Ron Lanton 1/27/22 Ron Lanton 1/27/22

Lanton Law Speaks with Pharmacy Times About the Mark Cuban Cost Plus Drug Company

Lanton Law spoke with Pharmacy Times about the possible market implications of the new Mark Cuban Cost Plus Drug Company.

“In an interview with Pharmacy Times, Ron Lanton III, Esq, principal at Lanton Law, said entrepreneur Mark Cuban's new venture into the pharmacy field is very interesting, although it maybe just another player in the mail-order pharmacy market.

In the interview, Lanton discussed the company's steep discounts on drugs in a myriad of disease states, as well as the company's pharmacy benefits manager, which is expected to be operational in 2023. Ultimately, Lanton said the company's broader impacts on the pharmacy field and drug pricing remain to be seen, although several other legislative efforts to lower drug prices have been discussed in recent years.”

The interview can be seen by clicking here.

Ron Lanton 1/5/22 Ron Lanton 1/5/22

New York Enacts New Pharmacy Benefit Manager Law

Governor Kathy Hochul has issued a press release announcing the enactment of S3762/A.1396 which provides for PBM registration and licensure.

Governor Kathy Hochul has issued a press release announcing the enactment of S3762/A.1396 which provides for PBM registration and licensure. According to the release:

“Legislation S.3762/A.1396 requires licensure for pharmacy benefit managers and specifies their duties and obligations as service providers. This bill also allows the department of financial services to receive complaints when a PBM violates the law and will ensure PBMs abide by standards established by law and regulation.”

Why is this important?

Based on our experience and our clients, Lanton Law strongly believes that PBMs have been hindering pharmacy operations and reimbursement for far too long. This new law is a great step in the right direction. With PBMs there is always more work to be done. Pharmacy advocates can use this law as a model in their own respective states.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation.

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.

Ron Lanton 1/5/22 Ron Lanton 1/5/22

CMS Ends Most Favored Nation Drug Price Model Proposal

According to the Centers for Medicare and Medicaid Services (CMS), the agency has published a final rule in the Federal Register on December 27, 2021, that rescinds the November 27, 2020, MFN Model interim final rule with comment period. The final rule rescinding the Most Favored Nation Model interim final rule with comment period can be found here.

Proposed Rule Background:

CMS included the following background to the issue in its announcement:

“In the August 10, 2021 Federal Register (86 FR 43620), we published a proposed rule (86 FR 43618, hereafter, referred to as “the August 2021 proposed rule”) that would rescind the Most Favored Nation (MFN) Model interim final rule with comment period (85 FR 76180) that appeared in the November 27, 2020 Federal Register (hereafter, referred to as “the November 2020 MFN Model interim final rule”). The November 2020 MFN Model interim final rule established a 7-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act), with the model performance period beginning on January 1, 2021. The MFN Model was not implemented on January 1, 2021 as contemplated following four lawsuits and a nationwide preliminary injunction. On December 28, 2020, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction in California Life Sciences Ass'n v. CMS, No. 3:20-cv-08603, which preliminarily enjoined HHS from implementing the MFN Model and the November 2020 interim final rule. For additional information on the MFN Model and the related lawsuits, see the August 2021 proposed rule, the November 2020 MFN Model interim final rule, and the MFN Model website.[1]”

Why does this matter?

Drug price continues to be an issue and it is essential for stakeholders to monitor how reimbursement will be for your operations.

How Lanton Law Can Help

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 12/15/21 Ron Lanton 12/15/21

Senator Wyden Requests FTC To Investigate Retail Pharmacy Market Consolidation

In a recent press release Senator Wyden (D-OR) has sent a letter to the Federal Trade Commission (FTC) to according to “investigate recent consolidations in Oregon’s retail pharmacy market to assess whether large national pharmacy chains and health plans have acted to make this market less competitive.”

“Wyden’s letter highlights ongoing industry dynamics that pose significant challenges to small, independent pharmacies. One particular practice known as direct and indirect remuneration, a form of retrospective fees imposed on pharmacies by pharmaceutical benefit managers (PBMs) has been cited as a particular challenge for these pharmacies to maintain healthy finances. According to a report by the Centers for Medicare and Medicaid Services (CMS), PBMs increased pharmacy DIR fees under Medicare Part D by 91,500 percent from 2010 to 2019.”

DIR fees have been something that the Senator has been monitoring. His press release states “In October, Wyden also urged the federal Centers for Medicare and Medicaid Services (CMS) to review pharmacy closures nationwide in the last five years with a focus on how fees imposed by Medicare Part D plans and middlemen known as pharmacy benefit managers are driving those closures.”

Ron Lanton 12/3/21 Ron Lanton 12/3/21

Congressional Cannabis Caucus Advocates for Medical Marijuana Access to Veterans

On December 1, 2021 the Congressional Cannabis Caucus composed a letter to the Secretary of Veterans Affairs regarding the Caucus’ advocacy for medical marijuana access for veterans.

The letter stated “As bipartisan Co-Chairs of the Congressional Cannabis Caucus, we are pleased to learn the Department of Veterans Affairs (VA) is considering a change in policy to allow for access to medical cannabis for VA patients. We implore your agency to act swiftly and implement this change as soon as possible.”

On December 1, 2021 the Congressional Cannabis Caucus composed a letter to the Secretary of Veterans Affairs regarding the Caucus’ advocacy for medical marijuana access for veterans.

The letter provides useful statistics and suggests benefits against certain disease states with the utilization of cannabis.

As time goes on we are seeing more opportunities for policy cooperation where cannabis is concerned, which means more marketplace opportunities for interested stakeholders.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

Ron Lanton 12/2/21 Ron Lanton 12/2/21

New Congressional Pharmacy Benefit Manager Bill Aimed at Spread Pricing Reintroduced

According to a December 1, 2021 press release, Representatives Carter (R-GA) and Gonzalez (D-TX) have reintroduced the Drug Price Transparency in Medicaid Act. The legislation “would limit the power of pharmacy benefit managers (PBMs) to artificially spike Medicaid drug prices. The Drug Price Transparency in Medicaid Act bans the use of spread pricing by middlemen (PBMs) in Medicaid managed care. PBMs drive up prescription drug costs without adding any value to the consumer.”

This legislation would help stop the under reimbursement that pharmacies are experiencing, while also helping to create much needed drug price transparency where Medicaid programs nationwide are concerned.

Ron Lanton 11/23/21 Ron Lanton 11/23/21

CURES 2.0 Biomedical Legislation Introduced Into Congress

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are back as they recently introduced their long anticipated and bipartisan Cures 2.0 legislation. The bill is discussed via Congresswoman DeGette’s press release.

So what does this proposed legislation do:

Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.
Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it.
Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.
Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.
Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.
Conduct a nationwide study on the implications of long COVID; and
Develop a nationwide testing and vaccine distribution strategy to be used in future pandemics.

The proposed bill can be viewed here while a section by section summary can be viewed here.

Ron Lanton 11/19/21 Ron Lanton 11/19/21

Pharmacy Celebrates Another Win Over PBMs in the 8th Circuit

This week the 8th Circuit issued a decision in the case of Pharmaceutical Care Management Association v. Wehbi, which supported North Dakota’s legislative actions to regulate pharmacy benefit managers (PBMs). PCMA v. Wehbi is the first case at the federal appellate level since the landmark Rutledge v. PCMA decision last year that upheld Arkansas law also regulating PBMs.

The PCMA v. Wehbi case can be found here.

With these huge decisions serving as tailwinds for pharmacy there is still more work to be done.

Ron Lanton 11/16/21 Ron Lanton 11/16/21

Newly Introduced States Reform Act Proposes to End Current Federal Prohibition on Marijuana

Rep. Nancy Mace (R-SC) has introduced The States Reform Act, which is aimed at becoming the first prominent policy push by a House Republican to end the current federal prohibition on marijuana.

Rep Mace said the following regarding her legislation in a newly released press statement:

“Today, only 3 states lack some form of legal cannabis. My home state of South Carolina permits CBD, Florida allows medical marijuana, California and others have full recreational use, for example. Every state is different. Cannabis reform at the federal level must take all of this into account. And it’s past time federal law codifies this reality,”

“This is why I’m introducing the States Reform Act, a bill which seeks to remove cannabis from Schedule I in a manner consistent with the rights of states to determine what level of cannabis reform each state already has, or not.

“This bill supports veterans, law enforcement, farmers, businesses, those with serious illnesses, and it is good for criminal justice reform. Furthermore, a super-majority of Americans support an end to cannabis prohibition, which is why only 3 states in the country have no cannabis reform at all.

“The States Reform Act takes special care to keep Americans and their children safe while ending federal interference with state cannabis laws. Washington needs to provide a framework which allows states to make their own decisions on cannabis moving forward. This bill does that.”

The U.S. Department of Agriculture would oversee growers
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives would oversee the cannabis industry.
Medical marijuana would be regulated by the Food and Drug Administration,
There would also be a 3% federal excise tax on all cannabis products, where these proceeds would be reinvested in small businesses, mental health and law enforcement

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

Ron Lanton 10/20/21 Ron Lanton 10/20/21

FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.”

Furthermore, “The FDA granted approval of Cyltezo to Boehringer Ingelheim on October 15, 2021. To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.”

The FDA’s announcement can be viewed here.

This is an exciting announcement by the FDA, as competitors to the originator now have a viable path forward to make market inroads.

Ron Lanton 10/8/21 Ron Lanton 10/8/21

California Enacts Genetic Privacy Legislation

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies.

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies. The bill can be viewed here. Below are the highlights of the bill:

This bill would establish the Genetic Information Privacy Act, which would require a direct-to-consumer genetic testing company, as defined, to provide a consumer with certain information regarding the company’s policies and procedures for the collection, use, maintenance, and disclosure, as applicable, of genetic data, and to obtain a consumer’s express consent for collection, use, or disclosure of the consumer’s genetic data, as specified.

This bill would require a direct-to-consumer genetic testing company to honor a consumer’s revocation of consent in accordance with certain procedures, and to destroy a consumer’s biological sample within 30 days of revocation of consent. The bill would further require a direct-to-consumer genetic testing company to implement and maintain reasonable security procedures and practices to protect a consumer’s genetic data against unauthorized access, destruction, use, modification, or disclosure, and develop procedures and practices to enable a consumer to access their genetic data, and to delete their account and genetic data, as specified. The bill would exclude from its provisions the California Newborn Screening Program, specific tests, and certain information, providers, entities, and activities subject to specified state and federal laws.

This bill would provide that the act does not reduce a direct-to-consumer genetic testing company’s duties, obligations, requirements, or standards under any applicable state and federal law for the protection of privacy and security and would further provide, if a conflict exists between the act and any other law, that the provisions of the law that afford the greatest protection for the right of privacy for consumers shall control.

This bill would impose civil penalties for a violation of those provisions, as specified. The bill would require actions for relief pursuant to these provisions to be prosecuted exclusively by the Attorney General, a district attorney, county counsel, city attorney, or city prosecutor, as specified, in the name of the people of the State of California upon their own complaint or upon the complaint of a board, officer, person, corporation, or association or upon a complaint by a person who has suffered injury in fact and has lost money or property as a result of the violation of the act. Because the bill would require local officials to perform additional duties, the bill would impose a state-mandated local program.

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

Ron Lanton 10/5/21 Ron Lanton 10/5/21

Biden Administration Issues Interim Final Rule on Surprise Medical Billing

The Centers for Medicare and Medicaid Services (CMS) in conjunction with the Departments of Health and Human Services (HHS), Labor (DOL), Treasury (collectively, the Departments), and the Office of Personnel Management (OPM) has issued an interim final rule with a comment period that seeks to implement the No Surprises Act aimed at surprise medical billing.

According to the CMS announcement “This rule details a process that will take patients out of the middle of payment disputes, provides a transparent process to settle out-of-network (OON) rates between providers and payers, and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals. It also adds protections in the external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims.”

The interim final rule can be viewed here.

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

Ron Lanton 9/27/21 Ron Lanton 9/27/21

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

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

Ron Lanton 9/24/21 Ron Lanton 9/24/21

SAFE Banking Act Passes House in Defense Legislation

The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation.

The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation. The bill would give safe harbors to financial institutions servicing cannabis industry stakeholders. The text of the SAFE Banking Act can be found here.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

Ron Lanton 8/27/21 Ron Lanton 8/27/21

Lanton Law Speaks with Medical World News Second Opinion Regarding Mandated COVID-19 Vaccines

Lanton Law was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

The full episode can be viewed at: here.

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 1 can be viewed here.

Ron Lanton 8/27/21 Ron Lanton 8/27/21

Home Infusion Stakeholders to be Helped by Newly Introduced Congressional Legislation

According to a press release by Senator Warner (D-VA), a newly introduced “bipartisan bill in the U.S. Senate proposes to ensure Medicare patients maintain access to home infusion therapies that require the use of an infusion pump. The Preserving Patient Access to Home Infusion Act — introduced by Sen. Mark Warner (D-VA) and Sen. Tim Scott (R-SC) — would ensure patients with serious viral and fungal infections, heart failure, immune diseases, cancer, and other conditions can receive the intravenous (IV) medications they need while at home.”

The Preserving Patient Access to Home Infusion Act can be viewed here.

How did this legislation come to be?

“Congress included provisions in the 21st Century Cures Act and the Bipartisan Budget Act of 2018 to create a professional services benefit for Medicare Part B home infusion drugs. The intent in establishing this benefit was to maintain patient access to home infusion by covering professional services including assessments, education on administration and access device care, monitoring and remote monitoring, coordination with the patient, caregivers and other health care providers, and nursing visits.

Despite Congress’ intent — as detailed in multiple letters to the agency — the Centers for Medicare and Medicaid Services (CMS) improperly implemented the benefit by requiring a nurse to be physically present in the patient’s home in order for providers to be reimbursed. As a practical matter, the current home infusion therapy benefit only acknowledges face-to-face visits from a nurse and fails to account for the extensive clinical and administrative services that are provided remotely by home infusion clinicians. As a result, provider participation in Medicare’s home infusion benefit has dropped sharply and beneficiaries have experienced reduced access to home infusion over the last several years.

The Preserving Patient Access to Home Infusion Act provides technical clarifications that will remove the physical presence requirement, ensuring payment regardless of whether a health care professional is present in the patient’s home. The legislation also acknowledges the full scope of professional services provided in home infusion — including essential pharmacist services — into the reimbursement structure.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. We have lobbied for and consult home infusion stakeholders.

If you are either thinking about getting into or are a current home infusion stakeholder and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

Ron Lanton 8/20/21 Ron Lanton 8/20/21

Latest FDA Refusal to Approve CBD as a Food Ingredient or Supplement Causes Stakeholder Frustration

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. This decision was outlined in an FDA letter to the company found here.

“Under 21 U.S.C. § 350b(a), the manufacturer or distributor of a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. FDA reviews this information to determine whether it provides an adequate basis for such a conclusion. Under 21 U.S.C. § 350b(a)(2), there must be a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the condition recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. § 342(f)(1)(B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.

FDA has carefully considered the information in your notification and other available information and determined that your NDI 1202 cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act). The definition of a dietary supplement is set forth in 21 U.S.C. § 321(ff) (section 201(ff) of the Act), which states in relevant part:

(ff) The term ‘dietary supplement’ . . . (3) does . . . (B) not include – (i) an article that is approved as a new drug under section 355 of this title . . . or (ii) an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval . . . or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

FDA has concluded that CBD products are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act).

We also conclude that, even if your NDI 1202 was not excluded from the definition of dietary supplement, the agency has concerns about the adequacy of safety evidence included in your submission as a basis for concluding that a dietary supplement containing NDI 1202 will reasonably be expected to be safe under the conditions of use described in your notification.”

Many in the industry were hoping to get some additional clarity on how FDA would oversee CBD and whether FDA’s views have evolved. Unfortunately that is not the case yet. CBD continues to be an item that has an uneven regulatory scheme.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

Ron Lanton 8/10/21 Ron Lanton 8/10/21

FDA Approves First Interchangeable Biosimilar

The U.S. Food and Drug Administration (FDA) has “approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.”

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

Ron Lanton 8/10/21 Ron Lanton 8/10/21

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.

Ron Lanton 7/12/21 Ron Lanton 7/12/21

President Biden Issues Executive Order Aimed at Multiple Industries

President Biden has issued an Executive Order (EO) titled Executive Order on Promoting Competition in the American Economy.

President Biden has issued an Executive Order (EO) titled Executive Order on Promoting Competition in the American Economy. The EO advocates for promoting “competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.” In doing so multiple sectors of the economy including labor, healthcare, transportation, agriculture, communications, technology, banking and finance have been targeted.

As our economy emerges from the pandemic, we foresee that state and federal policymakers will be taking a look to see what laws need to be strengthened or reworked for our reimagined economy.

Lanton Law is a national boutique law and lobbying firm that focuses on highly regulated industries such as healthcare, technology, and finance. 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.