As you may have seen in a separate communication, I will be leaving the ASBMT in early November. I am not gifted enough with words to adequately express my deep respect for the individuals that make up this community. And a community is exactly what you are – the multidisciplinary, collaborative efforts in this field are amazing. I have always viewed my contribution as minor in comparison to yours, but my goal was always to do my best in reducing the administrative barriers that plague your teams as you attempt to provide the best possible care for your patients.
In the 10 years that I have been working on these issues between my time at the NMDP and ASBMT, we have come a tremendous way as a group. This community has my deepest thanks for advocating when I asked you to, identifying issues as they arose and for taking the time to explain the nuances of your work to a non-clinician so I could appropriately represent all that you do to external stakeholders. Your passion for the patients you care for is unmatched, and it has truly been a privilege to work with all of you.
CMS Outpatient Payment Prospective System
The OPPS Final Rule is issued at the beginning of November. Due to the preparation timeline of this newsletter, we had not received the rule and could not author a synopsis for you. Please watch for a separate communication summarizing key aspects of the rule.
NUBC Update
In August, the National Uniform Billing Committee approved several new codes to support the reporting of cell and gene therapies on inpatient claims. These changes will go into effect in April 2019. A summary of the changes can be found on the NUBC website (pgs. 2-3).
CAR-T Reporting
As part of our efforts to advocate for improved reimbursement for CAR-T from Medicare, we completed an analysis of the 86 claims submitted to CMS in the first two quarters of Fiscal Year 2018 (10/17-4/18). Of these claims, approximately half were coded as clinical trial episodes of care. The remainder of the claims varied widely in the reporting of the CAR-T product costs, included in the Pharmacy billing total. Submitting complete and accurate reporting of CAR-T inpatient episodes will be critically important as we seek improved reimbursement mechanisms. Reporting the clinical trial diagnosis code (Z00.6) and the condition code modifier (30) will be very important as the field grows and new products are under investigation, as those claims can then be appropriately separated from others that include the costs of a commercial product. We have developed a brief flow chart that can help assist in internal audits of your center’s Medicare claims. As a reminder, claims can be resubmitted to CMS within a year of the original date of service; if your facility submitted inaccurate claims, it is highly recommended those are resubmitted.
Administration Moves on Drug Pricing Disclosures
The Trump administration released a proposed rule through CMS that would require drug manufacturers to include list price disclosures in television ads as part of its ongoing efforts to reduce consumer drug prices. The proposal would apply to sellers of drugs covered by the Medicare and Medicaid programs and would require inclusion of the cost for a typical course of treatment in a “legible textual statement at the end of a television ad. Ahead of CMS’ announcement, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced that its members would voluntarily include directions in ads to online pricing data, but HHS Secretary Alex Azar stated that the move was not sufficient for serving consumers.
Critics of the administration’s plan, which has been expected as part of the drug pricing blueprint released by HHS, say that the list price may be confusing or even irrelevant, as few consumers pay the full upfront cost for drugs, known as the Wholesale Acquisition Cost (WAC). However, Azar stated that the WAC does have an effect on patients with coinsurance or high-deductible plans. Others have questioned whether the agency has the regulatory authority to enforce such a rule, and legal action by the pharmaceutical industry is expected. Comments on the proposal are being accepted until mid-December. CMS has specifically asked for public comment on whether the WAC is the best reflection of “list price” for drugs, how to determine “typical course of treatment” and whether the regulation should apply to ads in other media besides television.
Read the proposed rule here.
FTC May Investigate Hospital-Insurer Contracts
Sen. Chuck Grassley (R-IA), chair of the Senate Judiciary Committee, sent a letter to the Federal Trade Commission (FTC) asking the agency to investigate contracts between insurers and large hospital systems. A recent Wall Street Journal investigation found that these contracts may limit competition in the healthcare marketplace and drive up costs by requiring health plans to include more costly systems and prevent plans from directing their customers to lower-cost options. Grassley’s letter asks the FTC to examine “how prevalent the use of such contractual provisions is in the health-care industry, whether there is anticompetitive use of these provisions, and whether consolidation in the marketplace increases the potentially harmful impact of these provisions on competition.”
Read more here.
CMS Revises Local Coverage Determination Process
The Center for Medicare & Medicaid Services (CMS) has released new revisions to the process for Local Coverage Determinations (LCDs). LCDs are decisions published by Medicare and their Medicare Administrative Contractors (MACs) to provide coverage information and determine reasonable and necessary services offered by Medicare-participating providers. The new procedures include a number of changes aimed at improving transparency in the LCD process. These include an improved process “roadmap,” a standardized summary of clinical evidence requirements, a new LCD request process, and options to request informal meetings with MACs, among other changes.
Read a fact sheet summarizing the changes here.
CMS Launches eMedicare Initiative for Improved Beneficiary Experience
On Oct. 1, CMS announced a multi-year initiative to update Medicare resources to “meet beneficiaries’ expectation of a more personalized customer experience.” The eMedicare program is meant to provide a more modern online health care experience, with a particular focus on consumer data integration and improved access to personal health data. Ahead of this year’s open enrollment period, CMS is launching some of the planned new features for eMedicare, including an improved coverage wizard for comparisons between Original Medicare and Medicare Advantage, a mobile-optimized out of pocket cost calculator, and a webchat option with the Medicare Plan Finder.
Read CMS’ press release on the new initiative here.
ICYMI
NHS England Strikes Deal for Ground Breaking Cancer Treatment in a New European First – After announcing coverage of Novartis’ Kymriah therapy for young patients in September, England’s National Health Service unveiled a new agreement to cover Gilead’s Yescarta treatment for adult patients.
CVS Health and Aetna $69 Billion Merger Is Approved With Conditions – The Justice Department’s antitrust review of the proposed merger between the two health care giants was approved, paving the way for the last major independent pharmacy manager to join with one of the nation’s largest insurers.
Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations – The Food and Drug Administration has released guidance for sponsors, investigators, and institutional review boards on human subject protection under the “Common Rule” as revised in 2017. The general compliance date for the revised rule is Jan. 21, 2019.