On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day. Within a day, the Unified Agenda was reposted with references to the so-called 340B Mega-Guidance removed, and HRSA acknowledged that its inclusion in the Unified Agenda was an error. The 340B Guidance remains shelved.  Continue Reading Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices

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.

This week, the House Energy & Commerce Committee will hold its second round markup of opioid-related legislation. While they remain on pace for passage by Memorial Day, the timing will be determined by how smooth the markup this week goes. Additionally, Ways & Means is also considering a markup of four large packages of opioid legislation. Anything the House passes will have to go to the Senate. In other words, the June work period seems more likely for significant action in this space.

Additionally, the Administration is moving ahead with its drug pricing initiative. While the initial reaction was skepticism, the Administration would not have put the initiative in writing if they didn’t mean it. As the key players continue discussing the various proposals, understanding where the Administration has the authority to act and how it could impact what you do is key to staying ahead of any proposals that gain traction. We cover this and more in this week’s health care preview, which you can find here.

On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid distribution and diversion by the pharmaceutical industry. The second hearing came out of the E&C Subcommittee on Health, which examined the current statutory restrictiveness on the medical profession’s ability to coordinate substance use disorder (SUD) treatment due to prohibitions on certain patient information disclosure. The third hearing came out of the House Judiciary Committee and examined best practices in international and domestic enforcement on drug traffickers in curbing the supply of opioids across the U.S. Continue Reading Congress Holds Hearings and Proposes Legislation to Combat Vexing Opioid Crisis

This week, Congress is back in session with the House continuing its work on addressing the opioid crisis. There are three hearings and a markup on several pieces of legislation intended to address the ongoing epidemic. Once the House finishes its work, focus will move to the Senate side where the prospects of passage become more challenging as we head into summer. On the Affordable Care Act, insurers are beginning to submit rate increase proposals for 2019 which could lead to some jaw-dropping increases as we saw in Virginia last week. 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.

Continue Reading CMS Continues to Focus Medicare Plans on Preventing Opioid Abuse

This week, the focus shifts back to the Congressional push around addressing the opioid epidemic after the President’s speech on drug pricing was postponed. Both committees of jurisdiction in the House and Senate are moving on opioid legislation this week, so that has our immediate attention. The speech delay offers a momentary reprieve for stakeholders, but there’s still a Request for Information of some kind pending at the Office of Management and Budget, so it is likely that there will be action in this eventually.

Additionally, on our radar are new Democratic proposals around expansion of health coverage as well as the Administration’s potential action regarding ACA nondiscrimination protections. We cover this and more in this week’s health care preview, which you can find here.

The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.  Although the Fifth Circuit Court of Appeals remanded the case, Family Rehabilitation, Inc. v. Azar, back to the district court and thus it is still too soon to tell the ultimate outcome, it reversed the district court and held that there is jurisdiction for a district court to enjoin CMS recoupment during the administrative appeals process.  This decision is a big win for companies navigating the difficult and seemingly one-sided process of Medicare recoupment actions. Continue Reading Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative Remedies

In March, the Medicare Payment Advisory Commission (MedPAC) released its biannual report to Congress on matters affecting the Medicare program. MedPAC is an independent congressional agency that advises Congress on issues relating to Medicare.

Though the March report includes several policy proposals, one of the most significant is MedPAC’s recommendation that Congress eliminate the Merit-based Incentive Payment System (MIPS) passed as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The report formalizes a vote the Commission took back in January to recommend repealing MIPS and replacing it with a voluntary value program (VVP) that MedPAC predicts would better achieve the goals put forth in MACRA. Continue Reading MedPAC Recommends Significant Changes to MACRA

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that new Medicare cards would be issued starting next month. As we previously reported, the government has been planning to revamp the card to reduce fraud. Medicare cards have historically included a SSN-based Health Insurance Claim Number (HICN) that was an easy target for identity thieves and fraudsters. A new randomly-generated Medicare Beneficiary Identifier (MBI) will replace the HICN on the new cards.

The move to issue new cards was set in motion by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which requires SSNs to be removed from Medicare identification cards within four years after MACRA’s enactment.

CMS will have a transition period during which either the HICN or the MBI can be used to exchange data with CMS. The transition period is set to begin no earlier than April 1, 2018, and run through December 31, 2019.

For those looking for additional information, CMS has created presentations explaining the card’s impact on different health care industry stakeholders.