What’s Ahead: This Week

Wednesday, January 8
- House Energy & Commerce Committee, Health Subcommittee, “Legislation to Improve Americans’ Health Care Coverage and Outcomes.”

Wednesday, January 8
- Bipartisan Policy Center (BPC), “BPC’s 20/20 Health Care Series: A Snapshot of Early Primary Voters.” Additional information: http://bit.ly/37w13yQ

Weekly Wrap-Up: Notable Health Care Developments from Last Week

On December 23, Rep. Kind (D-WI) and five bipartisan cosponsors introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019 (H.R. 5534), which would provide for extended months of Medicare coverage of immunosuppressive drugs for kidney transplant patients, and for other purposes. Bill text: http://bit.ly/37I7D5F

On December 31, the 10^thS. Circuit Court of Appeals reversed a lower court decision in a ruling that would uphold the HHS risk adjustment methodology for the individual and small group market. Decision: http://bit.ly/36hZ6Wy
On January 3, a coalition of Attorney Generals in 20 Democratic-led states and the District of Columbia filed a petition asking the U.S. Supreme Court to review a recent decision by Fifth Circuit Court of Appeals ruling that the individual mandate is unconstitutional. Petition: https://on.ny.gov/2ZNhrZf

On January 3, CMS announced a call for nominations to develop quality measures for two Technical Expert Panels: development of a days at home quality measure; and development of a quality measure assessing delay in progression of chronic kidney disease. More information: https://go.cms.gov/2MUh21P

On December 26, CMS released an informational bulletin to update the 2020 Supplemental Security Income and Spousal Impoverishment Standards. Included is a chart that displays the new standards. Bulletin: http://bit.ly/35jH3OC Chart: http://bit.ly/2QJhBwp
On December 27, CMS extended the comment period for the Medicaid Fiscal Accountability Regulation, which would strengthen the fiscal integrity of the Medicaid program and help ensure that state supplemental payments and financing arrangements are transparent and value-driven. Comments are now due by February 1. Proposed rule: http://bit.ly/2ZLDakg

On December 30, CMS announced the Direct Contracting Model Options application webinar for January 7. More information: http://bit.ly/2tnye9c
On December 31, CMS announced that on January 8, it will hold office hours for the Direct Contracting Model on benefit enhancements and provide an application overview. More information: http://bit.ly/2sIVAWK
On January 3, CMS posted a clarification document for the request for applications (RFA) for the Kidney Care Choices Model. The clarification document expands upon eligibility requirements regarding revenue calculations and practices’ Tax Identification Numbers (TINs). Applications are due by January 22. RFA Clarification: http://bit.ly/2Qnd5VF

On December 27, CMS extended the comment period for the Transparency in Coverage Proposed Rule, which would require most group health plans, including self-insured plans, and health insurance issuers to disclose price and cost-sharing information to participants, beneficiaries, and enrollees. Comments are now due by January 29. Press release: https://go.cms.gov/2tuSnKd Proposed rule: http://bit.ly/36lHKIh
On December 30, HHS Office for Civil Rights (OCR) announced that an ambulance company agreed to pay $65,000 to settle allegations of longstanding HIPAA noncompliance. In addition to the monetary settlement, the ambulance company will undertake a corrective action plan that includes two years of monitoring. Press release: http://bit.ly/2QKhzV8

On December 27, White House Office of National Drug Control Policy (ONDCP) announced an additional round of 42 new grants for its Drug-Free Communities Support Program, which provides grants to community-based coalitions to strengthen the infrastructure among local partners to create and sustain a reduction in local youth substance use. Press release: http://bit.ly/39zc1FC

On December 31, CDC announced the updated number of confirmed and probably injury cases and deaths associated with e-cigarette product use to 2,561 injury cases and 55 deaths. Press release: http://bit.ly/2QiQTvM
On January 2, FDA finalized enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint. Under the 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. HHS Press release: http://bit.ly/2SRdxNo FDA Press release: http://bit.ly/2rPIaaU
Also on January 2, FDA released a guidance document describing enforcement priorities for electronic nicotine delivery systems and other deemed products on the market without premarket authorizing. Guidance: http://bit.ly/2Qmr3an

On December 23, U.S. Government Accountability Office (GAO) released a report stating that additional monitoring by agencies could help HHS and the U.S. Department of Agriculture (USDA) ensure meal programs meet nutritional requirements and help providers meet older adults’ varying nutritional needs. Summary with link to report: http://bit.ly/39xD0Bs
On December 30, HHS Office of Inspector General (OIG) issued an annual notification of intent to develop regulations related to new anti-kickback statute safe harbors and special fraud alerts. Comments are due by March 2. Notification of intent: http://bit.ly/2QM17Uf
On December 31, Sen. Grassley (R-IA) posted highlights of his 2019 policy and oversight accomplishments, including among other things his work on drug prices, health care, illegal and illicit drugs and Veterans. Press release: http://bit.ly/2FhHmyD