The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 was signed into law on December 8, 2003. Title I of the MMA establishes a new voluntary outpatient prescription drug benefit under Part D of title XVIII of the Social Security Act (the Act). The prescription drug benefit, referred to as Medicare Part D, as well as an employer subsidy for qualified retiree health plans, became effective on January 1, 2006.
Select the links below to access additional information about the MMA.
The Social Security Act (the Act) was enacted into law in 1935, and has had numerous amendments since its inception. One of these amendments was the addition of Title XVIII, Health Insurance for the Aged and Disabled. Part D in Title XVIII is the legislation that sets forth the Medicare prescription drug benefit.
Select this Title XVIII link to navigate to Part D laws specific to the Medicare Prescription Drug Benefit.
the regulations that implement the Part D law. There is a wealth of information in the Preamble that will assist Plans in understanding the law and rules for Part D.
These are the regulations that implement the laws for the Medicare Prescription Drug Benefit. The regulations are in Title 42 of the Code of Federal Regulations.
Select the following links to access the complete Federal Register for 42 CFR Parts 400, 403, 411, 417, 422 and 423 of the Medicare Prescription Drug Benefit.
The CMS Online Manual System is used by CMS program components, partners, contractors, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. They are also a good source for Medicare and Medicaid information for the general public. In 2003, CMS transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. The following link provides access to the Internet Only Manuals (IOMs). These manuals are an exact replica of the agency’s official record copy. To explore the IOMs, please visit the link below on the CMS website.
The Prescription Drug Benefit Manual (Chapter 18) provides in-depth information on the appeals process for Medicare Part D. It provides definitions for commonly used terms, outlines the responsibilities of Part D Plans, and discusses grievances, Coverage Determinations and subsequent appeals handled by Plans, the Part D QIC, ALJs and the MAC.
Select this link to access Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance.
Chapter 6 of the Medicare Prescription Drug Benefit Manual, entitled “Part D Drugs and Formulary Requirements,” provides guidance regarding the limits on Medicare Part D coverage, the formulary requirements for Part D plans, and requirements for enrollee access to covered Part D drugs. The links below provide the reader with guidance regarding coverage issues associated with Medicare Part B vs. Part D coverage for prescription drugs. The first link provides a table for quick and easy reference of Part B vs. Part D coverage issues. This guide addresses the most frequent B/D coverage determination scenarios facing Part D plans and Part D pharmacy providers. It does not address all potential situations. The second link directs you to Appendix C of Chapter 6 of the Medicare Prescription Drug Benefit Manual and it provides a more extensive look at the Part B versus Part D discussion. .
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was passed to provide consumers with increased access to health care insurance, to protect the privacy of health care data, and to promote efficiency in the health care industry. A major component of HIPAA addresses the privacy of individuals’ health information by establishing a federal standard concerning the privacy of health information and how it can be used and disclosed. This federal standard generally preempts all state privacy laws except for those that are more stringent. The HIPAA privacy laws became effective on April 14, 2003.
HIPAA privacy standards apply to health information created or maintained by health care providers who engage in certain electronic transactions, health plans, and health care clearinghouses. Developed by the Department of Health and Human Services (HHS), these standards provide patients with access to their medical records and more control over how their personal health information is used and disclosed. The Office for Civil Rights (OCR) is the departmental component responsible for implementing and enforcing the privacy regulations. (See the Statement of Delegation of Authority to the Office for Civil Rights, as published in the Federal Register on December 28, 2000). HIPAA ensures that those who have access to health information are authorized to have access, and that they will use it appropriately.
Per HIPAA regulations, protected health information (PHI) includes (but is not limited to) name, address, date of birth, social security number, medical records, enrollment data, diagnostic information, payment for healthcare, participation in government health programs and prescription information. This is the kind of information that MAXIMUS Federal Services routinely handles in adjudicating Part D appeals. Protecting PHI is a federal requirement that plans, providers, pharmacies, hospitals and other covered entities, as well as CMS, must comply with, and so must MAXIMUS Federal Services. Accordingly, MAXIMUS Federal Services has very strong PHI protective mechanisms in place to safeguard PHI. MAXIMUS Federal Services cannot: share or sell PHI with other companies for marketing purposes; use PHI for any work that is not part of our contract with CMS; discuss PHI with anyone beyond those with the right to know. Most importantly, MAXIMUS Federal Services must safeguard PHI from unauthorized use or disclosure. Accordingly, MAXIMUS Federal Services has the requisite technology and security to safeguard patient records, electronic PHI, and to limit access to this information to only those with the right to know.
For further information on HIPAA, and for additional resources, click on this link.