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:
- familiarize themselves with the problems they have created by reading this article in STAT news.
- begin work on legislation to force the repeal of the CDC Guidelines
- 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.
A BILL TO DETER DEPARTURE OF PROVIDERS FROM PAIN MANAGEMENT
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
111 IT IS THEREFORE DIRECTED upon CDC, NIH, FDA, and HHS/CMS that
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. ======================================