06 October

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Sunshine Health Update: What Providers Should Know About Continued Medicaid Benefits During Appeals

By: Zoey Chotiner

Sunshine Health recently announced a new process for cases involving continuation of benefits during the Medicaid appeal and fair hearing process.

What is a continuation of benefits, and what is Sunshine Health changing?

Continuation of benefits allows a Medicaid member to keep receiving certain healthcare services while appealing a decision to reduce, suspend, or terminate those services. Sunshine Health recently announced that, in some cases, if a member continues receiving services during the appeal process and the final hearing decision upholds Sunshine Health’s original action, Sunshine Health may seek recovery of the costs of those services. If Sunshine Health decides to pursue recovery, it will send written notice to the provider and the member explaining who it is seeking recovery from and what steps come next.

What should providers know?

Providers should continue following the authorization that is currently in effect. This means that providers should:

Continue providing authorized services while continuation of benefits remains active.
Continue submitting claims through the normal billing process.
Not reduce or deny services because repayment may be requested later.
Keep clear records of authorizations, dates of service, appeal notices, and claims.
Carefully review any recovery notice before taking action.
Avoid seeking payment from the member unless permitted under Medicaid requirements and the provider’s agreement.

Most importantly, providers should continue treating members while continuation of benefits is in effect. Providers should also stay organized, keep good documentation, and carefully review any recovery notice they receive.

How Jones Health Law Can Help Providers

A recovery notice from Sunshine Health does not necessarily mean that repayment is automatically owed. Providers should carefully evaluate the underlying authorization, continuation-of-benefits status, appeal history, claims, and applicable Medicaid requirements before responding or agreeing to any repayment.

Jones Health Law has experience assisting healthcare providers with Medicaid and commercial payer disputes, audits, recoupment demands, payment suspensions, and appeals. When a provider receives a Sunshine Health recovery notice, our attorneys can review the notice and underlying documentation, evaluate the basis for the requested repayment, identify potential legal, contractual, billing, or procedural issues, and develop an appropriate response strategy.

Depending on the circumstances, we can also communicate directly with Sunshine Health on the provider’s behalf, prepare written responses or challenges to the recovery demand, organize and present supporting documentation, and help the provider navigate any available dispute or appeal process. Our goal is not only to address the immediate repayment demand, but also to help protect the provider’s reimbursement rights and minimize unnecessary financial and operational disruption to the practice.

Providers should avoid ignoring a recovery notice or agreeing to repayment before understanding the basis for the demand and their available options. If your practice has received a Sunshine Health recovery notice, is facing a Medicaid recoupment issue, or has questions regarding continuation of benefits during an appeal, contact Jones Health Law to discuss the matter with an experienced health law attorney and determine the appropriate next steps.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice; it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please get in touch with me using the contact information listed above.

All information and references to laws, rules, regulations, and advisory opinions were accurate as of this time, but laws are constantly evolving. Please get in touch with me to ensure that the law governing your business is up to date. Thank you.

29 September

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What to Expect in a Denial Appeal Process with Health Insurers

Posted by Jamaal R. Jones, Esq.

in Blog

By: Pearl Walia

When do Payer Disputes Result in an Appeal?

According to the Change Healthcare 2020 Denials Index, about 50% of denied claims result from front-end issues, including eligibility or prior authorization problems, service coverage disputes, questions of medical necessity, inadequate documentation, or untimely filing. In simple terms, the payer refuses to pay the claim at all for one of these reasons.1

However, appeals don’t arise from outright denials; they can also result from an underpayment or overpayment. An underpayment occurs when the payer pays less than the contracted amount for the service provided, often due to downcoded CPT/HCPCS codes. An overpayment occurs when the payer determines it reimbursed the provider more than it should have, which is often discovered during audits; overpayments are typically deducted from future claim payouts, a practice known as a “takeback.” Providers have the right to appeal a denial, underpayment, or overpayment.

The good news is that many denials are recoverable, though the process takes real work. Understanding the appeals process and preparing the right documentation is critical to a streamlined, successful appeal. Once a claim is submitted, if a payer denies it, the provider may file an internal appeal requesting that the payer reconsider its decision. The appeal process then proceeds as follows:

Establish Appeal Legitimacy

Because payers deny payment for a variety of reasons, it is important to categorize each denial by its likelihood of recovery. Few practices have the time and resources to appeal every denial, so an efficient appeal strategy means focusing the effort where it counts. The same logic applies for underpayment and overpayments: make sure you have the adequate documentation to support your position before moving forward. Payer denials generally fall into two categories:

“Soft” (administrative) denials: Caused by billing errors, untimely filing, or missing documentation, these have high recovery rates (often 60-80%), if addressed within the payer’s appeal deadline.
“Hard” (clinical) denials: These stem from a lack of prior authorization, unapproved out-of-network services, lack of medical necessity, or other policy exclusions. Because they challenge the eligibility of the service itself, they require significant clinical justification and have lower recovery rates (typically 20-40%).

Identifying the root cause of each denial and sorting it up front helps a practice focus its limited time and resources where they’ll actually pay off.

Track the Appeal Deadline

Before anything else, note the deadline for filing, according to the individual payer’s requirements: ● Medicare and Medicaid: generally allow 120 days from the denial notice to file a redetermination

Commercial Payers: typically allow anywhere from 30 to 180 days, depending on the plan. Always verify the specific deadline for the plan to prevent forfeiting the appeal entirely. 3. Gather the Necessary Appeal Information and Documentation

Once the provider has decided to move forward with an appeal, they need to assemble the paperwork useful in recovering payment, including:

A letter of appeal: a cover letter that explains to the payer why the claim should be reconsidered and how the attached documentation supports the case.
Supporting Records: lab results, medical records, committees findings that back up the claim. ● Explanation of Benefits (EOB) or Claim Number: This ties the appeal to the original claim among the thousands a payer receives every day, preventing mix-ups or duplicate filings.

Follow the Payer’s Appeals Process:

The appeals process is not uniform across all insurance companies. It’s worth confirming their exact requirements before submitting, as appeal procedures can vary by insurance company and state law.

Submit the Appeal
Follow-Up with Health Plans During Pending Appeals

Once the appeal is filed, practices should keep a running log of open appeals and check in with payers regularly to ensure that claims are being processed correctly and paid on time.

File an External Appeal if Necessary

If the payer continues to deny the requested reimbursement, the provider can request an external review. External reviews are conducted by neutral experts who are independent of the payer and evaluate the denied claim. It is important to double check the state’s requirements for filing deadlines and information necessary to proceed with an external appeal. An external review can uphold the payer’s decision, overturn it, or overturn it in part. This decision is binding.

Why Can Appeals Feel So Frustrating?

The appeal processes of certain health insurers can often discourage providers from filing at all. For example, some payers require appeal packets over a dozen pages long. The process of filing an appeal and waiting for the results can take a toll on a practice, especially if the appeal isn’t prioritized because it isn’t considered life-threatening. In an effort to guard against overutilization of health care, many payors place heavy emphasis on prior authorization and medical necessity requirements, and many claims are initially denied simply because the provider failed to adequately support the need for that treatment. These denials are burdensome not only because of the treatment and payment delays, but also because of the confusion around learning how to effectively self-advocate.

How Can We Help?

Our firm can make this tedious process simple. The most important objective of any practice is to provide timely, quality care for its patients and to be reimbursed appropriately for its hard-earned services. Because the appeal process can take significant time and resources, providers are encouraged to consult an experienced attorney to guide them through the process according to their individual needs and objectives.

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22 September

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Are Direct Primary Care and Concierge Services Increasing and Are They Feasible For Providers?

Posted by Jamaal R. Jones, Esq.

in Blog

By: Pearl Walia

As payer disputes continue to rise and burden healthcare provider operations, physicians are increasingly looking for ways to limit their interactions with payers. Direct primary care (DPC) and concierge care have emerged as alternative practice models. But are these models feasible for practices in the long run?

What is Direct Primary Care?

Direct primary care (DPC) is a subscription-based model for delivering primary care without accepting insurance. The practice generates income from a flat monthly fee paid by patients, focusing on routine, affordable, and preventative care without the complexities of insurance. Services often include physical exams and wellness checkups, routine lab tests, vaccinations, minor injury care, and treatment for infections or the flu. Because patient volume is lower, patients often receive same-day or next-day appointments, longer visits, and direct access to their doctor by phone, email, or video call. DPC allows providers to focus more on personalized patient care and less on the administrative burden of insurance billing. It’s important to note, however, that DPC does not replace insurance for services such as emergency care, specialist visits, or hospitalizations. DPC practices often serve around 2,000 patients.

What is Concierge Medicine?

Concierge Medicine similarly offers greater access and a closer relationship between patient and physician. Patients pay a monthly or annual retainer fee, but practices under this model still bill insurance for office visits, labs, and certain procedures, ultimately adding back in visit-length constraints, billing complexity, and documentation requirements. This gives concierge practices two revenue streams: membership fees and insurance reimbursement. It also allows physicians to coordinate with hospitals, specialists, and other providers within the patient’s existing healthcare network. Concierge practices typically range from 300 to 600 patients.

What Patient Population Do Concierge and DPC Practices Serve?

Both models primarily attract patients who need more frequent visits or direct access to their doctor without navigating a referral chain or insurance approval process. Families with young children, for example, tend to visit the doctor more often due to routine check-ups, sick visits and follow-up care. Busy adults who need to reach their doctor quickly are another common audience. Patients managing chronic conditions such as high blood pressure, diabetites, asthma, or thyroid disease also benefit from these models, since they require regular check-ins and cannot accommodate constant scheduling conflicts.

How are these New Models Shaping the Future of Medical Practices?

According to research from the Johns Hopkins Carey Business School, Oregon Health & Science University, and Harvard Medical School, the number of DPC and concierge practices in the United States grew by 83.1% between 2018 to 2023, a clear sign of the widespread adoption of membership-based healthcare models. This growth is driven largely by physicians moving away from traditional primary care, which often brings burnout, heavy workloads, and significant administrative burden from insurance paperwork.

Pros of Switching to a DPC or Concierge Model

Smaller patient volume
Stronger patient relationships
More focus on patient care, less on administration
Reduced interaction with insurers
Minimal to no insurance battles
Higher revenue through membership fees

Cons of Switching to a DPC or Concierge Model

Fewer patients (due to affordability concerns)
Building a patient base from the scratch, with the risk of losing existing patients
Complications of operating outside traditional payment models
High overhead costs

Considering a Switch to DPC or Concierge Medicine? What Providers Should Know

Compliance with Pricing and Regulatory Requirements: Before switching models, providers should ensure compliance with federal and state laws on fee-splitting and anti-kickback/anti-referral statutes, as well as regulations governing retainer fees and medical memberships, which vary by jurisdiction.
Structuring Contracts and Marketing Materials: Because these models offer more limited scope of included services, it’s important to clearly outline services, fees, and limitations in contracts and marketing materials, in compliance with advertising and privacy laws.
Determining Whether to Accept Commercial Insurance: Concierge practices must decide whether to accept commercial insurance alongside membership fees or remain fully independent, as with DPC. This decision will shape reimbursement policies and billing protocols.
Ensuring Data and Privacy Compliance: Given the 24/7 access to physicians and the increase in in-person and remote communication, practices must comply with HIPAA’s security and privacy requirements, as well as any other applicable telemedicine regulations. Practices using AI tools such as chatbots to support patient communication must also have policies in place to ensure responsible AI use and protect patient privacy.

How Does a Practice Know if DPC or Concierge Medicine is Right for Them?

Concierge medicine and DPC offer physicians greater independence and a stronger focus on patient care compared to traditional primary care. However, this model isn’t for every provider. Despite the autonomy it offers, it significantly limits patient volume due to affordability constraints and requires careful attention to regulatory structuring and the challenge of building a practice from the ground up. Like any business venture, starting a DPC or concierge practice involves upfront costs and financial risk. Providers are encouraged to consult an experienced healthcare attorney to evaluate their current practice, long-term goals, and whether this model fits their individual needs.

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15 September

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Revenue Recovery Series Part 4: Mastering the No Surprises Act & IDR Arbitration Focus

Posted by Jamaal R. Jones, Esq.

in Blog

By: Pearl Walia

What is the No Surprises Act and Why was it Passed?

Before the COVID-19 pandemic, two-thirds of Americans feared they would not be able to afford an unexpected medical bill. For years, many people with private health insurance were surprised with high medical bills after being treated by an out-of-network (OON) provider. In December 2020, Congress passed the No Surprises Act (NSA) to address this problem and protect patients from these unexpected costs. The Act applies to both emergency and nonemergency services.

Before the NSA, OON provider bills were common for patients admitted to hospitals or treated in emergency departments. A study from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) found patients paid an average of $628 out of pocket for an emergency department visit, and $2,040 for an inpatient hospital admission. These unexpected costs caused significant financial distress for much of the population.

The NSA addressed this by prohibiting surprise “balance billing” for services rendered by OON providers. Balance billing occurs when a provider bills a patient for the difference between the provider’s charges and the amount covered by insurance. For example, if a patient receives OON services (i.e air ambulance transport), or is treated by an OON provider at an in-network hospital, the patient cannot be billed for the amount their insurance does not cover. Instead, they only pay only the normal in-network costs: copay, coinsurance, or deductible. If the insurer and provider cannot agree on a price, either party may request an independent resolution process to determine appropriate reimbursement rate.

What Happens if the Provider and Payer Can’t Agree on OON Reimbursement?

When a dispute arises over OON payment, the parties must first attempt “open negotiation,” before proceeding to arbitration. If they reach no consensus within 30 days of the open negotiation notice, either party may initiate arbitration through Internal Dispute Resolution (IDR).

IDR is a binding arbitration process overseen by the U.S. Department of Health and Human Services, the Department of Labor, and the Department of the Treasury. Under this system, the parties select a certified third-party entity from an approved list to resolve the dispute and determine a settlement amount that both sides must accept. Payment is then due within 30 calendar days.

What Information Do Providers Need to Initiate the IDR Process?

Before starting the IDR Notice of Initiation web form, providers should have the following information and documents ready:

Identification of the qualified IDR services, and whether they are batched or bundled.
Dates and location of qualified IDR services
Type of qualified IDR services (i.e. emergency services and post-stabilization services)
Item and service codes, along with the corresponding place of service
Attestation that qualified IDR services fall within the scope of the Federal IDR process
The provider’s preferred IDR entity

The Federal IDR Portal

In enforcing the NSA, the government recognized that providers often lacked sufficient information to determine whether a claim qualified for the IDR process. In response, the NSA now requires insurance companies to include special billing codes on their Explanation of Benefits (EOBs) and remittances, informing providers whether a claim is covered under the NSA and is eligible for IDR. Insurance companies must also register with the Federal IDR Portal, receive a unique ID number, and provide information about the health plan and employer sponsor at various stages of the process. Together, these requirements give providers the information they need to quickly determine whether a payment dispute is eligible for IDR.

As noted above, before a payment dispute can proceed to arbitration, the parties must first engage in open negotiation for 30 business days through the IDR portal, not simply through emails or phone calls. The party initiating negotiation must submit a standard online form listing details such as the names of both parties, the amount the insurance company originally paid or denied, and the amount the provider believes it should be paid. The portal creates a clear, transparent record of the negotiation and ensures that both parties have the information they’ll need if the dispute later proceeds to arbitration.

What is “Batching” of Claims?

Batching refers to grouping multiple OON claims together into a single dispute for the IDR process, allowing providers and insurers to resolve several claims at once. It is an economically efficient way to group lower-dollar disputes and reduce the need for repeated arbitration. NSA provisions limit batched disputes to 50-line items

Parties may batch disputes if:

The same provider and payer are involved in the dispute
Timing requirements are met (the services were furnished by the same provider to the same plan or issuer within 30 days).
The services were provided to a single patient on one date of service, or on consecutive dates of service
The services share the same or comparable service (i.e. CPT codes, HCPCS, DRG codes)
For specific high-volume specialities such as anesthesiology, radiology, pathology, and laboratory services, claims can be batched using specific CPT code ranges, as long as they fall into similar procedure types (i.e. scans or tests) or relate to the same body part

What are some Common Batching Errors?

Some common batching errors include:

Batched services are recorded under a single emergency episode of care despite using multiple service codes
Disputes are submitted as single line items but include the total cost of all services provided during the episode of care
The services were not provided by the same provider
Payment for the services was not made by the same group health plan
The services were provided outside the 30-day window following the first service in the batch

To avoid these mistakes, the party initiating the IDR process should contact the certified entity to clarify its batching guidelines. It is also recommended to include an EOB in the portal documentation to help the entity understand the batching method chosen. Providers and payers should continue to monitor upcoming federal guidance on batching criteria and IDR portal functionality, as changes may introduce new open negotiation and initiation requirements.

Strategies to Succeed in Arbitration

Arbitration can be costly, especially when the parties have not agreed on payment rates by contract. The NSA uses “baseball-style” arbitration, also known as final-offer or pendulum arbitration. Under this system, each party submits a final offer, and the arbitrator must choose one or the other; there is no middle ground. This means the losing side may end up paying or receiving significantly more than it considers fair.

Strategies for succeeding in this style of arbitration include:

Strong Documentation: There’s no such thing as too much evidence. Success in arbitration is closely tied to through preparation of strong data, solid evidence, and skilled negotiators. It is a strong practice to include EOBs that clearly explain why specific services were provided, along with complete patient medical records and treatment summaries.
Know What Factors Arbitrators Consider: The Act requires arbitrators to weigh several factors equally, including: the qualifying payment amount; the market share of both parties; the training, expertise, and scope of services of the provider; and evidence of good-faith efforts to reach a prior agreement, including any contracted rates between the parties in the previous four years.
Check How Your Proposed Rate Aligns with the QPA: The Qualifying Payment Amount (QPA) is a plan’s median contracted rate for same or similar services in the same geographic market. The QPA serves as a baseline that helps arbitrators judge the reasonableness of an offer. A submitted offer should align closely with the QPA, and any significant deviation should be backed by credible, objective evidence.
Emphasize Provider Qualifications: Submit evidence of the clinician’s or facility’s training, expertise, and quality of care to further support the offer.

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08 September

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Protected Series LLCs Now Available in Florida: What You Should Know

Posted by Jamaal R. Jones, Esq.

in Blog

By: Zoey Chotiner

Florida business owners have a new option for structuring their companies. Effective July 1, 2026, Florida’s new series LLC law lets a single parent LLC create multiple protected series. For business owners managing multiple properties, investments, or ventures, a protected series LLC may offer an alternative to forming several independent LLCs.

What is a Protected Series LLC?

A Florida protected series LLC is a new type of Florida limited liability company that can designate one or more protected series. A protected series is a legally distinct portion of an LLC, but it is not a separate legal entity and does not have its own record or document number on Sunbiz.

Instead, a single parent LLC can create one or more internal divisions, or protected series, that function much like standalone entities for certain purposes. Each protected series can have its own assets, liabilities, business activities, members, and managers. This new structure may help reduce costs and simplify operations for business owners with multiple ventures.

Think of this like an apartment building. The building is the parent LLC, while each apartment is a protected series. Each unit is part of the same building, but each has its own locked door and separate contents.

A Florida LLC may establish a protected series by filing a Designation of Protected Series with the Florida Department of State. Each protected series has two parts. The first part must begin with the full name of the parent LLC. The second part must include a protected series identifier, such as “PS,” “P.S,” or “Protected Series.” The name must also be distinguishable from the other protected series and cannot include identifiers associated with other types of business entities, such as “GP” or “Incorporated.”

What are the benefits of a Protected Series LLC?

Protected Series LLCs may be useful for business owners who manage multiple properties, investments, or business ventures and want to keep them separate without creating a new LLC for each one.

Real estate investors are a good example of who will benefit. An investor with several rental properties could place each property into its own protected series. If a lawsuit or debt is connected to one property, the other properties are usually kept separate and protected from that liability.

Entrepreneurs and family businesses may also benefit. For entrepreneurs, instead of forming a separate LLC for every business project, each one can operate under its own protected series while working under the same parent LLC. Entrepreneurs can do the same thing.

Another benefit is cost and administrative efficiency. Because an owner can create multiple protected series under a single parent LLC, there may be fewer formation filings, fewer registered agent fees, and less duplicative paperwork.

Protected series LLCs also provide flexibility because each series can have its own assets, managers, members, and business purposes. Florida will also recognize certain series LLCs formed in other states, which opens new business opportunities for businesses expanding in Florida.

How does the liability protection work?

A Protected Series LLC has two types of liability protection.

The first is the traditional “vertical” liability shield that comes with a regular LLC. This protects the owners personally from debts and obligations of the business.

The second is a newer “horizontal” liability shield that is created by the Florida protected series LLC. This helps keep the parent LLC and each protected series separate from one another. Simply, if one protected series has debts or gets sued, the assets of the other protected series and the parent LLC are usually protected from that liability.

However, the horizontal shield protection depends on keeping each series properly separated. Florida law requires clear records showing which assets and liabilities belong to each protected series. In practice, this could mean separate financial records, clear ownership documents, careful transaction tracking, and disciplined recordkeeping for every transaction.

Is a Protected Series LLC right for you?

Protected Series LLCs give Florida businesses a new and potentially useful way to separate assets, operations, and liabilities.

However, the structure is still new to Florida, so business owners should understand both its benefits and its requirements before deciding whether to rely on it. As the law continues to develop, legal counsel can help determine whether a protected series LLC is the right fit compared with using multiple traditional LLCs.

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01 September

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The Future of Peptides: What Patients and Providers Should Know

Posted by Jamaal R. Jones, Esq.

in Blog

By: Zoey Chotiner

What are peptides, and how do they work?

Peptides have become increasingly popular in medicine, wellness, and weight loss. Peptides are short chains of amino acids, which are the building blocks of proteins, and they can have a wide range of effects on the body. They can be thought of as smaller and simpler versions of proteins that can help regulate hormone activity, immune defenses, tissue repair, and growth. Peptides are used in some FDA-approved medications to treat disorders such as diabetes and obesity. For instance, injectable insulin and GLP-1 medications are examples of peptide-based drugs. Many people also use peptide injections and supplements to enhance their health and fitness goals.

Federal Law and Peptides

At the federal level, the Food and Drug Administration (FDA) regulates peptide drugs. They are regulated under the same general framework as other drugs. Usually, a drug must receive FDA approval after studies of its safety and effectiveness before it can be marketed for treatment. However, there is an exception for certain compounded medications. A compounded medication is essentially a custom drug created by a pharmacist or physician who combines or alters ingredients to fit the specific needs of a patient. A drug may be compounded for a patient who cannot be appropriately treated with an FDA-approved medication. However, compounded drugs are not reviewed or approved by the FDA for safety and effectiveness in the same way as FDA-approved drugs.

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, pharmacists and physicians are not allowed to choose any peptide they want and compound it for patients. They may only compound drug products using bulk drug substances that comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, are components of FDA-approved drug products if an applicable USP or NF monograph does not exist, or appear on the FDA’s list of bulk drug substances that may be used in compounding. Bulk drug substances must also be accompanied by a valid certificate of analysis and manufactured by an establishment registered with the FDA.

Many peptides are marketed or labeled as “for research use only” or “not for human consumption.” This generally means they are being sold for laboratory or experimental purposes rather than as approved medical treatments. However, some suppliers market research peptides directly to consumers in ways that suggest human use. This can create legal risks, especially when the products are promoted as providing health, wellness, or other medical benefits.

Florida Law and Peptides

In Florida, peptide use is regulated by a combination of federal FDA rules and state healthcare regulations. The Florida Board of Medicine oversees physicians who prescribe or administer peptide treatments, while the Florida Board of Pharmacy regulates pharmacies and compounding practices. The Florida Department of Health oversees these professional boards and helps enforce state healthcare laws.

Florida does not currently have a separate law that specifically regulates all peptides as one category. Instead, peptides are generally managed by existing Florida drug, pharmacy, prescribing, and professional practice rules. This means the legal status of a peptide may depend on what the substance is, whether it requires a prescription, whether it is FDA-approved, how it is compounded, and how it is being sold or marketed.

Recent FDA Developments

Recently, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in favor of adding six peptides—BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax—to the list of bulk drug substances that may be used under Section 503A. This is a major development for the compounding industry. These peptides have been proposed for uses involving ulcerative colitis, insomnia, wound healing, migraines, and other conditions. However, this does not mean the peptides are FDA-approved. The process can take time, and the FDA still has to decide whether to formally allow these peptides to be used in compounding. If the FDA does move forward, patients may have a clearer way to access them through licensed physicians and compounding pharmacies instead of relying on unregulated online vendors.

Some view this as a victory for patients and personalized medicine, while others are concerned that there is not enough data on the peptides’ safety and effectiveness to support wider access. Just because a peptide is being considered for addition to the compounding list does not mean it has full FDA approval. The FDA has raised concerns about the available information regarding the safety, effectiveness, and quality of some of these substances. Now, the FDA must decide what to do with the advisory committee’s recommendations while considering those concerns. The committee’s recommendations can carry significant weight in the FDA’s decision-making process, but they are advisory rather than binding. Ultimately, it is up to the FDA whether it chooses to follow recommendations.

Future of Peptides

In the future, peptides could become easier to access through licensed physicians and compounding pharmacies if the FDA allows more of them to be legally compounded. This could make patients less likely to rely on unregulated websites or “research use only” products. At the same time, newer drugs show how much potential peptide-based treatments may have in certain areas of health.

However, greater access will likely come with more rules and regulations. The FDA will most likely continue to focus on safety, product quality, clinical evidence, and how these drugs are marketed. Ultimately, peptides may become a much larger part of mainstream medicine, but their future will depend on stronger research, clearer legal pathways, and tighter regulation.

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12 August

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Revenue Recovery Series Part 3: What Is ERISA and How Does It Affect Healthcare Providers?

Posted by Jamaal R. Jones, Esq.

in Blog

By: Pearl Walia

What is ERISA in Simple Terms?

ERISA, the Employee Retirement Income Security Act of 1974, is a federal law that establishes standards for most employer-sponsored retirement and health benefit plans in order to protect employees’ retirement assets. Before ERISA, employers often mishandled funds and failed to deliver promised benefits, leaving workers vulnerable to arbitrary coverage denials. In response, Congress enacted ERISA to protect employees by setting minimum requirements for how benefit plans must be administered, outlining the responsibilities of plan guidelines of plan fiduciaries, and establishing legal remedies when benefits are improperly denied or mishandled. Because ERISA is a federal law, it generally preempts, or overrides, conflicting state laws related to employer-sponsored benefit plans, creating a standardized set of rules that employers, insurers, and third-party administrators must follow.

ERISA’s scope extends beyond employer-sponsored pension and retirement plans to private-sector plans as well, including those that provide medical, surgical, hospital, prescription drug, and disability benefits. When an employer sponsors a health plan, that plan is often subject to ERISA’s federal rules, which govern reporting, disclosure, fiduciary responsibility, and enforcement rights, even though ERISA was not originally enacted as a healthcare statute.

Why Does ERISA Matter to Providers?

According to the U.S. Census Bureau, employer-sponsored health insurance covers 53.8% of the U.S. population. Because ERISA governs so much of the employer-sponsored plan landscape, it remains a critical framework for providers to understand, as they bill for a growing share of patients under this plan type.

ERISA has a significant impact on provider reimbursement for patients with employer-sponsored benefit plans. Many patients receive coverage through employer-sponsored plans governed by ERISA, which means that providers must follow the plan’s specific procedures for claims, appeals, and reimbursement when seeking payment. When billing for a patient covered under an ERISA employer-sponsored plan, providers should be familiar with ERISA’s provisions and how they differ from traditional state-level rules. Only a small percentage of providers fully understand how ERISA works, but with the right guidance, providers can learn their rights and how ERISA may help or limit them in reimbursement. Some key differences between ERISA and conventional state-level payer laws include:

Filing Time Requirements: State and local laws often impose a fixed deadline for submitting medical claims, such as 90 or 180 days, which may be outlined in the provider’s contract. Under ERISA, however, there is no specific statutory time limit for timely filing. Instead, the employer’s health plan is permitted to set its own filing deadlines.
Timeframe for Appeals: Payers traditionally may require appeals within 30 or 60 days under contract. However, ERISA imposes an 180-day appeal deadline for denied claims.
Retroactive Reviews and Recoupments: Some provider contracts allow payers to recoup overpayments from future claims. In other words, if a payer accidentally overpays a provider, it can deduct that amount from future payments owed. Under an ERISA-governed health plan, however, this kind of retroactive recoupment is prohibited.
Discretionary Decisions of Fiduciaries: A fiduciary is anyone with discretionary authority over how a plan is implemented and how funds are dispensed. Fiduciaries have the discretion to hire and monitor service providers, including health care providers, third-party administrators (TPAs), and pharmacy benefit managers (PBMs). This matters to providers because it reflects ERISA’s additional disclosure and reporting requirements, as well as the fiduciary’s role in plan administration.
Access to Medical Criteria: Under ERISA, payers must provide, upon request and free of charge, the regulations or criteria used to deny a claim, along with any scientific or clinical judgement that supported the denial.

How Can Providers Use Federal Law to Bypass State-Level Payer Stalling Tactics?

It is essential for providers to understand the complexities of ERISA, and how it can affect reimbursement, particularly during payer disputes, denials, or delays. Unlike other federal health and insurance laws, which often set a foundational framework that states can build upon, ERISA broadly overrides conflicting state rules that attempt to regulate employer health plans. While payers commonly rely on strict approval tactics during claim reviews, providers may be able to counter these tactics using ERISA’s federal provisions instead. Providers are advised to first confirm that a patient’s health plan is governed by ERISA, then review its specific provisions to understand how timelines and procedures may impact reimbursement. Providers should also keep a copy of each patient’s insurance policy on file and review it for any limitations that may apply.

Leveraging ERISA as a Tool for Success

More than half of the American population receives health insurance through their employer, and many of these plans are governed by ERISA. While most billing teams focus primarily on state insurance laws, contract provisions, and routine appeals, ERISA creates a separate set of federal rights for employer-sponsored plans. Because it governs how fiduciaries must select and monitor providers, and prohibits health plans from paying more than reasonable compensation, providers are encouraged to become well-versed in these provisions and how they affect the health plan. ERISA remains a powerful tool in payer disputes, establishing strict, federally managed regulations that health plans must follow when handling claims. Many providers are unaware of the unique rights ERISA provides, leaving valuable recovery strategies for improperly denied claims and appeals largely untapped. Our firm can help providers navigate ERISA’s provisions and understand how they apply to their practice amid the growing number of employer-sponsored health plans. We can help transform ERISA from a framework that may seem intimidating into a simple, valuable tool for providers.

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05 August

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Revenue Recovery Series Part 2: What is a Clinical Denial and How is it Different From Standard Administrative Appeals?

Posted by Jamaal R. Jones, Esq.

in Blog

By: Pearl Walia

Healthcare providers routinely face claim denials from payers, but not all denials are the same. Understanding their differences is critical to effectively manage revenue cycle operations. A clinical denial occurs when a payer determines that a medical service, procedure, treatment, or admission does not meet its coverage requirements. Clinical denials differ from administrative denials, which typically result from non-clinical, technical issues such as billing errors or missing information.

Clinical denial appeals are more challenging for providers than standard administrative appeals as they are based on medical judgement and require more detailed evidence to demonstrate that the services rendered were medically necessary and consistent with the payer’s criteria.

The top 4 reasons for clinical denials include:

Lack of Medical Necessity

From a payer’s perspective, a service is medically necessary when it is needed to help diagnose, treat, or prevent a medical condition, and this is supported by documentation. A denial for lack of medical necessity occurs when the record does not clearly reflect the care provided. This constitutes one of the most common reasons for denials.

Best Practices: Providers should thoroughly document all stages of a patient’s condition, symptoms, and reasons behind the service provided. It is also important to remain familiar with payer-specific documentation guidelines.

Document Deficiencies

A claim denial for documentation deficiencies is simply due to missing information, vague terminology or incomplete notes. A minor error like a missing lab value or missing date can prevent a payer from verifying the necessity of the treatment, potentially leading to a denial.

Best Practices: Providers are advised to implement standardized documentation templates and continuously review their documentation procedures to ensure the records are complete and accurate, and to reduce the need for time-consuming record reconstruction during appeals.

Prior-Authorization Issues

Many payers require prior authorization for certain services, including high-cost medications, specialized procedures, extended hospital stays, and off-label drug use. Denials may occur when authorization was not obtained, expired before treatment, or did not correspond to the services provided.

Best Practices: Providers are advised to implement clear workflows between clinical and administrative teams to verify authorization requirements before treatment is rendered.

Experimential or Investigational Treatment

Payers often deny coverage for services they classify as experimental or investigational. These types of treatments are classified as those which are under the clinical trial or experimental stage. Payers strictly limit coverage to therapies which have proven safety and efficacy, and experimental treatments lack regulatory approval and scientific consensus. However, some experimental treatments may be permissible upon prior authorization, so it is important to inquire into payer requirements.

Best Practices: Providers are advised to review payer policies and obtain any required authorizations before offering experimental treatment to prevent denials.

When Should Providers Seek Counsel When Facing Clinical Denials?

Clinical denials can place a significant burden on a practice’s operations, and can disrupt patient access to timely healthcare services. Providers are advised to consult experienced healthcare attorneys not only after receiving a clinical denial, but also when evaluating their operational practices. Proactive legal guidance can help identify any operational vulnerabilities in the practice, develop a strong appeal strategy, and help streamline the workflows to reduce the occurrence of denials. Ongoing education, documentation, and communication among teams is only a part of the journey toward an efficiently-run practice.

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