Who We Serve

Your Healthcare Legal Team

Barrera & Barrera LLP

Healthcare & Life Sciences Attorneys

Who We Serve

Allied Health Professionals

More than half of the healthcare providers in the U.S. are allied healthcare providers. Increasingly, due to the shortage of primary care physicians, allied healthcare professionals are the front line of patient care. The allied healthcare professionals that our healthcare lawyers serve, include:

· Advanced Practice Nurses, Registered Nurses, and Nurse Practitioners

· Audiologist and speech language pathologists

· Clinical Psychologists

· Dentists

· Emergency medical personnel (EMTs, paramedics)

· Imaging specialists

· Licensed Social Workers

· Medical Assistants

· Pharmacists

· Physical Therapists

· Physician Assistants

Allied healthcare professionals have special legal needs, because they are sometimes subject to legal rules that also affect physicians, yet are separately defined and operate under idiosyncratic legal structures.

Behavioral & Mental Health Professionals

Allied Health Professionals

Behavioral and mental health care professionals have unique legal and regulatory needs, as they come under different Boards and regulatory structures than physicians. Our law firm is experienced in handling the needs of:

· Licensed Educational Psychologists (LEP)

· Licensed Professional Clinical Counselors (LPCC)

· Marriage and Family Therapists (MFT)

· Psychologists (PhD)

· Social Workers (CSW, MSW)

The regulatory territory for behavioral healthcare providers is complex and always changing. We keep up with the latest regulatory developments, both federal and state.

Additionally, we understand the needs of mental health professionals and the healthcare facilities that serve clients with addiction, mental healthcare, marriage and family, and other issues. We resonate well with therapists and therapeutic facilities because of our unique commitment to human growth and evolution. As a law firm, we understand the value of personal and professional growth and we are always developing and refining our best selves and we’re committed to bringing the best of our legal knowledge and regulatory brainpower (right and left) to our clients.

We can advise on how to structure your clinical practice, including issues of:

· Contracts and General Corporate Legal Issues

· Employment Agreements for Clinicians

· Informed Consent

· Insurance Practices

· Liability Risk Management

In additional to counseling behavioral healthcare clients on legal transactions, our behavioral health attorney team also advises on healthcare regulatory issues, such as:

· Board Investigations and Disciplinary Issues

· HIPAA and information security compliance

· Incorporation – Professional Corporation

We understand the needs of mental healthcare providers as they often diverge from the liability concerns of our physician clients. We can navigate through difficult issues such as:

· Prohibitions against the corporate (unlicensed) practice of medicine and psychology

· Scope of practice limitations on non-MD, behavioral health providers

· Rules governing professional corporations

· Legal rules relating to naming and branding

· Third-party reimbursement issues

· Stark / self-referral and anti-kickback / fee-splitting concerns

· Liability risk management; and

· Privacy, security, and HIPAA issues

State laws differ in the way they define the professional practice of psychology, marriage and family therapy, social work, professional counseling, and other behavioral and mental health disciplines so it is important that our healthcare attorneys are well versed in multiple areas of the law affecting mental and behavioral healthcare practices and practitioner

Biotechnology & Life Science Companies

Allied Health Professionals

Concierge & Direct Primary Care Practices

Biotechnology and life sciences companies must deal with a wide range of contracting issues and strategic decisions as they move from early stage development through clinical trials and final approval to market their product.

We provide legal and strategic support to business teams, clinical development teams and in-house legal teams to work through these issues. We can help you with:

Manufacturing and Supply Agreements

Quality and technical Agreements

Clinical Trial Agreements (U.S. and ex-US sites)

Confidentiality and Nondisclosure Agreements

Clinical Packaging Agreements

Product Formulation and Development Agreements

Services and Master Services Agreements

Material Transfer Agreements

Pharmacovigilance and SDEA Agreements

Distribution and Manufacturing Agreements

Joint Venture Agreements

Co-Promotion Agreements

Data Use Agreements

Data Storage and Data Transfer Agreements

Software Agreements

License Agreements

Investigator Initiated Study Agreements

Authorship Agreements

HIPAA Releases and ICF Review

We can draft and negotiate agreements with an understanding of your business needs and address the issues that matter most. Time is of the essence in clinical trials and we support drug development programs by developing templates and negotiation guidance for CROs, or negotiate directly with sites on behalf of the company, to get the agreements completed and executed in a timely manner.

We provide the support you need in developing your contracting strategy as well as developing policies and procedures to fit your companies needs within your resources.

Concierge & Direct Primary Care Practices

Healthcare Facilities (Hospitals, Labs, Pharmacies)

Concierge & Direct Primary Care Practices

Concierge medical practices raise legal issues requiring knowledge of insurance laws, contract legal issues, ethical rules applicable to medical doctors and other clinicians, anti-kickback and fee-splitting laws, and other regulatory issues.

In general, the concierge practice would benefit not only from clear legal review by an experienced health care and contracts attorney, but also by having the lawyer draft a contract between the practice and the patient that clearly specifies the services to be covered by the access or subscription fee; the Medicare status of the physicians involved; whether those providers accept insurance; how the billing will be managed; and what will happen when the patient is terminated from the program.

Any concierge medicine practice must be structured carefully by an attorney well-versed in corporate practice of medicine, fee-splitting and kickback laws, insurance law, and other legal rules, so that the transaction is legally compliant. We can help you craft an appropriate concierge program, as well as all the legal documentation to help manage your regulatory and legal risk.

Healthcare Facilities (Hospitals, Labs, Pharmacies)

We counsel a variety of licensed and non-licensed healthcare facilities such as:

· Addiction treatment centers

· Ambulatory care facilities

· Clinical laboratories

· Clinical research organizations (CROs)

· Clinical laboratories

· Home health agencies

· Hospices

· Hospitals

· Information technology companies

· Long-term care facilities

· Outpatient service providers

· Pharmacies

· Psychiatric facilities

· Rehabilitation facilities

· Residential treatment facilities

· Senior services facilities

· Skilled nursing facilities

· Urgent care centers

The regulatory issues on which our healthcare facility clients seek legal counsel, can range from HIPAA compliance to licensing issues to FDA regulations and everything in between. Let us help guide you through the healthcare regulatory labyrinth.

Management Services Organizations (MSOs)

Healthcare Facilities (Hospitals, Labs, Pharmacies)

The Management Services Organization (MSO) model is one that many healthcare businesses use in order to help mitigate the risk of enforcement for corporate practice of medicine (CPM) and fee-splitting (kickbacks).

The key concept behind the MSO model is that the physician, chiropractor, acupuncturist, nutritionist or dietitian, physical therapist, psychologist, or other clinical healthcare provider is busily engaged with the clinical side of practice, while the MSO runs the business.

The MSO model can be deployed in many ways for the healthcare practice or healthcare venture that seeks to make a profit from the actual business side of health and wellness.

The MSO model is particularly useful where healthcare regulators have shown regulatory sensitivity to business models that carve into the clinical space. MSO services can be quite broad and include such things as:

· front desk/scheduling

· sublease of space or equipment

· billing and collecting on behalf of the practice

· staffing

· marketing

We focus on legal strategies and solutions for our healthcare clients, based on an evaluation of what the healthcare client wants to do, what legal or regulatory roadblocks stand in the way, and how our healthcare lawyers can best deploy their knowledge and experience to move the client toward their goals with eye on maximizing business opportunities while mitigating risk.