Healthcare Law
Healthcare Law Overview
The dynamics of the health care industry has made it eminent on providers to reduce costs, comply with complex Medicare, Medicaid, Antitrust, Tax, and other Regulations. The compelling industry pressures have virtually led to establishing horizontal and vertical affiliates.
If you are a Healthcare Provider or a Law Firm with Health Care Practice, Promantra can provide you with several critical areas, including health care regulatory, transactional, compliance, insurance, tax, employee benefits, antitrust, and litigation. Our support solutions can benefit profit and nonprofit hospitals, nursing homes, physician groups, home health agencies, durable medical equipment suppliers, practice management companies, management service organizations, health maintenance organizations and other organizations that provide health care services.
Our Health Care Practice has strength in both our seasoned resources and our diverse experience. We can help you with day-to-day operational and contracting challenges. The standards and regulatory specifications are integral to how HHS visualizes healthcare entities and their security. The new rules under section 164.306 are the heart of the new security rules, and tracks the part of the HIPAA statute that governs security standards and safeguards (42 USC 1320d-2). Covered entities must meet four security requirements specified in section 164.306(a):
- (1) Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity creates, receives, maintains, or transmits.
- (2) Protect against any reasonably anticipated threats or hazards to the security or integrity of such information.
- (3) Protect against any reasonably anticipated uses or disclosures of such information that are not permitted or required under subpart E of this part.
- (4) Ensure compliance . . . by its workforce.
And these are our foremost concerns while providing high quality health services.
We have varied experience and knowledge for regulatory matters in the health care industry with an established track record of helping complicated transactions and a full range of health care legal support to our clients.
Health Care Business and Corporate.
We assist numerous acquisitions and affiliations of hospitals including helping you with your business negotiations and conducting regulatory compliance reviews. Promantra Legal Support can support the process of corporate restructuring of health care providers, mergers and acquisitions of health care providers, joint ventures and strategic alliances among providers and other transactions. In addition, our transactional lawyers who have extensive experience can help you with:
- Development, financing, and acquisition of facilities throughout the United States
- Formation of physician practice management companies
- Structuring the acquisition vehicles and advice on private placement issues under the federal and state securities laws
- Advice on health regulatory and corporate matters
- Negotiation of exclusive arrangements between physicians and hospitals
- Numerous physician employment, recruiting, and income guaranty agreements
- Hospital management agreements
Health Care Fraud and Compliance
We work closely with lawyers and healthcare facilities on general fraud investigation or allegations of health care fraud or victims of the fraud of others. We can also assist health care clients in the ongoing education and training of their employees in methods to prevent and detect fraud, as required by corporate compliance programs. We can assist you with:
- Development and implementation of health care fraud and corporate compliance programs for hospitals and home health care companies
- On criminal or civil investigation for health care providers
- Proceedings on drug misbranding and adulteration investigation conducted by the FBI and Food and Drug Administration
- Negotiation of a favorable settlement of civil false claims
- Hospital-physician joint ventures and employment and independent contractor agreements
- Appointment of appropriate senior personnel to oversee the corporate
- Compliance plan effectiveness scorecard
- Corporate integrity and consent decrees / summary of requirements chart
- Document retention memorandum for internal investigation
- File memo re: compliance hotline response
- Healthcare compliance questionnaire
- Model corporate responsibility program (CRP) policy
ERISA and Employee Benefits
We also provide support on issues related to employee benefits and executive compensation area. You may find yourself confronting transactions and fiduciary responsibility rules under ERISA, we can help you deal with these complexities in structuring entities and designing qualified retirement benefit plans, advising on welfare plans, compliance with applicable requirements under the Internal Revenue Code, and other federal laws including state laws under ERISA. Our services would span through the following:
- Agreement to submit to random drug and alcohol testing and required counseling
- Amendment to physician employment agreement
- Drug testing policy
- E-mail usage policy for healthcare organizations
- Employment agreement sample provisions
- Immigration information sheet
- Professional administrative services employment agreement
- Telecommuting agreement
- Total compensation tally sheet
- Whistleblower employee handbook language
Antitrust
The collaborative efforts among healthcare competitors can present significant legal issues under federal and state antitrust, consumer protection, and health care laws. We have in depth experience in counseling health care clients on various structures to address these issues. Our legal team can assist your law practise in federal and state courts throughout the country as well as before the Federal Trade Commission, the Antitrust Division of the Department of Justice, and state attorneys general. Our Antitrust support would include:
- Antitrust compliance guidelines
- Clinical trial agreement
- Contract term sheet
- FDA regulatory due diligence drug manufacturer
- Document/information request
- FDA regulatory due diligence drug manufacturer issue checklist
- Grant assessments audit plan
- Hospital-physician group coverage agreement
- Hospitals service agreement
- Initial due diligence request and transaction evaluation for health centers
- Non-disclosure agreement
- Professional services agreement between a medical center and physician
Professional Liability and Litigation
We can assist you in civil litigation cases and in the defense of a wide range of commercial and malpractice actions. Our jurisdiction expertise enables us in assisting you on real estate finance and development; health planning; Medicare reimbursement; insurance coverage; medical malpractice; banking; antitrust enforcement; construction contracts; and business torts. The firm is also active in providing support in arbitrations, mediations, and other forms of alternative dispute resolution. We can help you with the following documentations:
- Agreement for professional legal services
- Ambulatory surgical center license and registration checklist
- Arbitration agreement (separate from the admission agreement)
- Arbitration clause for insertion into admission agreement
- Clinic certification and license checklist
- Contract review and execution policy
- Development of a physician enterprise model (PEM) checklist
- Disclosure and apology workbook
- Discovery of alcohol, chemical substances or weapons in patient’s possession / policy
- Document retention memorandum for internal investigation
- Hospital licensing checklist
- In-house counsel legal subject matter staffing chart
- In-house counsel quality audit checklist
- Insurance coverage analysis for patients enrolled in a clinical trial
- Medical device evaluation committee / procedures for committee independence and conflicts of interest
- Non-disclosure agreement
- Vendor visitation and interaction policy
- Provider services and license agreement
- Surgery center code of conduct
