Health care organizations, manufacturers and investors seeking reimbursement for goods and services need to understand an intricate set of rules and regulations.
Ropes & Gray lawyers have a long history of providing advice about reimbursement requirements and evolving reimbursement policy standards. We understand even the most controversial issues confronting providers and others. We can help health systems, hospitals, physicians, managed care organizations, insurers, and other providers with reimbursement from government health care programs, private insurers and other third party payors.
Our health care lawyers regularly advise clients about the traditional fee-for-service Medicare program, Medicare Advantage, and Medicare Part D, as well as the Medicaid program and SCHIP. We help hospitals and health systems, physician practices, federally qualified health centers, other providers, and health plans apply the full range of Medicare and Medicaid laws, regulations and policies including:
- Reimbursement for physician and hospital services, and increasing reimbursement through issues related to direct and indirect graduate medical education, wage index, geographic classification, and Medicare hospital payment status
- Billing for services provided in clinical trials, billing and reimbursement rules for drugs under Part B, coding for self-administered drugs, and billing options for integrated delivery systems
- Appeals to the Provider Reimbursement Review Board and to the courts
- Requirements for Medicare secondary payers, marketing to potential enrollees, coverage of working aged, provider contracting requirements, federal and state regulation of risk contracts and global capitation contracts, payments to non-contracting providers, coverage of emergency services, beneficiaries’ rights to appeals, and preemption of state insurance laws
- Obtaining necessary insurance licensure requirements to participate in Medicare Part D as a Prescription Drug Plan
- Challenging denials of reimbursement through the applicable administrative appeals process, such as the Medicare Provider Reimbursement Review Board
- Advising providers participating in state Medicaid programs and waiver demonstration programs across the country about payment, coverage, provider qualifications, beneficiary cost sharing, and eligibility issues under fee-for-service and managed care arrangements
- Advice regarding state and federal Medicaid issues relating to payment standards, coverage issues, EPSDT, Medicaid drug formularies, managed care regulations, asset counting and verification, provider conditions of participation, beneficiary cost sharing, fair hearing requirements, Medicaid as payer of last resort, and re-assignment of claims, as well as other issues relevant to Medicaid providers such as the 340B drug discount program
Ropes & Gray lawyers regularly work with managed care organizations and insurers that provide services through government health programs and the private market. We help drug and device manufacturers obtain coverage for their products under government and private insurance programs. We also advise manufacturers about required reporting of pricing information.
We can help with:
- Coverage and payment for drugs and medical devices, including HCPCS code revisions and coverage of off-label uses
- Assessing options for the application of existing billing codes to new technologies and establishment of new billing codes
- Compliance with federal and state rebate and discount requirements applicable to pharmaceutical products
Health care investors turn to Ropes & Gray to evaluate whether a potential health care investment or acquisition will be profitable or a health care product or service worthwhile to license. We assist investors on a broad range of reimbursement issues, including:
- Analysis of reimbursement potential and the future reimbursement environment for health care providers, suppliers, and products under government programs, managed care programs, and private insurance
- Potential liability exposure relating to noncompliance with payment and coverage standards
Our experienced team of health care and litigation lawyers works with a diverse group of health care providers, medical device manufacturers, insurers and other organizations. We provide state of the art advice about reimbursement from government and private sources.
Recent experience includes:
- Advising pharmaceutical manufacturers on structuring reimbursement support programs and patient assistance programs.
- Advising a global biotechnology company in developing a system for streamlining its process for complying with state, federal and international requirements regarding tracking and disclosure of payments to healthcare professionals and other recipients.
- Assessing the off-label promotion risks with respect to the product portfolio of a major US medical device manufacturer and advising on corrective measures.
- Developing contract templates for the engagement of healthcare professional consultants that include appropriate parameters for the relationships.
- Developing and updating compliance policies and procedures on topics such as marketing interactions with providers, grants, publications, privacy, charitable donations and physician consultants for various medical device and pharmaceutical manufacturer clients.
- Representing a chain of nursing homes in the Midwest in a grand jury investigation of alleged Medicare overcharges.
- Defending a Texas provider of home health care against an indictment for Medicare overcharges.
- Defending major academic medical center in its capacity as an owner of a home care/home infusion company in a lengthy federal grand jury investigation conducted by the FBI, and OIG into whether the owner violated the federal anti-kickback statute.
- Representing a number of community hospitals in investigations being conducted by the Department of Justice, FBI and OIG into whether the hospital’s coding of “complex pneumonia” cases was part of a scheme to defraud Medicare.
- Defending a multi-hospital system against Civil False Claims Act investigation for alleged upcoding of pneumonia DRGs.
- Defending a community-based provider of psychiatric and substance abuse treatment in a criminal investigation of Medicare billing.
- Representing a New England hospital in connection with a Civil False Claims Act investigation of “upcoding” of clinical procedures and allegedly improper laboratory charges.
- Representing eight major academic medical centers in the West, the Midwest, the Middle Atlantic States, and New England concerning faculty physician billing practices and coding of procedures, and potential Civil False Claims Act liability.
- Defending two major pharmaceutical manufacturers in grand jury investigations focused on whether the marketing practices of these companies violated the anti-kickback statute and other laws.
- Representing a medical device manufacturer in a protracted federal grand jury investigation conducted by the FBI and the Food and Drug Administration into possible adulteration and misbranding violations of the Food and Drug laws, as well as other allegations.
- Representing academic medical centers and faculty practice plans around the country in extensive investigations by the OIG and the Department of Justice into physician billing under the Physician at Teaching Hospitals or “PATH” initiative.
- Representing a medical transportation company in several criminal and civil investigations conducted by OIG and the Department of Justice directed at allegedly improper billing.
- Representing a medical device manufacturer in a preliminary investigation conducted by a number of federal law enforcement agencies as a result of a qui tam complaint and convinced the government that the allegations had no merit.
- Representing six academic medical centers from around the country in a nationwide OIG investigation directed at whether Medicare billing for investigational cardiac devices was appropriate.
- Representing a number of hospitals from several states in a nationwide investigation by the Department of Justice and the OIG into whether the hospitals violated the rules relating to outpatient and DRG billing.
- Assisting a number of pharmaceutical and medical device companies, pharmacies and a PBM in the development, review and revision of compliance programs and policies.
- Advising pharmaceutical and medical device companies on the development and/or appropriate treatment of discounts or other marketing promotions in contracts with distributors, GPOs and health care providers, including interpretation and application of federal anti-kickback safe harbors.
- Presenting legal educational programs to in-house counsel of various pharmaceutical and medical device companies covering a range of topics, including: government enforcement. initiatives, innovative pharmaceutical marketing initiatives, government price reporting obligations, compliance with state marketing laws, federal regulation of research, federal and state legislative developments in managed care reform laws, formulary management programs, reimbursement support programs, and patient assistance programs.
- Assisting a medical device company acting as a business associate with assessment of its HIPAA compliance program; drafting privacy and security policies and procedures tailored to the company's operations and development; and implementing HIPAA training.