Rupal Healthcare Law Group counsels and defends providers in regulatory matters, advise healthcare providers about medical practice management issues, ranging from business structure to operations to the smallest details of patient care.
We ensure our clients that their practices are insulated from complaints by patients and government investigators alike. Our experience and awareness of the “enforcement agenda” of healthcare regulatory entities enables Rupal Healthcare Law Group in making sound risk management choices.
Examples of practice management services include:
· Review and revision of provider contracts and forms
· Review and assessment of medical records practices
· Review and assessment of coding and billing practices
· Review and assessment of personnel practices
Medicare: From enrollment issues to recovery audits, Rupal Healthcare Law Group works with providers who experience problems with their participation in the Medicare program. The incidence of Medicare recovery audits against healthcare providers is on the rise as the U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services (CMS) has identified physician “overpayments” as a promising source of financing. Through the Recovery Audit Contractor (RAC) program and other initiatives, Medicare increasingly denies providers payments or audits them for alleged overpayments. In addition, Rupal Healthcare Law Group defends healthcare providers in Medicare Part B recovery audits and appeals, including audits by the administrative contractor (i.e. the carrier), formerly NHIC and, effective September 2, 2009, Palmetto GBA.
In defending recovery audits, Rupal Healthcare Law Group attorneys also advise providers in navigating complex Medicare issues and in Medicare compliance, including Medicare enrollment issues and Medicare Secondary Payor (MSP) issues.
Medi-Cal: Rupal Healthcare Law Group also works with providers who experience problems with their participation in the Medi-Cal (i.e. California Medicaid) program, from enrollment issues, to suspensions, to recovery audits. In contrast to the delegated contractor structure of the Medicare program, the Medi-Cal program is administered by the California Department of Healthcare Services (DHCS, formerly known as Department of Health Services or DHS). Providers are often caught off guard by significant differences between the two programs and the approach of DHCS in comparison to the Medicare contractors.
Our law group represents providers in a wide range of issues, in all aspects, before DHCS and Medi-Cal compliance issues. We assist physicians who face suspensions, disenrollment, Procedure Code limitations (PCL), civil monetary penalties (CMP), or other problems. We also represent providers facing denials of payment and “overpayment” recovery audits, and assist clients in all stages of the Medi-Cal administrative hearing process. Rupal Healthcare Law Group will take a proactive approach on any issues with the Medi-Cal program.
The federal Stark regulations and Anti-Kickback Statute (AKS) are implicated by any arrangement or relationship that involves any federal Healthcare program (such as Medicare or Medicaid). Healthcare businesses and transactions are subject to additional scrutiny for their compliance with the state and federal restrictions on self-referral, and other prohibited economic relationships. California has additional, distinct, and broader statutory rules (including PORA) governing Healthcare providers’ business relationships. Violating these statutes can include criminal and civil penalties, as well as exclusion from participation in federal Healthcare programs. Rupal Healthcare Law Group advise healthcare providers on the legal permissibility of relationships with other providers, managers, marketers, and other business entities. Our law group also advises clients on compliance with the Stark Laws, the Anti-Kickback Statute, and other state and federal prohibitions on self-referral. For these reasons, it is imperative that practitioners in the healthcare arena have a basic grasp of the Statute, its safe harbors, and its practical application.
At Rupal Healthcare Law Group, we assist providers in achieving compliance on both federal and state levels. Compliance with HIPAA (the Health Insurance Portability and Accountability Act) and the CMIA (California Confidentiality of Medical Information Act) has never been more essential for Healthcare providers and their business associates. The HITECH Act, embedded in 2009’s American Recovery and Reinvestment Act, resulted in new health information privacy and security requirements as well as enhanced enforcement and penalties for breaches. Additionally, proposed federal regulations will extend HIPAA Business Associate requirements to subcontractors.
Recent changes to the CMIA and state laws have resulted in more stringent compliance requirements for providers, including a 5 day reporting requirement for breaches by certain provider types. It is imperative that healthcare providers evaluate and update policies, procedures, and agreements, and be prepared to quickly assess and properly report certain breaches of healthcare information. Our law group assists covered entities, business associates, and subcontractors in navigating the complex and day-to-day aspects of health information privacy compliance. We offer a variety of compliance-related services to clients throughout California.
At Rupal Healthcare Law Group, we specialize in long-term care, and are the pre-eminent experts on virtually every legal issue facing the long-term care profession. Whether it is the intricacies of Medicare and Medicaid reimbursement, the maze of regulation burdens under federal and state law, or governmental investigations undertaken by CMS contractors, the OIG or the Department of Justice, we are at the forefront of these issues.
We also assist long term care operators with strategic planning and expansion projects. We bring significant relevant expertise to acquisitions and financings for both for-profit and non-profit entities and are well versed in crafting appropriate joint venture and management relationships of all types in the long term care arena
We understand and appreciate the unique challenges and special responsibilities and risks associated with owning and operating long term facilities. Our law group is knowledgeable in all forms of long term care reimbursement, licensing and certification issues, governmental investigations and prosecutions, regulatory and legislative advocacy and litigation.
We understand that behavioral health providers often face unique challenges distinct from those faced by other Healthcare providers. At Rupal Healthcare Law Group, we have considerable experience in representing psychiatric hospitals and hospital systems, psychiatric units of acute care facilities, behavioral health clinics, community mental health centers, mental health rehabilitation centers, residential care facilities for youth and for the elderly, private social service agencies, and mental Healthcare practitioners in both administrative and civil tribunals.
Our law group serves as general counsel for these clients, integrating our firm-wide expertise into behavioral health and community-based care in areas such as consent and standard of care issues, regulatory compliance, risk management, contracts, labor issues, strategic planning and business transactions.
The U.S. Food and Drug Administration (FDA), is responsible for protecting and advancing the public health, by ensuring that: foods are safe, unadulterated, and properly labeled; drugs are safe and effective; medical devices have a reasonable assurance of safety and effectiveness; and that cosmetics and electronic product radiation are not harmful. At Rupal Healthcare Law Group, we consist of attorneys and consultants who advise clients within the food and dietary supplement, drug, cosmetics, and medical device industries.
Our counsel’s acute grasp of FDA regulatory procedures allows us to anticipate and prevent problems, such as recalls or administrative detentions, before they disrupt a client’s business. We guide manufacturers, importers, processors and distributors through the intricate labyrinth of government oversight that shapes the international marketplace of food, drugs, cosmetics, and medical devices.
Our law group possesses knowledge and experience in other disciplines including Healthcare regulation, administrative law and litigation allowing us to develop interdisciplinary legal strategies for a wide range of clients across numerous industries.
Providers and regulators alike are often confused about the rules and regulatory requirements governing the manufacture and sale of nutraceuticals. There are distinct categories, including traditional drugs, traditional foods, supplements (which make no specific health claims), and medical foods (which are intended for the nutritional management of a specific disease under physician supervision). Legal and compliance issues that call for careful attention include labeling and advertising claims and content, mandatory and voluntary submissions, product manufacturing and packaging.
Rupal Healthcare Law Group advances and defends our clients’ interests with respect to nutraceuticals before courts and federal and state enforcement officials (including the FDA and California Board of Pharmacy). We frequently advise clients in anticipating and addressing issues before they bloom into full-fledged problems of regulatory enforcement or negative publicity. We assist clients in FDA and other audits and inspections.
Some examples of representative matters include:
· Advising an online start-up medical food business on compliance with FDA requirements
· Defending a Board of Pharmacy action involving enteral nutrition (infant formula) products
· Auditing a physician group to ensure compliance with federal and state requirements in nutraceuticals sales
· Defending FDA investigations of dietary supplement manufacturer
Rupal Healthcare Law Group counsels manufacturers and resellers on legal and regulatory issues related to cosmeceuticals. Providers and regulators alike are often confused about the rules and regulatory requirements governing the manufacture and sale of cosmeceuticals. Legal and compliance issues that call for careful attention include required disclosures, ingredients, labeling and advertising claims and content, mandatory and voluntary submissions, and packaging. We also assist clients in entering this business and, when necessary, defends clients whose manufacture or sale of cosmeceuticals is reviewed. Our objective, when possible, is to counsel clients proactively to avoid issues.
Some examples of representative matters include:
· Advising a physician practice on the launch of retail and Internet launch of a cosmeceuticals division
· Representing a client in an FDA inspection of manufacturing plant
· Defending a Medical Board investigation of physician marketing of cosmeceuticals
Navigating the litany of federal and state regulations placed on pharmacies can be difficult for a busy organization. Spending time and resources pouring over government paperwork and trying to extrapolate what you learn into policies and procedures can be time consuming at best, unfeasible at worst.
Rupal Healthcare Law Group understands your frustration, and understands the regulations and which pharmacy policies and procedures you need to institute to fully comply with them. We advise pharmacists and pharmacies on compliance with state and federal regulations and defend them in investigations and enforcement actions. Among other things, we have:
· Advised national pharmacies on California-specific requirements
· Assisted pharmacies in auditing compliance with state and federal requirements
· Defended pharmacies in administrative actions by the Board of Pharmacy
At Rupal Healthcare Law Group, we advise clients on ensuring regulatory compliance in clinical research trials, and assist in all phases of the regulatory process, including:
· Identifying legal issues in structuring clinical trials, including Stark and Anti-Kickback issues in relationships with participating physician investigators and consultants;
· Ensuring compliance with Food & Drug Administration (FDA) requirements, including investigational device exemption (IDE) applications and off-label use issues;
· Ensuring compliance with Office of Human Research Protection
(OHRP), National Institutes of Health (NIH) and Office of Research Integrity (ORI) regulatory requirements;
· Ensuring compliance with FDA and state informed consent and electronic records requirements;
· Obtaining Institutional Review Board (IRB) approval;
· Drafting agreements, consents, and other documentation necessary for clinical research trials;
· Responding to federal and state investigations of clinical research trials and, when necessary, defending civil administrative proceedings.
Rupal Healthcare Law Group helps patients, caregivers, collectives and physicians navigate the evolving medical marijuana regulatory landscape in California as safely and effectively as possible. We do not advocate or promote safe and legal access to marijuana. Rather, we help clients maintain strict compliance with state law related to cultivating, possessing, using, dispensing and recommending of medical marijuana.
The attorneys of Rupal Healthcare Law Group represent physicians who are the target of peer review, as well as providing skilled representation to medical staffs and other organizations that review doctors.
If you believe you are being targeted through peer review, it is important to contact a lawyer as soon as possible as these proceedings can have profound consequences for you and your career. While many peer review proceedings and investigations are conducted in response to legitimate concerns about physician performance or conduct, they can also be initiated in bad faith for retaliatory, personal or economic reasons. Further, even if there are legitimate quality concerns, there are almost always less damaging ways to address those concerns.
Medical Staff Representation
In addition to representing individual physicians in peer review matters, Rupal Healthcare Law Group, advise numerous medical staffs and professional groups with peer review responsibilities, counseling them on how to properly investigate and evaluate concerns regarding physician performance and conduct. Because proper peer review is a blend of law and medicine, our law group works as closely as possible with our clients throughout the entire process to make sure it is accomplished fairly and effectively.
Formal peer review hearings also require a knowledgeable hearing officer. Rupal Healthcare Law Group will serve as a hearing officer and be available to perform this highly specialized service upon request.
As of March 2012, compliance planning will be mandatory, and not optional. Although larger business entities, such as hospital systems, have almost universally adopted internal, self-governed compliance plans on their own, the long-term care industry has been slower to follow suit. Compliance plans serve this function by ensuring that employees, residents, and their families share a common understanding and expectations about everything from resident care to privacy to staff conduct. Implementing and sustaining compliance plans demonstrates a serious commitment to transparency and strict attention to both the law and quality of care. Through the various components of an effective compliance plan, Healthcare providers have the best opportunity of protecting their residents and themselves from risk.
Rupal Healthcare Law Group assists clients in designing, implementing, and overseeing skilled nursing compliance plans. Often, Healthcare providers do not discover serious operational or reimbursement problems until a third party acts. Sometimes, the first “indicator” of a problem is government action: notice of a post-payment audit or an investigation. In other cases, providers are surprised by lawsuits concerning care rendered at a facility. In all cases, the most effective way to prevent serious problems and significant liabilities is by developing a program of self-policing to ensure that issues are addressed proactively and stopped right away.
The convergence of several recent developments, including the HITECH Act’s (HITECH) “meaningful use” and other requirements, the billions of dollars available to hospitals and physicians to implement electronic health records (EHR) systems through the 2009 Federal Stimulus Act, and Healthcare reform with its focus on value-based purchasing and accountable care organization initiatives has made the adoption and implementation of EHR systems an imperative for you as a Healthcare provider or payer.
Rupal Healthcare Law Group can assist you in developing vendor RFPs for the initial procurement or upgrading of EHR systems; negotiating vendor agreements and managing the vendor process, including counseling on contractual concerns; and advising on compliance with meaningful use and other HITECH requirements. Our Healthcare attorneys also are adept at assisting you in navigating the complex legal and compliance issues confronted in providing EHR technology to physicians, such as the development of criteria for participation in physician subsidy arrangements and the preparation of legally compliant subsidy agreements, as well as in entering into broader strategic hospital/physician alignment relationships. In this regard, our law group can identify and offer creative solutions to you on antitrust, tax-exemption, and fraud and abuse (state and federal anti-kickback statute and Stark compliance) concerns.
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