On The Hill

Congress reconvened for the second session of the 116th Congress, with the main focuses on impeachment and Iran. The House Energy & Commerce Subcommittee on Health held a hearing on multiple bills that would strengthen patient protections for Medicare and Medicaid, including H.R. 5534, the “Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act,” which aims to extend Medicare coverage and access to immunosuppressive drugs past the current deadline of 36 months after transplant. Elsewhere, the Centers for Medicare and Medicaid Services (CMS) released Part I of the 2021 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies and the US Food and Drug Administration (FDA) issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. Additionally, HHS and CMS announced that Brad Smith with serve as the new Director of the Center for Medicare and Medicaid Innovation (CMMI) at CMS.

Hearings

House E&C

The House Energy & Commerce Subcommittee on Health held a hearing on Wednesday, January 8, 2020, entitled, “Legislation to Improve Americans’ Health Care Coverage and Outcomes.” H.R. 5534, the “Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act,” was the main topic of discussion at the House E&C Subcommittee on Health’s hearing on a number of bipartisan bills. Dr. Matthew Cooper, a transplant surgeon in Washington, DC, outlined the numerous reasons why H.R. 5534 needs to be enacted in order to extend the Medicare coverage and access to immunosuppressive drugs past the current deadline of 36 months. Chairs and ranking members of the full committee and subcommittee made note of H.R. 5534 in their opening statements and all mentioned they were pleased that it was getting addressed and should be moving forward on it in the committee soon. The most significant testimony on H.R. 5534 came during Rep. Mullin’s (R-OK) questioning when he mentioned that Section Two of the bill mentions that the Indian Health Service (IHS) recipients are not eligible for Medicare coverage that H.R. 5534 offers. Both Chairwoman Eshoo (D-CA) and Ranking Member Burgess (R-TX) said that needs to be changed and that the issue needs to be addressed. H.R. 3935, the “Protecting Patients Transportation to Care Act,” was the other significant legislation discussed in the hearing. Both Reps. Carter (R-GA) and Cardenas (D-CA), who introduced the bill, outlined the benefits of the legislation. They noted that the transportation issues that are in the bill are for medical services such as dialysis and addiction treatments, not for emergency room services. They also mentioned that the bill doesn’t discriminate and should benefit individuals in both urban and rural communities. An executive summary of the hearing can be found here.

Surprise Billing

House Ways & Means and Energy & Commerce Committees’ leadership are continuing initial discussions on how to bridge their differing proposals on surprise billing. A link to an article on the latest on surprise billing can be found here.

FDA E-Cig Flavor Ban

To start off the new year, The U.S. Food and Drug Administration (FDA) issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions. ^[1] 

2021 Medicare Advantage Advance Notice

This week, CMS released Part I of the 2021 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies (the Advance Notice), which contains key information about proposed updates to the Part C CMS-Hierarchical Condition Categories (HCC) risk adjustment model and the use of encounter data. The 2021 Advance Notice is being published in two parts again this year due to requirements in the 21st Century Cures Act, which mandated certain changes to Part C risk adjustment and a 60-day comment period for these changes. Changes to other payment methodologies proposed for the following calendar year that are typically contained in the Advance Notice only require a 30-day comment period and will be released in accordance with that statutory deadline. The payment policies for 2021, proposed in both Part I and Part II of the Advance Notice, will be finalized in the annual Rate Announcement on or before April 6, 2020. The 21st Century Cures Act requires that CMS phase in changes to risk adjustment payments based on section 1853(a)(1)(I) of the Social Security Act over a 3-year period, beginning with 2019, with such changes being fully implemented for 2022 and subsequent years. In order to phase in the model that meets the statutory requirements (the 2020 CMS-HCC model), for calendar year (CY) 2021 for calculating risk adjustment payments, CMS is proposing to calculate risk scores for CY 2021 payment as follows:

Continue to phase in the implementation of the risk adjustment model finalized for CY 2020 for payment to Medicare Advantage (MA) organizations and certain demonstrations by calculating risk scores using the sum of:

• 75% of the risk score calculated with the 2020 CMS-HCC model and
• 25% of the risk score calculated with the 2017 CMS-HCC model. ^[2]

References

^[1] “FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.” FDA. 2 Jan 2020. https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children

^[2] “2021 Medicare Advantage Advance Notice Part 1 – Risk Adjustment.” CMS. 6 Jan. 2020. https://www.cms.gov/newsroom/fact-sheets/2021-medicare-advantage-advance-notice-part-i-risk-adjustment

[3] “HHS and CMS Announce Brad Smith as CMMI Director, Senior Advisor for Value-Based Transformation.” HHS. 6 Jan. 2020. https://www.hhs.gov/about/news/2020/01/06/hhs-cms-announce-brad-smith-cmmi-director-senior-advisor-value-based-transformation.html