It is past time for Congress to correct the mess they have made of the regulation of opioid pain relievers. Here is contact information for your Senators, Representatives, and Governors’ offices. Call them and demand that they:

  1. familiarize themselves with the problems they have created by reading this article in STAT news.
  2. begin work on legislation to force the repeal of the CDC Guidelines
  3. reign in regulators and drug enforcement authorities from their senseless and unfounded persecution of doctors.

To make it easy for them, here is model legislation that, if enacted, will do all of the above.


Date: July 2019

1        Be it enacted by the Senate and House of Representatives of the United

2       States of America in Congress Assembled.

3       SEC. 1.

4       Title: Deterring Departure of Providers From Pain Management Act

5       SEC. 2.

6       Explanation of terminology:

7       (a) Medical provider means any physician, physician assistant, nurse,

8       nurse practitioner, pharmacist or other medical practitioner licensed at any

9       time since January 1, 2010, to prescribe or dispense Scheduled opioid

10       medications.

11       (b) Chronic, non-cancer pain means “pain lasting longer than 90 days that

12       is not associated with active cancer or outcomes of the treatment of

13       cancer.”

14       (c) Acute pain means “pain of duration less than 90 days, attending injury

15       or disease assessed by a licensed healthcare provider to be temporary in

16       nature, including pain attendant to surgery or other medical interventions.

17       (d) Non-terminal means “not assessed by a licensed healthcare provider

18       as likely to result in death of the patient.”

19       (e) Medically established need means “any measure or program of

20       patient therapy developed by a healthcare provider who is licensed

21       to prescribe Scheduled opioid medications.”

22       (f) AMA means American Medical Association.

23       (g) CDC means the US Centers for Disease Control and Prevention

24       and subsidiary Centers and organizations.

25       (h) FDA means US Food and Drug Administration and subsidiary Centers and organizations

26       (i) VHA means the US Veterans Health Administration

27       (j) HHS/CMS means the US Department of Health and Human Services,

28       Centers for Medicare and Medicaid Services and subsidiary Centers and

29       organizations

30       (k) NIH means US National Institutes of Health and subsidiary 31 organizations

32       (l) Opioid means a class of drugs that are pharmaceutical-grade

33       medicines available legally by prescription and used for control of pain.

34       This Bill does not apply to nor is it intended to modify, any law

35       concerning illegal, drugs such as heroin or illegally manufactured or

36       imported synthetic opioids such as fentanyl.

37       (m) MMED means “Morphine Milligram Equivalent Dose”, an estimate of

38       the pharmacological strength of drugs in the class of opioids, relative to

39       morphine.

40       (n) Legacy patient means “any patient who has been treated previously

41       by a licensed healthcare provider in a therapy plan that includes any

42       medication or medications among the class of opioids.”

43       SEC. 3.

44       Purpose of this Bill: To deter the departures of providers from pain

45       management practice by amending and redirecting Federal policy and

46       regulation pertaining to prescribing opioid medications to patients with

47       acute or chronic pain, as applied by CDC, FDA, NIH, and HHS/CMS.

48       SEC. 4.

49       No additional funding is required for this Bill. Enforcement and

50       administration of this Bill will not be modified.

51       SEC. 5.

52       Enactment Date: 30 days following signature by the President.

53       WHEREAS: The US CDC issued a Guideline in March 2016 for

54       prescription of opioids to adults with chronic non-cancer pain; and

55       WHEREAS: The CDC Guideline has been challenged broadly by many

56       medical professional associations, individual researchers and

57       practitioners on grounds including unacknowledged anti-opioid bias on the

58       part of the CDC writers, failure to establish consistent standards of

59       research quality, failure to address the natural variability in individual

60       genetic profiles affecting patient metabolism for opioid analgesics; and

61       consequent harms to both legacy and new patients due to withholding of

62       opioid therapy, coerced tapers, consequent withdrawal symptoms, and under-treatment of pain; and

63       WHEREAS: Regulatory over-reach referenced to or grounded upon the

64       2016 CDC Guideline has interfered with doctor-patient relationships and

65       usurped physicians’ authority to manage treatment regimens which

66       include prescribing opioids for pain; and

67       WHEREAS: Thousands of new and legacy patients with medically

68       documented needs for management of acute, chronic, non-cancer and

69       non-terminal pain are being denied the only pharmaceutical products in

70       the formulary that are effective for many of them; and

71       WHEREAS: It is now known definitively that the declared National crisis in

72       opioid addiction and overdose deaths is driven almost entirely by illegal

73       street drugs rather than by medically prescribed opioids; and

74       WHEREAS: When managed and used by medical providers and patients

75       for medically established needs, opioids have for decades been known to

76       be safe and effective pharmaceuticals for controlling acute and chronic

77       pain; and

78       WHEREAS: The American Medical Association affirms that some patients

79       with acute or chronic pain can benefit from taking opioid pain medications

80       at doses greater than generally recommended in the 2016 CDC Guideline

81       and that such care may be medically necessary and appropriate; and

82       WHEREAS: In violation of the intent of the CDC Guideline, both Federal

83       and State drug enforcement agencies have seized upon the Guideline as

84       a standard for assessing when providers are “over prescribing” opioids to

85       their patients; criminal investigations of providers have ruined medical

86       practices by prominent announcements in public media, attempting to

87       coerce practice employees to disclose provider misbehavior, seizing

88       and freezing access to patient records, and in some instances seizing civil

89       assets — often for months before cases are brought to court ; and

90       WHEREAS: The hostile regulatory environment created by such sanctions

91       is prompting hundreds of providers, practices, and hospitals to cease

92       prescribing opioid analgesic medications or to depart from practice

93       entirely; and

94       WHEREAS: There is documented proof from data published by CDC that

95       rates of opioid prescribing by healthcare providers are unrelated to rates

96       of overdose-related mortality from all sources – including legal

97       prescriptions, diverted prescriptions and illegal street drugs; and

98       WHEREAS: The US Congress made the CDC Guidelines mandatory for

99       medical practice in the Veterans Health Administration in the budget

100       resolution bill of December 2015 — three months before CDC publication.

101       VHA interpreted the Guideline to require that all patients being treated

102       with opioid pain relievers must be tapered to zero; many patients are now

103       offered Tylenol or Ibuprofen at high doses after surgery, creating risks of

104       liver or kidney failure; and

105       WHEREAS: Due to over-regulation of opioid supplies and insurance

106       providers’ application of “high prescriber” alerts toward providers and

107       pharmacies, National chain pharmacies are failing to stock adequate

108       supplies of prescription opioids and turning away patients presenting valid

109       prescriptions written by licensed healthcare providers.

110       SECTION 6


112       (a) Section 6.1

113       It is henceforth Federal policy and practice for regulation of prescription

114       opioid pain relievers, that no Federal Agency shall apply MMED (Morphine

115       Milligram Equivalent Dose) thresholds as anything more than

116       non-mandatory guidance; further, that — in the absence of other

117       indications of verifiable harms to patients — no medical provider shall be

118       subject to professional discipline, loss of board certification, loss of clinical

119       privileges, criminal investigation, prosecution, civil liability or other

120       penalties or practice limitations, solely as a consequence of prescribing

121       opioids at quantitative levels above any fixed numeric MMED threshold,

122       including those of the 2016 CDC Guideline.

123       (b) Section 6.2

124       The 2016 CDC Guideline on Prescription of Opioids to Adults With

125       Chronic Pain is hereby withdrawn, pending rewrite by an Inter Agency

126       Task Force to be led by the NIH Office for Pain Policy, for completion

127       on or before May 31, 2021. This rewrite shall be conducted in a publicly

128       transparent process that includes patients and/or their advocates as voting

129       members of the writers group.

130       (c) Section 6.3

131       Section 131 of the “Veterans Administration Mission Act” of 2018 is hereby

132       repealed; within two years of enactment of this Act, VHA is directed to

133       withdraw and rewrite its “Opioid Safety Initiative” and all Clinical Practice

134       Guidelines associated therewith, to reflect Federal policy changes directed

135       above.

136       (d) Section 6.4

137       Within 30 days of enactment of this Act, HHS/DHS is directed to rescind

138       January 2019 Medicare Part D and Medicare Advantage rule changes

139       which authorize insurance providers to require pharmacies to conduct

140       “safety edits” for prescriptions which exceed numerical MME thresholds.

141       (e) Section 6.5

142       Within 30 days of enactment of this Act, VHA, HHS/CMS, and FDA are

143       directed to publish letters to all medical providers licensed under their

144       respective healthcare systems, conveying the mandatory changes of

145       Federal regulatory policy above. These letters shall further be

146       disseminated to all State Medical Boards, Pharmacy Boards, Departments

147       of Health, Medicaid programs, Insurance Boards, and State Attorney

148       Generals. ======================================