U.S. House passes legislation to extend telehealth waivers through 2024

The U.S. House of Representatives has passed passed the Advancing Telehealth Beyond COVID-19 Act of 2022 (H.R. 4040). The bill proposes to extend telehealth flexibilities under Medicare that were initially authorized during the public health emergency of COVID-19. The bill heads to the U.S. Senate. 

Specifics of the proposal are as follows:

• Provides that certain flexibilities continue to apply until December 31, 2024, if the emergency period ends before that date. 

• Beneficiaries to continue to receive telehealth services at any site, regardless of type or location (e.g., the beneficiary's home); 

• Occupational therapists, physical therapists, speech-language pathologists, and audiologists to continue to furnish telehealth services;

• Federally qualified health centers and rural health clinics to continue to serve as the distant site (i.e., the location of the health care practitioner);

• Evaluation and management and behavioral health services to continue to be provided via audio-only technology; and

• Hospice physicians and nurse practitioners to continue to complete certain requirements relating to patient recertifications via telehealth.

The bill also delays implementation of certain in-person evaluation requirements for mental health telehealth services until January 1, 2025, or the first day after the end of the emergency period, whichever is later.

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

Amazon to Acquire Primary Health Care Provider

Amazon has decided to take another step forward in healthcare by acquiring One Medical.

According to the press release “One Medical is a human-centered, technology-powered national primary care organization on a mission to make quality care more affordable, accessible, and enjoyable through a seamless combination of in-person, digital, and virtual care services that are convenient to where people work, shop, and live.”

Amazon will acquire One Medical for $18 per share in an all-cash transaction valued at approximately $3.9 billion, including One Medical’s net debt.

We have been monitoring Amazon’s healthcare moves for a while. In 2017 we forecasted our thoughts in a blog post with Victor Morrison on whether the company would wade into healthcare. We posted when Amazon Launched its U.S. Pharmacy Business and followed their moves into biometrics. This is definitely not the last move the company will make in healthcare. The only issue is whether there will be antitrust scrutiny.

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

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? 

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.

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. The interview can be heard here.

Protecting Rural Telehealth Access Act Introduced

Via a recently released a press release describing how a  group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent. 

“This legislation would ensure rural and underserved community healthcare providers are able to continue offering telehealth services after the current public health emergency ends. These services include the ability to offer audio-only telehealth appointments because many rural Americans don’t have reliable, affordable broadband access.”

According to the press release the proposed Act would: 

• Allow payment-parity for audio-only health services for clinically appropriate appointments. During COVID-19, recognizing not everyone has access to the technology in their home, Congress made allowances for audio-only telephone services to be used to allow doctors to reach patients wherever they are.

• Permanently waive the geographic restriction allowing patients to be treated from their homes. Pre-COVID-19, the home was allowed as an eligible originating site in Medicare and some Medicaid programs, but only for very specific services, and only for the patient, not the provider.

• Permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services.

• Lift the restrictions on “store and forward” technologies for telehealth. Currently this is only allowed in Hawaii and Alaska. 

• Allows Critical Access Hospitals (CAHs) to directly bill for telehealth services.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our telepharmacy practice has been helping pharmacies and physicians with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting.

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.

Verizon Enters the Telehealth Market

According to a Verizon press release, the company announced its new telehealth venture called BlueJeans Telehealth. 

“According to the “The Future of Telehealth - Balancing Security and Ease of Use” white paper, healthcare organizations (81%) expect to see a greater investment in telehealth solutions over the next 2-3 years, with 85% of decision-makers identifying “ease of use” as a top-five driver in producing good outcomes from telehealth. While many hospitals and health clinics have adopted video conferencing services during the pandemic for providing patient care, BlueJeans Telehealth was designed from the ground up for healthcare organizations to simplify the virtual join and visit experience and offer greater access to care, provide more flexibility for providers and patients, improve safety and extend the reach of services available.” 

Verizon went on to describe the service. 

“BlueJeans Telehealth delivers an intuitive experience for patients, providers and administrators. Using the device of their choice, patients can easily and quickly meet with their providers through their desktop or mobile browser or the BlueJeans app. BlueJeans with Dolby Voice Audio® provides high-quality audio, minimizing disruptions to the visit so patients and providers can communicate important clinical information clearly. Providers and administrators will also benefit from a streamlined experience, as visits are embedded directly within their existing Electronic Health Record (EHR) workflows.

To simplify administrations and reimbursements, licensing is based on a per-visit model, which allows for straightforward data capture and reporting—an important aspect considering 59% of survey respondents cited uncertainty about telehealth reimbursement as a top challenge for adoption and utilization moving forward. BlueJeans Telehealth licenses will also be available in a named host format.”

Lanton Law has been active with telehealth/telemedicine policy advocacy as well as interpreting current laws while giving clients strategic advice on potential regulatory pitfalls. 

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

New 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). 

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.  

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.    

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. 

New York Proposing Its Own Biometric Law

The New York State legislature has introduced Assembly Bill 27, which seeks to make New York the fourth state to enact a biometric privacy law. If successful it will be the second state that will allow consumers a private right of action to see companies for improper data handling. 

New York is definitely taking its cue from Illinois, as that state became the first to require businesses to collect biometric data to provide notice and obtain the owner’s written consent prior to using this information. We have written about the Illinois Information Privacy Act or (BIPA) in a previous post. 

The New York proposal seeks to do the following: 

Establishes the biometric privacy act; requires private entities in possession of biometric identifiers or biometric information to develop a written policy establishing a retention schedule and guidelines for permanently destroying biometric identifiers and biometric information when the initial purpose for collecting or obtaining such identifiers or information has been satisfied or within three years of the individual's last interaction with the private entity, whichever occurs first. 

New York has enacted facial recognition laws in the past. In December 2020 Governor Cuomo released a press statement where he signed A6787-D/S5140-B into law that suspended “the use of facial recognition technology and other kinds of biometric technology in schools, directing a study of whether its use is appropriate in schools and issuing recommendations. The legislation places a moratorium on schools purchasing and using biometric identifying technology until at least July 1, 2022 or until the report is completed and the State Education Commissioner authorizes its use, whichever occurs later. It applies to both public and private schools in New York State.” 

Proposed Assembly Bill 27 shows that New York will continue to press forward in this area and will likely inspire other states. If you are a biometric, Health IT/digital health or technology stakeholder, your interests will be impacted.    

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Contact us today to learn about your organization’s options to prepare for additional regulatory oversight.

New York State of the State 2021 Calls for Proposal to Safeguard Data Security Rights

Last month as part of the State of the State 2021, Governor Cuomo announced a comprehensive law around personal data and privacy protections for New York state residents.

So what does this proposal outline?

According to the Governor’s proposal “This law will mandate that companies that collect information on large numbers of New Yorkers disclose the purposes of any data collection and collect only data needed for those purposes. Governor Cuomo will also establish a Consumer Data Privacy Bill of Rights guaranteeing every New Yorker the right to access, control, and erase the data collected from them; the right to nondiscrimination from providers for exercising these rights; and the right to equal access to services.”  

“The proposal also expressly protects sensitive categories of information including health, biometric and location data and creates strong enforcement mechanisms to hold covered entities accountable for the illegal use of consumer data. New York State will work with other states to ensure competition and innovation in the digital marketplace by promoting coordination and consistency among their regulatory policies. 

New York’s proposal seems to be following a trend set by California’s Privacy Rights and Enforcement Act. We believe that we are witnessing a slow moving transition towards similar oversight in other states. 

The increasing demands around data security and data privacy has presented new challenges to business operations and compliance efforts. Not to mention there are new rising risks around consumer data privacy expectations. 

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. We are the dedicated business partner that you need behind you to help you confront the changing regulatory landscape around data. 

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!

Lanton Strategies: D.C. Based Lobbying Firm with No State Boundaries

COVID-19 has changed the way that we interact in a variety of ways. One of them being the way that businesses large and small interact with the government. Gone are the days where we can meet people in person without having to worry about travel restrictions and COVID-19 protocol. What remains is that businesses still need to get their voices heard. This is where Lanton Strategies has a strategic advantage. 

For years our firm has made connections nationwide that have allowed us to tap our business and industry rolodex in order to get client goals realized. Our unique holistic approach enables us to lobby legislators and regulators, no matter the state. In essence we are that “digital lobbyist firm” that you need. 

If you are looking for federal or state solutions and you’re unsure how to get something done, contact Lanton Strategies; a division of Lanton Law 

FDA Announces the Launch of its Digital Health Center of Excellence

With all the attention on the 2020 elections, what may have been lost in the fray was the announcement that the FDA created the Digital Health Center of Excellence, within the Center for Devices and Radiological Health (CDRH). According to the FDA’s release, the new Center is dedicated “to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”

So what is the mission of the Digital Health Center of Excellence? According to the FDA:

“The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.”

As COVID 19 has forced our society to become more mobile and technologically dependent, the trends of big data, AI, machine learning and mobile health to name a few are here to stay. 

Lanton Law is an innovative firm that sees itself at the center of tomorrow’s legal, policy and market trends. We continue to monitor the developments of emerging sectors and give counsel to stakeholders in highly regulated industries. If you are a stakeholder examining your options for this year and need advice, contactLanton Law to discuss yourlobbying andlegal strategies.