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. 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.

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. 

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. 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. 

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.

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.

PBM U.S. Supreme Court Case Rescheduled for this Fall

We at Lanton Law along with many other pharmacy stakeholders have been closely monitoring the events surrounding the pending U.S. Supreme Court case of Rutledge v. Pharmaceutical Care Management Association.

We released our first blog about this case in December 2019 and are proud to be quoted in the January 2020 Pharmacy Times article regarding Rutledge.

To refresh the U.S. Supreme Court has provided a brief summary of the facts: 

Thirty-six States have enacted legislation to curb abusive prescription drug reimbursement practices by claims-processing middlemen-known as pharmacy benefit managers (PBMs)-who make money on the spread between the rates at which they reimburse pharmacies and the drug prices they charge health plans. In response, Respondent Pharmaceutical Care Management Association (PCMA), a PBM trade association, has launched a barrage of litigation across the country arguing that state regulations of PBMs generally, and state drug-reimbursement regulations specifically, are categorically preempted by the Employee Retirement Income Security Act of 1974 (ERISA). Disregarding this Court's ERISA precedent (and contrary to the First Circuit's conclusion that PBM regulations are categorically not preempted by ERISA), the Eighth Circuit embraced that argument.

The question presented is “Whether the Eighth Circuit erred in holding that Arkansas's statute regulating PBMs' drug-reimbursement rates, which is similar to laws enacted by a substantial majority of States, is preempted by ERISA, in contravention of this Court's precedent that ERISA does not preempt rate regulation.”

Due to COVID-19 the U.S. Supreme Court has rescheduled arguments for this case to its October 2020 term. 

Lanton Law will continue to monitor the developments around Rutledge v. PCMA and will advise our clients accordingly. If you have an issue that we can assist you with please feel free to contact us.    

The New Concerns of a Digital Workplace

We are honored to have worked with STACK for Pharmacy on a great and timely webinar titled “The New Concerns of a Digital Workplace. COVID-19 has changed the way that we work, communicate and transfer information and finances. We discuss the early trends of what we are seeing from a transitioning marketplace.

Click here to access the webinar

Upcoming Webinar with STACK and Lanton Law

STACK will be teaming up with Lanton Law to do an April 22, 2020 webinar at 1:00 PM EST titled “The New Concerns of a Digital Workplace.” Join Jonathan Ogurchak, Founder & CEO of STACK and Ron Lanton III, Esq, Principle of Lanton Law to discuss the following:

Challenges facing healthcare organizations with a rapid deployment to “work from home” environments

Considerations to ensure ongoing compliance and ensure appropriate use

Future areas for advancement related to the “new normal” organizations are likely to face

Click here to register

Lanton Law; Your Digital Lawyer & Lobbying Team

As organizational needs evolve right now, businesses are looking for innovative ways to become efficient and manage risks. 

For years our team at Lanton Law have been helping businesses around the country remotely with a variety of transactional needs. 

Legal services include but not limited to:

• Contract drafting, review and negotiation

• Due diligence in transactional matters

• Change of ownership

• Corporate governance matters

• Employment matters

• Privacy and data security 

• Leases

• Business strategy and growth objectives

• Day to day operational matters

• Litigation readiness and response

• Pre-litigation dispute resolutions such as arbitration and mediation

• Regulatory compliance 

• Acquisition due diligence/transfer of ownership

• Payor network access   

Additionally, our government affairs services include:

• Federal and state lobbying

• Strategic consulting

• Bill composition/bill check service

• Submitting regulatory comments

• Regulatory monitoring

New Rule: Transition to BLA Pathway Is Complete

We have a new article with the Center for Biosimilars titled “New Rule: Transition to BLA Pathway is Complete.”

Click here for the article

For those having difficulty accessing the article, we have provided the text from the article below.

As of today, March 23, 2020, the life sciences industry completes “the transition.” New categories of biologics will now be licensed via the biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA). 

This transition occurs 10 years after the 2009 enactment of the BPCIA. During that interim, manufacturers of certain biologics approved and under review for approval were in limbo as to how their products and rights of exclusivity would be treated under the new policy.

Now, biologics previously approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FDC) will automatically be “deemed” biologics licensed under section 351 of the Public Health Service Act (PHS). Ultimately, these drugs will be categorized as biologics, subject to biosimilar and not generic competition.

Unfortunately, the original BPCIA statute did not provide instructions to the FDA on how to implement this change. Therefore, the FDA has taken certain steps to enact the transition via several proposed rules and the implementation of its Biosimilars Action Plan (BAP). 

The BAP was released in July 2018. The plan is in 2 sections. The first defines key areas in which the FDA wants to focus its regulatory efforts: improving clarity and efficiency of the biosimilar approval process, enhancing understanding through better public communications, and addressing anticompetitive practices.  

The second section is made up of key actions. These are steps that the FDA is either taking or planning to take to improve review processes, create information resources, upgrade guidance, and encourage public feedback. Many of these actions have already been initiated.

On February 21, 2020, the FDA released a final rule that goes into effect today. It amends the FDA’s regulatory definition of a biological product so that it is aligned with the BPCIA. “Under the final rule, the term protein means any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” This is one of the final steps in the 10-year transition process. It opens the door for insulins to be approved via the biologics license application (BLA) pathway.  

Over 100 products that had been approved via new drug applications under the FDC now must be reviewed as BLAs under section 351 of the PHS. Drugs that will be transitioned include naturally occurring proteins such as hyaluronidase, human growth hormones, and menotropins.

The FDA is focusing on insulins and has made waves with the release of draft guidance on insulin biosimilars. The FDA indicated that switching studies may not be needed for a designation of interchangeable insulins if analytical assessments suggest high similarity between biosimilars and reference products. This could speed the arrival to market of the first interchangeable biosimilars in the United States for insulin.

The FDA has also released 2 question-and-answer documents that discuss the transition for patients and healthcare providers. With the BAP and guidance, the FDA has signaled that they are moving forward with the transition as a means of introducing more affordable medicines into the healthcare system—specifically, by expanding the use of biosimilars.
 

Election May Determine Pace of Biosimilar Legislation

We have a new article out with the Center for Biosimilars titled “Election May Determine Pace of Biosimilar Legislation.” The article can be viewed here.

If you are having difficulty accessing the article, we have provided it below:

By the end of 2019, 26 biosimilar products had been launched in the United States. As 2020 gets underway, there are several pending legislative proposals designed to encourage more commercialization of these cost-saving drugs.

House Legislation

HR 3: Elijah E. Cummings Lower Drug Costs Now Act
Many parts of this legislation could indirectly affect biosimilars. Two proposals of note would directly change drug costs for biosimilars if the law is passed.

The first proposal would require the HHS secretary to add a new set of measures to the 5-star rating system under Medicare in order to encourage increased access to biosimilar biological products. Specifically, the proposed legislation calls for determining whether a biosimilar is on formulary and whether and how utilization management tools are applied with respect to a biosimilar. The bill also calls for determination of the percentage of enrollees prescribed the biosimilar product when the reference biologic is also available.

The second proposal would temporarily increase the amount Medicare Part B pays for biosimilars for 5 years. This means that Medicare would pay the average sales price (ASP) plus 8% rather than plus 6%. The product would have to meet certain pricing criteria in order to qualify.

Both proposals may increase the utilization of biosimilars. The star rating system currently used does not make a distinction for biosimilars and allows payers to use the same policies for biosimilars and brands as they do for generics and brands. This can mean that a specialty pharmacy that dispenses under Part B does not get the same credit as a pharmacy that dispenses for Part D. Establishing new guidelines for the star rating system can help specialty pharmacy use more biosimilars and get credit toward its ratings with the payer.

An ASP increase of 2 percentage points could help cover additional costs for specialty pharmacy for educating consumers about biosimilar utilization.

This bill has passed the full House and has yet to be taken up by the Senate.

HR 4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act
This bill would eliminate a patient’s copay for a biosimilar under Medicare Part B. The bill would drive down medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options. This bill has been referred to the Subcommittee on Health in the House.

HR 2375: Preserve Access to Affordable Generics and Biosimilars Act
This would prohibit prescription drug companies from compensating other prescription drug companies to delay the market entry of a generic drug, biosimilar biological product, or interchangeable biological product. This would basically make “pay for delay” in patent settlements illegal. This legislation has cleared the Judiciary Committee and is pending in the House.

Senate Legislation

S 1416: Affordable Prescriptions for Patients Act of 2019
Originally, this legislation was aimed at allowing the Federal Trade Commission antitrust enforcement powers to sue manufacturers who use patent thickets to block generic and biosimilar products from launching. Since its introduction, the bill’s main sponsor, Sen John Cornyn, R-Texas, has stated that he is redesigning the bill to shift the enforcement power to the FDA instead of the FTC. As currently modified, the bill addresses anticompetitive practices involving manipulation of the availability of reference drugs. There is other patent thicket legislation proposed, which would be stricter than S 1416, but it is unknown when this would come to a vote in the Senate.

With the election season well underway, it remains to be seen whether any of these bills will advance before the year’s end.

Pending Antitrust Actions Could Change Biosimilar Dynamics

I have a new article that was published in the Centers for Biosimilars titled Pending Antitrust Actions Could Change Biosimilar Dynamics. If you have trouble accessing the link above we have provided the article text below:

There are 3 major antitrust actions on the biosimilar scene still pending. These have a long way to go before any court resolution, unless the parties involved settle before then. One is a class-action lawsuit attacking the use of patent thickets and pay-for-delay tactics. The other is a claim alleging anticompetitive contract practices to retain market share for an originator product. Related to the latter, an investigation by the Federal Trade Commission (FTC) remains in progress.

Humira (adalimumab) antitrust litigation (1:19-cv-01873)
United Food and Commercial Workers Local 1500 filed a class-action lawsuit against AbbVie, the holder of patents for its blockbuster drug Humira, claiming a monopoly had been created by AbbVie via its use of patent thickets and pay-for-delay tactics to block less-expensive biosimilars of adalimumab and raise prices for indirect purchasers. One of the main allegations is that AbbVie amassed more than 100 patents to prevent biosimilar versions of Humira from reaching market before 2023. Another main argument is that AbbVie colluded with biosimilar makers by using financial inducements to delay the launching of competitors in the United States while allowing them in Europe. AbbVie denies using these tactics to create a monopoly and contends that the lawsuit threatens to “upend the well-settled balancebetween the patent and antitrust laws.” This case is ongoing.

Pfizer versus Johnson & Johnson (J&J; 2:17-cv-04180) 
Pfizer, the maker of the biosimilar Inflectra (infliximab), has sued J&J for alleged anticompetitive sales practices in regard to the infliximab reference product (Remicade). J&J is accused of using exclusionary contracts to keep the biosimilar out of the market. These contracts allegedly “led to the near total foreclosure of Inflectra and other infliximab biosimilars.” Bundling Remicade with other drugs in these contracts for hospitals and infusion centers was also done in order to retain market control, Pfizer alleges. Rebate penalties for payers and providers are also alleged. This case is in the discovery phase and will be well into 2020.

Walgreens/Kroger versus Johnson & Johnson (2-18-cv-02357)
Walgreens and Kroger sued J&J in 2018 for antitrust regarding its contracts with wholesale distributers purchasing Remicade which inflated its price. The case was dismissed for lack of standing or insufficient connection to and harm from the action challenged. Walgreens and Kroger appealed to the Third Circuit stating that the lower court was wrong in dismissing the case because of anti-assignment provisions between the wholesaler and the plaintiffs. The Third Circuit overturned the lower court ruling stating that the case could go forward in spite of the clause because the claim arises out of federal anti-trust law and not the contract itself. This case will now go back to the lower courts and start over from scratch. More cases like this could arise as distribution contract anti-assignment clauses are common and may have prevented many from suing in the past.

FTC Civil Investigation 

The FTC issued a Civil Investigative Demand (CID) to J&J regarding its contracting practices for Remicade, meaning it is investigating J&J’s contracting practices with respect to the reference product. Although the CID was issued in June 2019, J&J has yet to comment on the investigation. Because the inquiry is in its early phase, it remains unclear whether the FTC will lodge an antitrust suit against J&J. They would need to determine if bundling deals and the rebate practices involved constitute antitrust practices. 

All of this litigation may take years to resolve. If the court judgements do not come down in favor of the product originators, the cases could significantly change how biologics are priced, by either eliminating rebates or forcing payers to place both biosimilar and originator products on formularies

Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy

Jennifer Nessel of Pharmacy Times has featured Lanton Law in an article titled “Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy.” The article can be read here. In case you have difficulty reading the article, we have featured it below. This article appeared in Pharmacy Times on 2/17/20.

As utilization and drug spending continue to rise, health care providers are looking to resolve key questions that address drug pricing and biosimilar implementation in specialty pharmacy.

Hospital and health systems saw nearly 20% growth in the specialty drug market in 2018, according to Becker’s Hospital Review.2 The diversity of specialty pharmacies has resulted in variability across all operational areas, including tracking adherence, educating patients, dispensing medications, and ensuring drug safety.3

However, although the specialty industry has had a positive impact on health systems’ quality and continuity of care initiatives, the administration of specialty drugs is challenging and highly complex given the number of new therapies and payer requirements.

According to Ron Lanton, III, Esq, principal of Lanton Law and biologics committee chair of the New York State Bar Association, policymakers on the federal level understand that the issue of drug pricing needs to be resolved but they are having a hard time coming to an agreement on how this reform should be done.

The Drug Price Conundrum
Due to the fact that the legislative session has recently begun in many states and in Congress and that it is an election year, it is difficult to determine whether there will be a unifying drug-legislative solution for drug prices.

However, California’s Governor Gavin Newsom (D-CA) has recently proposed that California become the first US state to manufacture its own generic prescription label, with a goal of making affordable medications available to the state’s almost 40 million residents. However, the governor’s proposal has yet to pass the California legislature.

According to Lanton, a manufacturer could leverage its influence over smaller states to stop legislation such as Governor Newsom’s from advancing. However, due to its size and the fact that its policies may influence other state legislatures, California may be a harder market for a manufacturer to confront.

“I [have to] question as to whether California’s efforts would further drive down an already deflated generic drug market and whether California would be able to determine how much it will charge for generics once manufacturing costs, such as raw materials, are concerned. Not to mention how much this is going to cost since that remains unknown at this point in time,” Lanton explained to Directions in Specialty PharmacyTM.  

Although the proposal marks the first state-wide attempt to lower prescription drug prices, there have been attempts within federal legislation to corral drug prices. The Trump administration recently attempted to lower drug costs through its Blueprint to Lower Drug Costs, and the FDA has recently been an advocate for greater generic and biosimilar utilization.

“To date, there has been no silver bullet to deal with rising prescription drug costs. Notwithstanding whether I agree with this plan, I applaud California in trying to solve a problem that refuses to go away quietly,” Lanton said.

Biosimilar Implementation
Specialty drugs, with nearly 700 therapies currently under development for treatment areas such as cancer, hepatitis C virus, HIV, autoimmune disorders, and multiple sclerosis, are expected to claim 9 of the top 10 spots among bestselling drugs in 2020.3 Although specialty drugs have been hallmarked as important treatment options for patients with cancer or other complex diseases, there can be issues surrounding access and affordability.

The cost of specialty medications and the increased adoption of high-deductible health plans have placed a higher financial burden on patients. As out-of-pocket costs increase, including insurance denials, patients are more likely to abandon their treatment plans.4

Biosimilars are potentially more affordable specialty medications for patients with complex disease states. According to Managed Health Executive, biosimilars could bring approximately $250 billion in savings by 2024.3

Pending legislation may have a large impact on biosimilar implementation across the specialty pharmacy landscape. There are several bills that Lanton singled out for the 2020 year1:
 

• HR 4597 Acting to Cancel Co-pays and Ensure Substantial Savings for Biosimilars (ACCESS) Act would eliminate a patient’s co-pay for a biosimilar if they normally would pay full cost of a biologic drug under Medicare Part B. The bill seeks to drive down medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options.

• HR 4629 Star Rating for Biosimilar Act would require the Secretary of Health and Human Services to add a new set of measures to the 5-star rating system under the Medicare Advantage program in order to encourage increased access to biosimilar biological products.

• HR 4913 would require Medicare prescription drug plan (PDP) formularies to include covered generic drugs and biosimilars for which the wholesale acquisition cost is less than that of the reference (ie, brand-name) product. PDP sponsors must also establish specific cost-sharing tiers that apply lower cost-sharing requirements for such covered generic drugs and biosimilars as compared to those for brand-name products. The bill also prohibits PDP sponsors from instituting certain requirements relating to access to such covered generic drugs and biosimilars that are more restrictive than those for brand-name products (eg, prior authorization requirements).

• HR 2375 would prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

• S 1681 proposes to educate health care providers and the public on biosimilar biological products. Under this bill, the Secretary shall establish, maintain, and operate a website consisting of educational materials regarding the meaning and use of biosimilar biological products and interchangeable biological products.

Affordable Care Act (ACA) Transition 
On March 23, 2020, the life sciences industry will undergo “the transition,” according to Lanton. Currently, the FDA has and will continue to regulate biologics, but historically the agency regulated biologics as drugs under the Food, Drug and Cosmetic Act instead of as products licensed under the Public Health Service (PHS) Act.

“In order to bring all biologics under the same legal and regulatory system, the Biologics Price Competition and Innovation Act of 2009 found in the ACA included the ‘Deemed to be a License’ provision,” Lanton said.

This meant that 10 years after enactment, on March 23, 2020, applicable biologics will automatically be deemed biologics licensed under the PHS Act. Unfortunately, the statute did not provide instructions to the FDA on how to do this, meaning the agency will decide on which products transition and how, according to Lanton.

“This basically means no more new drug applications or abbreviated new drug applications for select biologics, only biologic license applications of the 351(a) and 351(k) varieties. Also, not only will they be categorized as biologic[s], but they will be subject to the biosimilar, not generic competition. Specifically, drugs [to] be transitioned are insulins and other naturally occurring proteins, such as hyaluronidase, human growth hormones, and menotropins,” Lanton said.

Reference

1. Lanton, Ron, III, Esq. Interview with Pharmacy Times [email]. Accessed February 11, 2020.

2. 5 Trends Health System Pharmacies Can Expect in 2020. Becker’s Hospital Review. Published December 9, 2020. https://www.beckershospitalreview.com/pharmacy/5-trends-health-system-pharmacies-can-expect-in-2020.html. Accessed February 12, 2020.

3. Biologics Build Oncology Drug Pipeline. Managed Healthcare Executive. Published November 1, 2019. https://www.managedhealthcareexecutive.com/news/biologics-build-oncology-drug-pipeline. Accessed February 12, 2020.

4. Galante, Dominic. Accreditation Explosion Among Top Specialty Pharmacy Trends. J Clin Pathways. 2018;4(7):35-38. doi:10.25270/JCP.2018.09.00037. Accessed February 12, 2020.

Biosimilars Made Simple: A Micro-Analysis Of Biosimilars & Relevant Policy

With all the promise biosimilars hold, why we are not seeing increased market uptake? There are many reasons that involve policy, legislation, and the legal system that have led to the current state of the biosimilar market in the U.S. Our white paper examines the basics. We like to thank Biosimilar Development for featuring our new analysis!

Download our micro-analysis here.

With the Debate Over Data Privacy Increasing, Senator Gillibrand Proposes Legislation to Create New Data Protection Agency

U.S. Senator Kirsten Gillibrand (D-NY) has announced the creation of new legislation titled the Data Protection Act. According to the Senator’s press release, the bill would create “the Data Protection Agency (DPA), an independent federal agency that would protect Americans’ data, safeguard their privacy, and ensure data practices are fair and transparent. 

The DPA will have the authority and resources to effectively enforce data protection rules—created either by itself or congress—and would be equipped with a broad range of enforcement tools, including civil penalties, injunctive relief, and equitable remedies. The DPA would promote data protection and privacy innovation across public and private sectors, developing and providing resources such as Privacy Enhancing Technologies (PETs) that minimize or even eliminate the collection of personal data. The U.S. is one of the only democracies, and the only member of the Organization for Economic Co-operation and Development (OECD), without a federal data protection agency.”

The proposed bill will have three core missions:

• Give Americans control and protection over their own data by creating and enforcing data protection rules

• Maintain the most innovative, successful tech sector in the world by ensuring fair competition within the digital marketplace

• Prepare the American government for the digital age

Governmental oversight into data is showing no signs of slowing down. Gone are the days where you don’t have to worry about regulations in order to operate. If you are a healthcare, technology and financial services stakeholder, data privacy will be the most important issue to overcome within the next 10-20 years. Ensuring against breaches of personally identifiable information (PII), protected health information (PHI), personally identifiable financial information (PIFI), and other sensitive data will be key to compliance, trust and market competitiveness. Contact Lanton Law so that our experts can use their advocacy and legal services to help you prepare and succeed in a more interconnected world.   

Private Equity Presence Grows in Physician Practices As Well As Congressional Scrutiny

The Changing Market

As the consolidation of independent physician practices continues, one finds that there is a new player in the corporatization of medicine. While hospitals, health systems and insurers continue to make physician practice acquisitions, these entities suddenly find themselves competing against private equity firms.

Several physicians are finding themselves struggling in today’s reimbursement landscape. Whether you are in orthopedics, oncology, dermatology, urology, women’s health and gastroenterology for example, not only are reimbursement pressures much worse than in prior years, but transitioning to value based care has caused these and other physician practices to struggle with acquiring specialized personnel, new workflows and innovative technology.

What is Private Equity?

Private equity firms are backed by money from high net worth individuals, sovereign wealth funds, pensions funds, etc. that seek to invest in specialized sectors for an average return of 20% within 5-7 years. Once these firms take a majority stake in these practices and scale down costs to make the practice efficient, these same firms exit their positions after a short period while the remaining physician owners profit from the resale. The goal is to target a market, region or to create a multi-specialty practice. Besides the goal of financial returns, these firms can use their market clout to negotiate better rates and compete for more contracts with payers. 

To date, there are many questions surrounding private equity firms purchasing physician practices. Do they improve patient outcomes? Do all employees within these new scaled practices work for the private equity firm? What legal liabilities exist for the physicians? Are physicians considered owners or employees in these newly acquired entities? 

Private Equity Transactions Debated by Congress

Transactions such as the ones described above are now being debated by Congress. The House Ways and Means Committee is debating whether transparency is warranted by private equity firm ownership of physician practices. Should these firms have to file disclosures with the Internal Revenue Services (IRS) on Medicare payments, as well as provider rents and mortgages? Additionally, the question of whether an increase in patient surprise billing is the result of private equity ownership is also currently being examined.    

How Can Lanton Law Help?

Lanton Law’s advocacy and legal services  can help physician practices think about your options in this changing marketplace. If your position is not to sell your firm, we can help you with both legal and advocacy options that will assist with better reimbursement and network access. If you are thinking of selling your practice we can help walk you through your strategies. Once you sell, your practice will transition not only operationally, but also how you care for your patients. Not having complete managerial control will likely occur after the transaction so making sure that you sell to the right stakeholder is crucial. Contact us today for more information.  

What is the Potential Fallout from FTC’s Decision to Investigate Big Tech?

What is the Potential Fallout from FTC’s Decision to Investigate Big Tech?

The Federal Trade Commission (FTC) issued a press release announcing that the agency will examine prior acquisitions by large technology companies between the years of January 1, 2010-December 31, 2019. With a 5-0 vote, the Commission seeks to examine subsequent trends of large cap acquisition on smaller firms to determine whether competition was restricted or whether competitive concerns should have been raised. 

“The Federal Trade Commission issued Special Orders to five large technology firms, requiring them to provide information about prior acquisitions not reported to the antitrust agencies under the Hart-Scott-Rodino (HSR) Act. The orders require Alphabet Inc. (including Google), Amazon.com, Inc., Apple Inc., Facebook, Inc., and Microsoft Corp. to provide information and documents on the terms, scope, structure, and purpose of transactions that each company consummated between Jan. 1, 2010 and Dec. 31, 2019.

The Commission issued these orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct wide-ranging studies that do not have a specific law enforcement purpose. The orders will help the FTC deepen its understanding of large technology firms’ acquisition activity, including how these firms report their transactions to the federal antitrust agencies, and whether large tech companies are making potentially anticompetitive acquisitions of nascent or potential competitors that fall below HSR filing thresholds and therefore do not need to be reported to the antitrust agencies.”

What specifically is the FTC looking for?

“The Special Orders require each recipient to identify acquisitions that were not reported to the FTC and the U.S. Department of Justice under the HSR Act, and to provide information similar to that requested on the HSR notification and report form. The orders also require companies to provide information and documents on their corporate acquisition strategies, voting and board appointment agreements, agreements to hire key personnel from other companies, and post-employment covenants not to compete. Last, the orders ask for information related to post-acquisition product development and pricing, including whether and how acquired assets were integrated and how acquired data has been treated.”

What are the options for the FTC under this action?

With this review being operated by the agency’s Office of Policy Planning under Section 6(b) of the FTC Act the review could trigger an enforcement action but that this inquiry would not be able to share information with the Department of Justice unless there is an enforcement action.

So what does this mean?

The FTC has significant power to scrutinize mergers and stop them. In this case, the FTC’s aim is to examine how big tech became big tech? The answer is simple, not only did they innovate to create go to products, but these large companies like Amazon, Facebook, Alphabet, Microsoft and Apple grew through acquisitions. Determining whether to incorporate competition or “kill” acquired companies has heavily contributed to their success. While the FTC does have power to make problems for these companies, the fact that the agency’s scrutiny could go on for years poses the question of whether the FTC has enough resources to make any meaningful differences. Additionally, will these same scrutinized big tech companies provide a marketplace solution themselves by divesting certain businesses before policymakers require them to do so. 

This may be different for tech companies that aren’t large cap tech. Knowing what the competitive playing field is along with how regulators are overseeing this market is crucial to your success. Contact Lanton Law to learn about your options to put together a solid strategy to reach your goals.

For more information contact

Ron Lanton III, Esq. 

Principal 

Lanton Law 

rlanton@lantonlaw.com

Disclaimer

The materials and information provided in this update is for informational purposes only and not for the purpose of providing legal advice. Use of and access to this article or any of the materials or information contained within this article do not create an attorney-client relationship between Lanton Law and the user or viewer. You should contact an attorney to obtain advice with respect to any particular issue or problem. 

What Is Medicare for All?

Healthcare Policy Update 

What is Medicare for All? 

As the Democratic primary heats up, we believe it is fitting to examine one of the most discussed topics of the campaign season: healthcare. Since last year, we have witnessed an increased debate on whether the country should move towards Medicare for All. But what is this program? 

The idea of a single national health service began in 1912 with President Roosevelt and has evolved over time. Today, this idea is being championed as Medicare for All by Sanders (D-VT) as he is the primary sponsor for S. 1129 titled the Medicare for All Act of 2019. The House also has a companion bill sponsored by Representative Jayapal (D-WA) also known as H.R. 1384.  

In addition to making healthcare a human right, the proposed bill will create a single national health insurance plan for every American. All public insurance plans such as Medicaid, Medicare, the Children’s Health Insurance Plan (CHIP) individual health insurance plans and employer-sponsored health insurance plans would be phased out. However; some federal programs like the Veterans Health Administration and Indian Health Service would continue.

The plan would cover inpatient and outpatient acute care services, preventative services, emergency services, vision, dental, nursing home, and long term care. Foreseeable out of pocket costs would be for some prescription drugs and elective services. 

Cost-sharing such as copayments, deductibles, and premiums would also go away. It is also foreseeable that taxes will increase depending on individual income levels. Private insurance plans would likely continue to exist offering more specialized options for elective services. Lastly, there would be a four year transition period to the new plan should this be the direction of healthcare.

The Medicare for All bill establishes the following: 

• A national health insurance program that is administered by the Department of Health and Human Services (HHS) 

• Among other requirements, the program must (1) cover all U.S. residents; (2) provide for automatic enrollment of individuals upon birth or residency in the United States; and (3) cover items and services that are medically necessary or appropriate to maintain health or to diagnose, treat, or rehabilitate a health condition, including hospital services, prescription drugs, mental health and substance abuse treatment, dental and vision services, and home- and community-based long-term care.

• The bill prohibits cost-sharing (e.g., deductibles, coinsurance, and copayments) and other charges for covered services, with the exception of prescription drugs. Additionally, private health insurers and employers may only offer coverage that is supplemental to, and not duplicative of, benefits provided under the program.

• Health insurance exchanges and specified federal health programs terminate upon program implementation. However, the program does not affect coverage provided through the Department of Veterans Affairs or the Indian Health Service. Additionally, state Medicaid programs must cover certain institutional long-term care services.

• The bill also establishes a series of implementing provisions relating to (1) health care provider participation; (2) HHS administration; and (3) payments and costs, including the requirement that HHS negotiate prices for prescription drugs and establish a formulary.

• Individuals who are age 18 or younger may enroll in the program starting one year after the enactment of this bill; other individuals may buy into a transitional plan or an expanded Medicare program at this time, depending on age. The bill's program must be fully implemented four years after enactment.
  

What are the risks of this bill? 

At this point, the immediate risks would be to the insurance industry. Companies like CVS Health, Cigna, Centene, Humana, and UnitedHealthcare would face an uncertain reality if Medicare for All actually becomes the law of the land. They would have four years to figure out how they can remain in the market by either moving to coverage for elective services or data services for providers. 

Currently, S. 1129 has 14 co-sponsors while H.R. 1384 has 118 co-sponsors. The House version is a lot stronger than its Senate counterpart, especially since the House usually is less moderate than the Senate regardless of which political party is in power. This law will probably not move forward as the Senate is controlled by the Republicans. This does provide insight into how strong this bill is for 2021, which is especially true depending on if the Democrats are able to hold the House and capture the Senate, the White House or even both. If Bernie Sanders does win the nomination for the Democrats his policy ideas such as Medicare for All will continue to gain momentum. No matter who wins the White House in 2020 there will be changes to the current health system. 

For more information contact:

Ron Lanton III, Esq. 

Principal 

Lanton Law 

rlanton@lantonlaw.com

The materials and information provided in this update is for informational purposes only and not for the purpose of providing legal advice. Use of and access to this article or any of the materials or information contained within this article do not create an attorney-client relationship between Lanton Law and the user or viewer. You should contact an attorney to obtain advice with respect to any particular issue or problem. 

Lanton Law

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Washington D.C. 20036

240-482-6060

Surprise Medical Billing: What is it and what’s being done to stop it?

Surprise medical billing is an issue that has been widespread for a while, but due to social media and more intense scrutiny, we are now seeing the effects of how common this problem is among patients accessing our healthcare system. According to a study by Kaiser “roughly 1 of every 6 emergency room visits and inpatient hospital stays in 2017, patients came home with at least one out-of-network medical bill.” The question is what is surprise medical billing?

Surprise medical bills generally have two components. The first component is the higher amount the patient owes under her health plan, reflecting the difference in cost-sharing levels between in-network and out-of-network services. 

The second component of surprise medical bills is an additional amount the physician or other provider may bill the patient directly, a practice known as “balance billing.” Typically, health plans negotiate discounted charges with network providers and require them to accept the negotiated fee as payment-in-full. Network providers are prohibited from billing plan enrollees the difference (or balance) between the allowed charge and the full charge. Out-of-network providers, however, have no such contractual obligation. As a result, patients can be liable for the balance bill in addition to any applicable out-of-network cost sharing.

To illustrate a patient can find his or herself in a situation where the patient needs emergency care but cannot select the emergency room or the ambulance provider in a certain situation. Another instance is where a patient knowingly goes to an in-network hospital to receive surgery but does not know that an anesthesiologist is an out of network provider.   

So what’s being done about this? 

The Administration:

Last May, the Administration released a fact sheet on medical billing that advocated for the following: 

• In emergency situations, balance billing for amounts above the in-network allowed amount should be prohibited.

• Before scheduling their care, patients should be given information about whether the care providers are out of their network and what related costs that may bring.

Congress:

In Congress there have been bills this session to combat surprise medical billing, but these solutions have differing philosophical approaches. For example one method calls on the use of arbitration, where an insurer and a provider would advance a proposed payment rate for the service provided to the patient and then an independent arbiter would adjudicate a fair price. On the other hand insurers have been advocating for benchmark payment rates as a solution to surprise medical billing where benchmark payment rates would ensure that providers are paid a standard rate for out-of-network services provided.

H.R. 3630: This bill sponsored by Rep. Pallone (D-NJ) expands restrictions on charging health care plan holders out-of-network rates for certain services. First, the bill requires insurers offering plans that cover emergency services to bill plan holders no more than the median in-network rate for a particular emergency service, even if the service provider is out of network. The bill further prohibits insurers from billing plan holders more than the median in-network rate for nonemergency services provided by out-of-network providers at in-network facilities. Out-of-network providers may not bill plan holders for the difference between the in-network and out-of-network rates for emergency services. The bill further prohibits out-of-network providers from billing plan holders for the difference in rates for nonemergency services provided at an in-network facility unless the provider complies with specified notice and consent requirements. 

S. 1895: This bill sponsored by Senator Alexander (R-TN) applies in-network cost-sharing requirements to certain emergency and related nonemergency services that are provided out-of-network, and prohibits health care facilities and practitioners from billing above the applicable in-network cost-sharing rate for such services. Additionally, it requires health care facilities and practitioners to give patients a list of provided services upon discharge and to bill for such services within 45 days.

Most recently, two U.S. House Committees have moved forward with additional possible solutions to this issue. The U.S. House Ways and Means Committee released a surprise billing plan, that calls for a dispute resolution process between the insurer and the provider. This bill does not address patients who are billed for air ambulance rides but does require providers to share cost data and insurers to share claims data to the Department of Health and Human Services. If enacted this language would be effective in 2022. 

The U.S. House Education and Labor Committee has released its proposal that is similar with what the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee (HELP) proposed in December 2019, where insurers would pay out-of-network providers the median in-network rate for that geographic area for amounts up to $750. For larger amounts, either side could request an arbitration process. When a patient receives a surprise bill from an air ambulance provider, the threshold would be $25,000. Both House committees plan to discuss their respective bills this week. 

State Legislative Protections:

States have created their own but varied approaches to surprise medical billing. According to an analysis by The Commonwealth Fund, 28 states have enacted laws to protect enrollees against this issue. Last year Colorado, Nevada, Texas and Washington State passed enhanced or new surprise medical billing laws.   

Conclusion

In conclusion, this issue will continue to be debated in the states until there is a federal solution. With this being an election year, it is uncertain as to whether this issue will pass Congress. While this issue can be a bi-partisan victory for patients nationwide, it is also questionable as to whether either the Democrats or Republicans are willing to give the other side a share in a political victory during the crucial 2020 election season.

Department of Justice Will Hold February 2020 Workshop on Section 230 Which Will Impact Tech Stakeholders

Earlier this month, we released a blog post titled Tech Companies and the Uncertain Future of §230. In it we focused on what Section 230 of the Communications Decency Act is and how the tech community would be impacted by changes currently being debated by both sides of the political aisle in Congress. 

Interestingly, the Department of Justice (DOJ) has announced that it will hold a public workshop in Washington, D.C. on Feb. 19, 2020, titled “Section 230 – Nurturing Innovation or Fostering Unaccountability?” According to the DOJ the workshop will discuss the law, its expansive interpretation by the courts, its impact on the American people and business community, and whether improvements to the law should be made. 

Additionally, the Department stated “Following the public workshop, the Justice Department will invite stakeholders with diverse perspectives for private listening sessions and roundtables to seek additional input and discuss the problems, benefits, and potential improvements to Section 230.  The department will publish readouts on the various perspectives and debate from those meetings.”

Congressional officials have been increasing their desire to modify this law. Democrats have complained that the law allows tech companies to be lax in patrolling misinformation or violent extreme content while Republicans have advocated that the law prevents them from imposing actions against tech companies for removing conservative political content.  

As we continue to become an increasingly connected world, being able to digitally share content with each other is not likely to slow down anytime soon. However; the market and our intentions in sharing data have changed significantly since when section 230 was enacted in 1996. While major tech titans like Facebook, Twitter, Alphabet are at the center of this debate, we foresee that other tech stakeholders should take note of these developments and plan accordingly. We don’t believe that this debate will slow down at all so making adaption to section 230 is key. Contact Lanton Law for more details.