This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week. On the Administration’s side, several agencies took steps forward consistent with the President’s agenda on drug pricing. How this plays out over the next several months will be relevant to all stakeholders in this space. We cover this and more in this week’s preview, which can be found here.
As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time, so there is a lot of information for Medicare Advantage organizations and Part D plan sponsors to absorb. One major topic area that CMS focuses on in these documents is the prevention of opioid misuse and abuse.
As you know, we have been following this topic closely in the last few months: first, we discussed how the proposed rules set out a framework for plan sponsors to monitor and reduce the potential misuse of frequently abused prescription drugs. We then discussed the Advance Notice and Call Letter outlining utilization review controls for Part D plans to use to address opioid misuse and abuse.
The Final Rules and 2019 Call Letter work together to establish a number of new policies aimed at helping Medicare plan sponsors prevent and combat prescription opioid overuse. There is significant discussion, including CMS’s response to commenters, in the final documents linked above. Here, we provide a high-level overview of the new policies.
Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter. The Final Rules and Call Letter are typically CMS’s most comprehensive regulatory announcements relating to Medicare Advantage and Part D each year and have historically not been released together. Because of the simultaneous release of these announcements, Medicare Advantage organizations (MAOs) and Part D plan sponsors have a lot to digest. Continue Reading CMS Releases 2019 MA and Part D Final Rules and Call Letter
CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.
In November of 2017, in the proposed Medicare Advantage and Part D regulations for CY 2019 CMS set out a framework for Part D plans to monitor and reduce the potential misuse of prescription opioids. Continue Reading CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic
Today, the White House released its FY 2019 budget proposal, outlining its policy priorities for the fiscal year. In health care, the President’s budget focuses on prescription drug pricing and opioid funding. It included a number of legislation proposals relating to Medicare Part D, as well as the creation of a Medicaid demonstration allowing states to test new financing structures to cover prescription drugs. The proposal also discusses the future of the Affordable Care Act, including the Medicaid expansion, as well as appropriating cost-sharing reduction payments for FY 2018 through the end of calendar year 2019. Proposals in the budget that are regulatory in nature are certainly items worth monitoring since its likely they would be approved and implemented under this Administration.
We cover this and more in the budget analysis, which can be found here.
Based on the most up-to-date information on the budget deal, we have developed a new timeline for the major health care extenders. This new timeline is important because these provisions were once all tied together and now, they are not.
*Note this post assumes the budget deal will pass tonight and is based on information as of 4:00pm on February 8, 2018.
**Emma Zimmerman of ML Strategies contributed to this post.
Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice and Call Letter). The Advance Notice and Call Letter should be read hand-in-hand with the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for the Medicare Advantage (MA) CMS-HCC Risk Adjustment Model (2019 MA Risk Adjustment Changes) that CMS released on December 27, 2017. Both documents request comments from interested parties and have a submission deadline of March 5, 2018. Continue Reading CMS Releases Advance Notice and Call Letter for Medicare Advantage and Part D
Late Monday night (February 5, 2018), the House of Representatives released a continuing resolution to keep the government funded and running until March 23, 2018. This CR includes many health care related provisions, specifically many of the health care “minibus” riders. In the chart below we summarize major health care provisions in this CR specific to the health care minibus. Note, the entire CHRONIC Care Act is included in this CR. Additionally, two key health care provisions are not included in this CR – the Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) and the Money Follows the Person (MFP) program. Please click here to see our chart summarizing key health care provisions of the February 5 CR.
On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary. Mr. Azar was more recently an executive at Eli Lilly and Company. As summarized here, Mr. Azar received many questions regarding Medicaid, CHIP, the Affordable Care Act, and most notably and often, drug prices. Continue Reading Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices
Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. (Those interested in a high-level overview of the Proposed Rules should see our post from last month). Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic