The future looks bright for ASCs

The stock market is down. Partisan tensions on Capitol Hill and in the White House are up. At the time of this writing, the government is shut down over a border wall.

It has been challenging to find holiday cheer in the midst of such chaos. However, if we reflect on our professional lives as surgeons, clinical staff, and administrators, and consider the needs of our patients and the prospects for a healthy and prosperous future for our surgery centers, there is cause for great optimism in 2019 and beyond. Why do I say this?

I visited last April with a high-level staff member on the House Ways and Means Committee, complaining about reimbursement and regulatory issues of concern to ASCs that were pending before the Centers for Medicare and Medicaid Services (CMS). To paraphrase his response: “ASCs are going to get what they need from Congress and the Executive Branch. Your guys are not the problem — but the solution — to what ails our healthcare delivery system.”

Just a few months ago, in publishing its 2019 ASC payment rule, CMS stated the following: “To the extent that it is clinically appropriate for a beneficiary to receive services in a lower cost setting, we believe it would be appropriate to continue to develop payment incentives and remove payment disincentives to facilitate the choice.”

And the agency stepped up with a series of policy changes that the Outpatient Ophthalmic Surgery Society (OOSS) and the ophthalmology and ASC communities have sought for many years:

• ASCs will receive, starting in 2019, the Hospital Market Basket as an annual update factor rather than the lower Consumer Price Index (Urban).
• Payments will be augmented for procedures that involve very costly devices and implants.
• Obsolete ASC quality reporting requirements will be removed.
• CMS is considering eliminating the requirement that an H&P be performed prior to cataract surgery and other procedures.
• Implementation of the burdensome and costly ASC patient experience/satisfaction survey has been indefinitely suspended.

These developments have all transpired within the past several months. The fruits of the efforts of OOSS, the ASC, and medical communities to educate patients, policymakers, and media about the benefits of ASCs are being realized. The nation’s ophthalmic ASCs are committed to providing Medicare beneficiaries with access to the highest quality surgical care while lowering their cost-sharing obligations and assisting the Medicare program in the containment of health expenditures. And I believe there is greater recognition now, at a time when legislators and regulators are searching for meaningful healthcare reform — improving quality and access, while reducing costs — that ASCs embody the potential to be a significant part of the solution.

Let’s discuss these and other critical legislative and regulatory issues in greater detail.

ASC Payment Rate Updates

After years of lobbying, CMS has agreed, for the period 2019-2023, to update ASC payment rates by the Hospital Market Basket rather than the lower Consumer Price Index (Urban). OOSS has been a leader in the effort to effectuate this change for more than 20 years, seeking to convince CMS and Congress of its merits. Under this new policy, ASCs would receive the same update as hospitals, subject to certain adjustments. Under the new proposed policy, ASC payment rates would be updated by 2.1% in 2019. (Note that HOPD rates, because of a different set of payment adjustments, would receive a 2019 update of 1.25%, or 0.75% lower than ASC payments.)

Higher Device Payments

Like HOPDs, ASCs often utilize expensive devices during certain procedures, yet our centers struggle to pay for them because our facility fees are barely half those received by hospitals. As recommended by the ASC community, CMS has reduced the device-intensive threshold from 40% to 30%, enabling ASCs to offer services that encompass higher device costs.

Ophthalmic ASC Sterilization Practices

Despite the exceptional record of ASCs in providing vision-restoring surgical care to millions of Medicare patients each year with negligible infection rates, it has been necessary for the ophthalmology and ASC communities to battle the government over appropriate infection control standards for ophthalmic ASCs. In 2014, CMS issued an update to the Medicare Conditions for Coverage stating that immediate use steam sterilization could no longer be used in the ASC to clean instruments. Such a policy appeared to require ASCs to utilize terminal sterilization units and likely acquire many more sets of instruments.

OOSS, ASCRS, and the Academy have embarked on a comprehensive effort to educate CMS staff and the private standard-setting bodies, such as AORN, regarding the etiology of TASS and endophthalmitis and the current sterilization and instrument cleaning practices of ophthalmic ASCs. We’ve made some progress.

CMS has clarified that the cleaning and processing practices of most of our facilities are acceptable if we follow manufacturers’ instructions for use (IFU). The problem is that some IFUs recommend enzymatic cleaners for processing instruments, and these cleaners contribute to the incidence of TASS and endophthalmitis. Our organizations have sponsored studies that demonstrate the difficulty in eliminating microscopic residues, even with prompt and thorough rinsing. We are working with manufacturers of equipment and instruments to modify their IFUs to conform to our organizations’ guideline recommendation that enzymatic detergents not be used in cleaning surgical instruments.

OOSS, ASCRS, and the Academy have also sponsored studies by an independent laboratory assessing the sterilization practices of ophthalmic ASCs, testing sterilizers commonly used by our members, including the Statim and Steris units. These studies establish the safety and acceptability of short-cycle ophthalmic instrument processing for sequential same-day surgery, even when the drying phase is interrupted. We are hopeful that these results will provide meaningful ammunition to facilities if surveyors challenge common, effective processing practices.

Leveling the Playing Field Between ASC and Hospital Rates

Hospitals are paid about twice as much as an ASC for providing the same services at commensurate cost to the same patients. Recent tax and budget legislation will require policymakers to reduce Medicare expenditures by several hundred billions of dollars in the years ahead. Reducing hospital rates to ASC levels is one of the few initiatives available to Congress with the potential to generate such significant saving. I believe this policy will be seriously considered during the next Congress. Why should ASCs care about this development when our rates might not increase? It’s a volume proposition: Services will undoubtedly migrate from the HOPD to surgery centers because many hospitals already are less than enamored with ophthalmic surgery. Concerns will be heightened if payment rates are substantially reduced.

ASC Quality Reporting

Although quality reporting has not posed a particularly burdensome exercise for ASCs to date — remarkably, more than 98% of facilities are in reporting compliance — the ophthalmology and ASC communities have been concerned with some of the CMS initiatives to transition from process- to outcomes-based measures that focus on cataract surgery. Several CMS proposals in recent years have reflected little understanding of cataract surgery and the operations of the ophthalmic ASC. Fortunately, to date, we have quashed these injudicious endeavors by successfully arguing that they fail to meet what we believe are the foundational criteria for facility-level quality reporting measures in the ASC.

In sports parlance, OOSS believes that a good offense is a good defense. Increasingly impatient with the efforts of CMS and other agencies to develop and proffer reasonable and appropriate ASC quality measures, the ophthalmology and ASC communities are developing and testing our own measures that meet the aforementioned parameters, are not unduly burdensome, and will, potentially, generate meaningful data for consumers.

Indeed, CMS adopted for 2018 a measure proposed by OOSS, Unplanned Anterior Vitrectomy in Cataract Surgery Patients, and we are hopeful that the agency will approve for 2021 a measure on TASS. These measure topics are well-supported by the clinical literature, and we believe that measuring these events in the ASC and HOPD settings presents an opportunity to improve the quality of cataract surgery for Medicare patients receiving care in the ASC.

In addition, CMS accepted our recommendations for elimination of reporting on several obsolete measures.

Elimination of Burdensome Medicare Certification Requirements for Comprehensive H&Ps and Transfer Agreements

CMS is proposing to replace the requirement that every patient have a comprehensive medical history and physical examination within 30 days prior to surgery in an ASC with a requirement that allows the operating physician and ASC to determine which patients would require more extensive testing and assessment prior to surgery. ASCs would be required to establish and implement a policy that identifies patients who require an H&P assessment prior to surgery. The agency cited cataract with IOL implant and after cataract laser surgery as examples of procedures that should not routinely require a comprehensive H&P. OOSS strongly endorses this initiative.

The agency is also proposing the removal of provisions requiring facilities to have a written transfer agreement with a hospital or ensure that all physicians have admitting privileges in a hospital. CMS states that “this long-standing requirement is now duplicative of other regulatory requirements and has been rendered obsolete by other patient protections.”

Payment for Intracameral Drugs

Medicare pays under Part D for drugs that are self-administered by patients following cataract surgery. OOSS and ASCRS believe that CMS should also implement a policy to cover drugs under Part B that:

1. are administered at the time of cataract surgery;
2. are not integral or necessary to the cataract procedure itself; and,
3. have an FDA-approved indication to treat or prevent post-operative complications, such as pain, infection, and inflammation. We are working with CMS to adopt such a policy.

Office Cataract Surgery

Two years ago, CMS commenced an examination regarding the advisability of providing a facility fee for cataract surgery performed in the physician’s office. For OOSS, the response was clear and unequivocal: This is a bad idea, one that, if implemented without adequate regulatory safeguards, potentially threatens the health and safety of our patients.

OOSS has been the lone voice amongst the major ophthalmology organizations to thoroughly oppose treating cataract patients in the unregulated office setting.

In its recent physician payment rulemaking, CMS was silent regarding office cataract surgery. This is a positive sign that our message has been received. Nonetheless, OOSS will remain vigilant in representing our members and ensuring that this ill-advised and imprudent policy never sees the light of day.

What About OOSS?

We have loads of issues on our plate. However, I am bullish on our prospects to place the ophthalmic ASC in a position, not just to survive, but to THRIVE in this competitive, cost-conscious, and regulatory environment. This is where I make my pitch for every ophthalmic ASC to become a member of OOSS.

I ask you to consider where our practices, facilities, and patients would be at present but for the work of OOSS over the past 38 years. Would surgeons be permitted to own and refer their patients to ASCs? Would our facility payments have increased by 300% or would they have dropped like professional fees? Would we be able to perform and be reimbursed for virtually every ophthalmic procedure in the ASC? Would Medicare facility regulations be more burdensome — might we have been regulated out of business?

We hope you consider joining or renewing your membership to OOSS. ■