When a Growing Company Needs More Than a Handbook

As a company grows, employment issues rarely arrive one at a time. New hires may work across several states. Managers may handle discipline inconsistently. Employment agreements may not keep pace with changes in compensation, remote work, or responsibilities.

These problems are easier to address before they become disputes. A growing company should periodically review its employment agreements, workplace policies, classification practices, hiring processes, and approach to investigations and termination decisions.

The goal is not to create unnecessary bureaucracy. It is to give managers a clear framework, give employees consistent expectations, and help the company grow without allowing avoidable employment risks to become expensive distractions.

The PBM Business Model May Be Reaching a Policy Tipping Point

For years, most of the PBM debate focused on individual practices. Pharmacy reimbursement was one fight. Rebates were another. Then there was spread pricing, steering, pharmacy networks and transparency.

Those issues are all still being debated, but something has changed. We are starting to see pressure on several parts of the PBM business model at the same time.

Congress has already changed some of the federal rules around PBM compensation and transparency. States are going further. PBMs and health plans are challenging some of those state laws under ERISA, and the courts are beginning to tell us where the boundaries are.

That is why a new decision from the U.S. Court of Appeals for the Seventh Circuit matters.

On its own, the case is another important decision involving PBM regulation and ERISA. Put it next to what is happening in Illinois, Tennessee and Washington, and a bigger issue starts to come into view.

We may be moving beyond a debate over individual PBM practices and toward a larger fight over the economics of the PBM business model itself.

Rutledge Left the Door Open

The Supreme Court's 2020 decision in Rutledge v. Pharmaceutical Care Management Association gave states important room to regulate what PBMs pay pharmacies. The Court concluded that Arkansas's reimbursement law amounted to cost regulation and did not dictate how an ERISA plan had to structure its benefits.

That did not mean states could regulate PBMs however they wanted.

In Mulready v. Pharmaceutical Care Management Association, the Tenth Circuit found that ERISA preempted portions of an Oklahoma law affecting pharmacy network design. That gave PBMs a stronger argument when state regulation moves beyond price and begins affecting how an ERISA plan operates its pharmacy network.

Importantly, Mulready did not overrule Rutledge, nor could it. Rutledge remains the controlling Supreme Court precedent. Instead, Mulready helped define where courts may draw the line between state regulation of PBM costs and state laws that affect the structure or administration of an ERISA plan.

The fight since then has been over where that line should be drawn.

On August 26, the Seventh Circuit added another piece.

The court upheld an Arkansas rule allowing the state to require additional dispensing fees when pharmacy reimbursement is not considered fair and reasonable. A self-funded health and welfare plan argued that ERISA preempted the rule.

The court disagreed.

The dispensing fee, according to the court, was still cost regulation of the kind permitted under Rutledge. The fact that it could make prescription benefits more expensive did not mean Arkansas was dictating how the plan had to be structured.

The court also upheld an Arkansas reporting requirement tied to pharmacy compensation, although that part of the decision came with an important caveat.

Congress recently created new federal ERISA reporting requirements covering some of the same pharmacy compensation information Arkansas is collecting. Those federal requirements have not yet taken effect. The Seventh Circuit therefore did not decide whether the new federal rules will eventually preempt Arkansas's reporting requirement, expressly leaving that question for another day.

That detail is easy to overlook, but it says a lot about where PBM regulation is heading. Congress, the states and the courts are no longer operating on separate tracks. What Congress does can change the ERISA analysis courts apply to state laws, while those court decisions can determine how much room states have to continue regulating PBMs.

States Are Already Moving Further

Illinois is testing those boundaries now.

Its Prescription Drug Affordability Act addresses spread pricing, steering and transparency, among other PBM practices. PCMA has challenged portions of the law, arguing that Illinois has crossed the line when its requirements affect ERISA plans and their pharmacy networks.

Tennessee has gone further.

Its FAIR Rx Act does not simply regulate reimbursement or require more disclosure. It challenges vertical integration by restricting companies that own PBMs from also owning or operating pharmacies in the state.

That law is also being challenged.

This is where the PBM debate begins to look different. The largest PBMs today are part of much larger healthcare companies that can include insurance, pharmacy benefits, specialty pharmacy, retail pharmacy and healthcare services under the same corporate organization. Once policymakers begin questioning not only how PBMs operate, but whether some of those businesses should remain under common ownership, the debate moves beyond PBM compliance and into the structure and economics of the business itself.

Congress Is Applying Pressure From the Other Direction

Washington matters here too.

Congress has already enacted reforms affecting PBM compensation, rebates and transparency. Additional federal proposals would go further.

None of this dismantles the PBM model. States are not uniformly moving in the same direction either, and Mulready demonstrated that ERISA places real limits on state authority.

Still, look at the areas being challenged at the same time: reimbursement, spread pricing, rebates and compensation, transparency, steering, pharmacy networks and vertical ownership.

None of these changes on its own is likely to remake the PBM business model. The concern is what happens when several of them start happening at the same time.

PBMs are going to be regulated. That question has largely been settled. What matters now is whether all of this pressure begins to change the economics of the business itself.

Follow the Money

This is where the issue becomes relevant well beyond PBMs and pharmacies.

The economics of pharmacy benefits do not exist in a vacuum. Money moves among manufacturers, PBMs, health plans, employers, pharmacies and patients, and the large vertically integrated healthcare companies operating across several of those businesses have spent years building around that flow. If the rules governing that system change, the money does not simply disappear. It moves.

Higher pharmacy reimbursement could move more value toward pharmacies. Changes to rebates and PBM compensation could affect what employers and health plans retain and how they negotiate contracts. Restrictions on steering could change the economics of affiliated specialty and retail pharmacies, while restrictions on ownership could raise a much larger question about the value of vertical integration in the first place.

The point is not that all of these changes will happen, or that the PBM model is about to disappear. There are still major legal questions to be resolved. Mulready showed that ERISA places real limits on what states can do, and some of the more aggressive state laws may not survive.

What is changing is the nature of the risk. A reimbursement mandate or a new transparency requirement can be treated as another regulatory development. The calculation starts to look different when policymakers are changing reimbursement, compensation and transparency while also challenging network design, steering and even ownership.

At that point, the issue begins to look less like a collection of compliance problems and more like business model risk.

The Seventh Circuit did not decide where all of this ends. What it did confirm is that Rutledge continues to leave states with room to regulate PBM costs. Illinois and Tennessee are now testing how much further that authority can reach, while Congress is changing parts of the federal framework at the same time.

For PBMs, pharmacies, health plans and employers, the outcome will matter operationally. For executives and investors looking at the broader healthcare market, there is another question worth following: if policy changes where value is captured in the pharmacy benefit system, who captures it next?

That may ultimately be the bigger story.

FDA Extends Certain DSCSA Exemptions for Small Pharmacies: What the Additional Year Means

The Food and Drug Administration has given qualifying small pharmacies another year to implement certain enhanced drug distribution security requirements under the Drug Supply Chain Security Act.

On August 6, 2026, FDA announced that small dispensers, along with their trading partners where applicable, will receive exemptions from certain requirements through November 27, 2027. The prior exemption period was scheduled to end on November 27, 2026.

For independent and community pharmacies still working through technology, data exchange, staffing, and trading partner challenges, the additional year is meaningful. It is not, however, a suspension of DSCSA compliance.

The exemption applies only to specific enhanced drug distribution security requirements. Other DSCSA responsibilities remain in effect, and FDA is continuing to urge small dispensers to make progress toward full implementation.

Which Pharmacies Qualify?

For purposes of the new exemptions, FDA considers a dispenser to be a small dispenser if the company that owns the dispenser has 25 or fewer full time employees who are licensed pharmacists or qualified pharmacy technicians as of November 27, 2026.

This means the analysis is based on the company that owns the pharmacy, not necessarily the employee count at one individual pharmacy location. Organizations operating multiple locations should therefore examine their ownership structure and total number of qualifying employees before concluding that the exemption applies.

Qualifying small dispensers do not need to submit an application or notify FDA to use the exemption. A pharmacy should still document its eligibility internally and be prepared to explain the basis for relying on it.

What Has Been Extended?

The exemptions apply to certain enhanced security requirements involving interoperable, electronic, package level product tracing.

During the exemption period, qualifying small dispensers and, where applicable, their trading partners may continue using existing methods for certain activities that would otherwise require fully interoperable electronic systems. These include aspects of:

• Exchanging transaction information and transaction statements electronically

• Including package level product identifiers in transaction information

• Conducting product verification at the package level

• Responding to government requests for transaction information during recalls or investigations

• Gathering transaction information back through the supply chain

• Processing certain saleable returns

The exemption also covers specific product identifier verification requirements when a qualifying pharmacy investigates suspect or illegitimate products. It does not eliminate the pharmacy’s other investigation and verification responsibilities.

What the Exemption Does Not Cover

The extension should not be treated as a general waiver from DSCSA.

Pharmacies must still purchase prescription drugs from authorized trading partners. They must maintain applicable transaction records, identify and investigate suspect products, quarantine products when appropriate, and notify FDA and relevant trading partners when illegitimate products are discovered.

Pharmacies must also maintain policies and procedures that allow employees to recognize and respond to products that may be counterfeit, diverted, stolen, adulterated, or otherwise unfit for distribution.

The additional year changes the timeline for certain enhanced electronic requirements. It does not erase the underlying obligation to protect the integrity of the drug supply chain.

Why FDA Granted More Time

FDA granted the additional exemption while an independent assessment examines whether small dispensers can feasibly implement interoperable, electronic tracing at the package level.

That assessment will evaluate the technology and software available to small pharmacies, including whether existing systems are accessible, functional, and economically feasible. FDA is encouraging small dispensers to complete its assessment survey by September 22, 2026. A small dispenser may designate another organization, such as a consultant, to complete the survey on its behalf.

The survey gives independent pharmacies an opportunity to document the practical difficulties they encounter, including system costs, integration problems, staffing limitations, data quality issues, and dependencies on wholesalers or technology vendors.

How Pharmacies Should Use the Additional Year

The safest approach is to treat the extension as an implementation period, not a waiting period.

A pharmacy relying on the exemption should first document why it qualifies. That documentation should identify the ownership entity, the relevant employee count, and the methodology used to determine which employees are included.

The pharmacy should then evaluate its current DSCSA capabilities. This includes confirming whether it can receive and retrieve transaction information, identify its authorized trading partners, investigate suspect products, quarantine inventory, respond to information requests, and preserve the required records.

Pharmacies should also speak with their wholesalers, buying groups, and technology providers. A pharmacy may qualify for an exemption while one or more of its trading partners operate under different requirements. Understanding how each party will transmit, receive, store, and retrieve information can help prevent purchasing disruptions and inventory delays.

Written policies should reflect what the pharmacy is actually doing today. Employees responsible for purchasing, receiving, returns, inventory management, and product investigations should understand those procedures and know when a problem must be escalated.

Finally, pharmacies should keep records of their implementation efforts. Contracts, vendor communications, training records, system testing, written procedures, corrective actions, and internal assessments can help demonstrate that the pharmacy used the exemption period responsibly.

The Legal and Operational Risk Has Not Disappeared

DSCSA compliance is not solely a technology project. It involves vendor contracts, licensing, purchasing controls, record retention, employee training, product investigations, and relationships with trading partners.

A pharmacy that waits until the exemption is about to expire may discover that its software cannot communicate effectively with a wholesaler, its transaction data cannot be retrieved promptly, or its written policies no longer reflect its operations. Those problems can affect more than regulatory compliance. They can interrupt purchasing, delay returns, create audit exposure, and ultimately affect patient access.

FDA’s extension gives qualifying small pharmacies valuable time to address those risks. The best use of that time is to build a compliance program that is both operationally workable and legally defensible.

Lanton, Lanton & Sosa Law PLLC advises pharmacies, healthcare organizations, and other regulated businesses on compliance, contracting, audits, licensing, reimbursement, and operational risk. Organizations evaluating the DSCSA exemption should assess both their eligibility and the steps necessary to reach full compliance before the exemption ends.

This article is provided for general informational purposes and does not constitute legal advice.

How PBM Reform Is Changing the Employer Relationship

Greater disclosure is shifting leverage toward plan sponsors, but the real test is whether transparency produces better purchasing, access, and patient care.

The cost of healthcare is placing real pressure on employers, providers, and the patients they serve. Employers are paying for care on behalf of their workforces, providers see what happens when coverage rules interrupt treatment, and patients experience the system through premiums, out-of-pocket costs, delays, restricted networks, and difficult choices at the pharmacy counter.

That reality shaped a recent panel I moderated for Managed Healthcare Executive, The American Journal of Managed Care, Pharmacy Times, and the Pharmacy Benefit Management Institute. I was joined by Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health; Robyn Crosson, vice president of government relations at Navitus Health Solutions; and Kathy Oubre, CEO of Pontchartrain Cancer Center. Together, we examined how PBM reform is affecting payers, providers, employers, pharmacies, and patients.

The panel's message was clear: PBM reform cannot stop at more disclosure. It is changing who has leverage, what employers are expected to know, how service providers are evaluated, and whether the prescription-drug benefit is producing value for the people who pay for and depend on it.

Affordability is becoming a fiduciary responsibility

PBMs administer prescription-drug benefits by negotiating with manufacturers, managing formularies and pharmacy networks, processing claims, and negotiating pharmacy reimbursement. What has changed is the scrutiny surrounding how those functions are performed and how money moves through the system.

During the panel, Mitchell explained that self-insured employers bear the financial risk for their plans and spend their own money on behalf of their employees. That makes access to cost, compensation, and performance data essential to effective purchasing. Crosson described employers and their advisers as asking more detailed questions, demanding more frequent reporting, and testing whether rebates, spreads, and affiliated-pharmacy payments match what appears in standard procurement materials. Oubre brought the issue back to the patient: in community oncology, formulary placement, network restrictions, and steering can determine whether a patient receives an oral cancer therapy promptly, must ration it, or goes without it.

The Department of Labor's proposed PBM fee-disclosure rule reflects the same concern. It would require covered PBM service providers to give fiduciaries of employer-sponsored self-insured plans detailed information about direct and indirect compensation and to permit audits of that information. The proposal is not yet a final rule, but it reinforces the direction of federal policy: plan fiduciaries are expected to understand PBM economics, identify conflicts, and evaluate whether an arrangement and its compensation are reasonable.

Disclosure changes the question for employers

The panel repeatedly returned to the changing relationship between employers and PBMs. Greater access to information can move an employer from accepting a vendor's spreadsheet to selecting and monitoring a genuine partner. It also gives benefits teams a stronger basis for negotiating contract terms instead of simply accepting language drafted by the PBM.

That opportunity comes with responsibility. Employers have long had fiduciary obligations under ERISA, but expanding disclosures and rising litigation have made those obligations harder to treat as someone else's problem. An employer cannot assume that reliance on a consultant, broker, or PBM ends the inquiry. The plan sponsor still needs to understand the recommendation, identify the compensation and relationships behind it, and document why the final arrangement serves the plan.

Consultants and advisers therefore belong inside the transparency discussion. Mitchell noted that employers often depend heavily on outside expertise because purchasing healthcare is not their core business. The concern is not that every adviser is conflicted. It is that undisclosed compensation or placement arrangements can shape which PBMs reach an employer's request-for-proposals process. Better disclosure should help employers determine whether the advice they receive is neutral and whether credible alternatives were excluded before the competition began.

The legal question is moving from "What did the PBM disclose?" to "What did the fiduciary do with the disclosure?"

Transparency will not eliminate attempts to preserve revenue

The panel did not assume that new requirements would automatically end the practices under scrutiny. Oubre warned that when a particular fee or practice is regulated, compensation may reappear under a new administrative, technology, or clinical-management label. Mitchell raised a related concern: revenue can shift among affiliates or other entities, and indirect compensation may remain difficult to see unless regulatory definitions and employer contracts are broad enough to follow the money. Crosson noted that newer laws are attempting to capture more categories, but plan sponsors still need to ask persistent questions.

This has competitive consequences. Smaller, pass-through, or less vertically integrated PBMs may gain an opening as employers look for alternatives to the dominant model. At the same time, those companies can face proportionally heavier compliance costs when federal and state reporting requirements differ. Reform can level the competitive field only if it exposes financial incentives without creating duplicative obligations that smaller competitors cannot absorb.

For employers, the practical lesson is straightforward: do not evaluate a PBM solely through a rebate guarantee or a bottom-line number in a bid spreadsheet. Review the definitions, affiliated entities, payment flows, audit rights, formulary incentives, network design, and the consultant's compensation together.

The patient impact appears through access, steering, and pharmacy survival

A narrow review of plan spending can miss what happens elsewhere. A formulary decision can affect the employer's cost, the employee's out-of-pocket obligation, the provider's ability to prescribe an appropriate therapy, and the pharmacy's ability to dispense it. Reported savings in one part of the system can reappear as treatment delays, administrative burdens, medication deserts, or higher costs for patients.

Oubre described oncology practices encountering more aggressive steering toward PBM-affiliated specialty pharmacies, sometimes creating confusion over whether a patient actually requested a prescription transfer. She emphasized that these are not merely business disputes. In cancer care, prior-authorization delays, denials, network restrictions, and interruptions in access can directly affect treatment. Crosson and Mitchell likewise stressed the downstream harm to independent pharmacies and the communities that depend on them.

The panel viewed direct-to-consumer cash-pay platforms as potentially useful but incomplete. They may improve access to certain common drugs and allow patients to bypass parts of the traditional system. They may also confuse patients about whether spending counts toward insurance benefits, fragment information about the medicines a patient is taking, and do relatively little for expensive specialty biologics and oncology therapies. DTC access can complement PBM reform; it does not replace it.

Biosimilars illustrate the value of pairing purchasing strategy with patient communication. The panel agreed that reforms should improve the opportunity for biosimilars, but formulary access alone is not enough. Crosson described a large biosimilar transition in which advance outreach encouraged patients to speak with their physicians and produced broad acceptance. The lesson is that patients should be participants in benefit changes, not the last people to learn about them.

The PBM of the future will have to prove its value

When I asked how the PBM's role might change, the panel described a return to the function PBMs were originally expected to perform. Oubre envisioned a model that looks less like an opaque, vertically integrated profit center and more like a transparent claims administrator whose compensation is disclosed, auditable, and less dependent on drug prices. Mitchell described the need for an administrative partner that negotiates fair prices and passes value back to employers and patients. Crosson argued that PBMs will increasingly have to distinguish themselves through clinical performance, better outcomes, and visible alignment with the plan sponsor.

That future is not guaranteed. The market remains highly concentrated, entrenched financial arrangements will not disappear voluntarily, and independent pharmacies are already under significant strain. Still, the panel agreed that reform has not necessarily arrived too late. Employers are more active, policymakers are paying closer attention, new competitors are entering the market, and patients and providers are demanding a system that works better.

Employers do not need to wait for every rule or lawsuit to be resolved before strengthening their own process. They can identify who is responsible for plan oversight, review PBM and consulting contracts together, test whether disclosures are complete and usable, verify audit rights, examine affiliated arrangements, and evaluate compensation, formulary performance, patient cost sharing, utilization management, pharmacy access, complaints, and outcomes as parts of one system.

Healthcare affordability will not be solved by disclosure alone. The opportunity is to turn information into oversight, oversight into better purchasing, and better purchasing into lower costs and more reliable access for the people the health plan is supposed to serve.

Sources and further reading

• Managed Healthcare Executive webinar, A Look at PBM Reform and Transparency: Payer, Provider and Patient Impact (August 11, 2026)

• U.S. Department of Labor, Proposed Pharmacy Benefit Manager Fee Disclosure Rule (fact sheet)

• U.S. Department of Labor, Understanding Your Fiduciary Responsibilities Under a Group Health Plan

• Federal Trade Commission, Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies (July 2024)

• Federal Trade Commission, Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers (January 2025)

Ron Lanton Discusses Antitrust Risk in a Potential AstraZeneca and Bristol Myers Squibb Merger

Pharmaceutical Executive recently spoke with Ron Lanton, Senior Partner and Global Strategist at Lanton, Lanton & Sosa Law PLLC, about the legal issues that would arise if AstraZeneca and Bristol Myers Squibb pursued a merger.

Although the reported discussions remain unconfirmed, a transaction involving two pharmaceutical companies of this size provides an important illustration of how regulators evaluate consolidation in the life sciences industry.

Lanton explained that the Federal Trade Commission would look beyond the overall size of the companies and focus on where their marketed drugs and pipeline products compete. Potential areas of concern could include oncology treatments, cell therapies, antibody drug conjugates, and research programs that may become future competitors.

The review could also require the companies to sell a major drug franchise or pipeline program to preserve competition. If the overlapping assets are too interconnected, the divestitures needed to secure approval could undermine the strategic purpose of the transaction itself.

The conversation also addressed the different regulatory hurdles posed by the Federal Trade Commission, the European Commission, and the United Kingdom’s Competition and Markets Authority, as well as the companies’ obligations to disclose credible merger discussions or respond to market rumors.

Read the full conversation in Pharmaceutical Executive seen here.

FDA Peptide Advisory Votes Could Reshape Telehealth and Compounding—But They Are Not Yet a Green Light

The debate over wellness peptides is moving out of the online “grey market” and into the formal FDA regulatory process.

On July 23, 2026, the FDA’s Pharmacy Compounding Advisory Committee recommended placing BPC-157, KPV, TB-500, and MOTS-C on the list of bulk drug substances that may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The committee reviewed both the free-base and acetate forms of the substances. It is scheduled to consider emideltide, epitalon, and Semax on July 24. 

The votes could eventually create a significant opportunity for telehealth platforms, medical practices, and compounding pharmacies interested in longevity, recovery, metabolic health, and other emerging wellness services.

They do not, however, make the peptides FDA-approved. They also do not immediately authorize pharmacies or telehealth companies to begin prescribing, compounding, marketing, or shipping them nationwide.

Why the 503A Bulks List Matters

Section 503A provides a pathway through which a state-licensed pharmacy or licensed physician may compound a medication for an identified individual patient.

When a pharmacy compounds from a bulk drug substance, that substance generally must satisfy one of three conditions: it must comply with an applicable United States Pharmacopeia or National Formulary monograph, be a component of an FDA-approved drug, or appear on FDA’s 503A Bulks List. The substance must also come from an appropriately registered establishment and be accompanied by a valid certificate of analysis. 

Placement on the Bulks List could therefore remove an important federal barrier to lawful compounding of certain peptides.

That is different from FDA drug approval. Compounded drugs do not go through the same premarket review as approved drugs, and FDA does not independently verify their safety, effectiveness, or quality before they are dispensed. 

A favorable committee recommendation is also only one step in the process. FDA must consider the committee’s advice, complete its review, and determine how it will address the substances through regulation or enforcement policy. FDA’s own briefing materials emphasize that the agency will not make a final determination until the advisory process and its reviews are complete. 

The Committee and FDA Staff Reached Different Conclusions

The votes are particularly significant because FDA staff recommended against adding the peptides considered on July 23 to the Bulks List.

FDA has identified concerns involving limited human safety information, potential immunogenicity, peptide-related impurities, and the difficulty of characterizing certain active pharmaceutical ingredients. Its existing safety materials state, for example, that it lacks sufficient information to determine whether BPC-157, KPV, MOTS-C, and TB-500 could cause harm when administered to humans through the proposed routes. 

Supporters offered a different policy argument. Consumers are already purchasing peptides through overseas vendors and online sellers that label their products for research use. Allowing licensed prescribers and regulated pharmacies to serve this market, they argue, could move patients toward products with greater professional oversight, sourcing controls, testing, documentation, and traceability.

That argument may have persuaded the committee. It does not eliminate the underlying questions surrounding evidence, dosing, manufacturing quality, informed consent, adverse-event reporting, and promotional claims.

Why Telehealth Companies Are Paying Attention

Telehealth companies have already been investing in the infrastructure needed to enter the peptide and longevity markets.

Hims & Hers acquired a California-based peptide facility in 2025, describing the transaction as part of its strategy to strengthen its domestic supply chain for personalized medications. Noom announced in April 2026 that it had acquired Tailor Made Compounding, a Section 503A pharmacy operating across numerous states, as it expanded into healthy-aging and peptide-related services. 

A favorable FDA decision could make those investments more commercially valuable. It could also encourage other telehealth platforms, physician groups, pharmacies, and investors to enter the market.

Vertical integration does not simplify the legal analysis, however. It can make the analysis more complicated.

A platform that owns or contracts with a medical practice, pharmacy, laboratory, marketing company, and technology provider must determine which entity is making clinical decisions, prescribing the medication, compounding it, dispensing it, communicating with the patient, collecting payment, maintaining records, and responding to safety concerns.

Each part of that arrangement can be governed by a different set of federal and state requirements.

Inclusion Would Not Permit Unrestricted Peptide Sales

Even after a substance is added to the 503A Bulks List, a pharmacy must continue to satisfy the other conditions of Section 503A.

Compounding generally must occur pursuant to a valid prescription for an identified individual patient, although limited anticipatory compounding may be permitted based on an established prescribing history. Section 503A is not intended to allow a pharmacy to operate as a conventional manufacturer or distribute standardized products without patient-specific prescriptions. 

Companies must also consider:

• State pharmacy and prescriber licensing requirements

• Telehealth prescribing and patient-evaluation standards

• Corporate-practice-of-medicine restrictions

• Pharmacy ownership and management rules

• Interstate dispensing and distribution limitations

• Supplier qualification and certificate-of-analysis requirements

• Sterility, potency, quality-control, and recordkeeping obligations

• Patient disclosures and informed-consent procedures

• Advertising and social-media claims

• Adverse-event collection and regulatory reporting

• Contracts among the platform, medical group, pharmacy, laboratory, and suppliers

The promotional issue may be especially important. A business should not describe a compounded peptide as “FDA-approved” simply because its underlying bulk substance appears on the 503A Bulks List. Claims concerning healing, recovery, weight loss, anti-aging, cognitive performance, or disease treatment must also be evaluated in light of the available evidence and applicable FDA, Federal Trade Commission, medical-board, and consumer-protection requirements.

How Lanton, Lanton & Sosa Law Can Help

Lanton, Lanton & Sosa Law assists telehealth platforms, compounding pharmacies, physicians, healthcare entrepreneurs, and investors with the legal and regulatory questions involved in developing or expanding peptide-related services.

Our attorneys can evaluate whether a proposed product and dispensing model fits within Section 503A or another regulatory pathway, review state pharmacy and medical-practice requirements, and assess corporate and contractual relationships among the telehealth platform, prescribers, pharmacies, laboratories, suppliers, and management entities.

We can also assist with pharmacy and professional licensing strategy, telehealth policies, patient disclosures, marketing review, quality and supplier agreements, adverse-event procedures, acquisition due diligence, medical- and pharmacy-board inquiries, and responses to FDA or state enforcement activity.

The peptide market may be moving toward a more regulated pathway. A single advisory committee vote does not complete that transition. Companies considering entering the market should understand how the federal compounding rules interact with state licensing, clinical practice, pharmacy operations, contracting, advertising, and patient safety before launching or expanding a program.

This article reflects developments available as of the morning of July 24, 2026. The PCAC meeting and FDA review process remain ongoing.

Responding to a Medical Board Inquiry: What Physicians Should Know

Receiving a letter, records request, interview notice, or other communication from a state medical board can be stressful. Physicians may be unsure what the board is reviewing, how much information to provide, or whether the matter could affect their license.

A board inquiry does not necessarily mean that a physician violated the law or professional standards. Complaints may arise from patient concerns, documentation issues, prescribing questions, employment disputes, or other matters that require further review.

Even so, physicians should not treat the communication as routine correspondence. The initial response should be handled carefully.

Understand What the Board Is Requesting

Medical board communications can take several forms. A physician may be asked to provide patient records, explain a clinical decision, complete a questionnaire, participate in an interview, or respond to a formal complaint.

Before responding, the physician should identify what issue the board appears to be reviewing, which records or information are being requested, and the deadline for responding. The physician should also consider whether the matter overlaps with an employment, malpractice, prescribing, billing, or credentialing issue.

A request that appears simple may still raise legal and professional questions. Understanding the scope of the inquiry at the beginning can help prevent confusion later.

Review the Records Before Responding

Physicians are accustomed to explaining their clinical decisions. When a board asks questions, the natural reaction may be to provide an immediate explanation.

It is generally better to review the relevant records and surrounding facts first.

The response should be consistent with the medical record, supported by available documentation, and focused on the board’s actual request. Physicians should also avoid altering, reconstructing, or supplementing records after learning of an inquiry without first obtaining legal guidance.

A careful review may identify important context, including follow-up care, communications with the patient, consultations with other practitioners, or practice policies that informed the physician’s decision-making.

Avoid Overexplaining

Providing more information is not always better.

An overly broad response may raise issues beyond the board’s original inquiry. An incomplete response, however, may fail to address the board’s concerns.

The goal is to provide a clear, accurate, and appropriately focused response. Legal counsel can help determine what information is responsive, what context is necessary, and how the physician’s position should be presented.

Consider Related Professional Issues

Not every medical board inquiry leads to discipline. Still, a licensing matter may affect other areas of a physician’s professional life.

Depending on the circumstances, the physician may need to consider hospital privileges, employment obligations, credentialing, payer participation, professional liability coverage, prescribing authority, or licenses held in other states.

These issues do not arise in every case, but identifying them early can help the physician make informed decisions and avoid separate reporting or contractual problems.

How Lanton, Lanton & Sosa Can Help

Physicians should consider obtaining legal advice soon after receiving a complaint, records request, interview notice, subpoena, or other communication from a state medical board.

Lanton, Lanton & Sosa Law assists physicians and other licensed healthcare professionals with medical board inquiries and related regulatory matters. Our attorneys can review the board’s communication, evaluate the relevant records and facts, identify applicable deadlines and obligations, and help prepare a clear and appropriately focused response.

We can also help physicians prepare for interviews, evaluate next steps if the matter develops further, and consider whether the inquiry may affect employment, credentialing, prescribing, telehealth activities, or other professional interests.

Early legal review can help clarify the board’s request, preserve relevant information, identify potential concerns, and reduce the risk of an incomplete or poorly framed response. The goal is not to make the process unnecessarily adversarial. It is to help the physician understand the inquiry and respond carefully, professionally, and with the broader implications in mind.

If you have received a communication from a state medical board, Lanton, Lanton & Sosa Law can help you understand the process and determine an appropriate response.

This article is provided for general informational purposes and does not constitute legal advice. Medical licensing laws, board procedures, and attorney-admission requirements vary by jurisdiction. Representation is subject to conflicts review and applicable professional-responsibility requirements.

Tennessee’s PBM Law Signals a Broader Challenge to Healthcare Vertical Integration

For years, vertical integration was treated as the natural direction of the U.S. healthcare market.

Insurers acquired pharmacy benefit managers. PBMs acquired or affiliated with specialty, mail-order, and retail pharmacies. Health systems expanded into physician practices, outpatient facilities, pharmacies, technology platforms, and other services.

The business case was familiar: common ownership could reduce fragmentation, improve coordination, create efficiencies, and lower costs. That argument is now receiving much greater scrutiny.

Tennessee’s recently enacted Freedom, Access, and Integrity in Registered Pharmacy Act, commonly called the FAIR Rx Act, is one of the clearest examples. Rather than limiting itself to PBM transparency, reimbursement practices, or patient-steering rules, Tennessee is challenging whether pharmacy benefit managers and health insurers should be permitted to own or control pharmacies at all.

The larger message for healthcare companies is not that vertical integration is that integrated ownership structures can no longer be seen as inherently efficient or politically secure.

When a business model depends on directing prescriptions, referrals, reimbursement, data, or revenue toward affiliated entities, ownership itself can become a regulatory risk.

What Tennessee Changed

Governor Bill Lee signed the FAIR Rx Act on May 22, 2026. The law restricts certain common ownership and control relationships involving pharmacies, PBMs, and health insurance issuers. Subject to limited exceptions and transition provisions, affected organizations must separate prohibited ownership interests by July 1, 2028.

The law reaches pharmacies licensed in Tennessee as well as nonresident pharmacies dispensing or shipping prescriptions to Tennessee residents. This can include mail-order, specialty, central-fill, telepharmacy, and automated dispensing operations.

It also requires disclosures involving direct and indirect ownership, affiliates, contractors, and other arrangements that may provide a PBM with influence over pharmacy operations.

That makes Tennessee’s approach different from many traditional PBM laws.

Most PBM legislation regulates conduct. It may prohibit patient steering, require rebate disclosure, establish reimbursement standards, or impose reporting and fiduciary obligations.

Tennessee is taking a different approach. The law reflects a judgment that certain conflicts may be too embedded in the ownership model to be corrected through disclosure or contract regulation alone.

CVS Health and Cigna’s Express Scripts have challenged the law in federal court. They argue that the restrictions could interfere with pharmacy access and improperly target integrated companies. Tennessee lawmakers have defended the measure as a response to concerns about competition, drug costs, and the ability of PBMs to direct prescriptions toward affiliated pharmacies.

The litigation will determine how far Tennessee can go. The strategic significance of the law, however, is already clear.

State policymakers are becoming more willing to examine whether the structure of a healthcare company creates incentives that cannot be adequately controlled through ordinary compliance requirements.

Why Vertical Integration Is Under Pressure

Tennessee’s law did not just happen overnight. 

The three largest PBMs manage most prescription drug claims in the United States. Each operates within a larger healthcare organization that owns or affiliates with other parts of the healthcare financing, pharmacy, provider, or distribution system.

That concentration has caused regulators and lawmakers to focus less on size by itself and more on how integrated companies use contracting authority, reimbursement decisions, network design, patient data, and ownership relationships.

Federal Trade Commission staff have reported that large PBMs sometimes reimbursed affiliated pharmacies more than unaffiliated pharmacies for certain specialty generic drugs. The FTC also raised concerns that PBM-affiliated pharmacies may benefit from prescription steering and other advantages unavailable to independent competitors.

Congress has pursued PBM transparency and compensation reforms involving rebates, reporting, and the relationship between PBM compensation and drug prices. Federal proposals have also considered restrictions on common ownership involving PBMs, insurers, and pharmacies.

States too are developing their own approaches to this problem. Arkansas enacted a law directed at PBM ownership of pharmacies, while California has pursued restrictions involving steering, formulary practices, and affiliated pharmacies. Several of these measures are now being litigated.

These developments do not establish that all vertical integration is unlawful or undesirable. They simply show that the burden of persuasion is changing.

With times changing they way they are, an integrated company may no longer be able to defend its structure simply by citing efficiency. Policymakers, regulators, customers, and courts are examining whether the company directs business toward its own affiliates, treats affiliated and independent organizations differently, restricts customer choice, or retains value in ways that are difficult for plan sponsors and patients to evaluate.

It's less about whether entities share common ownership and more about how that ownership affects commercial behavior.

How Independent Companies Can Use the Shift

Regulatory pressure on vertical integration creates opportunities for independent healthcare companies.

Independent pharmacies, specialty pharmacies, physician groups, technology vendors, and healthcare service organizations can position their lack of ownership conflicts as a commercial advantage.

Their strongest message is that an independent organization can offer clearer economics, broader choice, greater flexibility, and fewer incentives to favor an affiliated channel.

An independent pharmacy may be able to show that its dispensing and clinical decisions are not influenced by a parent PBM. A technology company may emphasize that its platform supports multiple payers, pharmacies, and providers without favoring a related business. A physician group may use its independence to negotiate across several networks instead of relying on one vertically integrated partner.

As customers become more sensitive to steering and self-preferencing, independence can become part of the company’s value proposition.

That advantage should be supported by contracts, operating practices, and evidence. 

What Buyers and Investors Should Reevaluate

Healthcare buyers and investors should reconsider how they evaluate vertically integrated growth strategies.

A transaction involving a pharmacy, provider group, health platform, or distribution business may appear attractive because of projected referrals, cross-selling opportunities, preferred network access, or administrative synergies.

Those assumptions may be vulnerable if the expected value depends on steering, reimbursement advantages, exclusive contracting, or preferential treatment among affiliates.

Due diligence should examine whether the target’s revenue depends heavily on an affiliated payer, PBM, provider, pharmacy, distributor, or management company. Buyers should also determine whether key contracts would remain economically viable if anti-steering rules, ownership restrictions, equal-treatment requirements, or stronger disclosure obligations were imposed.

Ownership and management agreements should accurately reflect who exercises operational control. Affiliate arrangements should be evaluated for fair-market terms, conflict-management procedures, and regulatory exposure.

The most important question for investors is whether the economics of the transaction remain defensible under the regulatory environment that may exist several years from now.

A business model that depends on regulatory tolerance for affiliate preference may warrant a lower valuation, stronger contractual protections, or a different transaction structure.

What Integrated Companies Should Do Now

Existing integrated companies should not assume that divestiture is inevitable.

They should assume that greater justification will be required.

Executive teams need a clear explanation of how the integrated structure benefits patients, customers, employers, and the healthcare system. That explanation should be supported by data and operating evidence rather than corporate messaging alone.

Companies should review whether affiliated and unaffiliated organizations receive comparable access and treatment. They should examine whether customers have meaningful choices, how reimbursement methodologies are established, and whether contracts could be viewed as coercive or exclusionary.

Boards should understand where earnings are generated across related entities. A business line that appears modest on a standalone basis may direct substantial volume or margin to another affiliate. Regulators may focus on that relationship even when each individual agreement appears commercially reasonable.

Governance practices should reflect this risk. Contracts and transactions among affiliates may require stronger documentation, independent review, conflict-management procedures, and clearer evidence of commercial reasonableness.

Companies that can establish a defensible record now will be in a stronger position when facing legislative scrutiny, contract renegotiation, litigation, or regulatory review.

The Executive Decision

The Tennessee FAIR Rx Act reflects a broader shift in how policymakers evaluate healthcare consolidation.

Attention is moving from the existence of common ownership to the ways integrated companies control patient flow, reimbursement, distribution, information, and market access.

Executive teams should map their ownership, referral, reimbursement, data, and contracting relationships. They should identify where one affiliate has the ability to influence business flowing to another and determine whether that relationship could be characterized as steering, self-preferencing, discriminatory treatment, or hidden compensation.

They should also be able to show measurable value for patients or customers and demonstrate that the business model would remain viable if affiliates and independent companies were required to compete on more equal terms.

Organizations that cannot support those conclusions may have a structural vulnerability.

Organizations that can may have a meaningful competitive advantage.

The Larger Business Lesson

Tennessee’s law may survive, be narrowed, or be struck down. Its importance does not depend entirely on the result of the current litigation.

The law reflects a broader change in the political and regulatory treatment of healthcare consolidation. Vertical integration is no longer automatically viewed as an efficient response to a fragmented system. It is increasingly evaluated through the conflicts, incentives, and commercial power that ownership may create.

That shift will affect acquisitions, joint ventures, management arrangements, preferred networks, affiliate contracts, and market-entry strategies across healthcare.

The companies that respond most effectively will examine their structures now, determine where regulation could change the economics of the business, and use that analysis to make better decisions about transactions, contracts, governance, and growth.

Lanton, Lanton & Sosa Law advises healthcare and regulated organizations on transactions, contracting structures, regulatory change, compliance, governance, and commercial strategy. In a market where ownership structures are becoming policy questions, legal analysis must extend beyond what is permitted today to how a business model may be evaluated tomorrow.

Boston's Life Sciences Real Estate Market Has Changed: What Property Owners Should Do Next

Boston's life sciences market has long been one of the strongest commercial real estate sectors in the country. For years, biotechnology companies, pharmaceutical manufacturers, research institutions, and investors fueled an unprecedented demand for laboratory and research facilities throughout Greater Boston and Cambridge.

Today, however, the market looks very different.

Higher interest rates, slowing venture capital investment, and the delivery of millions of square feet of new laboratory space have created increased vacancy rates and new financial pressures for property owners and developers. While these market conditions present challenges, they also create opportunities for owners who make informed legal and business decisions.

Whether you own a laboratory building, are developing a life sciences project, or are evaluating an acquisition, understanding the legal implications of today's market is essential.

Why Has the Market Changed?

For nearly a decade, Boston's life sciences industry experienced remarkable growth. Developers responded by constructing new laboratory and research facilities to meet increasing demand.

As market conditions shifted, however, several factors converged:

• Venture capital funding slowed.

• Interest rates increased.

• Some biotechnology companies delayed expansion plans.

• Demand for laboratory space softened.

• New construction continued entering the market.

The result has been increased vacancy in several life sciences submarkets and greater competition among landlords for qualified tenants.

Although demand for life sciences space has moderated, Boston remains one of the world's leading biotechnology markets. The current environment requires a more strategic approach to ownership, leasing, financing, and development.

What Does This Mean for Property Owners?

Owners are facing decisions that would have been unlikely only a few years ago.

Common questions include:

• Should existing laboratory space be repositioned?

• Is it time to renegotiate leases?

• Should construction projects continue as planned?

• Are financing terms still sustainable?

• Does it make sense to sell or recapitalize assets?

• Can a property be converted to another use?

Each decision carries legal, financial, and operational consequences that should be evaluated together rather than independently.

Evaluating Existing Leases

Commercial leases often become the first area requiring attention during changing market conditions.

Owners may experience:

• Requests for rent concessions.

• Tenant downsizing.

• Expansion delays.

• Early termination requests.

• Sublease proposals.

• Assignment requests.

Rather than viewing these requests solely as disputes, landlords may benefit from evaluating whether negotiated solutions better protect the long-term value of the property.

Lease amendments, rent restructuring, revised tenant improvement obligations, and carefully drafted extensions can preserve occupancy while reducing litigation risk.

Every proposed modification should be reviewed carefully to ensure it aligns with the owner's broader investment strategy.

Is Adaptive Reuse the Right Strategy?

One of the most significant trends emerging from today's market is adaptive reuse.

Some owners are evaluating whether highly specialized laboratory properties should be converted into alternative uses, including:

• Traditional office space.

• Medical office buildings.

• Residential developments.

• Mixed-use projects.

• Flex industrial facilities.

These projects often require extensive legal planning before any physical work begins.

Owners should carefully evaluate:

• Local zoning requirements.

• Municipal permitting.

• Existing lease obligations.

• Environmental regulations.

• Building code compliance.

• Financing restrictions.

• Title and easement issues.

Early legal planning can help identify obstacles before significant resources are committed to redevelopment.

Construction Projects May Require Reassessment

Projects initiated during stronger market conditions may now face different economic realities.

Developers should review:

• Construction contracts.

• Financing agreements.

• Completion deadlines.

• Contractor obligations.

• Change order procedures.

• Delay provisions.

• Insurance requirements.

Revisiting these agreements early may provide opportunities to reduce risk, negotiate modifications, or preserve flexibility as market conditions continue to evolve.

Financing Should Not Be Overlooked

Commercial financing deserves close attention in today's environment.

As loans mature, owners may encounter:

• Higher refinancing costs.

• Lower property valuations.

• Increased lender scrutiny.

• Reduced loan proceeds.

Waiting until a loan default occurs often limits available options.

Property owners should consider discussing potential restructuring strategies with legal counsel before financial challenges become more difficult to resolve.

New Opportunities for Investors

Periods of market adjustment frequently create attractive acquisition opportunities.

Investors evaluating distressed or underperforming assets should conduct comprehensive legal due diligence before closing.

Important areas of review include:

• Existing leases.

• Environmental reports.

• Title matters.

• Pending litigation.

• Municipal compliance.

• Development approvals.

• Financing obligations.

• Construction contracts.

Proper due diligence helps investors understand both the opportunities and the risks associated with complex commercial acquisitions.

Why Experienced Legal Counsel Matters

Commercial real estate transactions rarely involve a single legal issue.

A lease amendment may affect financing.

A financing modification may influence redevelopment plans.

A zoning issue may delay construction.

A construction dispute may impact investor relationships.

Understanding how these issues interact allows owners and investors to make more informed business decisions while reducing unnecessary legal exposure.

Experienced counsel can help coordinate these moving parts, negotiate practical solutions, and position projects for long-term success.

Looking Ahead

Boston's life sciences sector remains one of the country's most innovative and resilient industries. Although the market is experiencing a period of adjustment, organizations that proactively evaluate their legal and business strategies will often be better positioned to capitalize on future opportunities.

Whether the next step involves renegotiating leases, restructuring financing, acquiring distressed assets, or exploring redevelopment options, early planning can significantly reduce risk and preserve long-term value.

How Lanton Law Assists Commercial Real Estate Clients

Lanton Law represents commercial property owners, developers, investors, landlords, tenants, healthcare organizations, and businesses throughout Massachusetts in a wide range of commercial real estate matters.

Our attorneys regularly advise clients on:

• Commercial leasing and lease negotiations.

• Property acquisitions and dispositions.

• Purchase and Sale Agreements.

• Due diligence investigations.

• Commercial financing transactions.

• Construction and development contracts.

• Land use and zoning matters.

• Joint ventures and business structuring.

• Commercial real estate disputes.

Every commercial real estate matter presents unique legal and business considerations. We work closely with our clients to identify practical solutions that protect their investments while supporting their long-term business objectives.

If you own, lease, develop, or invest in commercial real estate in Massachusetts, our team is available to discuss your project and help you navigate today's evolving market with confidence.

New York State Bar Association (NYSBA) Journal Publishes Ron Lanton III Article on Global Healthcare Reform and Life Sciences Strategy

Lanton, Lanton & Sosa Law PLLC is pleased to share that Ron Lanton III’s article, “The Global Healthcare Divorce: How US and EU Reforms Are Reshaping the Structure of Life Sciences Companies,” was published in the Summer 2026 issue of the New York State Bar Association Journal.

The article examines how healthcare reform in the United States and European Union is beginning to affect more than compliance. These changes are also shaping life sciences strategy, company structure, market access, exclusivity, reimbursement planning, and capital decisions.

For healthcare and life sciences companies, the larger takeaway is that regulatory change is becoming a business planning issue. Companies operating across markets need to understand how policy developments may affect contracts, commercialization strategy, investor expectations, and long-term growth.

At Lanton, Lanton & Sosa Law PLLC, we work with healthcare organizations, life sciences companies, pharmacies, physician groups, and health-adjacent businesses on the legal, regulatory, and strategic issues that affect growth in highly regulated markets.

The article begins on page 51 of the Summer 2026 NYSBA Journal seen at https://nysba.org/wp-content/uploads/2026/06/jrnl_summer2026-6-23-26-FINAL-WEB.pdf

PBM Reform After Rutledge: Why ERISA Still Matters

In 2020, the U.S. Supreme Court gave states a major victory in the fight over PBM regulation.

In Rutledge v. Pharmaceutical Care Management Association, the Court upheld an Arkansas law that regulated pharmacy reimbursement. For pharmacies, state policymakers, and patient-access advocates, that decision mattered. It confirmed that state PBM laws are not automatically preempted by ERISA simply because they affect prescription drug benefits.

That was a big moment but apparently it was not the end of the ERISA fight.

After Rutledge, many people understandably viewed the Supreme Court’s decision as a turning point for state PBM reform. States had been trying to respond to reimbursement pressure and pharmacy deserts by regulating PBMs, but many states were hesitant on how far they could go with PBMs threatening to sue under ERISA. Rutledge gave states more confidence to keep going.

However; the PBM industry did not stop litigating and their arguments in favor of ERISA evolved.

Before Rutledge, the broader argument was that many state PBM laws were preempted because they touched employer-sponsored health plans. After Rutledge, that argument became harder to make in its broadest form. The Supreme Court had already said that states could regulate certain PBM reimbursement practices without automatically interfering with ERISA plan administration. So the next phase for PBMs became more targeted.

In PCMA v. Mulready, the Tenth Circuit reviewed Oklahoma’s Patient’s Right to Pharmacy Choice Act. The court held that several parts of the law were preempted by ERISA. Oklahoma later asked the U.S. Supreme Court to review the case, but the Court declined to take it. This is important because Mulready is not a U.S. Supreme Court decision. It did not overrule Rutledge and it did not say states are powerless to regulate PBMs. What it did do was give PCMA a post-Rutledge roadmap.

The lesson from Oklahoma is that courts may treat reimbursement regulation differently from laws that reach deeper into network design or plan administration. A state law focused on what pharmacies are paid may be viewed differently from a law that affects which pharmacies must be included in a network, how preferred pharmacy arrangements are structured, or how an ERISA plan administers its pharmacy benefit.

That distinction is becoming central to the next phase of PBM litigation. This also comes at a very different moment politically.

Congress passed PBM reform this year. That was a watershed moment. For years, PBM reform was largely a state-level issue. State legislatures were often the ones responding to community pharmacy concerns, patient-access issues, and questions about transparency. Now Congress has entered the conversation in a meaningful way.

The 2026 federal PBM reforms may not solve every issue in the market, and they do not replace the need for state action. They still matter because they show that PBM oversight has moved from a statehouse issue into the national healthcare-policy conversation.That changes the environment around these lawsuits.

PBM reform is no longer a fringe debate. It has become a bipartisan healthcare issue. Once Congress acts, it becomes harder to argue that PBM oversight is unusual or unnecessary. This may be one reason ERISA litigation becomes even more important to the PBM industry.

If the political momentum is moving toward more PBM oversight, then the legal fight becomes about where the boundaries are drawn. PCMA does not need to defeat every PBM law to change the practical effect of reform. It can try to narrow the parts of state laws that reach network access, preferred pharmacy structures, anti-steering rules, or plan administration.

That is why the recent lawsuits challenging state PBM laws in Illinois and Tennessee are worth watching.

According to PLANSPONSOR, PCMA has again turned to ERISA preemption arguments in challenging those state laws. The details of those laws are not the focus of this article. The larger point is that PCMA is continuing to use ERISA preemption as a central litigation tool even after Rutledge. This is the post-Rutledge strategy in action.

The argument is not that states cannot regulate PBMs. The argument is that some state laws cross the line from regulating PBM conduct into regulating the design and administration of ERISA plans.

For pharmacies, pharmacy associations, and policymakers, the takeaway is practical. Passing a PBM reform law is only the first step. The next fight is often in federal court. That means the drafting matters.

A state PBM law should be clear about what it is regulating and why. If the goal is reimbursement fairness, patient access, transparency, anti-steering protection, or pharmacy network accountability, the statute should be written with the expected ERISA challenge in mind.

This does not mean states should stop acting. It simply means states need to be precise.

The same is true for pharmacy advocates. PBM reform cannot be built only for the legislative hearing room. It also has to be built for the courtroom that may come next.

Taken together, these developments show where the PBM fight is moving. Rutledge gave states room to regulate. Mulready showed that ERISA preemption still has limits to test. Congress has now moved PBM reform into the national healthcare-policy conversation.

For pharmacies, healthcare organizations, and policymakers, this is not an academic issue. The policy momentum around PBM reform is real, but so is the legal risk. Passing a law is only the first step. The next question is whether that law can survive the federal preemption challenge that may follow.

Commercial Real Estate Deals Move Fast. Legal Risk Should Not Be an Afterthought.

Commercial real estate deals usually start with the business terms.

Location. Price. Financing. Timing. Use of the space. Growth potential.

All of that matters.

The challenge is that those are only part of the deal.

In Massachusetts, a commercial real estate transaction can raise legal and business issues long before the final documents are signed. A lease may look straightforward until the tenant starts thinking about buildout obligations, assignment rights, renewal terms, maintenance responsibilities, signage, parking, default provisions, or future expansion. A purchase may look attractive until diligence, title, financing, zoning, environmental review, or municipal approvals start to shape what the buyer can actually do with the property.

That is why legal review should not be treated as the last step in the process.

For developers, landlords, tenants, investors, brokers, and growing businesses, the early questions often determine whether the transaction works in practice.

Can the intended use operate at the property? Are there permitting or licensing issues that need to be addressed before the client commits? Does the lease give the business enough flexibility if the company grows, changes, or needs to exit? Are the closing conditions aligned with the financing and diligence timeline?

These questions are not just technical legal points. They affect the business decision.

At Lanton, Lanton & Sosa Law, we look at commercial real estate as part of a broader business strategy. A lease, acquisition, development project, or expansion decision should support the client’s operations, financial goals, and long-term risk position.

That perspective is important because commercial real estate decisions are rarely isolated. A healthcare provider opening a new location, a pharmacy expanding its footprint, a professional practice negotiating office space, a developer evaluating a project, or a business owner signing a long-term lease is making a decision that can affect revenue, compliance, staffing, financing, and future flexibility.

The legal work should reflect that reality.

Our role is to help clients understand the risk without slowing down the momentum of the deal. That means identifying issues early, communicating clearly with the business team, and working constructively with brokers, lenders, landlords, tenants, developers, and other professionals involved in the transaction.

Good commercial real estate counsel should not make a deal harder.

It should make the deal more informed.

Whether the matter involves leasing, acquisitions, development, permitting, financing, diligence, or general outside counsel support, the goal is the same: help the client understand what they are signing, what obligations they are taking on, and how the real estate decision fits into the larger business plan.

For many businesses, the real estate document is not just a property agreement. It is part of the company’s operating plan, risk profile, and growth strategy.

Commercial real estate moves quickly.

The legal strategy should move with it.

Ron Lanton Discusses 340B Compliance and Patient Access with Drug Topics

Lanton, Lanton & Sosa Law is pleased to share that Ron Lanton III, Esq., Senior Partner of the firm, was recently featured in Drug Topics in a discussion on the 340B Drug Pricing Program and its importance to pharmacists, safety-net providers, and the patients they serve.

The 340B Program remains one of the most important and complex areas in healthcare policy. For pharmacies, hospitals, covered entities, and other stakeholders, the program sits at the intersection of patient access, regulatory compliance, reimbursement pressure, and federal oversight.

In the Drug Topics discussion, Ron addressed how the 340B Program can serve as a critical infrastructure tool for safety-net providers, helping them stretch limited resources, support clinical services, and reach vulnerable patient populations. He also emphasized the importance of compliance readiness, program oversight, and understanding how evolving policy expectations may affect pharmacies and healthcare organizations.

At Lanton, Lanton & Sosa Law, our healthcare regulatory work focuses on helping clients understand complex policy environments before they become operational, compliance, or business risks. The 340B Program is a clear example of how legal, regulatory, and market issues often move together.

You can read the full Drug Topics FAQ here.

Buying or Selling a Healthcare Practice Is Not Just a Regular Business Transaction

Buying or selling a healthcare practice can look simple from the outside. There is a buyer, a seller, a purchase price, and a set of documents that need to be signed. In healthcare, it is rarely that simple.

A medical practice, pharmacy, therapy practice, dental office, med spa, or other healthcare business is not just a collection of patients, equipment, contracts, leases, and revenue. It operates inside a regulated environment. That means the transaction has to account for issues that do not always show up in a basic business sale.

Licensure, payer contracts, patient records all matter. Employee obligations, referral relationships, corporate structure, privacy rules, billing history, and compliance risk matter too. Any one of those issues can affect the value of the practice and the ability of the buyer to keep the business operating after closing.

That is where many healthcare transactions become more complicated than expected.

A buyer may believe they are purchasing a stable book of business, only to find out that certain payer contracts cannot be assigned. A seller may assume the transition will be straightforward, only to discover that licensing timelines, lease restrictions, or patient notice requirements slow the deal down. A lender or investor may focus on revenue, while missing the regulatory issues that make that revenue harder to preserve.

The structure of the deal matters too.

An asset purchase and an equity purchase can create very different legal and operational consequences. The parties need to know whether professional licenses are changing, whether the seller will stay involved after closing, whether key employees need new agreements, whether the lease can be assigned, and whether the buyer can continue billing under the same contracts.

These are not issues to save for the end of the transaction. They should be part of the conversation before the parties get too far down the road on price, timing, and closing expectations.

For sellers, preparation can make the deal much cleaner. Corporate records, contracts, employment files, compliance policies, leases, payer documentation, and licensing materials should be reviewed before a buyer starts asking for them. A practice that is organized is easier to value, easier to diligence, and easier to transfer.

For buyers, diligence is not just about confirming revenue. It is about understanding whether that revenue can continue after closing. That requires looking at the business through a healthcare regulatory lens, not only a financial one.

The best healthcare transactions are planned before they are negotiated. In a regulated market, the legal structure of the deal can be just as important as the business opportunity behind it.

AI Medical Advice Is Moving Faster Than Healthcare Risk Management

Artificial intelligence is quickly becoming part of the healthcare experience. Patients are using AI tools to ask questions, interpret symptoms, manage medications, and decide whether they need to seek care. Some of these tools are being introduced through formal healthcare partnerships. Others are consumer-facing platforms that were never designed to operate as part of the healthcare system.

The problem is that patients are not always seeing the difference between a tool that gives general information and a tool that sounds like it is giving medical guidance. This is where real risks comes in.

The recent lawsuit in Pennsylvania involving Character.AI is a reminder that healthcare risk is no longer limited to hospitals, physicians, pharmacies, or traditional medical technology companies. When patients rely on AI-generated information to make decisions about their health, the legal and regulatory questions become much more complicated.

Who is responsible if the information is wrong? Was the platform providing general information, or did it cross into something closer to medical advice? Did the user understand the limits of the tool? Was there any process for escalation, disclosure, clinical review, or human oversight?

These questions matter because AI is not entering healthcare through one clean channel. It is coming through consumer applications, state partnerships, provider workflows, payer systems, pharmacy tools, and patient-facing platforms. Some uses may be administrative. Others may influence clinical decision-making in ways that are not obvious at the beginning.

That creates a different kind of risk environment for healthcare organizations.

The issue is not whether AI should be used in healthcare. It will be used and increasingly so. The more important question is whether healthcare organizations have the governance structure to understand how it is being used, who is relying on it, and where the legal risk sits.

For providers, pharmacies, health systems, digital health companies, and other healthcare organizations, AI review cannot sit only with the technology team. It needs to involve legal, compliance, clinical, operational, and risk management leadership before the tool is placed in front of patients or built into a workflow.

That review should start with practical questions. What is the tool actually doing? Is it generating general information, making recommendations, triaging care, renewing medications, or influencing a provider’s decision? Who reviews the output? What disclosures are being made to patients? How are errors identified? What happens when the AI reaches the limit of what it should answer?

The answers to those questions may determine whether an organization is using AI as a helpful support tool or unintentionally creating a new source of professional, regulatory, and operational exposure.

Healthcare has always depended on trust. AI does not remove that obligation. It simply changes where the trust is being placed.

As AI becomes more visible in healthcare, the organizations that move carefully will not be the ones avoiding innovation. They will be the ones that understand that innovation needs structure around it.

NYSBA Program: Policy, Pricing, and Market Strategy

On May 15, 2026, at 12:00 PM ET, I will be speaking as part of the New York State Bar Association Food, Drug & Cosmetic Law Section program, “Policy, Pricing, and Market Strategy.”

Healthcare organizations are increasingly operating in an environment where policy decisions directly influence pricing strategy, reimbursement planning, commercialization, and long term market positioning. Drug pricing reform, trade pressures, supply chain risk, and evolving regulatory frameworks are no longer isolated legal issues. They are becoming central business considerations across the healthcare and life sciences industries.

I look forward to joining the discussion with colleagues from across the healthcare and legal sectors.

When AI Starts Practicing Medicine Without a License

A recent lawsuit filed by the Commonwealth of Pennsylvania against Character.AI may become one of the first major legal tests of how existing healthcare laws apply to artificial intelligence systems that interact directly with the public. According to the complaint, a chatbot allegedly represented itself as a licensed psychiatrist, claimed to hold a Pennsylvania medical license, discussed mental health symptoms with users, and suggested it could prescribe medication.

For healthcare organizations and employers experimenting with AI tools, the significance of this case extends well beyond one platform.

AI systems are increasingly moving from administrative assistance into spaces traditionally occupied by licensed professionals. Once that happens, organizations begin facing questions involving liability, supervision, disclosure obligations, documentation standards, and professional licensing restrictions.

Many healthcare systems are already integrating AI into scheduling, intake, documentation, patient communications, and behavioral health support. The line between “informational assistance” and “clinical guidance” can become blurred very quickly when conversational AI systems are designed to appear human and authoritative.

One of the more important signals from the Pennsylvania lawsuit is that regulators appear focused less on disclaimers and more on how users could reasonably interpret the interaction itself. That has implications far beyond chatbot companies.

The larger takeaway from the Pennsylvania lawsuit is that AI governance may develop through existing regulatory and licensing structures long before comprehensive federal AI legislation arrives.

For organizations deploying AI tools in healthcare and other high trust environments, the question is becoming less about whether AI can be used and more about how it is supervised, governed, and operationally controlled.

Ron Lanton Featured in Reuters on Global Drug Pricing and Market Strategy

Recent coverage in Reuters highlights how U.S. pricing policy is beginning to influence global launch strategy for pharmaceutical companies.

The article examines how manufacturers are adjusting decisions across markets in response to policy pressure and evolving reimbursement dynamics. Click here to view the article.

Mergers and Acquisitions Are Not About the Deal

Most M&A conversations begin with momentum. A buyer is interested, a seller is ready, the valuation makes sense, and the timeline is moving. From the outside, it looks like progress. What is actually happening is a change in direction. There is a moment in these deals that does not get enough attention, when everything still looks clean on paper. Then one question shifts the conversation. What actually changes the day after this closes? Not in theory, in practice. Contracts start to behave differently under new ownership. Revenue that felt stable begins to depend on relationships that may not carry over the way everyone expected. Regulatory exposure shows up in places that were easy to overlook when everything was still in a data room.

That is usually where the pace slows, not because the deal is wrong, but because something important has not been fully seen yet. Most deals close. Fewer hold together the way they were expected to. The issues tend to surface later, when a contract does not perform the way it was assumed or when a regulatory requirement becomes operational instead of theoretical. By then, the deal is already done and the room to adjust is smaller.

The work I focus on now starts earlier. It begins with understanding how the business actually functions before the deal takes shape, where revenue is coming from, how it is protected, and where the pressure points are. That perspective changes the outcome. The deal becomes something the business can actually operate inside of after it is done. Mergers and acquisitions are inflection points where capital, regulation, and operations all meet at once. When those elements are aligned, the business moves forward with clarity. When they are not, the friction shows up over time.

Most businesses do not need more deal activity. They need a clearer view of what happens after they move. That conversation usually starts earlier than people expect.

Ron Lanton Discusses FDA’s Single-Trial Approval Pathway with Pharmaceutical Executive

Ron Lanton spoke with Pharmaceutical Executive about the FDA’s evolving approach to drug approvals and the potential shift toward a single-trial evidentiary pathway. The discussion examines how changes in regulatory expectations could affect development strategy, litigation exposure, and pricing dynamics across the pharmaceutical sector. As regulatory signals increasingly influence market strategy, companies developing innovative therapies must evaluate not only the scientific strength of their programs but also how evolving FDA policy may shape investor expectations and commercialization timelines. Listen to the interview here.