix of fee-for-service and capitated care health-care delivery models 

in the United States, as well as the evolution of 

, a combination of teleglaucoma models could be sustainable, according to Dr. Rathi.

“For example, glaucoma care could be provided via synchronized consultation with the patient who is at home or in the primary-care physician’s office,” he said. “In the future, dedicated telehealth centers could have locations across the country.”

Dr. Rathi noted that like the Canadian version, asynchronized consultations could be useful where the optometrist or general ophthalmologist routes the clinical information to an off-site specialist for collaboration.

“Remote monitoring of glaucoma patients could include home-based IOP measurements and virtual reality visual field exams,” he said.

These remote glaucoma management models have unique advantages, but adoption of telehealth services is often determined by reimbursement. In the United States, a direct-to-consumer model where patients pay for telehealth services is not well-suited to glaucoma.

“Within a capitated healthcare system on the other hand, resources can more readily be dedicated toward creating the needed infrastructure,” according to Dr. Rathi.

Reading centers with peer-to-peer consultation networks would allow high-risk patients to be prioritized for in-person glaucoma clinic visits, while low-risk patients could be followed remotely. 

Fee-for-service is the predominant payment model in the United States

Medicare reimburses for telehealth if strict requirements are met. First, the patient must be physically located in a rural area-there is no coverage for patients in urban or suburban settings. Second, the patient must be located in a health-care facility (i.e., critical access hospital, rural clinic, or a physician’s office). The home setting is not included. The interaction must be over live two-way audio/video communication.

The physician must be physically located in the United States. If these requirements are met, payment is on par with in-person fees using standard remote patient monitoring codes with modifier 95 for synchronized telemedicine. Medicare covers asynchronized telemedicine only in Alaska and Hawaii, under active telemedicine demonstration programs (primarily for diabetic retinopathy screening).

Nutrition a priority for dry eye patients

 updates included now covering remote consultation and pre-recorded patient information where a physician can evaluate a video or image with an established patient and offer interpretation within 24 hours,” Dr. Rathi explained.

“Now, virtual check-ins with audio and medical discussions are reimbursable without rural location requirements. Medicare provides coverage for remote physiologic monitoring for chronic disease-IOP may fall into this category. It is important to note that this is new territory for ophthalmology and is evolving, and the specialty has no prior experience with these codes.”

Coverage by commercial carriers is often dictated by state. Some states have passed telemedicine parity laws that mandate commercial insurers extend telemedicine coverage for any covered in-person service. Although a positive development, most of these laws do not mandate payment parity.

A carrier can have large differences in its reimbursement rates for services rendered in telemedicine compared with in-person services, possibly disincentivizing physicians from providing these services. Physician medical licensure requiring physicians to be licensed in the state where the patient is physically located has been a regulatory barrier to telehealth adoption. In 2017, the Interstate Medical Licensure Compact allowed expedited licensure in party states.

“Reimbursement for telehealth initiatives is far from guaranteed, with capitated systems likely leading the way in initial teleglaucoma applications,” Dr. Rathi noted. As shown in Australia, reimbursement leads to 

increased adoption of telemedicine and virtual consultation

. Telemedicine parity laws are helping to move efforts forward as Medicare coverage of telehealth is evolving.

Practical tips, pearls help ease patients’ financial burdens

This article was adapted from Dr. Rathi’s presentation at the 2019 American Glaucoma Society annual meeting. He has no financial interest in any aspect of this report.

Capitated health-care models may be best positioned to take advantage of telehealth

Reimbursement remains a hurdle for teleglaucoma in United States

Dry eye can be straightforward to determine the etiology for diagnosis and treatment-but not always. Newer diagnostic tools have improved clinicians’ ability to treat and follow patients with dry eye, says Christopher J. Rapuano, MD.

Because dry eye disease (DED) is a multifactorial disease involving the hyposecretion of tears and excessive tear evaporation-meibomian gland dysfunction-

, said Christopher J. Rapuano, MD. There is a huge overlap between entities, and signs/symptoms of DED often do not match clinically (Figures 1 and 2).

Some concerns that physicians have regarding DED diagnostic tests are they are often not standardized; there may be no well-accepted universal endpoints for the measure; and many tests are technique-dependent, time consuming, and sensitive to the environment and external factors, said Dr. Rapuano, chief of Wills Eye Cornea Service, and professor of ophthalmology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia.

Some traditional questionnaires used for DED identification include the OSDI, the NEI-VFQ25, IDEEL, and McMonnies Questionnaire. The OSDI is complicated and takes patients a while to complete, Dr. Rapuano noted. More recent tests are concise. For example, SPEED and the UNC Dry Eye Management Scale are much simpler and easier for patients to take (Figures 3 and 4). A traditional method of evaluating of the tear film was with Schirmer’s I test (without anesthesia), later anesthesia was added with Schirmer’s II.

This test has moderately variable results and can cause superficial damage to the conjunctiva and cornea. Schirmer’s testing also takes 5 minutes-quite a while in the clinic, he added.

Another older test called tear ferning involves the indirect evaluation of mucus in tear film. A small tear sample is collected with a pipette and placed on a glass slide. After 10 minutes, the sample is examined under a light microscope. Normal mucus results in normal ferning. This sort of qualitative analysis is not helpful in the office, but it might have a place in research settings, Dr. Rapuano noted.

Tear breakup time, traditional test, evaluates tear stability. It is done prior to any other drops being in stilled or test performed, by placing fluorescein dye with saline in the eye. The patient blinks, and the seconds before a smooth surface is seen are counted. This is a relatively objective, easy, fast, and reproducible diagnostic. It also correlates well with ocular surface disease signs and symptoms, and remains useful in practice, Dr. Rapuano noted. Corneal fluorescein testing is also non-toxic and fast as well as relatively objective.

It reveals significant corneal epithelial damage. This is also an old test that is also still worth doing, he added. Rose bengal staining, on the other hand, is an older test that is no longer needed, he said. Though a fast and objective way of showing conjunctival damage, it is toxic, painful to the patient, and difficult to obtain, Dr. Rapuano noted. Lissamine green has replaced rose bengal staining; it is also fast, objective, and indicates areas of significant conjunctival epithelial damage. Lissamine is non-toxic, well tolerated, and easy to get, he said.

Tear osmolarity in essence looks for excess salt in tears. Higher numbers indicate a more abnormal reading. TearLab is the most widely used test in this arena. It must be performed before other drops and exams are administered, and both eyes must be tested. The osmolarity is abnormal when >308 mOsm/L or intereye difference is greater than 8 indicating instability.

The MMP9 test (Quidel) identifies higher levels of this marker of inflammation, indicative of worse DED. TearLab’s Discovery test in development will test both osmolarity and MMP-9, and the company will be adding inflammatory and perhaps allergy markers in the future. The LipiView I (Johnson & Johnson Vision) is an older device that measures the thickness of the lipid layer of the tear film. The device also provides an analysis of partial blinking, which is useful to show and discuss with patients.


	
	LipiView II (TearScience/Johnson & Johnson Vision) provides objective imaging of the meibomian glands, thus giving a window into their health (Figure 5). Oculus Keratograph 5M performs multiple analyses of the tear film as well as tear meniscus, eye redness, meibomian gland imaging, and noncontact tear breakup time. The device generates a report and scale creating what is called a JENVIS dry eye report (Figure 6), which is meant to provide information on how the factors interact and disease severity.

High-resolution anterior-segment optical coherence tomography (Optovue, Cirrus) can objectively evaluate tear film meniscus/tear volume

Traditional testing for SjÃ¶gren’s syndrome includes blood tests (ESR, RF, CBC, anti-SSA and -SSB and ANA) that can be nonspecific. Bausch + Lomb’s Sjo test combines these biomarkers plus novel, proprietary ones, and can reportedly detect disease at an earlier stage.

Dr. Rapuano notes he finds this test most helpful as backup when referring a patient to a rheumatologist. Dry eye can be straightforward to determine the etiology in order to diagnose and treat- but not always. Newer diagnostic tools have improved clinicians’ ability to treat and follow patients with DED.

New diagnostic modalities have enhanced clinical abilities, whereas some standbys still get the job done

Author | Conni Bergmann Koury

Articles

New battles taking shape in fight to control drug costs

New battles taking place in fight to control drug costs

Reimbursement remains a hurdle for teleglaucoma in United States

Detecting dry eye: What to keep, obtain, or omit