Lanton Law Interviews Famlee Founder & CEO Shelley Bailey
Ron Lanton of Lanton Law interviews Shelley Bailey of Famlee. They discuss fertility, entrepreneurship and the benefits of technology for the advancement of women's health.
Ron Lanton of Lanton Law interviews Shelley Bailey of Famlee. They discuss fertility, entrepreneurship and the benefits of technology for the advancement of women's health. The interview can be heard here.
Arizona passes new law requiring insurers to cover cancer biomarker tests
Arizona has enacted HB 2144 seen here which requires health care insurers, the Arizona Health Care Cost Containment System (AHCCCS) and its contractors to provide coverage for biomarker testing. Prescribes processes and requirements for the usage and coverage of biomarker testing.
Arizona has enacted HB 2144 seen here which requires health care insurers, the Arizona Health Care Cost Containment System (AHCCCS) and its contractors to provide coverage for biomarker testing. Prescribes processes and requirements for the usage and coverage of biomarker testing.
Bills like these are needed as they improve physicians’ abilities to target cancers more accurately which could lead to improved patient outcomes and less healthcare financial waste.
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 healthcare 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 priorities.
Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.
FDA Releases Draft Guidance To Encourage Enhancing Clinical Trial Diversity
The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.3 Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.
Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.
The draft guidance can be found here.
Lanton Law is a national healthcare and life science boutiquelaw andgovernment 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 ourlegal orlobbying services can help you attain your goals.
Lanton Law Micro Webinar on the Upcoming FTC Comment Period on PBMs
Check out our micro webinar on the upcoming FTC comment and period on pharmacy benefit managers.
We have a micro webinar on the upcoming FTC comment period on pharmacy benefit managers. Click here to view the micro webinar.
Pharmacy Focus: Oncology Edition - A Conversation About Biden's Cancer Moonshot Program
In the first episode of Pharmacy Focus: Oncology Edition, the Times spoke with Ron Lanton, JD, principal at Lanton Law. Although it is still too early to know how the program differs from private-sector efforts to improve cancer treatments, Lanton said the program has some interesting goals and approaches.
In the first episode of Pharmacy Focus: Oncology Edition, the Times spoke with Ron Lanton, JD, principal at Lanton Law. Although it is still too early to know how the program differs from private-sector efforts to improve cancer treatments, Lanton said the program has some interesting goals and approaches.
The podcast can be heard here.
CMS is Proposing to Delay the Radiation Oncology (RO) Model
Last week the Centers for Medicare & Medicaid Services (CMS) announced its proposal to delay the start of the Radiation Oncology Model. The announcement can be found here. No reason was given but the proposed reimbursement structure was undoubtedly the major reason behind this delay.
Last week the Centers for Medicare & Medicaid Services (CMS) announced its proposal to delay the start of the Radiation Oncology Model. The announcement can be found here. No reason was given but the proposed reimbursement structure was undoubtedly the major reason behind this delay.
So what is the RO Model? According to CMS “The Radiation Oncology (RO) Model aims to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether prospective, site neutral, modality agnostic, episode-based payments to physician group practices (PGPs), hospital outpatient departments (HOPD), and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries.”
Below are some key elements of the RO Model:
Alternative Payment:
Episode Payments: CMS makes prospective, episode-based (i.e., bundled) payments, based on a patient's cancer diagnosis, that cover RT services furnished in a 90-day episode for the included cancer types meeting the included cancer type criteria described in the final rule;
Site-neutrality: The Model uses site-neutral payment by establishing a common, adjusted national base payment amount for the episode, regardless of the setting where it is furnished;
Professional and Technical Payment Components: Episode payments are split into professional and technical components to allow the current claims systems for the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) to be used to adjudicate RO Model claims and for consistency with existing business relationships.
Linking Payment to Quality: The Model links payment to quality using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to RO participants. The Model meets the requirements to qualify as an Advanced Alternative Payment Model (APM) and a Merit-Based Incentive Payment System (MIPS) APM under QPP starting in performance year (PY) 1.
RO Participants in a Mandatory Model: The RO Model requires participation from RT providers and RT suppliers that furnish RT services within randomly selected CBSAs.
If you are a radiation oncology stakeholder, this is something to continue to watch.
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 healthcare 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 priorities.
Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.
House Passes Insulin Bill
The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here.
The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here. According to the bill’s summary this bill does the following:
Limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit.
Caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023.
Caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at $35 beginning in 2023.
Currently, the Centers for Medicare & Medicaid Services is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.
The bill also (1) further delays implementation of regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws, and (2) increases funding for the Medicare Improvement Fund.
The bill now goes to the Senate where 60 votes are needed to send it to the President.
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 healthcare 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.
Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.
What to Know about CURES 2.0
In November 2021, U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) today introduced their bipartisan Cures 2.0 legislation. The bill which is aimed at helping patients of innovative companies within healthcare and life sciences can be viewed here.
In November 2021, U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) today introduced their bipartisan Cures 2.0 legislation. The bill which is aimed at helping patients of innovative companies within healthcare and life sciences can be viewed here.
According to Congressman Upton’s press release the bill:
Creates an entirely new agency aimed at ending some of the world’s most difficult diseases – such as cancer, diabetes, ALS, Alzheimer’s and more. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country.
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.
We have featured this bill in a previous November 23, 2021 blog post. We believe that this is a great opportunity if you are a manufacturer, telehealth provider or clinical trial stakeholder. CURES 2.0 is something that we have been forceasting since 2020 as a way to make our system better.
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.
FDA Proposes Rule Impacting Wholesale Drug Distributors & 3rd Party Logistics Providers
According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”
According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”
The rule can be found here. The comment period ends June 6, 2022.
Lanton Law has personal experience in the wholesale distribution industry.
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 healthcare practice can help distribution 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.
Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.
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.
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.
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.
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.”
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.”
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.
House Committee on Oversight and and Reform Releases Report on Drug Pricing
Last week Representative Maloney (D-NY) who is the Chairwoman of the Committee on Oversight and Reform released the final staff report, resulting from a multi-year investigation into drug pricing. The Committee investigation was originally started by the late Representative Cummings.
Last week Representative Maloney (D-NY) who is the Chairwoman of the Committee on Oversight and Reform released the final staff report, resulting from a multi-year investigation into drug pricing. The Committee investigation was originally started by the late Representative Cummings.
Here are a few findings from the report.
Drug companies aggressively raise prices to meet revenue targets, and executive compensation structures create incentives to raise prices. The companies in the Committee’s investigation collectively raised prices more than 250 times on the 12 drugs examined. The drugs in the Committee’s investigation are now priced at a median of almost 500% higher than when they were brought to market. The Committee ’s investigation revealed evidence that company executives made aggressive price increases to meet ever-increasing revenue targets and earnings goals. All ten companies have compensation structures that tie incentive payments to revenue and other financial targets, and several companies directly tied incentive compensation to drug-specific revenue targets.
Drug companies target the U.S. market for higher prices and use the Medicare program to boost revenue. Internal strategy documents show that drug companies targeted the U.S. market for price increases—while maintaining or lowering prices in the rest of the world—in part because Medicare cannot negotiate directly for lower prices. The Committee’s analysis found that taxpayers could have saved more than $25 billion over a five-year period for just seven of the drugs investigated—Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog, and Lyrica—if private Medicare Part D plans had obtained the same discounts as other federal health programs that are empowered to negotiate.
Drug companies abuse the patent system and FDA market exclusivities to suppress competition. Collectively, the companies in the Committee’s investigation have obtained more than 600 patents on the 12 drugs examined, which could potentially extend their monopoly periods to a combined total of nearly 300 years.
Drug companies use strategies to suppress competition and maintain monopoly pricing. Every company in the Committee’s investigation engaged in one or more strategies to suppress competition from generics or biosimilars. These strategies include what are often described as “life-cycle management” or “loss of exclusivity” strategies: (1) shifting patients to new products or formulations of a drug just before facing generic competition for the old formula (known as “product hopping” or “evergreening”); (2) pursuing contracts with PBMs and insurers that condition rebates and discounts on excluding competitor products; and (3) aggressively marketing directly to patients and physicians to drive sales, especially as drugs faced generic competition. The Committee’s investigation also uncovered new evidence of “shadow pricing,” a practice in which would-be competitor companies follow each other’s price increases.
Drug companies use patient assistance programs as a public relations tool to boost sales. The Committee’s investigation uncovered new evidence that companies emphasized the significant returns on investment from these programs in the form of increased sales, particularly for drugs approaching loss of exclusivity. Internal documents show that companies view these programs as an important public relations tool, but that companies’ spending on patient assistance programs is minimal compared to the enormous amount of revenue brought in by these drugs. These programs often do not provide sustainable support for patients and do not address the burden that the company’s pricing practices have placed on the U.S. health care system.
Research and manufacturing costs do not justify price increases. The Committee’s investigation found that companies’ investments in R&D are far outpaced by revenue gains. The investigation also found that even if the pharmaceutical industry collected less revenue due to pricing reforms, drug companies could maintain or even exceed their current R&D expenditures if they reduced spending on stock buybacks and dividends. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period. In addition, companies dedicated a significant portion of their R&D expenditures to research intended to extend market monopolies, support the companies’ marketing strategies, and suppress competition.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our healthcare and life science practice has been helping entities nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help stakeholders 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.