Ron Lanton 7/29/20 Ron Lanton 7/29/20

House E&C Committee Democrats Press Tech Companies on COVID-19 Information

Democrats on the House Energy and Commerce Committee led by Chairman Pallone (D-NJ) along with Congresswoman DeGette (D-CO) Chair of the Subcommittee on Oversight and Investigations, Congresswoman Schakowsky (D-IL) and Congressman Doyle (D-PA) sent a letter to Facebook along with other tech companies requesting more COVID-19 transparency on their platforms. The request seeks monthly reports on this issue which mirrors a similar request from the European Union.

We continue to see an increase in federal and state policymaking when it comes to technology companies. The threat of looming technology legislation will undoubtedly lead to increased regulation. It’s better to be prepared now by knowing the landscape and preparing your strategic options in order to navigate the increased scrutiny.

Lanton Law is a national boutique law and government affairs 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.

Ron Lanton 7/27/20 Ron Lanton 7/27/20

Lanton Law Speaks with Pharmacy Times about U.S. Supreme Court Case Rutledge v. PCMA & Its Implication on Pharmacy Policy

Lanton Law was interviewed by Pharmacy Times on the implications of the October 6, 2020 U.S. Supreme Court case of Rutledge v. PCMA.

Lanton Law was interviewed by Pharmacy Times on the implications of the October 6, 2020 U.S. Supreme Court case of Rutledge v. PCMA. This case has major consequences for future PBM policies. Click here to access the interview.

Ron Lanton 7/27/20 Ron Lanton 7/27/20

New Executive Order Aimed at Pharmacy Benefit Managers (PBMs)

The White House has released an Executive Order titled “Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen.”

“One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process. The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs. Instead, these middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug.”

This Executive Order advocates for HHS to complete its prior January 2019 proposed rule aimed at “revising the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them.”

Not only does this Executive Order state that discounts offered on prescription drugs should be passed on to patients, but that HHS must confirm publicly prior to finalizing its proposed rule that “that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.”

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

Ron Lanton 7/27/20 Ron Lanton 7/27/20

White House Issues Executive Order Advocating for Importation

The White House has issued an Executive Order titled “Executive Order on Increasing Drug Importation to Lower Prices for American Patients,” which seeks to advocate for having supply chain entities proceed with importation.

“One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones. Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs. For example, in the European Union, a market characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for decades and has been estimated to reduce the price of certain drugs by up to 20 percent. Accordingly, my Administration supports the goal of safe importation of prescription drugs.”

The Executive Order gives stakeholders three methods to accomplish the goals of this order. Either allow reimportation of insulin products from Canada, finalize the December 2019 proposed rule addressing importation, or allow individuals to import drugs as long as the importation is designated by the Food & Drug Administration (FDA) as safe and results in lower costs to patients.

(a) facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);
(b) authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and
(c) completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.

Ron Lanton 7/27/20 Ron Lanton 7/27/20

The Administration Releases Executive Order Targeting Insulin and Injectable Epinephrine via 340B

The White House has announced a few Executive Orders targeting healthcare. One Executive Order titled Executive Order on Access to Affordable Life-saving Medications targets insulin and injectable epinephrine by requiring federally qualified community health centers to pass through 340B program discounts to patients using insulin and epinephrine auto-injectors.

Specifically the Executive Order outlines the following:

“It is the policy of the United States to enable Americans without access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs, such as Medicare and Medicaid, to purchase these pharmaceuticals from an FQHC at a price that aligns with the cost at which the FQHC acquired the medication.

To the extent permitted by law, the Secretary of Health and Human Services shall take action to ensure future grants available under section 330(e) of the Public Health Service Act, as amended, 42 U.S.C. 254b(e), are conditioned upon FQHCs’ having established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who:

(a) have a high cost sharing requirement for either insulin or injectable epinephrine;

(b) have a high unmet deductible; or

(c) have no health care insurance.”

This will be interesting to see how this gets enforced. The 340B program which is where manufacturers provide outpatient drugs to eligible healthcare entities at a reduced price has been embroiled in controversy the last several years between manufacturers and hospitals over pricing. This Order does not address hospital practices.

Ron Lanton 7/20/20 Ron Lanton 7/20/20

The Policy Conversations Around Tik-Tok Warrant Monitoring from Technology Stakeholders

With all the news surrounding the Trump Administration and its complex political and economic relationship with China, some may find it surprising that the latest company suspected to be possibly impacted by the two countries would be TikTok.

According to its website, TikTok is an app for short-form mobile videos. The company says it has offices in Los Angeles, New York, London, Paris, Berlin, Dubai, Mumbai, Singapore, Jakarta, Seoul, and Tokyo, but the company does have close ties to China through the company’s owner ByteDance; a Beijing-based technology company. TikTok has become more mainstream in the U.S. due to the pandemic, whereby various users including small business owners have been using the app to expand their economic reach.

The last few months have brought increased scrutiny over the app. Both India and Indonesia have banned the app, while the U.S. Navy and other U.S. armed forces branches have banned the app as well. Most of the concerns have been around the issue of national security and how much user information is shared with the Chinese government.

TikTok responded to this brewing controversy last year with a statement that addressed the company’s viewpoint on data privacy and security as well as content concerns. In response to the Administration threatening that it is considering a ban on TikTok, the company has been increasing its lobbying presence to hedge against a possible ban.

Will a possible ban have a chilling effect on U.S. technology companies? Currently, the answer is no. We don’t want to cause controversy by suggesting this, but with the recent activities in Congress, the Federal Trade Commission and the Department of Justice that we have been reporting about, warrants that technology stakeholders keep a close watch on how the industry is receiving a lot of policy interests. It is safe to believe that technology policy is on the verge of changing, as technology stakeholders can no longer sit back and think that this industry is immune from regulatory oversight.

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

Ron Lanton 7/20/20 Ron Lanton 7/20/20

This Week in Washington D.C.

It is widely anticipated this week that negotiation on another stimulus bill will begin on Capitol Hill. The backdrop of these negotiations are that we are starting to see an alarming increase in the number of COVID-19 infections nationwide, along with the fact that enhanced unemployment benefits that were approved in March 2020 will expire this week for many states without Congressional action to extend these benefits. The question is will we see another COVID-19 relief package that is similar to the CARES Act?

The House has been discussing $3 trillion in possible aid while the Senate is positioning for a possible $1 trillion in economic aid. At this point it is unclear where the Administration is on this issue. Major issues within this discussion are whether to include more finding for COVID-19 testing, contact tracing, etc.

The House late this spring passed a $3 trillion Heroes Act but since then the bill has been stalled in the Senate. The Senate is looking to create its own bill where the plan is the Senate version would be the blueprint to negotiate any possible further aid. It looks as though this may be the last possible economic relief bill before the election, however; this situation remains fluid.

Ron Lanton 7/17/20 Ron Lanton 7/17/20

New Telehealth Legislation Introduced In the U.S. House of Representatives

Lanton Law has been monitoring the state and federal policy developments with telehealth/telemedicine. We have noticed a newly introduced Congressional bill that is on point.

The Protecting Access to Post-Covid-19 Telehealth Act has been introduced by several members of the Congressional Telehealth Caucus including Representatives Schweikert (R-AZ), Thompson (D-CA), Welch (D-VT), Johnson (R-OH) and Matsui (D-CA).

This bi-partisan bill according to the bill’s press release “will continue the expanded use of telehealth beyond the Coronavirus pandemic by eliminating restrictions on the use in Medicare, providing a bridge for patients currently using the practices because of the crisis, and requiring a study on the use of telehealth during COVID-19.”

Here are the highlights of the legislation according to the release:

Eliminating most geographic and originating site restrictions on the use of telehealth in Medicare and establishing the patient’s home as an eligible distant site so patients can receive telehealth care at home and doctors can still be reimbursed,
Preventing a sudden loss of telehealth services for Medicare beneficiaries by authorizing the Centers for Medicare and Medicaid Service to continue reimbursement for telehealth for 90 days beyond the end of the public health emergency,
Making permanent the disaster waiver authority, enabling Health and Human Service to expand telehealth in Medicare during all future emergencies and disasters, and
Requiring a study on the use of telehealth during COVID, including its costs, uptake rates, measurable health outcomes, and racial and geographic disparities.

Ron Lanton 7/16/20 Ron Lanton 7/16/20

Update on Closely the Watched U.S. Supreme Court Case of Rutledge v. PCMA

We have been providing occasion updates through our blog on the U.S. Supreme Court case of Rutledge v. PCMA, whose outcome could have wide ranging policy and legal ramifications on pharmacy and pharmacy benefit managers.

We have been providing occasional updates through our blog on the U.S. Supreme Court case of Rutledge v. PCMA, whose outcome could have wide ranging policy and legal ramifications on pharmacy and pharmacy benefit managers.

This issue in this case according to the Court is “Whether the U.S. Court of Appeals for the 8th Circuit erred in holding that Arkansas’ statute regulating pharmacy benefit managers’ drug-reimbursement rates, which is similar to laws enacted by a substantial majority of states, is preempted by the Employee Retirement Income Security Act of 1974, in contravention of the Supreme Court’s precedent that ERISA does not preempt rate regulation.”

The case will now be heard on October 6, 2020 in front of the U.S. Supreme Court. Additional information on this case can be found here.

Ron Lanton 7/13/20 Ron Lanton 7/13/20

EXIM Policies Impacting Biotechnology & Life Science Stakeholders

The Export-Import Bank of the United States (EXIM) has established some new policies that will impact several stakeholder groups, especially biotechnology, biomedical sciences and life sciences stakeholders.

According to the EXIM’s release, the “EXIM’s historic seven-year reauthorization (P.L. 116-94), signed into law December 20, 2019, directs EXIM to establish a new “Program on China and Transformational Exports” (see Sec. 402). The Program’s purpose is to support the extension of loans, guarantees, and insurance, at rates and on terms and other conditions, to the extent practicable, that are fully competitive with rates, terms, and other conditions established by the People’s Republic of China or by other covered countries (as designated by the Secretary of the Treasury). The law charges EXIM with a goal of reserving not less than 20 percent of the agency’s total financing authority (i.e., $27 billion out of a total of $135 billion) for support made pursuant to the program, with a focus on specific industries.”

To achieve full implementation, EXIM will hold a July 16th call with Biotechnology and Biomedical Sciences. Additional information on this call can be found here.

Ron Lanton 7/9/20 Ron Lanton 7/9/20

Tech Companies to Testify At House Judiciary Antitrust Subcommittee on July 27th

The House Judiciary Antitrust Subcommittee has scheduled a July 27, 2020 hearing for the CEO’s of Amazon, Apple, Google and Facebook (Big Tech) to testify regarding the Committee’s ongoing investigation of digital marketplace competition. The hearing is titled “Online Platforms and Market Power, Part 6: Examining the Dominance of Amazon, Facebook, Google and Apple.”

The Committee’s press release has a joint statement from House Judiciary Committee Chairman Nadler (D-NY) and Antitrust Subcommittee Chairman Cicilline (D-RI) which states “Since last June, the Subcommittee has been investigating the dominance of a small number of digital platforms and the adequacy of existing antitrust laws and enforcement. Given the central role these corporations play in the lives of the American people, it is critical that their CEOs are forthcoming. As we have said from the start, their testimony is essential for us to complete this investigation.”

The Committee’s investigation launched its antitrust investigation last June. The Committee’s efforts are bipartisan and the Committee is attempting to address whether Congressional oversight is needed to pass tighter antitrust laws to ensure a more balanced marketplace. The Committee’s investigation will focus on documenting where competition is lacking in digital markets; exploring whether large companies are suppressing competition; and determining whether Congress and regulators need to do more to address Big Tech's dominance. If Congress decides that legislation is needed, it could lead to the first major policy revisions of U.S. antitrust law in decades.

Additional policy threats to technology companies remain besides Congress. In a mix of business and political reasons for determining whether a new class of start ups is being stifled by Big Tech, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) last year have announced joint efforts to investigate Big Tech. The FTC will have responsibility for investigating Amazon and Facebook while the DOJ will investigate Google and Facebook. It is looking as though some kind of regulatory action is coming by year end. Not to mention Big Tech has been receiving a lot of antitrust scrutiny from overseas.

It is no secret that oversight over technology stakeholders is near. It’s best to look at your risks to determine whether you have the tools to protect your business and be nimble enough to navigate the changing policy currents.

Ron Lanton 7/7/20 Ron Lanton 7/7/20

National Association of Insurance Commissioners release PBM Model Legislation Draft

The National Association of Insurance Commissioners’ (NAIC) Pharmacy Benefit Manager (PBM) Regulatory Issues Subgroup has released a draft of its model PBM legislation.

The National Association of Insurance Commissioners’ (NAIC) Pharmacy Benefit Manager (PBM) Regulatory Issues Subgroup has released a draft of its model PBM legislation. The model is called the [State] Pharmacy Benefit Manager Licensure and Regulation Act and “it seeks to establish the standards and criteria for the licensure and regulation of pharmacy benefit managers providing claims processing services or other prescription drug or device services for health benefit plans.”

The Task Force began discussion on this issue last year as the proposed model seeks to build on state legislative and regulatory efforts surrounding PBMs. The draft model addresses issues such as PBM licensure, the prohibition of gag clauses, state insurance commissioner enforcement, clawbacks, affiliate compensation and spread pricing to name a few.

A conference call is scheduled for July 16th to discuss this issue further.

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

Ron Lanton 6/28/20 Ron Lanton 6/28/20

New Legislation Targeting Technology Liability Shield Under Section 230

Now in addition to recent U.S. Department of Justice scrutiny, U.S. Senator Hawley (R-MO) has introduced the Limiting Section 230 Immunity to Good Samaritans Act, which seeks to provide accountability for bad actors who abuse the Good Samaritan protections provided under that Act.

Earlier this year we started our conversation with the technology industry urging stakeholders to be aware of the growing policy attacks on the responsibilities of an Internet Service Provider (ISP) via the technology law 47 U.S. Code § 230.

The law which is part of the Communications Decency Act (CDA), also called Title V of the Telecommunications Act of 1996, provides ISP’s with federal immunity to any cause of action that seeks to make ISP’s liable for information that originated with a third party service user.

Specifically, §230 states: “No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” The additional specifics of this law describe the liability shield that these companies currently enjoy which is further protected by federal preemption law.

A few weeks back we highlighted how politicians on both sides of the aisle have been more assertive in how tech companies are not living up to their expectations under Section 230. Now in addition to recent U.S. Department of Justice scrutiny, U.S. Senator Hawley (R-MO) has introduced the Limiting Section 230 Immunity to Good Samaritans Act, which seeks to provide accountability for bad actors who abuse the Good Samaritan protections provided under that Act.

According to the Senator’s press release the bill “would prohibit Big Tech companies from receiving Section 230 immunity unless they update their terms of service to promise to operate in good faith and pay a $5,000 fine (or actual damages, if higher) plus attorney’s fees if they violate that promise.” This legislation makes it easier for Americans to sue tech companies that censor political speech or hide competitor content. This bill mirrors more conservative politicians who feel that tech companies are censoring conservative viewpoints.

Regardless of your political viewpoint, if you are a tech stakeholder that has ISP capabilities or you are providing services that deal with the exchange of ideas, you should be monitoring this type of legislative action to avoid unnecessary surprises to your business model. We at Lanton Law can help.

Our legal and policy tools can help offer your organization a clear path forward to navigate what will be changing policies for technology stakeholders. Contact us today to discuss your options.

Ron Lanton 6/3/20 Ron Lanton 6/3/20

FCC to Vote in June on Commissioner Carr’s 5G Upgrade Order

The Federal Communications Commission (FCC) has announced that it will vote on Commissioner Carr’s 5G Upgrade Order as part of an initiative to accelerate U.S. wireless infrastructure improvement plans.

According to the FCC “The 5G Upgrade Order clarifies the FCC’s 2014 rules by:

Explaining when the 60-day shot clock for local approval begins
Specifying what new equipment qualifies for streamlined approval
Clarifying how local governments’ concealment and aesthetic conditions of approval apply
Asking for public comment on what activity related to a modification can occur outside of a wireless site”

The full Commission will vote on the 5G Upgrade Order at its next open meeting on June 9, 2020.

Ron Lanton 6/2/20 Ron Lanton 6/2/20

New Lanton Law Specialty Drug Blogcast with Ken Kaitin of Tufts University

We are excited to interview Kenneth Kaitin; Professor and Director for the Tufts Center for the Study of Drug Development at Tufts University School of Medicine in Boston, Massachusetts.

Our conversation touches on a wide variety of specialty drug issues such as oncology, orphan drugs, value based care, innovative payment models and Boston’s pharmaceutical R&D expansion.

Click here for the interview.

Ron Lanton 5/26/20 Ron Lanton 5/26/20

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

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

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

Below Is a summary of the interview from Pharmacy Times:

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

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

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

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

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

Ron Lanton 5/25/20 Ron Lanton 5/25/20

Online Political Advertising Legislation to be Introduced

U.S. Congressman Cicilline (D-RI) has announced his intent to introduce legislation “that tightly restricts the use of personal, online consumer data that is often used to ‘microtarget’ voters with misleading ads.” According to his release, the legislation will be titled the “Protecting Democracy from Disinformation Act” and has the following elements:

Restricts Microtargeting: Only allows advertisers and online platforms to use age, gender, and location when targeting political ads.
Improves Transparency: Requires disclosure and reporting on who paid for an ad, how much it cost, whom an ad is aimed at, and who saw the ad.
Holds Online Platforms Accountable: Provides enforcement through the Federal Election Commission’s existing authority, a private right of action, and criminal penalties for online platforms and ad intermediaries that knowingly and willfully violate the Act.

Expect issues such as microtargeting and others to come to the forefront as we enter in the election season of 2020.

Lanton Strategies; a segment of Lanton Law works to help advance our clients interests before both legislative and regulatory bodies on the state and federal levels. We use sources from the Hill, state houses, agencies, markets and trade associations, to inform our clients and achieve proactive results. Let us know how either our government affairs services or legal services can help you achieve your priorities.

Ron Lanton 5/21/20 Ron Lanton 5/21/20

Apple and Google Announce Digital Contact Tracing Partnership Amid Privacy Concerns

Apple and Google have announced their partnership to enable Bluetooth technology to help interested stakeholders such as healthcare agencies and governments to fight COVID-19.

Apple and Google have announced their partnership to enable Bluetooth technology to help interested stakeholders such as healthcare agencies and governments to fight COVID-19. The announcement describes the tech companies’ intent of “releasing draft documentation for an Exposure Notification system in service of privacy-preserving contact tracing.” The most important thing to note is that the companies will not be building contact tracing apps but will be providing tools around a unified programming interface that will allow these aforementioned stakeholders to create their own contact tracing applications. And while this partnership and others like it are a much needed resource during our fight against COVID-19, privacy concerns with how these companies are using our information loom in the background.

So what is contact tracing? It can come in two forms. The first form is human to human tracing, which is described in the Centers for Disease Control and Prevention’s (CDC) list of core principles.

Contact tracing is part of the process of supporting patients with suspected or confirmed infection.
In contact tracing, public health staff work with a patient to help them recall everyone with whom they have had close contact during the timeframe while they may have been infectious.
Public health staff then warn these exposed individuals (contacts) of their potential exposure as rapidly and sensitively as possible.
To protect patient privacy, contacts are only informed that they may have been exposed to a patient with the infection. They are not told the identity of the patient who may have exposed them.
Contacts are provided with education, information, and support to understand their risk, what they should do to separate themselves from others who are not exposed, monitor themselves for illness, and the possibility that they could spread the infection to others even if they themselves do not feel ill.
Contacts are encouraged to stay home and maintain social distance from others (at least 6 feet) until 14 days after their last exposure, in case they also become ill.

As you can see this is a very specialized skill that needs to be timely executed to prevent further spread of disease.

According to the CDC digital tracing on the other hand is another set of tools that can be used to “expand the reach and efficacy of contact tracers.” This is what we are seeing from the Apple-Google partnership, as well as other applications (apps) that we see flooding the market in an effort to provide additional tools to combat COVID-19.

Digital contact tracing can theoretically be more efficient because it doesn’t rely on memory, but requires user cooperation where people would have to download the relevant apps on their phones. In order for something like this to have an almost “real time” effect, a large number of people would have to adapt to this technology. Are we as a society ready for this? While emergencies like this would seem like the answer would be a common sense “yes” there are a lot of other issues at play such as are positive alerts to a user accurate and will a user’s information be protected? A great example of user worry could come in the form of potential genetic discrimination of which we wrote a prior blog post.

To date the skepticism of technology companies being able to use healthcare data has been rampant. For example, several industry stakeholders were surprised by the Wall Street Journal’s (WSJ) article that Google has been working since 2018 on a "secret" project involving patient data with Ascension, the St. Louis-based nationwide health system.

Project Nightingale would involve having Google be provided with millions of health records of U.S. citizens, which has prompted a recent follow up letter by three U.S. Senators to gain additional insight into the project’s specifics. Facebook has a new tool called Preventive Health that seeks to “connect people to health resources and checkup recommendations from leading health organizations.” And while Microsoft launched Microsoft Cloud for Healthcare; whose program applies “flexible capabilities to power individualized experiences, improve team collaboration, and unify data to unlock real-time insights,” demonstrates that while technology and healthcare are merging, the need for addressing privacy concerns remains at the forefront.

We need all the tools we can get our hands on during this difficult struggle against COVID-19, especially when it comes to digital contact tracing. There is no doubt that we need the efficiencies that technology has to offer. The potential is there, but there has to be buy in from a majority of people in order for this to work. Not only do we have to continue to work to ensure that everyone has access to smartphone technology, but we have to put some additional “safety checks” in place to ensure that ‘anonymized’ aggregated data isn’t sold, that sensitive protected health information (PHI) is guarded and the proper laws/regulations are put in place so that we can learn from the painful lessons that COVID-19 has taught thus far.

Ron Lanton 5/19/20 Ron Lanton 5/19/20

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

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

Click here to access the Lanton Law blogcast.

Ron Lanton 5/14/20 Ron Lanton 5/14/20

Will Immunity Passports Lead to Future Genetic Discrimination?

There is no need to rehash the harsh societal effects that COVID-19 has had not only on our psychological and financial wellbeing, but also on the vulnerable population’s immune system. Those having to deal with underlying health conditions such as diabetes, obesity, hypertension have been especially at risk, including some young and healthy individuals. As we race to understand the rationale behind why such an erratic disease impacts some but not others, the question that frequently comes up is whether a person’s genes has something to do with becoming infected?

While it seems like we have been discussing gene therapy for some time, understanding how to harness the potential of the human genome is still in the “early innings.” According to the National Human Genome Research it was found that there are about 20,500 genes in human DNA. This information had taken 13 years to find and was completed in 2003. There are so many things to learn about our genes in order to be precise enough to fully realize how we can get to the ultimate improvement in patient outcomes. Unfortunately, it seems as though time is not on our side when needing to understand how our genes play a key role in fighting this terrible disease. It seems like the best thing to mitigate our circumstances until we get a vaccine is how to contain it. From social distancing to contact tracing, one idea that has been gaining steam on re-opening the economy is the possibility of immunity passports.

So what are immunity passports? The World Health Organization (WHO) states “Some governments have suggested that the detection of antibodies to the SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an ‘immunity passport’ or ‘risk-free certificate’ that would enable individuals to travel or to return to work assuming that they are protected against re-infection. There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”

Currently there is so much fear and mistrust regarding information on COVID-19 that in order for this to work in my opinion, we would have to have certainty in antibody testing, as well as a 100% understanding about how long immunity actually lasts. Aside from a vaccine, this would certainly move economies forward as a way to slowly start to recoup the financial losses we have witnessed worldwide. But could well intentioned things like immunity passports lead to something unintended such as genetic discrimination?

According to the National Institutes of Health (NIH), genetic discrimination occurs when people are treated differently by their employer or insurance company because they have a genetic mutation that causes or increases the risk of an inherited disorder or they have a familial history of a specific health condition. Surprisingly, this issue could determine whether someone gets hired or fired and could mean the difference between receiving comprehensive coverage.

GINA does provide a solution to genetic discrimination. The Genetic Information Nondiscrimination Act (GINA) provides for protection against this type of discrimination. Title I of GINA prohibits genetic discrimination in health insurance, and Title II prohibits genetic discrimination in employment.

Under the first part of the act, it is illegal for health insurance providers to use or require genetic information to determine whether a person is eligible for coverage. The second part prohibits employers from using a person’s genetic information in making decisions about hiring, promotion, and various other terms of employment.

However, GINA and similar laws do not protect individuals from genetic discrimination under every circumstance, such as an instance in which an employer has fewer than 15 employees. The act also does not apply to those serving in the military or those insured under the Veterans Health Administration or Indian Health Service. Furthermore, the act does not protect against genetic discrimination in other forms of insurance, including life, disability, and long-term care, according to the NIH.

While GINA’s development was designed for genetic discrimination, I believe that we have not yet seen how this law could potentially evolve from its original intent, especially in this circumstance. Constantly looking through both a policy and legal lens, I see potential problems with an immunity passport. While I understand how this is designed to get the economy back on track, how will individuals be judged regarding obtaining an immunity passport. Is this something you will be required to have by an employer? Are there privacy issues that will evolve from having to declare whether you have an immunity passport? Will employees be looked at differently if they have a passport versus those that don’t? Will an employee’s cost of insurance increase because they happened to get COVID-19?

COVID-19 has changed our lives in ways that we cannot yet imagine. As we start transitioning back towards living with this complex disease until there is a cure, our minds are currently undergoing small yet lasting changes that will unconsciously shape the way we make decisions going forward. It is very foreseeable that society will try and mitigate risks to businesses, meaning that it is not unforeseeable that companies may try and understand any genetic risks that may exist to employees. Whether this is the new normal, a threat to privacy or something else remains to be seen.

*Disclaimer: The information provided in this blog post is an opinion and is for informational purposes only and not for the purpose of providing legal advice. Access to this information does not create an attorney client relationship between Lanton Law and the viewer. You should contact your attorney to obtain advice with respect to any particular issue or problem.