In an attempt to lower drug prices, CMS released a proposed rule last week to reduce payments for new drugs under the Part B program. CMS has proposed that effective January 1, 2019, for new drugs and biologicals that are currently reimbursed utilizing the wholesale acquisition cost (“WAC”) of the drug or biological plus 6 percent, will instead receive a reduced add-on payment of 3 percent. Because the change is limited to new drugs that are largely expensive, physician-administered, and infused or injected, such as chemotherapy and rheumatoid arthritis treatments, the financial impact of the proposed reduction could be significant.

Continue Reading CMS Proposes to Reduce Payments for New Drugs under Medicare Part B

It seems like every week, there are multiple new developments in the 340B program.  While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress.  But why, despite all these developments, does it feels like little has actually changed in the 340B world since January?  Continue Reading July 2018: Where Are We Now With 340B?

Congress is in session this week with six important health care hearings, including hearings on Medicare fraud, mental health, and Stark reform. Meanwhile, the Administration continues to put forth new proposed rules and guidance that will impact many stakeholders between now and the end of the year. We cover this and more in this week’s health care preview, which you can find by clicking here.

This week, focus turns to the Senate as the House overwhelmingly passed its opioid package known as H.R. 6 last week (see our previous coverage here). The Senate will look to combine its various proposals into one package for floor consideration and what passes will provide a timeline for reconciling the House and Senate packages. In other news, the Senate will spend time in the HELP and Finance Committee on drug pricing. With Secretary Azar set to testify, we look for signals that the Administration is moving forward with any aspect of its drug pricing blueprint. We cover this and more in this week’s preview, which you can find here.

The government is focusing on opioids.  Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials.  It is also a major piece of the health care legislation moving in both the House and the Senate.

In the Senate, the Judiciary Committee advanced five bills relating to the opioid crisis, and the HELP Committee advanced the “Opioid Crisis Response Act of 2018,” which has over 40 measures relating to opioids. Most recently (6/12), the Senate Finance Committee unanimously approved the Helping To End Addiction And Lessen (HEAL) Substance Use Disorders Act Of 2018.  That Act includes the expansion of the Physician Payment Sunshine Act to include payments to mid-level providers, as we previously blogged about here.  Click here for a summary of all Senate bills.

On the House side, over the last two weeks, the House passed over 50 bills to combat the opioid crisis and have received bipartisan support. Additional opioid related bills have been introduced and passed out of committee. On June 20, the House voted and passed three additional opioid bills (HR 5925, HR 9797, and HR 6082). Two of these bills were considered controversial. H.R. 5797, The IMD CARE Act, repeals the Medicaid IMD exclusion for individuals with opioid use disorders. H.R. 6082, The Overdose Prevention and Patient Safety Act, amends 42 CFR Part 2 confidentiality protections pertaining to substance use disorder patient records.  Continue Reading Opioids Have Our Attention

This week the Senate Finance Committee will mark up its opioid package. Additionally, the HELP Committee will hear from Secretary Azar on the Administration’s effort to lower prescription drug prices. For our complete review and what else to watch for this week, click here.

HHS’s Office of Medicare Hearings and Appeals (OMHA) has long faced a backlog in Medicare appeals to Administrative Law Judges (ALJs). In an effort to address this backlog, OMHA established a Settlement Conference Facilitation (SCF) process. OMHA describes SCF as an alternative dispute resolution process that gives certain providers and suppliers the opportunity to resolve all eligible Part A and Part B appeals at once.

The SCF pilot began in June 2014 focusing on Medicare Part B appeals and has gradually been expanded, due in part to its success. Last week, OHMA announced a new plan to expand the SCF program even further and offer providers a quicker option to resolve eligible payment disputes: SCF Express.

Continue Reading HHS Announces a “Settlement Express” Option for Medicare Appeals

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.