Health Care Regulatory Compliance
The health care industry today is wrought with complex and constantly evolving federal, state and local laws and regulations. The Patsos Law Office advises health care clients on matters such as federal and state anti-kickback, physician self-referral and other fraud and abuse laws and regulations, corporate practice of medicine and fee-splitting prohibitions, certificate of need requirements, New York State public health law issues, New York State Office of the Professions requirements, and issues involved with providing telehealth and telemedicine services.
The business of health care is evolving at a rapid pace. Increasingly, providers are consolidating, merging, expanding, and integrating with other providers, such as hospitals and large medical practices. Unlike most businesses, however, the business of providing health care services is subject to complex regulatory constraints, which are implicated in virtually every business transaction into which a health care practice enters. Whether the transaction involves a medical office sublease, equipment lease, administrative and management services agreement, physician recruitment, investment in a group practice or other investment interests, arrangements for items and services used for electronic health records, or even marketing services, the transaction must be structured in a manner that avoids violating various Federal and state laws and regulations.
The Patsos Law Office advises clients on structuring their business arrangements to ensure compliance with the anti-kickback and physician self-referral laws and regulations, corporate practice of medicine and fee-splitting prohibitions, and other fraud and abuse laws and regulations. The firm also counsels providers who are buying, selling, expanding or dissolving a practice. Furthermore, following the trend of provider consolidation and hospital-physician integration, the Patsos Law Office counsels providers entering such arrangements and negotiates the arrangements on their behalf.
HIPAA, HITECH and Privacy Laws
The privacy and security of patients’ protected health information (PHI), is of utmost importance for any medical practice or health care provider; and the government’s aggressive approach to enforcing the Health Insurance Portability and Accountability Act (HIPAA) of 1996, and the Health Information Technology for Economic and Clinical Health (HITECH) Act heighten the importance of protecting PHI. These laws and their accompanying regulations impose heavy and complicated burdens on providers and the entities with which they do business.
The Patsos Law Office advises providers on compliance with HIPAA, HITECH and state privacy laws, and prepares HIPAA- and HITECH-compliant internal policies and procedures, business associate agreements, and Notices of Privacy for patients. In addition, the Patsos Law Office counsels providers on how to conduct a risk assessment to determine whether a breach of PHI has occurred, and if so, what the data breach notification requirements are, and how to execute the required notifications.
Third Party Payor Audits and Reimbursement Issues
Your medical practice depends on optimizing third party payor reimbursement, and avoiding audits and potential recoupment of payments. Driven by escalating fraud in the health care system, however, government and private payors are increasing their efforts to pursue and investigate inappropriately paid claims. The Patsos Law Office represents providers facing withheld and/or recouped claim payments, defends providers subject to payor audits, provides counsel on self-disclosure requirements, and negotiates settlements of audits with third party payors in order to maximize their practice income.
Medicare and Medicaid Enrollment
Whether you are starting a practice or other health care entity, or changing your existing reimbursement structure, the Patsos Law Office can guide you through the process of Medicare and Medicaid provider enrollment, as well as opting out of Medicare, and preparing the required documents, notices and patient agreements. The firm also represents providers being excluded from the Medicare and/or Medicaid program(s), and assists them in becoming reinstated to such program(s).
In the current environment of increasing administrative and financial burdens of running a private practice, many physicians are opting for hospital or large practice employment. The Patsos Law Office advises physicians on the meaning and implications of employment agreement provisions, and negotiates employment agreements with employers on the physician’s behalf to achieve the optimum benefit and protection under the agreements.
As technology in health care increases, the Food and Drug Administration (FDA) is likewise expanding its reach on the products and devices it regulates. Many new mobile health, or mHealth, devises must now comply with FDA regulations, including premarket requirements and guidance. The Patsos Law Office provides regulatory guidance to clients to ensure that any new product or device they develop complies with FDA guidance and requirements.
Elder and Special Needs Law
In addition to counseling health care providers, the Patsos Law Office assists elderly and disabled individuals obtain government health benefits and ensure their continued eligibility for such benefits. Specifically, the firm helps seniors navigate through the complicated Medicare enrollment process, and assists elderly and disabled individuals apply for Medicaid, including advising on how to protect excess income and resources within the bounds of the law, such as through pooled income trusts and supplemental needs trusts.
The Patsos Law Office also prepares planning documents for individuals, such as Health Care Proxies and Powers of Attorney, to ensure that their health and finances are protected in the event they are unable to make decisions on their own. These documents are particularly important for seniors who want to remain at home and age in place, but subsequently become unable to handle their finances or make health care decisions. In the event that such advanced planning documents are not in place, the Patsos Law Office guides clients through guardianship proceedings to have guardians appointed over the incapacitated individual’s person and property. The firm also handles guardianship proceedings on behalf of disabled adult children.