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3. Rebalancing long-term care: the role of the Medicaid HCBS waiver program

5. Medicare and mental health: the fundamentals

6. Value-based coverage policy in the United States and the United Kingdom: different paths to a common goal

7. Health care price transparency and price competition

9. The prescription drug safety net: access to pharmaceuticals for the uninsured

13. Shaping Medicaid and SCHIP through waivers: the fundamentals

14. The Ryan White HIV/AIDS Program: the basics

18. The Medicare drug benefit coverage gap: the basics

19. National spending for long-term services and supports (LTSS): the basics

21. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

22. Advancement of emerging technology applications for pharmaceutical innovation and modernization

23. Compliance policy for required warning statements on small-packaged cigars

24. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

25. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

26. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

27. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

28. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

29. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

31. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

32. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

33. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

34. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

35. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

36. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice

38. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

39. Recurrent herpes labialis: developing drugs for treatment and prevention

40. Evaluating drug effects on the ability to operate a motor vehicle

41. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

42. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

43. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

44. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

45. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

46. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

47. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

48. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

49. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

50. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

52. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

53. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

54. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

55. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

56. Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

60. Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace

61. CMS validated hospital inpatient quality reporting program data, but should use additional tools to identify gaming

63. CDC generally met its inspection goals for the federal select agent program: however, opportunities exist to strengthen oversight

65. Round 2 competitive bidding for CPAP/RAD: disrupted access unlikely for devices, inconclusive for supplies

67. OHRP generally conducted its compliance activities independently, but changes would strengthen its independence

68. HHS's Office of Refugee Resettlement improved coordination and outreach to promote the safety and well-being of unaccompanied alien children

69. Medicare program shared savings accountable care organizations have shown potential for reducing spending and improving quality

72. As funding for BPA research increased, NIEHS followed its peer review process while also exercising its discretion

74. Medicare Part B drug payments: impact of price substitutions based on 2014 average sales prices

76. Drug supply chain security: wholesalers exchange most tracing information

81. Enhancements needed in the tracking and collection of Medicare overpayments identified by ZPICS and PSCS

82. A few states fell short in timely investigation of the most serious nursing home complaints: 2011-2015

84. Medicare Part B drug payments: impact of price substitutions based on 2015 average sales prices

85. Medicare payments for clinical diagnostic laboratory tests in 2016: year 3 of baseline data

86. Excluding noncovered versions when setting payment for two Part B drugs would have resulted in lower drug costs for Medicare and its beneficiaries

87. Medicaid Fraud Control Units: investigation and prosecution of fraud and beneficiary abuse in Medicaid personal care services

88. Followup review: CMS's management of the quality payment program

89. Potential misclassifications reported by drug manufacturers may have led to $1 billion in lost Medicaid rebates

90. Entities' experiences and perceptions of reporting the theft, loss, or release of select agents or toxins to CDC

91. Drug supply chain security: dispensers received most tracing information

93. Round two competitive bidding for oxygen: continued access for vast majority of beneficiaries

94. Round two competitive bidding for enteral nutrition: continued access for vast majority of beneficiaries

95. HRSA helped health centers with elevated risks and can continue to take additional steps

97. Part D plans generally include drugs commonly used by dual eligibles: 2018

99. Entities generally met Federal Select Agent Program internal inspection requirements, but CDC could do more to improve effectiveness

100. Opioid use in Medicare Part D remains concerning