Weekly Roundup (August 28-September 1, 2023)
Physician payment, coding, coverage, and quality reporting news highlights.
Although we are heading into the last weekend of August, this week was anything but the quiet last days of summer. The announcement of the first ten drugs selected for Medicare drug price negotiations dominated not only the health policy news but stories could also be found in the mainstream media. In other big news, Medicare seems to be doing a bit of a do-over with Surprise Billing, with two new proposed bills landing at the Office of Management and Budget (OMB) this week. Of course, there was also the high drama around the leaked Medicare report on nursing home staffing levels that seemed to support the position of stakeholders that there is no “one-size-fits-all” answer. I wish everyone a safe and restful Labor Day weekend – because if this was August, get ready for a crazy-busy September!
PAYMENT
Medicare Identifies First 10 Drugs for Price Negotiations – Long Road Ahead for Program Implementation. An enormous amount of electronic ink was spilled this week over the August 29 announcement of the ten drugs identified by the Centers for Medicare and Medicaid Services (CMS) that will be subject to Medicare price negotiation (although my favorite story was a podcast - the Daily podcast from the New York Times that included a trip down memory lane with clips from the Bush v. Gore presidential election).
Targeted at Medicare Part D drugs and a first-ever effort by the Medicare agency to negotiate drug prices, the authority to do this was provided by the Inflation Reduction Act and is part of a larger effort by the Administration to reduce drug prices. Drugs were selected in a process that considered Medicare spending, years the drug was on the market, and if it had no competition. CMS noted that these ten drugs accounted for $50.5 billion, or 20% of Medicare Part D spending from June 1, 2022, to May 31, 2023. When implemented, this program is expected to save the government billions annually, save beneficiaries a significant amount of out-of-pocket costs, and lower their Part D premiums. While the program is limited to Medicare Part D, there is a potential for it to impact prices in the commercial market eventually.
This announcement is the first step in a long process, with new prices not going into effect until 2026. As a next step, companies of drugs selected for negotiation must sign agreements to participate in the negotiation process by October 1, 2023; the negotiation period ends August 1, 2024; by September 1, 2024, CMS will publish the negotiated maximum fair prices for the selected drugs; and maximum fair prices are effective for selected drugs on January 1, 2026. There is a penalty if a company refuses to participate. They can either withdraw from the Medicare and Medicaid market throughout the U.S. or pay an excise tax on all U.S. sales – although none are expected to take this option. In addition to this long administrative process, the agency faces several legal challenges. Drugmakers and trade associations have filed at least eight lawsuits. In general, the lawsuits argue that the law and mandated price cuts would violate several amendments to the U.S. Constitution.
In addition to the lawsuits, while polls show bipartisan support for Medicare to negotiate drug prices, several Republican lawmakers have voiced opposition. Those who oppose Medicare negotiating drug prices and other policies of the Administration around reducing drug prices have said it could also have an unintended negative impact on Biden’s Cancer Moonshot goal by hampering innovation. Right now, much is uncertain other than the agency has a long road ahead, and let’s not forget that there is a presidential election in 2024 before any negotiated prices go into effect.
QUALITY
MIPS Preliminary Scoring Information Eliminated for Performance Year 2023. Under the Quality Payment Program, clinicians eligible for the Merit-based Incentive Payment System (MIPS) earn a payment adjustment based on their performance across four categories (i.e., Quality, Improvement Activities, Promoting Interoperability, and Cost). Beginning with the 2021 Performance Year, and in response to stakeholder feedback, CMS released preliminary scoring information when participants submitted their data to CMS.
The agency announced this week that they are eliminating the preliminary score and preliminary category-level scores information available upon submission, beginning with data submission for the 2023 Performance Year. Participants will continue to see their preliminary measure-level performance data.
CMS indicated they made this decision because as the program has become more diverse and complex, the reliability of the preliminary data has decreased. The changes and growing complexity of the MIPS program include three different data sets for three ways of participating (i.e., traditional MIPS, MIPS Value Pathways, and the Alternative Payment Model Performance Pathway), complex patient bonus points, performance period benchmarks, and reweighting cost scores. The agency acknowledges this is a significant change but is necessary due to the growing unreliability of the preliminary data.
CODING
Medicare Updates Guidance for Evaluation and Management (E/M) Codes. On August 29, 2023, CMS released an updated version of its Evaluation and Management Services Guide. This updated guidance reflects changes to E/M coding that took effect on January 1, 2023. Part B News has posted an article reviewing highlights from this guidance, including where the CMS guidance may not align with the CPT© code book.
CLIMATE CHANGE
CMS Announces Waivers for Florida. CMS announced that waivers are available to providers in Florida who have been affected by Hurricane Idalia. Clinicians who need additional flexibilities can submit a request to CMS. On August 28, 2023, President Biden approved an Emergency Declaration for Florida due to the emergency conditions resulting from Hurricane Idalia. Additionally, on August 30, 2023, Department of Health and Human Services Secretary Xavier Becerra determined that a Public Health Emergency exists in Florida. These declarations gave CMS the authority to implement the waivers.
Many experts feel that the warmer Gulf of Mexico temperatures from climate change have helped strengthen Hurricane Idalia in addition to other factors such as a natural El Nino and other random weather occurrences. While Idalia is expected to become the costliest natural disaster in 2023, forecasters at the National Oceanic and Atmospheric Administration predict an increase in Atlantic hurricanes this season due to record warm sea surface temperatures.
OTHER NEWS, IN BRIEF
Surprised Billing Proposed Rules Back at OMB. On August 29, 2023, two proposed regulations related to the No Surprises Act Independent Dispute Resolution (IDR) process arrived for review at the OMB. These regulations arrived after a judge ruled on August 25, for the third time, against the arbitration process. As a result, after the announcement of the judge’s ruling, CMS suspended all Federal IDR process operations. On August 8, CMS temporarily suspended operations but resumed processing certain batched disputes. Now, all operations have been suspended. At this time, the timeline for when the IDR process will resume is unclear. The agency will have to go through the proposed and final rule process, including a comment period, which includes written comments and potential meetings with stakeholders.
OIG Releases Strategic Plan for Medicare and Medicaid Managed Care. With the growth of managed care in the Medicare and Medicaid programs, the Office of the Inspector General (OIG) has developed a strategic plan to monitor this growing program area for CMS, covering more than half of Medicare enrollees and more than 80 percent of Medicaid enrollees. The OIG’s oversight of managed care plans will focus on risk areas based on the managed care life cycle drafted by the OIG: plan establishment and contracting, enrollment, payment, and beneficiary services. In addition to the strategic plan, the OIG has established a page on its website devoted to managed care.
OPPORTUNITIES TO ENGAGE
House Budget Committee Health Care Task Force, Request for Information (RFI) to Improve Patient Outcomes and Reduce Health Spending, Comment Deadline is October 15. The task force seeks to reduce healthcare spending, examine opportunities to modernize and personalize the healthcare system, and support policies to fuel innovation and increase patient access to quality and affordable care. Led by Republican members, this (RFI) is part of a larger effort to reduce federal spending. The task force was self-described in a recent editorial as “…an incubator for finding new ways to improve health outcomes while reducing federal spending. We will serve as a forum for developing and modeling legislation to improve spending efficiency, returns on federal investments, and an overall more cost-effective health care system.”
Registration is now open for the 2023 ONC Annual Meeting. For the first time since 2020, the Office of the National Coordinator for Health Information Technology (ONC) is holding its annual meeting in person. The meeting will be held December 14-15, 2023, in Washington, DC.
UPCOMING EVENTS
Events scheduled for next week (September 4-8) are below. For a complete list of upcoming health policy events and deadlines, please visit our new Health Policy Calendar.
Sept. 7
Physician Cost Measures and Patient Relationship Codes Technical Expert Panel Meeting
Sept. 7-8
Medicare Payment Advisory Commission (MedPAC) Public Meeting
ARTICLES THAT GRABBED OUR ATTENTION
This week, these articles grabbed our attention; we thought they would also interest you.
Who’s Accountable? Low-Value Care Received By Medicare Beneficiaries Outside Of Their Attributed Health Systems (Health Affairs; August 2023)
CMS Facing Challenges Attracting Practices to Value-Based Payment Models — Specialty Practices Say the Current Models Often Don't Work for Them (MedPage Today; August 28, 2023)
Adapting to Evolving ICD-10-CM Guidelines in the Era of Artificial Intelligence (RAC Monitor; August 28, 2023)
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For more information and questions, please contact:
Sheila Madhani, MA, MPH
Madhani Healthcare Consulting, LLC
Email: smadhani@madhani-health.com
www.madhani-health.com
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