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

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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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.

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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