Healthcare Law Blog
This blog is devoted to current legal and regulatory issues affecting health care providers in New York, New Jersey and nationally. We regularly publish on topics of interest to doctors, pharmacists, hospital administrators, and everyone who is interested in the current developments in the legal landscape affecting the healthcare industry.
· Healthcare laws and regulations – providers must ensure that their lease agreement is compliant with all applicable federal and state laws, rules, and regulations, including but not limited to, the federal anti-kickback laws (42 U.S.C. § 1320a-7b) and Stark law (42 U.S.C. § 1395nn), the regulations promulgated there under, and equivalent applicable state laws.
· The landlord-healthcare tenant relationship – Medical offices, which are usually in medical office buildings, have additional concerns unique to the medical office building setting. These leases require an extensive analysis to safeguard against common healthcare lease pitfalls, such as construction build out issues; office sharing issues, including use of medical equipment and staff; subleasing, assignment, and termination issues; as well as medical malpractice and general liability insurance issues.
· Non-compete and restrictive covenants – providers should ensure that their lease does not violate any existing restrictive covenants contained in any other lease entered into by the landlord or provider. Moreover, they should include their own non-compete provisions to protect their office from competition from other potential renters in the office building. Providers should seek guidance from an experienced healthcare attorney as they have an in-depth understanding of the healthcare economy and market conditions, and as such are better positioned to negotiate these provisions.
If you are planning to open a new office, whether in New York or another state, do not hesitate to call our firm and speak with one of our experienced healthcare attorneys. We have the comprehensive knowledge to ensure your interests are effectively protected while your practice grows! Please do not hesitate to contact our firm for a consultation with one of our knowledgeable healthcare attorneys by phone at 212-668-0200 or via email at .
In a recent decision, Justice Velasquez of Kings County Supreme Court held that our clients, a major importing and distribution company and its principal, were not guilty of civil contempt. The decision follows a two-day contempt hearing. In separate decisions, Justice Velasquez declined to reconsider his denial of the plaintiff's motion for a preliminary injunction and permitted counterclaims to proceed against our clients' opponent....
What should you do when a hospital approaches you with an offer to buy your practice? Will the hospital ownership make your practice prosperous and efficient, or will it destroy the goodwill that you have worked so hard to build, and lead to a significant income reduction?...
Owning your own practice is one of the most rewarding ways to practice medicine. Buying an existing practice at the right price could be a great way to immediately tap into an established patient base and avoid the stress and expense of building up a practice from scratch. It is important, however, to avoid several common mistakes to ensure the smooth transition and post-acquisition value of the practice....
Frequently, physicians who are looking to open a medical practice ask us a question: what can a healthcare attorney do for me to help me get started?...
Contact our healthcare attorneys for us to start fighting for your rights. Read More About Our Audit Defense Practice
New York HMOs are conducting sweeping cuts to providers’ reimbursement rates. Although, the unilateral decision may seem unbeatable, an experienced healthcare attorney, negotiating on your behalf, can stop or reduce the cuts.
Providers who have contracted with HMOs understand the overwhelmingly one-sided agreements HMOs offer. Due to HMOs’ superior bargaining power and “take it” or “leave it” approach, providers are seemingly left with no room for negotiation. However, this is rarely the case.
Regardless of the HMO’s rationale, a seasoned healthcare attorney can fight back against the extremely unjust terms.
Healthcare marketplace intelligence and in-depth understanding of the factors affecting the operations of managed care networks are essential. With a thorough understanding of changing market dynamics, legislative changes, and rates of reimbursement of similarly situated providers, a healthcare attorney is in a better position to negotiate on a provider’s behalf. The importance of understanding the healthcare marketplace prior to opposing the cuts cannot be overstated. The extent an HMO will reduce or stop its cuts will depend on countless factors concerning the provider’s role in the network. Providers who attempt to negotiate their rates without an exhaustive understanding of their market are much less likely to prevail.
Further, an experienced and diligent healthcare attorney’s review of a provider’s service agreement with an HMO can uncover subtle provisions that may serve to significantly strengthen the provider’s bargaining position in the fight against the suffocating rate cuts. Review of facts by an expert is simply necessary to receive essential proper guidance with respect to your position vis-a-vis a managed care plan.
If you are a physician or a group practice facing a tough cut, call MDRXLAW for a consultation with one of our expert healthcare attorneys specializing in defense and representation of physicians and other healthcare providers in New York and New Jersey.
Kristina Giyaur, Esq. is a partner at the healthcare law firm of Sauchik & Giyaur, P.C.
Ms. Giyaur can be reached directly at 212.668.0200.
Telemedicine and urgent care go hand in hand as both are primarily focused on treating injuries or illnesses in need of immediate care, but not serious enough to require an emergency room visit. With the development of telemedicine, urgent care clinics are prone for growth. The patient pool an urgent care center can treat can be expanded statewide, or potentially nationwide, rather than including only those who live within a 3- to 5-mile radius. Moreover, providers will be able to treat more patients in a day with less administrative overhead. Clinics can also provide telemedicine-based follow-up visits, a current rarity, that creates stronger relationships with patients and increases repeat business.
Although the ATA Guidelines are extremely helpful, there are still a number of important legal considerations an urgent care clinic must make before implementing an e-practice. The laws governing telemedicine vary from state to state and providers will need to comply with both the laws from the state where they are located as well as the laws of the state in which the patient is in. Accordingly, countless laws and regulations are involved, forcing providers to entirely reassess their compliance policies and procedures. Everything from displaying a license to obtaining informed consent is affected when conducting an e-visit. Thus, providers should always seek counsel from a knowledgeable healthcare attorney before attempting telemedicine.
Medical Malpractice Insurance – Not all malpractice insurance currently covers telemedicine. Providers should ensure that telemedicine is covered under their medical malpractice insurance policy or purchase a separate policy that specifically covers such visits.
Reimbursement – Some private insurance reimburse for telemedicine services. Medicare and Medicaid severely limit reimbursement but currently pending before the New York Senate is a bill that will require private insurers and Medicaid to provide coverage for even more telemedicine services, further expanding e-healthcare.
E-Prescribing– New York requires either a pre-existing physician-patient relationship or an in-person “touch” physical examination before prescribing of medication. However, at least 12 other states allow the prescribing of medication when the physical examination took place entirely electronically.
HIPAA – Obviously there are a number of concerns over providers’ ability to safeguard protected health information as required under Health Insurance Portability and Accountability Act when conducting an e-visit. However, it is certainly possible. Urgent care clinic’s need to ensure that the technology they utilize is secure and their HIPAA compliance policies are up to date.;
In Von Maack v. Wyckoff Heights Medical Center, 504150/13, a hospital staff pharmacist alleged that her employer, a hospital, revengefully terminated her for reporting unsafe conditions in the hospital’s pharmacy to the federal Occupational Safety and Health Administration (“OSHA”). The hospital, on the other hand, contended that Von Maack was terminated for her uncooperative behavior. Prior to this suit, an arbitrator found that Von Maack was terminated for “just cause,” however, Von Maack, represented by her 1199 SEIU union counsel, never conveyed her whistleblower defense.
The grounds for dismissal by the Supreme Court of the State of New York were as follows: 1) a pharmacist, is not an “employee” for purposes of the health care whistleblower law because pharmacists do not perform “health care services;” 2) the doctrine of collateral estoppel, whereby litigants are prohibited from re-raising previously decided issues, bars the claim; and 3) the complaint didn’t identify exactly which law, rule or regulation the hospital violated, thereby endangering the health or safety of the public or a specific patient.
The court’s strange decision to limit the definition of “employee” under §741 will likely be the most controversial aspect of its judgment. According to the court, pharmacists, do not make judgments as to the quality of patient care, and as such, are not entitled to the “exceptional and specialized whistleblower protection.” Thus, relying on past precedent, the court held that pharmacists do not perform “health care services” under §741.
Further, this case shows the importance of choosing arguments to bring forth in arbitration. Litigants must always present all of their arguments in arbitration or else risk having the argument not heard. Here, the court held that, although it might appear that the arbitrator decided an independent issue, the doctrine barred the claim because the underlying issue was the same, whether Von Maack was justly terminated. Von Maack should have raised her whistleblower retaliation argument during the arbitration hearing. To avoid similar mishaps, healthcare employees should ensure that their counsel understands the intricacies of argument preclusion and collateral estoppel, especially union employees facing arbitration.
Additionally, the decision illustrates the importance of pleading all required elements properly. Von Maack, relying on a pharmacy regulation, didn’t point to the specific section within the regulation the hospital violated. Likewise, her complaint stated that the danger may potentially threaten the health or safety of the public or a specific patient, rather than pointing to a specific instance where the health or safety of a patient was in jeopardy.
Clearly, the importance of proper pleadings and understanding the procedural intricacies of whistleblower retaliation claims cannot be emphasized enough. Healthcare industry employers and employees preparing for a §741 claim should always seek counsel familiar with, not just labor law, but healthcare law, whistleblower laws, and litigation and arbitration procedures.
Instructive regulations are set to be open for public comment this summer and published thereafter. Until then, 340B entities will have to rely on their pharmacy regulatory attorneys’ judgment to ensure compliance with all federal and state regulations. Failure to properly implement the 340B Drug Discount Program can lead to significant financial and criminal liability. Accordingly, retaining an experienced pharmacy attorney to provide expert guidance on 340B contract pharmacy arrangements is essential to avoid violations.
The experienced and dedicated pharmacy attorneys of our Health Care Team are here to address all your questions and concerns with respect to the 340B Drug Discount Program or any other legal issues. We can be reached by email at or by phone at 212-668-0200. For more information on our attorneys and areas of practice please visit our website at www.MDRXLAW.com.
Some of the partnership considerations a healthcare attorney must analyze include:
1. Underlying economics of the practice, its assets, liabilities, risks and prospects.
2. Financial structure of the practice, ownership rights, and governance documents, as well as, all documents, agreements, and contracts relating to the practice, including payor agreements, hospital agreements, property leases and subleases, equipment leases, management, employment, and other service agreements.
3. The representations and warranties contained in the Purchase & Sale and/or Buy-Out Agreement and their implications.
4. Compensation, buy-ins, buy-outs, restrictive covenants, and exit strategies including agreements regarding compensation upon dissolution of the partnership and/or death of a partner. Note that if the practice compensates owners based on their respective production, a healthcare attorney must review the initial structuring and ongoing execution of the arrangement to ensure it complies with the Stark Law, the Anti-Kickback Statute, applicable state laws, Medicare reimbursement regulations, and the Internal Revenue Service’s (IRS) unreasonable compensation regulations.
Before committing to becoming an owner of a practice, prospective partners should have their healthcare attorney extensively review the agreements and issues involved in joining a practice to ensure a financially successful and generally rewarding partnership
If you have any questions or would like a consultation regarding this or any other healthcare legal issues please do not hesitate to call one of our experienced healthcare attorneys at 212.668.0200 or email us at . Our healthcare partners have years of experience representing physicians in numerous transactions including practice buy-ins and buy-outs, partnership formations and dissolutions, practice mergers and acquisitions as well various types of contracting among healthcare providers. The attorneys at MDRXLAW are here to provide guidance and counsel on any of your healthcare legal matters.
Providers who receive unfavorable overpayment determinations have up to five levels of appeal available to them. First, the provider may request a redetermination from the CMS claims processing contractor. Second, the provider may appeal to a CMS Qualified Independent Contractor (QIC). Third, the provider may appeal to a CMS Administrative Law Judge (ALJ). Fourth, the provider may appeal to the Medicare Appeals Counsel (MAC). Finally, the provider can request a judicial review in a federal district court.
For each level of appeal, Medicare is required to give the provider a specific rationale for denying its claims or determining that an overpayment was made. An adequate, specific and detailed explanation for denial of a claim or a finding of an overpayment is an essential procedural component of the appellate process. It provides the information to effectively dispute the determination and serves as evidence that a contractor properly conducted the review. If CMS did not require its contractors to provide an explanation for denying a claim, then it would be able to circumvent the appellate process by systematically denying claims and then changing its rationale for denial upon hearing the provider’s defense. If a determination decision does not include specific reasoning for denial of a claim, the appeals process fails to function properly and denies the healthcare provider a full and fair appeal.
This same logic applies to overpayment calculations performed through extrapolation from a statistical sample. Often, CMS or one of its contractors will audit a sample of patient medical records and extrapolate its findings to all claims submitted during the look-back period. To adequately defend against such an extrapolation, a provider needs to be fully informed of the extrapolation methodology, particularly the sample used. In The Case of Global Home Care Inc., the MAC declined to review the ALJ’s decision to not use the extrapolation conducted by CMS’s contractor. The ALJ found that because the contractor failed to produce its sampling documentation to the provider, the provider was unable to recreate the “statistically valid random sample,” thereby denying him a full and fair appeal. Thus, providers are entitled to see the Medicare contractor’s extrapolation methodology documentation.
If you have been audited or an overpayment determination has been made against you do not hesitate to call our firm and speak with one of our experienced healthcare attorneys. We will ensure that your rights are effectively protected!
What is key for all physicians to realize is that PQRS is not simply a system of incentives, failure to comply with the new mandates will cause penalties in form of reimbursement adjustments on future claims. These penalties can and should be avoided simply by implementing a proper quality measures reporting system.
- Patient Safety,
- Person and Caregiver-Centered Experience and Outcomes
- Communication and Care Coordination,
- Effective Clinical Care,
- Community/Population Health, and
- Efficiency and Cost Reduction
Physicians take note! The PQRS will serve as the input source for CMS’s Value-Based Payment Modifier (“VBPM”) program. The VBPM program will apply a value modifier to physicians’ claims under the Medicare Physician Fee Schedule (“MPFS”) based upon the quality of care furnished in relation to total costs. Accordingly, what a physician reports under the PQRS this year, if anything, will determine how much money he gets two years from now. Moreover, under the VBPM, physicians who don’t participate in the 2014 PQRS will be subject to an additional -2.0% payment adjustment on all of their MPFS claims. Thus, physicians who fail to properly implement the PQRS this year will be subject to a 4% penalty plus a value based adjustment depending on the quality and efficiency of their care.
With this recent legislative developments , healthcare practitioners need to be extra vigilant in their HIPAA compliance policies and data protection. To avoid exposure, every practice is strongly encouraged to implement a comprehensive compliance program in line with the applicable state and federal regulations.
Please contact our experienced healthcare attorneys with any questions pertaining to implementation of a comprehensive compliance plan, for general regulatory and compliance guidance and, immediately, in the event of an audit or an investigation by any state or federal agency.
Implement Written Policies, Procedures, and Standards of Conduct: Practices must maintain documentation that clearly and specifically outlines the policies and procedures for ensuring such compliance. This often includes a comprehensive “Compliance Plan” and separate written policies and procedures. The Compliance Plan should describe compliance expectations as embodied in a code of conduct or code of ethics, implement the operation of the compliance program, provide guidance to employees and others on dealing with potential compliance issues, and identify how to communicate compliance issues to appropriate compliance personnel. A basic outline of an effective compliance program will consist of:
- Compliance Officer/Committee Designation and High Level Oversight
- Effective Training and Education
- Effective Lines of Communication & Whistleblower Protections
- Effective System for Monitoring, Auditing and Identification of Compliance Risks
- Procedures and System for Prompt Response to Compliance Issues
- Well-Publicized Disciplinary Standards
For example, a physician who unknowingly violates the PPACA, such as the recent Stark Law amendment requiring physicians to inform patients in writing that they have ownership or compensation relationships with providers of in-office ancillary services, could be subject to penalties of up to $15,000 for each service in violation of the Stark Law. Moreover, violations of the Anti-Kickback Statute now implicate the False Claims Act. Thus a simple gift from a physician to a referrer can subject the physician to monetary penalties of up to $25,000 and/or imprisonment of up to 5 years, as well as a penalty of $11,000 per false claim submitted, plus three times the amount of damages sustained by the federal government.Physicians and medical practices are strongly urged to obtain proper legal guidance in this time of high regulatory turbulence in the healthcare arena and ever-increasing complexity of the administrative aspects of the practice of medicine. For answers to all of your compliance related questions, as well as with audit resolution assistance, regulatory counsel, liability avoidance guidance or when in need of an expert professional licensure defense attorney please feel free to contact the healthcare group of our firm at or by phone at 212.634.6350 or 718.787.9500. For more information on our practice areas and the backgrounds of our experienced attorneys please visit our website www.mdrxlaw.com, a place where healthcare practitioners find answers to their legal questions.
One of the worst accusations a physician or any healthcare professional can face is a sexual misconduct complaint. If a physician is contacted by the Office of Professional Medical Conduct (“OPMC”) they should immediately seek legal counsel and avoid engaging in any communications with the investigators prior to securing legal representation. OPMC takes sexual misconduct complaints very seriously and thoroughly investigates even unsupported and plainly baseless accusations. If you or a physician you know is faced with allegations of sexual misconduct or a complaint has been filed by a patient alleging an incident involving inappropriate sexual conduct our team of experienced health care attorneys are here to answer all your questions and defend you in the event that proceedings are in fact initiated by the Office of Professional Medical Conduct....