October 24, 2018 | Blog | By Aaron Josephson
On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which are already posted on the Office of Information and Regulatory Affairs (OIRA) dashboard. The bulk of the rules on the Agency Rule List for Fall are under the purview of CMS or the FDA (63 and 77 rules, respectively). Also, earlier in October, FDA’s device center released a list of draft and final guidance documents it plans to publish in FY 2019. Many of these rules or guidance documents touch on issues top of mind and we expect that the administration will be moving forward with many of these priorities in the coming months.
October 17, 2018 | Blog | By Lauren Moldawer, Theresa Carnegie
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would require pharmaceutical manufacturers to disclose the list price of their pharmaceutical products in direct-to-consumer (“DTC”) television ads (the “Proposed Rule”).
October 15, 2018 | Blog | By Eli Greenspan
Congress has left town until after the midterm elections, but the Administration is continuing to advance its priorities in the regulatory arena. This week, the Administration is expected to publish the proposed rule, "Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency." We cover this and the political implications in this week's health care preview.
October 9, 2018 | Blog | By Eli Greenspan
While the House is out on recess, the Senate continues to be in session. This week the Senate has some non-health care related hearings scheduled as well as nomination hearings. We are looking for signals for a deal to finish work and send vulnerable Senators home to campaign. However, while legislative action may begin to cool down, regulatory activity at OIRA could be heating up.
Final Opioid Legislation Expands Treatment Options for Medicaid Beneficiaries with Substance Use Disorder
October 5, 2018 | Blog | By Cassandra Paolillo
The final bipartisan opioid package, which passed in the Senate this week and is expected to be signed into law, includes a significant revision from the original House bill that could lead to an increase in treatment options for Medicaid beneficiaries suffering from substance use disorder (“SUD”). The final version of the “SUPPORT for Patients and Communities Act” will provide state Medicaid programs with the option to cover SUD treatment in certain Institutions for Mental Diseases (“IMD”) for Medicaid beneficiaries between the ages of 21 and 64.
October 2, 2018 | Blog | By Eli Greenspan, Emma Zimmerman
On September 25, 2018, House and Senate negotiators agreed on a final legislative package to address the opioid crisis. Following this agreement, the House passed the opioid package on September 28, 2018. The Senate is expected to pass the package in the weeks ahead, and the President is expected to sign the package into law. ML Strategies has created a chart tracking the provision of the final opioid package.
October 1, 2018 | Blog | By Eli Greenspan
You might have missed it but Congress averted a government shutdown last week. While several appropriations bills passed on time for the first time in years, several agencies, including the FDA, were funded on a continuing resolution (CR). The CR provides funding until December 7th and will need to be addressed again by that time. However, the House is now in recess and won’t be back in town until after the midterm elections. So the lame duck session will have a few ‘must dos’ on the list.
September 24, 2018 | Blog | By Eli Greenspan
This week, Congress and the White House need to finalize a government spending bill in order to avoid a shutdown. While all signs point to a deal being reached, it is widely expected that several agencies will be operating on a continuing resolution for the first couple months of fiscal year 2019. While the Departments of Labor, HHS, and Education are expected to receive a full appropriation prior to September 30th, the FDA, which is funded through the Department of Agriculture, is expected to be funded through the continuing resolution, which will go through December 7th.
July 24, 2018 | Blog | By Theresa Carnegie
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.
July 23, 2018 | Blog | By Bridgette Keller
Earlier this month, CMS proposed changes to the Medicare Physician Fee Schedule and Quality Payment Program with the goal of “modernizing Medicare and restoring the doctor-patient relationship.”
July 18, 2018 | Blog | By Ellyn Sternfield
Timing is everything. In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop.
July 17, 2018 | Blog | By Ellyn Sternfield
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.
July 13, 2018 | Blog | By Ellen Janos
Some very good news for the telehealth community can be found amidst the more than 1,400 pages of the proposed Medicare Physician Fee Schedule for 2019(“Proposed Rule”) issued by CMS yesterday.
July 8, 2018 | Blog | By Ellyn Sternfield
State Medicaid Agencies have historically engaged in an epic balancing act. Federal law requires State Medicaid Agencies to ensure beneficiaries have access to medically necessary services. Federal law also requires State Medicaid Agencies to safeguard their Medicaid Programs against fraud, waste or abuse in billing for Medicaid services.
June 19, 2018 | Blog | By Ellyn Sternfield
It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s Request for Information (RFI) on the Blueprint. We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.
May 29, 2018 | Blog | By Bridgette Keller
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.
May 23, 2018 | Blog | By Eli Greenspan
In a previous blog, we reviewed pending and approved 1115 waivers in 11 states. These reviews provide an overview of 1115 waiver applications, including a focus on work requirements, lock-outs, changes in coverage structures, repealing the Medicaid IMD exclusion, and other behavioral health initiatives.
Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices
May 21, 2018 | Blog | By Ellyn Sternfield
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.
May 14, 2018 | Blog | By Susan Berson, Theresa Carnegie, Tara E. Dwyer
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.
May 1, 2018 | Blog | By Ellyn Sternfield
There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS signaling that additional changes to 340B may be coming?
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