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we will use the term DCAPS drugs for the ease of the reader) are not described in section 1842(o)(1)(C) of the Act, provisions under section 1847A of the Act would not apply, including requirements for manufacturers to report ASP to CMS on a quarterly basis (see sections 1847A(f) and 1927(b)(3)(A)(iii) of the Act)

(ii) Review the most recent version of the downloadable FDA Orange Book to determine whether another drug has been approved under a section 505(j) ANDA that is therapeutically equivalent to such generic drug

In the November 2011 final rule (76 FR 67853), we established the initial list of services, identified by Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, that we considered to be primary care services

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How can CMS ensure that advanced primary care hybrid payment increases access to health care services for patients without a usual source of primary care

Personalized care planning is a dynamic process