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No Recess for Regulations

08/09/18

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Chelsea Arnone, Regulatory Affairs and Government Relations Director

The House of Representatives has high-tailed it out of town for their annual August recess and the Senate will return next week to continue working through nominations and the government funding bills. That’s exactly as thrilling as it sounds, and normally, it’s a pretty quiet time here in Washington, DC.

Every July and August, as the temperature, humidity and dry cleaning bills rise, I have plenty of reading and analyzing to keep me busy – but without the worry of Congress causing any fire drills. Plus, there might be a chance to go through the stack of files and papers that have been on the corner of my desk and throw away all the post-it notes stuck to my computer. The annual payment regulations issued by the Centers for Medicare & Medicaid Services (CMS) are one of the only things that are certain in this town (other than death and taxes, of course). But this year, I realized that stack of papers on my desk and my post-it note collection wouldn’t be going anywhere soon.

On July 12, CMS dropped the Physician Fee Schedule (PFS) and Quality Payment Program (QPP) proposed rule for calendar year (CY) 2019 and –so you don’t have to read all 1,473 pages – Vizient prepared this handy summary. About an hour after finalizing that summary, CMS graced my inbox with the annual Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system proposed rule for CY 2019. I urge you to take the time to review our summary, because within those 761 pages are major changes that are being strongly opposed by many, including Vizient. Back to tidying up my… Oh wait, the inpatient prospective payment system (IPPS) and long-term health care (LTCH) PPS final rule for fiscal year (FY) 2019 is here! And it’s only 2,593 pages long…it looked like my desk was doomed to stay in organized chaos.

However, CMS has, for better or for worse, finalized most of the policies that they proposed back in April. There are a few exceptions worth noting. In our comment letter on the IPPS/LTCH proposed rule, we let CMS know we appreciate that they are prioritizing reducing regulatory burden on our members – and supported the goals of the new “Meaningful Measures Initiative.” We’ve asked them to streamline the quality measurements, so we will be closely monitoring their continued efforts to produce metrics that are easier to collect and report.

Nonetheless, CMS did not finalize their proposal to remove the five healthcare-associated infection (HAI) measures or the Patient Safety and Adverse Events Composite (PSI 90) measure from the Hospital Value-Based Purchasing (VBP) Program. In other words, CMS will keep these measures in both the Hospital VBP and Hospital-Acquired Condition (HAC) Reduction Program. CMS did finalize their proposal to remove these measures from the Hospital Inpatient Quality Reporting (IQR) Program, citing that this would “reduce some cost and burden for providers in having to track these safety measures in multiple programs.” We have concerns about the potential for “double penalties” in payment reduction that providers could incur as a result of these measures being used in both programs – and will continue to engage with CMS.

My other takeaway from this final rule is about reimbursement for chimeric antigen receptor t-cell (CAR T) therapy – which is exciting for patients but extremely expensive. I had to lean on several of my qualified colleagues to explain how it works, but the very oversimplified description is that a patient’s cells are genetically transformed (I’ve been assured it’s science, not magic), and then returned to the patient in a form that attacks cancer cells. While the magic/science is attacking, patients must be hospitalized. The two CAR T-cell therapies, YESCARTA® and KYMRIAH®, are so new, CMS still isn’t quite sure how to reimburse hospitals for providing them. Vizient advocates that hospitals receive adequate payment, while ensuring that patients have access to these potentially life-saving treatments.

For now, CMS approved the new technology add-on payment (NTAP applications) for these two therapies – but declined to finalize any other payment proposals. As medicine advances, and new therapies are approved, it’s important that a precedent is set to ensure patients have access to these treatments. In turn, we will continue to advocate for a payment methodology that accurately and appropriately reimburses hospitals that care for patients by providing these highly specialized, costly new treatments.

In summary, hooray for burden reduction on hospitals and health systems! On a separate note, if anyone has any suggestions for reducing the burden of acronyms on this regulatory affairs director –please let me know. I hope everyone enjoys the last few weeks of summer, and while I encourage you to come visit DC and enjoy our beautiful city, I highly recommend that you visit in the fall when the humidity drops to a tolerable level. I’m off to do some much-needed filing and recycling.

About the author. As regulatory affairs and government relations director in the Vizient Washington, D.C. office, Chelsea Arnone analyzes legislative and regulatory issues impacting hospitals, drafts public comment letters, strategy memos and summaries for members. She engages directly with members of Congress and staff on federal legislative and regulatory developments of importance to Vizient and its members. Arnone joined Vizient after serving as the regulatory and policy director at a D.C.-based health care consulting firm, and has also previously worked in the House of Representatives and consulted for several U.S. Senate, House and gubernatorial campaigns.

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