Overview of Medicaid Law

Medicaid is a medical assitance program jointly financed by state and federal governments for low income individuals and is embodied in 42 U.S.C. §1396 et seq. It was first enacted in 1965 as an amendment to the Social Security Act of 1935. Today, Medicaid is a major social welfare program and is administered by the Centers for Medicare and Medicaid Services (CMS).

Among the services that Medicaid covers are: in-patient hospital services, out-patient hospital services, laboratory and x-ray services, skilled nursing home services, physicians' services, physical therapy, hospice care, and rehabilitative services. Patients are restricted when selecting who will take care of their needs by selecting from pre-approved physicians and other providers of medical care. Because physicians are not fully reimbursed for services provided to Medicaid patients, many of them limit the number of Medicaid patients they see.

Federal law dictates that states may not reduce other welfare benefits people receive when they become eligible for Medicaid. Also, states may not impose citizenship or residency requirements other than requiring that an applicant be a resident of the state. Neither the age of the applicant nor the fact that he or she works are restrictions to receiving Medicaid.

Since its inception, the program has been plagued by fraud from both health care providers and patients. To curb these, Congress passed a law in 1996 making persons criminally liable for committing fraud in order to become eligible for medical assistance. (See 42 U.S.C.§§ 1320a-7b).

Pharmaceutical Product Commercialization

Increasing R&D costs, generic competition and fragile pipelines make the successful launch of new drugs critically important for pharmaceutical and biotechnology companies. Optimal resource allocation for the commercial development of emerging brands, however, continues to challenge companies across both sectors. This paper profiles one brand’s marketing expenditures and team headcounts throughout commercialization.
View Whitepaper

[Source: FierceBiotech]

The Difference with Biologics: The Scientific, Legal and Regulatory Challenges of Any Follow-On Biologics Scheme

The paper details the legal and regulatory implications of the many important differences between biologics and traditional “small molecule” drugs.
View Whitepaper

[Source: FierceBiotech]

Healthcare Regulation Overview

Regulation plays a major role in the healthcare industry and healthcare insurance coverage. Through various regulatory bodies, the Department of Health and Human Services (HHS) protects the public from a number of health risks and provides programs for public health and welfare. Together, these regulatory agencies protect and regulate public health at every level.

Healthcare

The Centers for Medicare and Medicaid (CMS), founded in 1965, oversee most of the regulations related directly to the healthcare system. CMS provides government-subsidized medical coverage through a number of programs:

• Medicare for the elderly and disabled
• Medicaid for lower-income individuals and families
• State Children’s Health Insurance Program (SCHIP) for health insurance coverage for children under 19

CMS is also responsible for ensuring compliance to the Health Insurance Portability and Accountability Act (HIPAA). HIPPA is a major piece of healthcare regulation instituted to improve the efficiency and effectiveness of the healthcare system – to “cut the fat” while at the same time protecting patients and providing better medical care.

The Agency for Healthcare Research and Quality (AHRQ) is another agency that falls under the auspices of HHS. It conducts research aimed at improving the quality of healthcare, reducing its costs, and addressing patient safety and medical errors.

Non-profit organizations serving as watchdogs and accreditation institutions for healthcare in America:

• The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is an NPO focused on ensuring that healthcare organization provide quality care. JCAHO employs a system in which healthcare organizations are examined and then given a score between 1-100, with higher scores being better. These scores are important to healthcare organizations as they are a factor in reimbursement from Medicare.
• The National Committee for Quality Assurance (NCQA) is an NPO that ensures the quality of America’s managed care plans. It was established in 1991 to provide standard, objective information about HMOs.
  

Other Public Health Regulation

In addition to the CMS programs, the HHS has many regulatory departments that oversee other forms of public health regulation.

• The Centers for Disease Control and Prevention (CDC) in Atlanta, GA, examines public health and warns of possible health threats from infectious diseases. The CDC monitors birth defects, disabilities, diseases and conditions, emergency preparedness and response, environmental health, genetics and genomics, health promotion, injury and violence, travelers’ health, vaccines and immunizations and workplace safety and health.
• The Food and Drug Administration (FDA) is the federal regulatory agency responsible for the controlling the safety and effectiveness of the country’s drug supply for both humans and animals. The FDA regulates food safety, cosmetics, feed supply for animals, dietary supplements, biologics and the national blood supply, medical devices, food additives, product recalls, and restaurant inspection.
• The United States Agency for Toxic Substances and Disease Registry (ATSDR) monitors and regulates the effects of hazardous materals on public health. The ATSDR responds to hazardous materal threats, educates the public on hazmat risks, and involves community members and organizations to encourage participation in ATSDR’s activities.

[Source: FierceHealthcare]

Tennessee Educates MDs on Drug-Fraud Law

Tennessee's Office of the Inspector General wants to be sure medical professionals know about new legislation designed to reduce TennCare drug fraud. So the state OIG just sent out letters to more than 30,000 doctors, pharmacists and nurses educating them on the details of a new law designed to cut down on patient "doctor shopping" (visiting multiple doctors to get similar or the same medications from each). The state's OIG was created three years ago specifically to root out and prosecute fraud against TennCare. Since its inception in February 2005, the office has arrested 460 individuals for TennCare fraud, has collected more than $700,000 in restitution, and avoided more than $75 million in costs.

To learn more about the new law:
- read this Memphis Business Journal item

[From Memphis Business Journal, July 25, 2007]
The letters advise physicians and others that it is a Class E felony for a person to "willingly go to different providers, with the intent to deceive, in search of a controlled substance without disclosing to the provider they have already received one from another provider within a 30-day period, and either the clinical visit or the controlled substance was paid for by TennCare."

[Source: FierceHealthcare, July 27, 2007]