Lanton Law Moderates Most Favored Nation Panel for MJH Life Sciences

Lanton Law was honored to be selected as a moderator for the MJH Life Sciences panel titled ““Most Favored Nation Order: Legal Battles, Market Shifts, and the Future of Drug Pricing Reform.”

The AJMC wrote a nice blog post on the panel. The panelists, included moderator Ron Lanton, JD, of Lanton Law; Mel Whittington, PhD, managing director and head of the Leerink Center for Pharmacoeconomics at MEDACorp, Inc.; Stephen Forster, JD, partner at the Health Care and Life Sciences Practice at Jones Day; and Peter Rubin, executive director of No Patient Left Behind. The panel discussed the voluntary Pfizer agreement, which aims to reduce prices by up to 85%, and the new TrumpRx platform, set to launch in 2026 to allow direct-to-consumer medication purchases.

The Pharmaceutical Executive story on the panel can be found here.

The AJMC article on the panel can be viewed here.

More Drugmakers Sue Biden Administration Over Medicare Negotiation

Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violate the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.

As part of the new law, the Centers for Medicare and Medicaid Services (CMS) will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Lanton Law Speaks at Summit & Reverse Expo

We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.

CMS Proposes Rescinding Most Favored Nation Interim Final Rule

The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register.  CMS is seeking public comment by October 12, 2021. 

This rule has already had some interesting history. According to the proposal, “In December 2020, while the comment period was open, four lawsuits were filed related to CMS's waivers of proposed rulemaking and delay in effective date as well as other aspects of the MFN Model and the November 2020 interim final rule.

On January 8, 2021, the Solicitor General determined not to appeal the preliminary injunction issued in California Life Sciences. On January 19, 2021, at the parties' request, the U.S. Northern District of California stayed the case until at least April 23, 2021. Subsequently, on April 26, 2021, another stay was granted until July 26, 2021. On July 29, 2021, another stay was granted until September 27, 2021.

In Regeneron Pharmaceuticals, on February 2, 2021, the plaintiff filed a letter seeking leave to file a motion for summary judgment, and HHS filed a letter seeking leave to file a motion for a stay. On February 10, 2021, the U.S. District Court for the Southern District of New York granted HHS's request and stayed the case for 90 days (that is, through May 11, 2021). On May 10, 2021, the stay in this case was extended for an additional 90 days, until August 9, 2021, to give HHS time to consider how to proceed with the rule in light of the “unanimous” court decisions to date. In its order, the court noted that HHS should “not assume that another stay will be granted,” as the stays gave HHS “a half-year to reach a conclusion regarding how to proceed[.]”

As a result of the nationwide preliminary injunction, the MFN Model was not implemented on January 1, 2021, as contemplated in the November 2020 interim final rule. While the nationwide preliminary injunction has been in place, CMS considered how to proceed given stakeholders' concerns about potential impacts of the MFN Model.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. 

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.  

According to Senator Cornyn’s press release “this legislation would direct HHS to establish a shared savings demonstration project to increase access to biosimilars in the Medicare program. This would encourage physicians to prescribe less-expensive biosimilars increasing patient access to more affordable, life-saving drugs and lowering patient out-of-pocket costs.

Under the demonstration, Medicare would provide an additional payment to providers for using lower-cost biosimilar products that reflects the savings created in contrast to administering the higher-cost reference biological product. Additionally, Medicare can use a portion of those savings to reduce the beneficiary’s coinsurance payment.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

New White House Drug Pricing Executive Order Released

On September 13, 2020, the Trump Administration released a new Executive Order (EO)  targeting drug pricing. The EO directs the Secretary of HHS to implement a “Most Favored Nation” drug pricing program for Medicare Parts B and D. This policy relies on international price competition and seeks to provide Americans with the same lower prices for prescriptions that we see in other countries.

Drug pricing has been a major point of contention as manufacturers and insurer/pharmacy benefit managers exchange blame over why drug prices are rising. Drug pricing has been a major issue that had been getting Congressional scrutiny until COVID-19. 

This issue will come back once a COVID-19 vaccine is available as there may be questions around the vaccine’s price. Additionally, once COVID-19 dies down, drug pricing for new therapies is expected to be front and center again.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today!

Pharmacy Times Interviews Lanton Law On How COVID-19 May Lead to the Expansion of Practice Laws for Pharmacists Across the Country

Alana Hippensteele; Editor, MA of Pharmacy Times interviewed Ron Lanton to discuss how COVID-19 may lead to expansion of practice laws for pharmacists across the country. Click here to access the interview.

Below Is a summary of the interview from Pharmacy Times:

Pharmacy Times spoke with Ron Lanton III, Esq, a regulatory and government affairs professional, about how the coronavirus disease 2019 (COVID-19) could lead to more expanded practice laws for pharmacists across the country.

Lanton noted that actions such as clinical laboratory improvement amendment (CLIA) waivers and additional steps by the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services (HHS) have been encouraging and have allowed pharmacists to be more involved in the pandemic response while beginning to get paid for these services.

“I think that was one of those tools that just wasn’t there before because of where we are, and now it’s there,” Lanton said. “It’s been very encouraging to have HHS and CMS there trying to make sure that this happens for pharmacy.”

Lanton added that although pharmacists have been discussing their value for a long time, the pandemic has pushed that knowledge into the forefront of patients’ and other health care professionals’ minds.

He encouraged pharmacists to follow news from CMS closely, because new policies and announcements are coming out almost daily. The ongoing stimulus packages passed by Congress may also offer a chance for pharmacists to push the field forward, by lobbying for provider status, personal protective equipment, and direct and indirect remuneration fee relief as part of the packages.

Lanton Law Interviews the Massachusetts Pharmacists Association on DIR & Provider Status

We are excited to have Lindsay De Santis; Executive Vice President of the Massachusetts Pharmacists Association (MPhA) do a blogcast with us. Our conversation covers pharmacy DIR (direct and indirect remuneration) fees, pharmacy provider status and COVID-19.

Click here to access the Lanton Law blogcast.