Amazon Launches U.S. Pharmacy Business

Many supply chain stakeholders have been fearing whether Amazon would ever open a retail pharmacy business. There have been traces of this occurring for years from its sporadic applications of pharmacy licenses in various states, to its June 2018 $753 million acquisition of PillPak. However; no coherent plan had come into focus until now. 

Today (November 17) Amazon has launched Amazon Pharmacy. According to the press release: 

“ Amazon.com, Inc. (NASDAQ: AMZN) today announced two new pharmacy offerings to help customers conveniently purchase their prescription medications. Amazon Pharmacy, a new store on Amazon, allows customers to complete an entire pharmacy transaction on their desktop or mobile device through the Amazon App. Using a secure pharmacy profile, customers can add their insurance information, manage prescriptions, and choose payment options before checking out. Prime members receive unlimited, free two-day delivery on orders from Amazon Pharmacy included with their membership. 

Also new today, Prime members can access savings on medications at Amazon Pharmacy when paying without insurance, as well as at over 50,000 other participating pharmacies nationwide. The Amazon Prime prescription savings benefit saves members up to 80% off generic and 40% off brand name medications when paying without insurance. Prime members will have access to their prescription savings at checkout on Amazon Pharmacy, or can learn more at amazon.com/primerx.

Together the Amazon Prime prescription savings benefit and Amazon Pharmacymake it simple for customers to compare prices and purchase medications for home delivery, all in one place. Now, filling prescriptions is as convenient as any other purchase on Amazon’s online store:

• Research Medications and Order Confidently: The same browsing experience customers are familiar with from Amazon makes it easy to discover what medications – including branded and generic versions, and different forms or dosages – are available through Amazon Pharmacy. Before checking out customers can compare their insurance co-pay, the price without insurance, or the available savings with the new Prime prescription savings benefit to choose their lowest price option.

• Seamless Transactions: Customers can add insurance information and ask their prescriber to send new or existing prescriptions directly to Amazon Pharmacy for fulfilment. Purchase is as simple as confirming the request on the Amazon App or website.

• Access Fully Digital, Personalized Quality Care: Customers have online self-service help options combined with phone access to customer care at any time. Friendly and knowledgeable pharmacists are available 24/7 to answer questions about medications.”

Notwithstanding today’s market moving news, we fully expect that our healthcare supply chain will continue to evolve. New players are moving into the sector and are looking for ways to either disrupt the model or have significant influence on reimbursement. To succeed you need to be in the know and planning ahead. 

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the LTC, CBD/hemp, specialty and retail pharmacy space, as well as manufacturers and suppliers. If you are an industry stakeholder with questions about strategy or simply need advice, contact us today.    

Online Marketplaces Will Benefit from November 2020 Sports Betting Ballot Initiatives

Online stakeholders in the sports betting market have made policy inroads from the November 2020 ballot initiatives. Below are three states that expanded sport betting capabilities.   

Maryland: The State of Maryland has joined both Virginia and the District of Columbia in legalizing sports betting. Voters passed Ballot Question 2 which allowed for legalized sports betting while having the revenue generated from this to go towards funding public education.

Louisiana: The State of Louisiana approved sports betting in the major cities of Baton Rouge, New Orleans and Lafayette. The following parishes approved the measure as well including: St. Tammany, Jefferson, Ascension, Livingston, St. Bernard, West Baton Rouge, Plaquemines, St. Charles and Terrebonne parishes.

South Dakota: Voters in South Dakota have allowed sport betting as early 2021. By approving Amendment B  sports betting is legal in the city of Deadwood as well as the state’s Native American gaming facilities.

Lanton Law’s fintech and online marketplace practice helps stakeholders understand and navigate regulatory complexities. Contact us today to learn more about how our services can help you.  

Psychedelic mushrooms take a policy step forward

In what has surprised many cannabis stakeholders it seems as though the November 2020 elections is bringing a new therapeutic item into the mainstream healthcare policy conversation: psychedelic mushrooms via ballot box initiatives. 

On November 3rd, Oregon voted to legalize psychedelic mushrooms for therapeutic usage with the passage of Measure 109. This is a first for the U.S.The ballot measure calls for a two year period to create a regulatory scheme to oversee this issue as well as what qualifications are required for overseeing therapists. The issue with psychedelic mushrooms turns on the use of psilocybin, who some therapists believe helps those battling depression, addiction and anxiety. Currently psilocybin is still classified as a Schedule I drug. 

Oregon also became the first in the nation via Measure 110 to decriminalize the possession of small amounts of drugs including heroin, cocaine, methamphetamine, ecstasy, LSD, psilocybin, methadone and oxycodone.     

Meanwhile in the District of Columbia, voters approved Ballot Initiative 81 that would decriminalize the use of magic mushrooms and other psychedelic substances.  The measure ensures that the prosecution of those who use and sell these substances would be “among the Metropolitan Police Department’s lowest law enforcement priorities.”   

There is definitely a policy change on the local and state levels. 

Lanton Law’s Cannabis practice is more than prepared to assist cannabis stakeholders. Whether you are a public or private cultivator, processor, distributor, dispensary, or an ancillary service related to the medical and/or adult-use cannabis business, we can help. 

Lanton Law assists our cannabis clients with the following services:  

• Offer strategic advice on the federal and state outlook

• Contract and lease drafting

• Corporate formation & governance

• Shareholder agreements

• Administrative representation

• Trademarks and copyrights

• FDA, USDA and FTC regulatory compliance 

• Banking and finance

• Licensing

• State and local permits

• Lobbying 

• Investor & early stage company issues

• Mergers and acquisitions

• Non-Compete and Non-Disclosure agreements

• Labor and employment

• General counsel services

To put your plans forward contact us today. 

California Passed Proposition 22 in a Win for Uber & Lyft

Proposition 22’s passage in California on November 3, 2020 will have a major impact on the future of the gig economy not just in California but potentially the rest of the country. 

Proposition 22 involved the issue of whether transportation drivers for app-based entities such Uber and Lyft should be classified as independent contractors. This now means that these companies would be exempt from a California law enacted last year that made it harder for these app-based companies to not classify their workers as employees.    

If you have questions about what this means for you contact Lanton Law. We are experts in the technology and fintech industries and can help stakeholders navigate these evolving markets.

November Election Yields Gains for Marijuana Legalization

The result of a few November 3, 2020 election ballot measures have yielded additional gains for marijuana. 

New Jersey: In New Jersey voters approved Question 1, which legalized recreational marijuana.

Arizona: Voters in Arizona approved Proposition 207 which legalizes possession and use of marijuana for adults, age 21 years or older, in Arizona and permits individuals to grow up to six marijuana plants in their residences.

South Dakota: The state has legalized marijuana possession and use for adults 21 and older. It also allows individuals to grow up to three plants if they live in a jurisdiction with no licensed marijuana retailers. It allows distribution and sales, with a 15 percent tax. Additionally, the state legislature would have to pass legislation legalizing medical marijuana and the sale of hemp by April 1, 2022.

Mississippi: Initiative 65A was passed, which restricts medical marijuana to terminally ill patients and would require pharmaceutical-grade marijuana products to have oversight by licensed physicians, nurses, and pharmacists.

Montana: Montana has passed two constitutional amendments regarding marijuana. CI-118 allows for the state legislature or a ballot initiative to set a legal age for marijuana use. Additionally, I-190 allows for marijuana possession use and growing for adults 21 or older. The measure allows for the creation of a regulatory scheme around growing and selling cannabis and imposes a sales tax on these goods.

Lanton Law’s Cannabis practice is more than prepared to assist cannabis stakeholders. Whether you are a public or private cultivator, processor, distributor, dispensary, or an ancillary service related to the medical and/or adult-use cannabis business, we can help. 

Lanton Law assists our cannabis clients with the following services:  

• Offer strategic advice on the federal and state outlook

• Contract and lease drafting

• Corporate formation & governance

• Shareholder agreements

• Administrative representation

• Trademarks and copyrights

• FDA, USDA and FTC regulatory compliance 

• Banking and finance

• Licensing

• State and local permits

• Lobbying 

• Investor & early stage company issues

• Mergers and acquisitions

• Non-Compete and Non-Disclosure agreements

• Labor and employment

• General counsel services

Lanton Law & Private Equity

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

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

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

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

Lanton Law Opens Cannabis Practice

Lanton Law believes that the cannabis market will continue to evolve and expand. Notwithstanding this market potential is the fact that medical and adult-use cannabis operations are confronted with a complex patchwork of state and federal laws and regulations that we assist a variety of businesses with. 

Whether you are a public or private cultivator, processor, distributor, dispensary, or an ancillary service related to the medical and/or adult-use cannabis business, we can help. 

Lanton Law assists our cannabis clients with the following services:  

• Offer strategic advice on the federal and state outlook

• Contract and lease drafting

• Corporate formation & governance

• Shareholder agreements

• Administrative representation

• Trademarks and copyrights

• FDA, USDA and FTC regulatory compliance 

• Banking and finance

• Licensing

• State and local permits

• Lobbying 

• Investor & early stage company issues

• Mergers and acquisitions

• Non-Compete and Non-Disclosure agreements

• Labor and employment

• General counsel services

Lanton Law Follow Up Interview with Law360

Lanton Law had a follow up interview with Law360 regarding the Rutledge v. PCMA Supreme Court oral arguments on October 6, 2020. Below is a link to the story titled “Justices Eye Arkansas PBM Law’s Impact on Workers.” The story can be viewed here.

If you have trouble accessing the story we have included Emily Brill’s article below.

Justices Eye Arkansas PBM Law's Impact On Workers

By Emily Brill

Law360 (October 6, 2020, 1:50 PM EDT) -- The U.S. Supreme Court on Tuesday focused on whether an Arkansas law's potential costliness to employee benefit plans is enough to place it in conflict with the Employee Retirement Income Security Act, with two conservative justices questioning whether the statute regulating pharmacy benefit managers would end up hurting workers.

Counsel for the Pharmaceutical Care Management Association, the PBM lobby that challenged Arkansas' Act 900, argued that increased plan costs could cause employers to squeeze benefits. Therefore, laws like Act 900 — which could increase plans' costs by increasing PBMs' costs in the form of compliance burdens — pose enough of a threat to workers' benefits that they should be preempted by ERISA, argued Seth Waxman, a partner at WilmerHale.

"Those additional costs, both in terms of reimbursement obligations and plan administration, would manifestly affect how munificent the pharmacy benefits a plan could offer would be," Waxman said.

Arkansas' solicitor general bucked this argument, claiming PCMA's approach to ERISA preemption would spell the end for far more laws than Congress intended to strike down when it stated that ERISA should be the only law regulating employee benefit plans.

"If you accept their position that anytime a regulation imposes cost, that can lead to preemption because it might affect the benefits calculation, that really has no limiting principle," Arkansas Solicitor General Nicholas Bronni said. "It would, frankly, preempt things like state minimum wage laws that have exactly that same effect."

Justice Brett Kavanaugh questioned why increased costs shouldn't be considered an ERISA preemption issue.

"Why shouldn't ERISA care about costs that are going to be increased and then passed on in the form of worse benefits to Arkansas workers?" Justice Kavanaugh asked the assistant to the U.S. solicitor general, Frederick Liu, who argued in support of Arkansas' position.

Liu responded that "increased costs actually don't affect the basic bargain between the plan and its beneficiaries," which was what Justice Kavanaugh had stated that ERISA was designed to protect.

"I totally agree that ERISA was enacted to protect that relationship, but increased costs don't affect the terms of that relationship," Liu argued.

Justice Samuel Alito Jr. questioned whether Act 900, which regulates how PBMs reimburse local pharmacies, would indeed increase costs for employee benefit plans and workers.

"You said that these laws affect the benefits that employees get, but do we know whether that is in fact true?" Justice Alito said. "Assuming they increase the costs for the PBMs, do we know how much of that increase in cost is passed on to plans and beneficiaries, and how much is absorbed by the PBMs?"

Waxman said he didn't "have specific data on this" but knew that "one way or another, in the very short term or the long term, this is going to cost plans more to administer," which would affect "the munificence of the pharmacy benefits that plans feel they can afford."

Arkansas Takes on PBMs

The case the justices heard Tuesday asks them to decide whether Arkansas was allowed to pass a law regulating the rates at which PBMs reimburse pharmacies for prescription drugs.

Critics of PBMs, which manage health insurance plans' relationships with pharmacies, say they're pushing local pharmacies out of business by regularly shortchanging them on prescription reimbursements, while paying PBM-owned pharmacies higher rates for the same drugs.

Those critics — which include pharmacy groups and a coalition of 46 attorneys general — say Arkansas was within its rights in 2015 to pass a law that purported to protect local pharmacies from unfair treatment by PBMs. Act 900, among other things, required PBMs to reimburse at rates at least equal to what pharmacies pay for drugs.

But supporters of PBMs, which include business and insurance trade groups, say Act 900 violated ERISA. They say Congress intended ERISA to be the only law that regulates matters impacting employee benefit plans, so Arkansas' law cannot stand.

In 2017, an Arkansas federal judge agreed with the law's challengers and struck down Act 900. The Eighth Circuit upheld the lower court's decision in June 2018, and Arkansas petitioned the Supreme Court for review in October 2018. The high court picked up the case in January.

Mulling Travelers

Much of Tuesday's debate on whether a law's costliness to benefit plans could trigger ERISA preemption centered on interpretation of the Supreme Court's 1995 decision in New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Insurance Co .

In the Travelers case, the high court upheld a New York law that required hospitals to impose a surcharge on patients with certain types of insurance, including employer-provided health insurance.

The justices ruled unanimously that the law wasn't preempted by ERISA because "it simply bears on the cost of benefits" without "bind[ing] plan administrators to any particular choice," as now-retired Justice David Souter wrote in the opinion.

Bronni argued Tuesday that the justices' logic in Travelers neatly applies to this case, saying that "for the same reason that New York's rate regulation wasn't preempted in Travelers, Arkansas' is not preempted here."

But Travelers left the door open for a law's costliness to trigger ERISA preemption if that statute produced "such acute, albeit indirect, economic effects as to force an ERISA plan to adopt a certain scheme of coverage," as Justice Souter put it in a footnote.

That's what PCMA is arguing could happen here, said Mark Casciari, a benefits attorney at Seyfarth Shaw LLP who watched Tuesday's oral arguments.

"A plan sponsor has to decide what they're going to cover, and this law could have the effect of forcing its hand on those decisions because of onerous administrative burdens," Casciari said. "By regulating costs, the state law is rearticulating the plan terms."

But PCMA's argument could be weakened by the fact it's choosing to pass on those costs to benefit plans, when it could just absorb those costs, said Ron Lanton, an attorney and lobbyist with 15 years of experience in health care law.

When Waxman referenced the footnote in the Travelers decision, Chief Justice John Roberts pointed out that increasing costs for PBMs doesn't necessarily increase costs for benefit plans; that only happens because PBMs set things up that way.

"If the state law produced economic effects as to force the ERISA plan to adopt a certain scheme of coverage, it would, indeed, be preempted," Waxman said.

"Well, it's not the state or the pharmacy's fault that the PBMs have such Byzantine procedures that affect drug prices," Justice Roberts said.

Lanton said he thinks Justice Roberts was "undermining PCMA's argument" with his comment.

"Where they're saying this affects the plan, I think Justice Roberts is saying, 'Yeah, I hear what you're saying, but we're only here because of the way you guys structured this business.'"

Arkansas Attorney General Leslie Rutledge is represented at oral arguments by Arkansas Solicitor General Nicholas Bronni.

The federal government is represented by Frederick Liu of the U.S. Office of the Solicitor General.

PCMA is represented by Seth Waxman of WilmerHale.

The case is Rutledge v. Pharmaceutical Care Management Association, case number 18-540, in the Supreme Court of the United States.

--Editing by Orlando Lorenzo.

Update: This article has been updated with more details from the hearing and further comment.

Lanton Law Quoted in Law360 Article on Rutledge v. PCMA

Lanton Law was quoted in Law360’s article titled “High Court to Weight States’ Ability to Rein in Drug Middlemen,” which was written in response to current developments around the Rutledge v. PCMA case. This case was heard this morning in the U.S. Supreme Court. The article can be accessed here.

We have included Emily Brill’s article from Law360 below in case you have trouble accessing it.

Analysis High Court To Weigh States' Ability To Rein In Drug Middlemen

By Emily Brill

Law360 (October 5, 2020, 7:45 PM EDT) -- The U.S. Supreme Court will hear arguments Tuesday over whether states can control the rates at which local pharmacies get reimbursed for drugs by health insurance plans, a case that could determine whether states can regulate pharmacy benefit managers without getting waylaid by federal benefits law.

Local pharmacists call the case the most significant health care suit the high court will hear this term aside from the one that threatens the Affordable Care Act. The pharmacists say a loss for their side would give pharmacy benefit managers — the middlemen who reimburse pharmacies for drugs on insurers' behalf — a green light to put pharmacies that lack PBM ties out of business.

"The outcome of the Rutledge case will be the tipping point of whether Americans will continue to have access to their local pharmacist or whether that access will go away," said Michael Hogue, the president of the American Pharmacists Association.

The outcome could also affect how far companies can stretch the Employee Retirement Income Security Act's preemption provision, which is often used in court to strike down state and local laws regulating employee benefit plans and related entities.

Here, Law360 breaks down what's at stake and what's being argued in Rutledge v. Pharmaceutical Care Management Association .

What Are the Arguments?

The Rutledge case concerns the viability of a 2015 Arkansas law that attempted to regulate PBMs. The law arrived after lobbying from local pharmacies, which said they would be forced to close if PBMs' allegedly predatory business practices weren't reined in.

Chief among those practices was PBMs' refusal to pay local pharmacies for drugs at the same rates that they paid their affiliated pharmacies, local pharmacists said. This practice led to local pharmacies consistently getting shortchanged on prescription reimbursements, making it difficult to stay in business, the pharmacists said.

In response to these concerns, Arkansas passed Act 900, which required PBMs to reimburse local pharmacies at the same rates as their affiliated pharmacies. But shortly after the bill became law, the PBM industry slapped the state with a lawsuit alleging that Act 900 was preempted by ERISA.

The suit, filed by the PBM industry lobbying group the Pharmaceutical Care Management Association, argued that Act 900 regulated business dealings that were central to administering benefit plans and that only ERISA is allowed to do that.

An Arkansas federal judge agreed, striking down the law in 2017. The Eighth Circuit upheld the ruling the following year, at which point Arkansas asked the Supreme Court to step in. The justices agreed to take the case in January.

Arkansas has argued that ERISA doesn't stretch as far as PCMA is claiming it does and that the courts are stepping into dangerous territory by accepting the PBM lobby's argument.

"Its approach would ... exempt ERISA plans from any number of generally applicable health-and-safety regulations. And that cannot be the case," Arkansas' attorney general, Leslie Rutledge, wrote in the state's opening brief to the high court.

What's at Stake?

Rutledge v. PCMA has attracted significant attention, drawing amicus briefs from 46 attorneys general and the U.S. solicitor general in support of Arkansas and from a number of employer interest groups in support of PCMA.

The state and federal governments argue that ERISA only preempts health care regulations that have an impermissible reference to employee benefit plans, which the Arkansas law does not.

Allowing PCMA to succeed in its argument could endanger states' ability to regulate health care, which could have dire consequences, the officials argued.

A ruling in favor of PCMA would also allow PBMs to operate essentially free of oversight, continuing business practices that have already bankrupted far too many local pharmacies, the pharmacists' groups argued.

If the Supreme Court upholds the Eighth Circuit ruling, "there's really nothing stopping a PBM from doing whatever it wants," said Ron Lanton, an attorney and lobbyist who specializes in health care law.

"It would be great if the Supreme Court ruled for Rutledge because then we won't have chaos," Lanton said.

But PCMA argues that a ruling in Rutledge's favor would create chaos for the PBM industry, subjecting it to a patchwork of state laws that would complicate the process of working with employee benefit plans that operate across state lines.

This argument gained PCMA the support of groups that represent employers and their benefit plans, such as America's Health Insurance Plans, the Society for Human Resource Management and the American Benefits Council.

"It was delicate for us to weigh in on because oftentimes there's no love lost between employers and PBMs," said Ben Conley, a partner at Seyfarth Shaw LLP who helped author SHRM's amicus brief. "But at the end of the day, employers want to pay less. They want the flexibility to design their plans in a manner that allows them to do so."

A win for Rutledge "could be seen as chipping away at ERISA preemption, which large, multistate employers view as of the utmost importance because it impacts their ability to design a uniform, nationwide plan," Conley said.

PCMA also argued that it has been unfairly vilified by local pharmacists, saying they have overstated the damage PBMs have done.

"The fact is the current state of independent pharmacies in the U.S. is secure," PCMA spokesperson Greg Lopes said in an emailed statement to Law360. He added that by attacking PBMs, local pharmacies are going after "the only entity in the prescription drug supply chain that is fighting to reduce drug costs for patients."

Counsel

Arkansas is represented by Leslie Rutledge, Nicholas Jacob Bronni and Shawn J. Johnson of the Arkansas Attorney General's Office.

The Pharmaceutical Care Management Association is represented by Michael B. Kimberly, Sarah P. Hogarth and Matthew Waring of McDermott Will & Emery LLP and Seth P. Waxman, Catherine M.A. Carroll, Paul R.Q. Wolfson, Justin Baxenberg, Claire H. Chung and Hillary S. Smith of WilmerHale.

The case is Rutledge v. Pharmaceutical Care Management Association, case number 18-540, in the Supreme Court of the United States.

--Additional reporting by Danielle Nichole Smith. Editing by Jill Coffey.

Where Do Biden & Trump Stand On The Issues?

With election season underway many are wondering where the two Presidential candidates stand on the issues of importance to voters.

Reuters did a great summary found here that explains the major differences from the economy, trade, healthcare, etc.

The winner of this election will certainly have policies affecting your interests. Whether you are in technology, healthcare/lifesciences or finance, it is important to know what your organization’s priorities are and to have a plan for either candidate should they win.

Lanton Strategies; a division of Lanton Law is a is a full service federal and state lobbying and government affairs firm that has a menu of services to help you achieve your goals.

Contact us today to get started in understanding your range of options as the new legislative session approaches.

The Department of Justice Releases Proposed Section 230 Legislation

For some time now we have been forecasting that technology stakeholders had to be aware of looming regulatory oversight, especially around the issues of antitrust and Section 230. 

Last week the Department of Justice (DOJ) sent draft legislation to Congress to reform Section 230 of the Communications Decency Act.  The draft legislative text implements reforms that the Department of Justice deemed necessary in its June Recommendations. 

The Justice Department’s proposals available here focus on two issues: addressing illicit activity online and promoting transparency and open discourse. 

Regardless of whether this or other legislation gets enacted this year, Section 230 comes under increasing scrutiny by policymakers. It’s a question of when for technology regulation, so if you are a technology stakeholder it is better to be prepared.

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.

FDA Cannabis Draft Guidance Comment Period Closes

On September 21st the FDA closed its comment period related to cannabis. Back in July the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” 

This draft guidance outlined FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance had been developed to help support clinical research into development of cannabis and cannabis-derived products. 

Additional information on the draft guidance can be found here.  

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

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!

New York Comptroller finds $605 million in unnecessary costs to the Medicaid program

The New York Comptroller recently released the results of an audit titled “Medicaid Program-Cost of Pharmacy Services Under Managed Care.” The audit covered the period January 1, 2016 to December 31, 2019.

The following outline the key findings of the audit;

• The Department missed opportunities to minimize costs on pharmacy services delivered through Medicaid managed care because Department officials did not take steps to ensure the use of the lowest net cost drugs to the Medicaid program. As a result, for the period January 1, 2016 through December 31, 2019, we estimated $605 million in unnecessary costs to the Medicaid program.

• The Department does not require MCOs to use the most cost-effective drugs to the Medicaid program, nor does it provide MCOs with information or assistance to determine the most cost-effective drugs.

• Medicaid-participating MCOs are required to regularly provide their drug formulary information, as well as information on costs and supplemental rebates (which MCOs did not always provide as required) for all drugs delivered under managed care, but the Department does not review this information to determine if MCO formulary preferences result in the use of the most cost-effective drugs.

The audit gave the following recommendation:

• Conduct timely routine analyses to identify the most cost-effective drugs to the Medicaid program and ensure drug utilization is steered toward drugs with the lowest net cost when medically appropriate.

If you are a healthcare stakeholder with an interest in New York state or do business within New York’s insurance system then you should be aware of this type of scrutiny. The legislature has already enacted a bill that will carve pharmacy benefits out of the Medicaid managed care program beginning in April 2021.

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 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!

New White House Drug Pricing Executive Order Released

On September 13, 2020, the Trump Administration released a new Executive Order (EO)  targeting drug pricing. The EO directs the Secretary of HHS to implement a “Most Favored Nation” drug pricing program for Medicare Parts B and D. This policy relies on international price competition and seeks to provide Americans with the same lower prices for prescriptions that we see in other countries.

Drug pricing has been a major point of contention as manufacturers and insurer/pharmacy benefit managers exchange blame over why drug prices are rising. Drug pricing has been a major issue that had been getting Congressional scrutiny until COVID-19. 

This issue will come back once a COVID-19 vaccine is available as there may be questions around the vaccine’s price. Additionally, once COVID-19 dies down, drug pricing for new therapies is expected to be front and center again.

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 current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today!

Lanton Law to Attend 9/14-9/18 2020 NASP Annual Meeting & Expo Virtual Experience

Lanton Law is proud to be attending the 9/14-9/18 2020 NASP Annual Meeting & Expo Virtual Experience.

We will be giving a presentation on the role of “State & Federal Regulations in Payer Contracting” and Ron Lanton will be serving as Vice Chair of Law Day! Additionally, we will be hosting a panel titled “Interoperability of Health Records: Providing Post-Market Data and Other Valuable Information.”

We are very much looking forward to interacting with our specialty colleagues including Sheila Arquette! Register today at https://lnkd.in/eU2VXaB

New Congressional Bill Aimed at Tech ISPs

The Platform Accountability and Consumer Transparency Act has been introduced by Sens. Brian Schatz (D-Hawaii) and John Thune (R-South Dakota), which targets Internet Service Providers and attempts to limit their protections under 47 U.S. Code § 230 of the Communications Decency Act (CDA), also called Title V of the Telecommunications Act of 1996. 

The proposed Act points out two critical facts: 

• “Online consumers are not adequately protected in the United States because, with the exception of Federal criminal statutes, providers of interactive computer services are immune from the enforcement of most Federal statutes and regulations.

• The bill among a list of proposed policies also seeks to preserve the internet and other interactive computer services as forums for diversity of political discourse, unique opportunities for cultural development, and myriad avenues for intellectual and commercial activity.”

Specifically, the interactive computer service provider shall provide the following elements:

• reasonably inform users about the types of content that are allowed on the interactive computer service;

• explain the steps the provider takes to

• ensure content complies with the acceptable use policy;

• explain the means by which users can notify the provider of potentially policy-violating content, illegal content, or illegal activity

• include publication of a quarterly transparency report outlining actions taken to enforce the policy

While there are some First Amendment concerns with this legislation, this demonstrates how Section 230 comes under increasing scrutiny by policymakers. It’s a question of when for technology regulation so if you are a technology stakeholder, it is better to be prepared.

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.

Senator Hawley Proposes New Congressional Legislation Targeting Behavioral Ads

U.S. Senator Josh Hawley (R-MO) has recently announced his new legislation titled the Behavioral Advertising Decisions Are Downgrading Services (BAD ADS) Act. This bill proposes to remove Section 230 immunity from Big Tech companies that display manipulative, behavioral ads or provide data to be used for them. Behavioral ads are defined in the legislation. 

It is unclear as to how this ties directly to Section 230 immunity and is different from other Congressional bills that create a nexus between Section 230 and its protections to content policies on websites. This bill would not apply to contextual ads  such as advertising that is directed to a user based on:

• ‘‘(aa) the content of the website, online service, online application, or mobile application to which the user is connected;

• ‘‘(bb) the location of the user, as of the time at which the advertising is directed to the user; or

• ‘‘(cc) the search terms that the user applied to arrive at the website, service, or application to which the user is connected

Regardless of whether this or other legislation gets enacted this year, Section 230 comes under increasing scrutiny by policymakers. It’s a question of when for technology regulation, so if you are a technology stakeholder it is better to be prepared.

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.

Lanton Law Newsletter is Out

We have released our August newsletter. This month we discuss our presentations at the National Association of Specialty Pharmacy, the new Executive Order aimed at PBMs, our recent Blogcast with Ken Kaitin, Professor and Director at the Tufts Center for the Study of Drug Development, the new LTC Congressional pharmacy bill and our interview with Pharmacy Times on Rutledge v. PCMA. Click here to view it.

Big Tech Company Executives Pressed On Capitol Hill On Their Market Influence

On July 29th four of the biggest tech companies CEOs testified in front of Congress. Jeff Bezos of Amazon, Tim Cook of Apple, Mark Zuckerberg of Facebook, and Sundar Pichai of Google all took questions from the U.S House Judiciary Subcommittee on Antitrust, Commercial, and Administrative Law. The hearing which can be viewed here was titled “Online Platforms and Market power, Part 6: Examining the Dominance of Amazon, Apple, Facebook, and Google.”  

Sadly, there was a lot of political posturing on both sides of the political aisle and not a lot of policy. The main takeaway is that there is still no clear bipartisan antitrust agenda. 

Democrats presented evidence regarding antitrust concerns. It seemed they had pointed questions regarding certain deals such as Amazon's purchase of Ring to control that sector of the market and Facebook's alleged threats against Instagram before its purchase of the company.  

Republicans focused on perceived anti-conservative bias in tech instead of addressing company size and market power. Their questions focused on whether the tech companies will participate in "electioneering" for Joe Biden and grilled Facebook about Twitter's shutdown of Trump Jr.'s account. 

This has been a year-long investigation by this Subcommittee with this testimony capping the investigation. Subcommittee members are still in the process of sending follow-up questions to the CEOs and finalizing their conclusions over the next few weeks. Once they are done the Subcommittee will file a report of its findings. 

This process has been highly politicized, and many tech stakeholders are wondering whether any significant policymaking will get done by the end of the year. While there is reason to be skeptical, there is a highly charged election about to take place, meaning it wouldn’t surprise us if a small step towards technology regulation was accomplished. The bigger question is what happens to tech policy at the start of 2021? 

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. 

Long Term Care Pharmacy (LTC) Legislation Introduced Aimed at Defining LTC Pharmacy

The Long-Term Care Pharmacy Definition Act of 2020 has been introduced by U.S. Senator Scott (R-SC) and co-sponsored by Senator Warner (D-VA). The bill has been introduced in the U.S. House of Representatives by Congressman Mullin (R-OK) and Congressman Schrader (D-OR). The bill seeks to establish a clear statutory definition of long term care pharmacy.

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the LTC, specialty and retail pharmacy space. If you are in industry stakeholder with questions about strategy or simply need advice, contact us today.