New York Proposes New Cybersecurity Regulations for State Hospitals

On November 13, the Governor unveiled new cyber regulations for state hospitals. The Governor’s FY24 budget includes $500 million in funding that health care facilities may apply to upgrade their systems in order to comply. 

On November 13, the Governor unveiled new cyber regulations for state hospitals. The Governor’s FY24 budget includes $500 million in funding that health care facilities may apply to upgrade their systems in order to comply. 

According to the release which can be read here states:

“The proposed regulations aim to strengthen the protections on hospital networks and systems that are critical to providing patient care, as a complement to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule that focuses on protecting patient data and health records. Under the proposed provisions, hospitals will be required to establish a cybersecurity program and take proven steps to assess internal and external cybersecurity risks, use defensive techniques and infrastructure, implement measures to protect their information systems from unauthorized access or other malicious acts, and take actions to prevent cybersecurity events before they happen.”

Lanton Law with offices in Boston and Washington D.C. is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and technology spaces.

Contact us to learn about how either our legal or lobbying services can help you attain your goals.

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Mass General Brigham partners with Best Buy to improve acute care at home via tech

Mass General Brigham has announced an innovative partnership with Best Buy.

Mass General Brigham has announced an innovative partnership with Best Buy. According to the press release:

“Together, they will develop solutions to support the transformational movement of shifting healthcare to patients’ homes by improving how quality and safe care are provided with technology and clinical expertise. Their first priority is to scale and support Mass General Brigham’s Home Hospital. This technology-enabled clinical delivery model will expand access to Massachusetts residents choosing to receive acute-level hospital care in the comfort of their home. This collaboration will also help address one of the biggest challenges the healthcare industry faces today — workforce shortages.”

They also addressed the future of care at home: 

“While workforce shortages plague the healthcare industry and threaten the ability of healthcare systems, the Home Hospital experience has shown an increase in employee satisfaction through innovative hybrid practice options and a reduction of clinician burnout. As part of this relationship, Best Buy Health and Mass General Brigham will engage with and make significant investments in the community to enable the next generation of the Healthcare at Home workforce. To do this they will create equitable, academic opportunities for individuals interested in pursuing nursing, paramedic and digital technology careers by offering scholarships to students choosing the at-home setting of care as their desired professional environment. They will also work to bring care in the home to the forefront of curriculum within these industries to further support the growing home healthcare model.”

Their full press release can be found here

Lanton Law with offices in Boston and Washington D.C. 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.

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Lanton Law Lobbies on Beacon Hill in Boston, Massachusetts for Pharmacy Issues

Lanton Law was on Beacon Hill this week advocating for pharmacy issues.

Lanton Law was on Beacon Hill this week advocating for pharmacy issues. We are happy to be working with several pharmacy allies within the legislature on meaningful issues around health promotion screening and pharmacy benefit manager transparency.

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Lanton Law Podcast speaks with the Vermont Office of the Health Care Advocate

For this episode of the Lanton Law Podcast we interview Sam Peisch of the Vermont Office of the Health Care Advocate. We discuss the new Office of the Health Care Advocate within Vermont Legal Aid, healthcare challenges in the state as well as efforts to address healthcare inequity within at risk communities in Vermont.

For this episode of the Lanton Law Podcast we interview Sam Peisch of the Vermont Office of the Health Care Advocate. We discuss the new Office of the Health Care Advocate within Vermont Legal Aid, healthcare challenges in the state as well as efforts to address healthcare inequity within at risk communities in Vermont.

Listen to the podcast here

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U.S. Supreme Court Rejects Medicare’s $1.6 Billion Reimbursement Reduction for Hospitals

The U.S. Supreme Court today has overturned the D.C. Circuit ruling that upheld the U.S.Department of Health and Human Services (HHS’) $1.6 billion annual reduction within the 340B program. In an opinion drafted by Justice Kavanaugh, the Court believed that HHS failed to gather a survey of hospital acquisition costs before deciding on the payment reductions at issue.

The U.S. Supreme Court today has overturned the D.C. Circuit ruling that upheld the U.S.Department of Health and Human Services (HHS’) $1.6 billion annual reduction within the 340B program. In an opinion drafted by Justice Kavanaugh, the Court believed that HHS failed to gather a survey of hospital acquisition costs before deciding on the payment reductions at issue. 

Absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful. The text and structure of the statute make this a straightforward case. Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals. HHS maintains that even when it does not conduct a sur- vey, the agency still may “adjus[t]” the average price “as necessary.” §1395l(t)(14)(A)(iii)(II). But HHS’ power to increase or decrease the price is distinct from its power to set different rates for different groups of hospitals. Moreover, HHS’s interpretation would make little sense given the statute’s overall structure. Under HHS’s interpretation, the agency would never need to conduct a survey of acquisition costs if it could proceed under option 2 and then do everything under option 2 that it could do under option 1. That not only would render irrelevant the survey prerequisite for varying reimbursement rates by hospital group, but also would render largely irrelevant the provision of the statute that precisely details the requirements for surveys of hospitals’ acquisition costs. See §1395l(t)(14)(D). Finally, HHS’s argument that Congress could not have intended for the agency to “overpay” 340B hospitals for prescription drugs ignores the fact that Congress, when enacting the statute, was well aware that 340B hospitals paid less for covered prescription drugs. It may be that the reimbursement pay- ments were intended to offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities. Regardless, this Court is not the forum to resolve that policy debate.

The Court did not entertain the possibility of overturning Chevron v. Natural Resources Defense Council, which requires judicial deference to reasonable agency readings of ambiguous statutes, as the Court did not address this legal theory. 

The Court decision can be found here.

This is a big development for 340B stakeholders. 

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

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How to Choose a Lobbyist

Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization?

Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization? 

First you want to make sure the lobbyist has experience. To be a good lobbyist there is no magic number of how many years you have worked within the political system. However; many lobbyists have worked an average of six months in the legislature as an aide to a legislator or on the other side of the spectrum, many legislators have left the legislature to work as a lobbyist. These individuals have an insider’s perspective into how the legislature works such as when a bill filing deadline date is and whether or not a bill can be introduced due to if a state is in an emergency session where the rules for introducing legislation is different from regular session. 

Second the lobbyist should have a minimum number of contacts in the legislature. Whether it is in Congress or on the state level, the lobbyist should be able to have a go to legislator that can get a bill introduced quickly. However; the most successful lobbyist will not be limited to one party. Having contacts on both sides of the aisle will allow the lobbyist the opportunity to bring any bill at any time regardless of what political party has the majority.   

Third the best lobbyist should be strategic. He or she should be able to know when a good time to introduce legislation is. The lobbyist should know what legislator to target as the bill sponsor. This is important because the bill sponsor will be the champion for your particular bill from start to finish. The lobbyist will need to educate the bill sponsor on the nuances of the bill so that the sponsor will be educated enough to be able to respond to technical questions during a hearing or when the sponsor is in caucus meetings; explaining to their respective party about why your bill should be voted on. The lobbyists should be able to pick and choose what committee will be best for your bill to go into, who to use as strategic allies for your legislation and be intuitive enough on when to negotiate and when not to.   

Next it is important for your lobbyist to know the industry and to have foresight. You need to be comfortable knowing that your lobbyist understands your industry because if not, how can you be sure that your lobbyist is communicating the correct outcome for you? The lobbyist should be skilled enough to draft a bill that solves your problem without having to continuously ask you how something works. Additionally, while many lobbyists only focus on the legislature, the best lobbyists will think long-term to determine if a regulatory body will be involved once your bill passes. If so a lobbyist should be able to guide you through the regulatory process without leaving you to fend for yourself after a bill has passed. 

Finally, as with any other professional, you need to be aware of the reputation your lobbyist has. Do they take the time to make sure their clients understand everything that is happening? Does the lobbyist prepare the client and relevant legislators ahead of time for crucial hearings? Does the lobbyist make everything easy to understand? Does the lobbyist dress appropriately for meetings and do they have the needed respect from the legislature? Does the lobbyist closely follow the bill from start to finish or are they overloaded with too many clients? These are important issues to talk with your prospective lobbyist about before entering into a contractual relationship. 

While there are other nuances to the lobbying relationship, these should be enough for you to think about as your organization considers whether to engage a lobbyist. Lobbyist should no longer be considered a luxury item. The best lobbyist are quickly becoming essential parts of today’s corporate environment for the value they bring to their clients in either advancing their interests through legislation, or being available to respond to legislative targeting that has been on the rise. You know you have picked the right lobbyist when you can breathe a sigh of relief knowing that they have your back.  

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

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Massachusetts Attorney General Agrees to Optum Atrius Health Merger

Massachusetts Attorney General Healey has agreed to Optum’s Atrius Health acquisition for a price of $236 million. With this Optum has taken another step in its acquisition of Massachusetts’ largest independent physician organization.

Massachusetts Attorney General Healey has agreed to Optum’s Atrius Health acquisition for a price of $236 million. With this Optum has taken another step in its acquisition of Massachusetts’ largest independent physician organization. 

The Massachusetts Health Policy Commission has also been reviewing this transaction. The Commission’s preliminary review on the transaction can be found here

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare, technology and clean energy. Our mergers and acquisitions practice focuses on helping stakeholders acquire targets as well as helping clients transfer assets.

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.

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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.

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President Biden Signs the Consolidated Appropriations Act of 2022 Impacting Telehealth and Health System Stakeholders

On March 15, 2022 President Biden signed the Consolidated Appropriations Act of 2022 into law. The announcement can be viewed here. This $1.5 trillion omnibus appropriations bill is important as there are several provisions applicable to hospitals and health systems contained within; namely touching on issues such as 340B eligibility and telehealth.

On March 15, 2022 President Biden signed the Consolidated Appropriations Act of 2022 into law. The announcement can be viewed here. This $1.5 trillion omnibus appropriations bill is important as there are several provisions applicable to hospitals and health systems contained within; namely touching on issues such as 340B eligibility and telehealth. 

Specifically regarding 340B the bill allows for limited protections for certain 340B hospitals that lost their eligibility due to a drop in their disproportionate share hospitals (DSH) adjustment percentage below the required threshold for 340B eligibility to gain limited access to the program. Access to the 340B drug discounts would be available only from the date of the bill’s enactment through the end of 2022 and not retrospectively.

For telehealth stakeholders, the new law would extend several telehealth flexibilities for 151 days after the end of the COVID-19 public health emergency. Additionally, the Medicare Payment Advisory Commission (MedPAC) shall “conduct a study on the expansions of telehealth services” and report their findings to Congress no later than June 2023.

Stakeholders in these groups have a lot of uncertainty in their specific industries. 

Lanton Law is a national boutique healthcare and technology law and government affairs firm.  We closely monitor legislative, regulatory and legal developments for our clients. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

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Prescription Digital Therapeutics (PDTs) Legislation Introduced

The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV).

The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by  Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV). 

“According to the bill’s release, it would expand Medicare coverage to include PDTs, which are software-based treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software.” 

The bill sponsors released a one page fact sheet about the bill and PDTs itself.

“Prescription Digital Therapeutics (PDTs) are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. These therapies are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software.

The COVID-19 pandemic and public health emergency rapidly accelerated the pace of innovation to address some of the most pressing challenges in health care. New tools are being rapidly deployed and adopted, particularly in the case of digital health, which are increasingly being used, PDTs provide clinicians and patients with evidence-based remote treatment modalities to treat substance and opioid use disorders, mental health, diabetes and other diseases and conditions. However, there is no clear statutory benefit category to allow for Medicare and Medicaid coverage for PDTs.”

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 HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM 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.

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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.

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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.

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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.

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Cybersecurity & FY 22 Discretionary Funding Request

The President’s request for fiscal year 2022 discretionary funding has been released. Below are a few mentions for cybersecurity:

The President’s request for fiscal year 2022 discretionary funding has been released. Below are a few mentions for cybersecurity:  

  • To support agencies as they modernize, strengthen, and secure antiquated information systems and bolster Federal cybersecurity the discretionary equest recommends $500 million for the Technology Modernization Fund, an additional $110 million for the Cybersecurity and Infrastructure Security Agency, and $750 million as a reserve for Federal agency information technology enhancements.  

With increased hacking and ransomware attacks, cybersecurity is going to be more front and center for both policy and legal discussions. For example in this request by the Administration, the attack on SolarWinds Corp. and Microsoft Exchange’s email servers were expressly mentioned. For stakeholders that traffic in data, cybersecurity policies are essential. Ensuring compliance with federal and state requirements are key and we can help. 

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

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New York Privacy Act Introduced into the New York State Legislature

A680 titled the New York Privacy Act has been introduced into the New York State Assembly. The bill is sponsored by Assemblywoman Rosenthal (D-District 67).

A680 titled the New York Privacy Act has been introduced into the New York State Assembly. The bill is sponsored by Assemblywoman Rosenthal (D-District 67). 

The proposed bill seeks to enact the NY privacy act to require companies to disclose their methods of de-identifying personal information, to place special safeguards around data sharing and to allow consumers to obtain the names of all entities with whom their information is shared. Furthermore the proposed bill creates a special account to fund a new office of privacy and data protection.  

While the bill has echoes of Europe’s General Data Protection Regulation consent requirements, this bill takes a hard line approach on the subject which requires consent for all   processing activities and third-party disclosures, with no exceptions, the proposed bill as currently written raises significant concerns with how businesses would realistically be able to comply with the proposal’s requirements. 

Penalties are very strong under this proposal as seen below:

The attorney general may bring an action in the name of the state,or as parens patriae on behalf of persons  residing  in  the  state,  to enforce this article.

In addition to any right of action granted to any governmental body pursuant to this section, any person who has been injured by reason of a violation  of this article may bring an action in his or her own name to enjoin such unlawful act, or to recover his or her  actual  damages,  or both  such  actions. The court may award reasonable attorney's fees to a prevailing plaintiff.

Any controller or processor who violates this article is subject to an injunction and liable for damages and a civil penalty. When calculating damages and civil penalties, the court shall consider the number  of affected  individuals,  the  severity of the violation, and the size and revenues of the covered entity. Each individual  whose  information  was unlawfully  processed  counts as a separate violation. Each provision of this article that was violated counts as a separate violation.

Privacy is a hotly trending topic that is showing now signs of slowing down. Bills like this one will require significant work as it makes its way through the legislature in order for New York to achieve consumer protection while enacting a workable law that businesses will be able to comply with. 

We at Lanton Law can help. Our legal and lobbying tools can help offer your organization a clear path forward to navigate what will be changing policies for healthcare, technology and clean energy stakeholders. We are a D.C. based firm with no state boundaries as we are active nationwide. Contact us today to discuss your options.  

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Virginia on Track to Become Second Second State to Pass Data Privacy Laws

Lanton Law’s privacy practice has been closely monitoring the various state conversations around data privacy. We previously wrote a blog post titled California’s Consumer Privacy Act Could Be Coming to a State Near You, where we traced how California took the first step to create a consumer privacy law in the wake of Europe’s General Data Protection Regulation.

Lanton Law’s privacy practice has been closely monitoring the various state conversations around data privacy. We previously wrote a blog post titled California’s Consumer Privacy Act Could Be Coming to a State Near You, where we traced how California took the first step to create a consumer privacy law in the wake of Europe’s General Data Protection Regulation.    

So what’s going on with Virginia? Earlier this month the Virginia Senate passed 

 Senate Bill 1392, titled the Consumer Data Protection Act. The Virginia House of Delegates approved a companion (identical) House Bill H.B. 2307 by an 89-9 vote. Each bill likely will be heard in committee next week by the opposite chamber, which provides additional opportunities to make amendments. The state General Assembly will adjourn on March 1, it is expected that Governor Northam will sign the legislation. 

What does the bill do? The proposed legislation seeks the following:

“Establishes a framework for controlling and processing personal data in the Commonwealth. The bill applies to all persons that conduct business in the Commonwealth and either (i) control or process personal data of at least 100,000 consumers or (ii) derive over 50 percent of gross revenue from the sale of personal data and control or process personal data of at least 25,000 consumers. The bill outlines responsibilities and privacy protection standards for data controllers and processors. The bill does not apply to state or local governmental entities and contains exceptions for certain types of data and information governed by federal law. The bill grants consumer rights to access, correct, delete, obtain a copy of personal data, and to opt out of the processing of personal data for the purposes of targeted advertising. The bill provides that the Attorney General has exclusive authority to enforce violations of the law, and the Consumer Privacy Fund is created to support this effort. The bill has a delayed effective date of January 1, 2023.”

As with major policy issues that have yet to have a federal solution, states like California, Virginia and others are creating piecemeal policies, which will create compliance issues for entities that operate in several jurisdictions. New York, Oklahoma, Washington State, Minnesota, and North Dakota are jurisdictions that we continue to monitor with brewing policies on point.  

As we become more reliant on technology which crosses several sectors now, businesses are finding that they have to increase their awareness of state and federal policy in order to remain compliant. We at Lanton Law can help. Our legal and lobbying tools can help offer your organization a clear path forward to navigate what will be changing policies for healthcare, technology and clean energy stakeholders. We are a D.C. based firm with no state boundaries as we are active nationwide. Contact us today to discuss your options. 

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Surprise Medical Billing Law Takes Effect January 1, 2022

The No Surprises Act was quietly a part of the omnibus spending bill that was signed into law on December 27, 2020 has caught several people by surprise (no pun intended). The law was created with the goal of shielding patients from receiving surprise medical bills after an emergency room or provider visit. Any disputes would now be left to their plan and provider to resolve via arbitration.

The No Surprises Act was quietly a part of the omnibus spending bill that was signed into law on December 27, 2020 has caught several people by surprise (no pun intended). The law was created with the goal of shielding patients from receiving surprise medical bills after an emergency room or provider visit. Any disputes would now be left to their plan and provider to resolve via arbitration. 

Prior to the enactment of the No Surprises Act, state balanced billing laws have been debated throughout state legislatures, especially in 2020 when more patients were being admitted to hospitals during the start of the pandemic. According to the Commonwealth Fund: 

“Balance bills” primarily occur in two circumstances: 1) when an enrollee receives emergency care either at an out-of-network facility or from an out-of-network provider, or 2) when an enrollee receives elective nonemergency care at an in-network facility but is inadvertently treated by an out-of-network health care provider. Since the insurer does not have a contract with the out-of-network facility or provider, it may decide not to pay the entirety of the bill. In that case, the out-of-network facility or provider may then bill the enrollee for the balance of the bill. No federal law currently limits this practice, but 32 states have enacted laws to protect enrollees from it.” Click here for more on their analysis. 

If you are an insurer, employer, health system/hospital, physician or air ambulance operator, your interests are definitely impacted by this law. 

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

With a law this new and complex, ensuring compliance will be key. Lanton Law is an expert in healthcare regulatory compliance and has tools to help. Contact us today for answers to your questions.

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Lanton Law & Private Equity

With increasing mergers and acquisitions in both the technology and healthcare sectors, investment opportunities abound for funds and interested stakeholders. In order for these stakeholders to be successful it is essential to know the limits and opportunities within a complex regulatory landscape.

With increasing mergers and acquisitions in both the technology and healthcare sectors, investment opportunities abound for funds and interested stakeholders. In order for these stakeholders to be successful it is essential to know the limits and opportunities within a complex regulatory landscape. 

At Lanton Law not only do we understand the issues, but we provide you with timely solutions to help you make informed decisions about either an acquisition target or ways to maximize value. 

We counsel clients by performing corporate due diligence, provide strategic advice for growth and business strategies as well as structuring and executing M&A transactions.

If you are a financial stakeholder including a private equity firm, hedge fund, bank, etc. we have a suite of strategic services that can help. Contact us today to learn more.

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