Oklahoma 2022 Regular Session

Oklahoma House Bill HB2649 Compare Versions

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Version 2 (New)

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1		-	An Act
2		-	ENROLLED HOUSE
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	3	+	ENGR. S. A. TO ENGR. H. B. NO. 2649 Page 1 1
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	28	+	ENGROSSED SENATE AMENDMENT
	29	+	TO
	30	+	ENGROSSED HOUSE
3	31		BILL NO. 2649 By: Echols of the House
4	32
5	33		and
6	34
7		-	~~Garvin, Dugger,~~ ~~and~~
8		-	~~Stephens of the Senate~~
	35	+	Dugger of the Senate
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9	37
10	38
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12	40		An Act relating to durable medical equipment;
	41	+	creating the Oklahoma Durable Medical Equipment
	42	+	Licensing Act; defining terms; requiring a license;
	43	+	providing for effective date of license; authorizing
	44	+	certain inspections; requiring promulgation of rules;
	45	+	construing provision ; providing for licensing
	46	+	qualifications; providing for license revocation or
	47	+	suspension; listing exceptions; providing for
	48	+	codification; and providing an effective date .
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	52	+	AUTHOR: Remove as principal Senate author Dugger and substitute as
	53	+	principal Senate autho r Garvin. Retain Dugger as Senate
	54	+	coauthor
	55	+
	56	+	AUTHOR: Add the following Senate Coauthor: Stephens
	57	+
	58	+	AMENDMENT NO. 1. Page 1, strike the title, enacting clause and
	59	+	entire bill and insert
	60	+
	61	+	“An Act relating to durable medical equipment;
13	62		creating the Oklahoma Durable Medical Equipment
14	63		Licensing Act; defining terms; requiring a license;
15	64		stipulating duration of license; aut horizing certain
16	65		inspections; requiring promulgation of rules;
17	66		construing provision; stating licensing
18	67		qualifications; requiring license for each individual
19	68		location; allowing licensing of out -of-state supplier
20	69		under certain condition and assessment of add itional
21	70		fee; requiring licensed supplier to meet established
22	71		safety standards; providing for license revocation or
23	72		suspension; listing exceptions; amending 59 O.S.
24	73		2021, Section 353.1, which relates to definitions
25	74		used in the Oklahoma Pharmacy Act; adding definition;
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26	101		amending 59 O.S. 2021, Section 353.7, which relates
27	102		to powers and duties of the State Board of Pharmacy;
28	103		broadening power to issue licenses; establishing
29	104		licensure fees for stated entities; providing for
30	105		codification; and providing an effective date.
31	106
32	107
33		-	SUBJECT: Durable medical equipment
34	108
35	109		BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
36		-
37	110		SECTION 1. NEW LAW A new section of law to be codified
38	111		in the Oklahoma Statutes as Section 375.1 of Title 59, unless there
39	112		is created a duplication in numbering, reads as follows:
40		-
41	113		Sections 2 through 5 of this act shall be known and may be cited
42		-	as the "Oklahoma Durable Medical Equipment Licensing Act ".
43		-
	114	+	as the “Oklahoma Durable Medical Equipment Licensing Act ”.
44	115		SECTION 2. NEW LAW A new section of law to be codified
45	116		in the Oklahoma Statutes as Section 37 5.2 of Title 59, unless there
46		-	is created a duplication in numbering, reads as follows: ENR. H. B. NO. 2649 Page 2
47		-
	117	+	is created a duplication in numbering, reads as follows:
48	118		As used in the Oklahoma Durable Medical Equipment Licensing A ct:
49		-
50		-	1. "Board" means the State Board of Pharmacy;
51		-
52		-	2. a. "Durable medical equipment" means equipment for which
53		-	a prescription is required, including for repair and
	119	+	1. “Board” means the State Board of Pharmacy;
	120	+	2. a. “Durable medical equipment” means equipment for which
	121	+	a prescription is required including for repair and
54	122		replacement parts, and that :
55		-
56	123		(1) can stand repeated use,
57		-
58	124		(2) has an expected useful life of at least t hree (3)
59	125		years,
60		-
61	126		(3) is primarily and customarily used to serve a
62	127		medical purpose,
63	128
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64	154		(4) is not generally useful to a person in the
65	155		absence of illness or injury,
66		-
67	156		(5) is appropriate for use in the home, and
68		-
69	157		(6) is intended for use by the consumer .
70		-
71	158		b. Durable medical equipment includes, but is not limited
72	159		to:
73		-
74	160		(1) ambulating assistance equipment,
75		-
76	161		(2) mobility equipment,
77		-
78	162		(3) rehabilitation seating,
79		-
80	163		(4) oxygen care and oxygen delivery systems,
81		-
82	164		(5) respiratory equipment and respiratory disease
83	165		management devices,
84		-
85	166		(6) rehabilitation environmental control equipment,
86		-
87	167		(7) ventilators,
88		-
89	168		(8) apnea monitors,
90		-
91		-	(9) diagnostic equipment, ENR. H. B. NO. 2649 Page 3
92		-
	169	+	(9) diagnostic equipment,
93	170		(10) feeding pumps,
94		-
95	171		(11) beds prescribed by physicians to alleviate
96	172		medical conditions,
	173	+	(12) transcutaneous electrical nerve stimulators, and
	174	+	(13) sequential compression devices; and
	175	+	3. “Supplier” means any person or entity that provides durabl e
	176	+	medical equipment services or products and that currently bills or
97	177
98		-	(12) transcutaneous electrical nerve stimulators, and
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99	202
100		-	(13) sequential compression devices; and
101		-
102		-	3. "Supplier" means any person or entity that provides durabl e
103		-	medical equipment services or products and that currently bills or
104	203		plans to bill a claim for reimbursement of services or products to a
105	204		third party.
106		-
107	205		SECTION 3. NEW LAW A new section of law to be codified
108	206		in the Oklahoma Statutes a s Section 375.3 of Title 59, unless there
109	207		is created a duplication in numbering, reads as follows:
110		-
111	208		A. Any supplier of durable medical equipment to a cons umer in
112	209		this state shall possess a durable medical equipment supplier
113	210		license issued by the State Board of Pharmacy pursuant to the
114	211		Oklahoma Durable Medical Equipment Licensing Act .
115		-
116	212		B. Licenses issued by the Board pursuant to the Oklahoma
117	213		Durable Medical Equipment Licensing Act shall be effective for
118	214		twelve (12) months from the date of issuance and shall not be
119	215		transferable or assignable.
120		-
121	216		C. The Board may initially and periodically inspect the
122		-	applicant's office or place of business.
123		-
	217	+	applicant’s office or place of business.
124	218		D. The Board shall promulgate rules necessary to implement the
125	219		provisions of the Oklahoma Durable Medical Equipment Licens ing Act.
126	220		Such rules shall prioritize patient safety and quality of durable
127	221		medical equipment. The Board may provide by rule that a ny person or
128	222		entity accredited by organizations recognized by the Centers for
129	223		Medicare and Medicaid Services is deemed to me et all or some of the
130	224		requirements of the Oklahoma Durable Medical Equipment Licensing
131	225		Act.
132	226
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133	252		E. Nothing in this section shall be construed to restrict or
134	253		prohibit private transactions between two parties.
135		-	ENR. H. B. NO. 2649 Page 4
136	254		SECTION 4. NEW LAW A new se ction of law to be codified
137	255		in the Oklahoma Statutes as Section 37 5.4 of Title 59, unless there
138	256		is created a duplication in numbering, reads as follows:
139		-
140	257		A. The State Board of Pharmacy may issue a license to an
141	258		applicant for licensure as a supplier of dura ble medical equipment
142	259		if the applicant pays the appropriate license fee established under
143		-	Section 8 of this act and submits, in a form prescribed b y the
144		-	Board, an application and proof that the applicant:
145		-
	260	+	Section 8 of this act and submits in a form prescribed by the Bo ard
	261	+	an application and proof that the applicant:
146	262		1. a. Maintains a physical office or place of busine ss
147	263		within this state, or
148		-
149	264		b. For a Medicare or Medicaid enrolled out-of-state
150	265		supplier, maintains a physical office or place of
151		-	business within one hundred (100) miles of a resident
152		-	of this state being served by the supplier ;
153		-
	266	+	business is within one hundred (100) miles of a
	267	+	resident of this state being served by the supplier ;
154	268		2. Has obtained a state sales tax permit and any other
155	269		necessary license or permit as determined by the Board including but
156	270		not limited to any permit from the S tate Department of Health; and
157		-
158	271		3. Meets all state and federal accreditation requirements .
159		-
160	272		Each individual physical office o r place of business o wned or
161	273		operated by the supplier must be licen sed separately.
162		-
163	274		B. 1. The Board may issue a license to a Medicare or Medicaid
164	275		enrolled out-of-state supplier who has at least one accredited
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165	302		facility within one hundred (100) miles of any resident of this
166	303		state being served by the supplier.
167		-
168	304		2. The Board may assess a fee on out-of-state suppliers
169	305		necessary to cover the cost of inspect ion of those suppliers. The
170	306		inspection fee shall be in addition to the licensure fee.
171		-
172	307		C. A supplier licensed by the Board shall meet all safety
173	308		standards established by the Board, which shall include, but not be
174	309		limited to:
175		-
176		-	1. Ensuring that all personnel engaged in delivery,
177		-	maintenance, and repair of durable medical equipment receive annual
178		-	continuing education;
179		-	ENR. H. B. NO. 2649 Page 5
180		-	2. Instructing the patient or patient 's caregiver about how to
	310	+	1. Ensuring that all personnel e ngaged in delivery, maintenance
	311	+	and repair of durable medical equipment receive annual continuing
	312	+	education;
	313	+	2. Instructing the patient or patient ’s caregiver about how to
181	314		use the durable medical equipment provided ;
182		-
183	315		3. Receiving and responding to complaint s from patients;
184		-
185	316		4. Maintaining records of all patients receiving durable
186	317		medical equipment; and
187		-
188	318		5. Managing, maintaining , and servicing durable medical
189	319		equipment.
190		-
191	320		D. The Board may revoke or suspend a license for:
192		-
193	321		1. Violation of state or federal la w;
194		-
195	322		2. Violation of rules promulgated pursuant to the Oklahoma
196	323		Durable Medical Equipment Licensing Act ;
	324	+	3. Permitting, aiding, or abetting any illegal act;
197	325
198		-	3. Permitting, aiding, or abetting any illegal act;
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200	351		4. Failing to meet the safety standards established by the
201	352		Board pursuant to the Oklahoma Durable Medical Equipment Licensing
202	353		Act;
203		-
204	354		5. Engaging in conduct or practices found by the Board to be
205	355		detrimental to the health, safety , or welfare of patients; or
206		-
207	356		6. Failing to renew a license.
208		-
209	357		SECTION 5. NEW LAW A new section of law to b e codified
210	358		in the Oklahoma Statutes as Section 37 5.5 of Title 59, unless there
211	359		is created a duplication in numbering, reads as follows:
212		-
213	360		The Oklahoma Durable Medical Equipment Licensing Act shall not
214	361		apply to:
215		-
216	362		1. Pharmacies and pharmacists;
217		-
218	363		2. Hospitals;
219		-
220	364		3. Ambulatory surgical centers;
221		-
222	365		4. Health care facilities owned or operated by the state or
223	366		federal government;
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225	367		5. Skilled nursing facilities;
226		-
227	368		6. Assisted living facilities;
228		-
229	369		7. Prosthetic or orthotic practitioners;
230		-
231	370		8. Health care practitioners who are licensed to practice
232	371		health care in this state and who provide durable medical equipment
233	372		within the scope of their health care practice;
234		-
235	373		9. Manufacturers or wholesale distributors that do not sell or
236	374		rent durable medical equipment directly to consumers;
237	375
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238	401		10. Suppliers of insulin infusion pumps and related supplies or
239	402		services; or
240		-
241		-	11. Suppliers of medical devices approved by the U.S. Food and
242		-	Drug Administration that are used in the treatment of cancerous
243		-	tumors.
244		-
	403	+	11. Suppliers of medical devices approved by the Food and Drug
	404	+	Administration that are used in the treatment of cancerous tumors .
245	405		SECTION 6. AMENDATORY 59 O.S. 2021, Section 353.1, is
246	406		amended to read as follows:
247		-
248		-	Section 353.1 For the purposes of the Ok lahoma Pharmacy Act:
249		-
250		-	1. "Accredited program" means those seminars, classes,
	407	+	Section 353.1. For the purposes of the Ok lahoma Pharmacy Act:
	408	+	1. “Accredited program” means those seminars, classes,
251	409		meetings, work projects, and other educational cou rses approved by
252	410		the Board for purposes of continuing professional education;
253		-
254		-	2. "Act" means the Oklahoma Pharmacy Act;
255		-
256		-	3. "Administer" means the direct application of a drug, whether
	411	+	2. “Act” means the Oklahoma Pharmacy Act;
	412	+	3. “Administer” means the direct application of a drug, whether
257	413		by injection, inhalation, ingestion or any other means, to the body
258	414		of a patient;
259		-
260		-	4. "Assistant pharmacist" means any person presently licensed
	415	+	4. “Assistant pharmacist” means any person presently licensed
261	416		as an assistant pharmacist in the State of Oklahoma by the Board
262	417		pursuant to Section 353.10 of this title and for the purposes of the
263	418		Oklahoma Pharmacy Act shall be considered the s ame as a pharmacist,
264	419		except where otherwise specified;
265		-
266		-	5. "Board" or "State Board" means the State Board of Pharmacy;
267		-
268		-	6. "Certify" or "certification of a prescription " means the
269		-	review of a filled prescription by a licensed pharmac ist or a ENR. H. B. NO. 2649 Page 7
	420	+	5. “Board” or “State Board” means the State Board of Pharmacy;
	421	+	6. “Certify” or “certification of a prescription ” means the
	422	+	review of a filled prescription by a licensed pharmacist or a
270	423		licensed practitioner with dispensing authori ty to confirm that the
271	424		medication, labeling an d packaging of the filled prescription are
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272	451		accurate and meet all requirements prescribed by state and federal
273		-	law. For the purposes of this paragraph, "licensed practitioner"
	452	+	law. For the purposes of this paragraph, “licensed practitioner ”
274	453		shall not include optometrists wit h dispensing authority;
275		-
276		-	7. "Chemical" means any medicinal substance, whether simple or
	454	+	7. “Chemical” means any medicinal substance, whether simple or
277	455		compound or obtained through the process of the science and art of
278	456		chemistry, whether of organic or inorganic origin;
279		-
280		-	8. "Compounding" means the combining, admixing, m ixing,
	457	+	8. “Compounding” means the combining, admixing, m ixing,
281	458		diluting, pooling, reconstituting or ot herwise altering of a drug or
282	459		bulk drug substance to create a drug. Compounding includes the
283	460		preparation of drugs or devices in anticipation of prescription drug
284	461		orders based on routine, regularly observed pre scribing patterns;
285		-
286		-	9. "Continuing professiona l education" means professional,
	462	+	9. “Continuing professiona l education” means professional,
287	463		pharmaceutical education in the general areas of the socioeconomic
288	464		and legal aspects of health care; the properties and actions of
289	465		drugs and dosage forms; and the etiology, char acteristics and
290	466		therapeutics of the diseased s tate;
	467	+	10. “Dangerous drug”, “legend drug”, “prescription drug” or “Rx
	468	+	Only” means a drug:
	469	+	a. for human use subject to 21 U.S.C. 353(b)(1), or
	470	+	b. is labeled “Prescription Only”, or labeled with the
	471	+	following statement: “Caution: Federal law restricts
	472	+	this drug except for use by or on the order of a
	473	+	licensed veterinarian”.;
291	474
292		-	10. "Dangerous drug", "legend drug", "prescription drug" or "Rx
293		-	Only" means a drug:
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295		-	a. for human use subject to 21 U.S.C. 353(b)(1), or
296		-
297		-	b. is labeled "Prescription Only", or labeled with the
298		-	following statement: "Caution: Federal law restricts
299		-	this drug except for use by or on the order of a
300		-	licensed veterinarian.";
301		-
302		-	11. "Director" means the Executive Director of the State Board
	500	+	11. “Director” means the Executive Director of the State Board
303	501		of Pharmacy unless context clearly indicates otherwise;
304		-
305		-	12. "Dispense" or "dispensing" means the interpretation,
	502	+	12. “Dispense” or “dispensing” means the interpretation,
306	503		evaluation, and implementation of a prescription drug order ,
307	504		including the preparation and delivery of a drug or device to a
308		-	patient or a patient 's agent in a suitable container appropria tely
	505	+	patient or a patient ’s agent in a suitable container appropria tely
309	506		labeled for subsequent ad ministration to, or use by, a patient.
310	507		Dispense includes sell, distribute, leave with, give away, dispose
311	508		of, deliver or supply;
312		-
313		-	13. "Dispenser" means a retail pharmacy, hospital pharmacy, a
314		-	group of chain pharmacies under c ommon ownership and control th at do ENR. H. B. NO. 2649 Page 8
	509	+	13. “Dispenser” means a retail pharmacy, hospital pharmacy, a
	510	+	group of chain pharmacies under c ommon ownership and control th at do
315	511		not act as a wholesale distributor, or an y other person authorized
316	512		by law to dispense or adm inister prescription drugs, and the
317	513		affiliated warehouses or distributions of such entities under common
318	514		ownership and control t hat do not act as a wholesale distributor.
319		-	For the purposes of this paragrap h, "dispenser" does not mean a
	515	+	For the purposes of this paragrap h, “dispenser” does not mean a
320	516		person who dispenses only products to be used in animals in
321	517		accordance with 21 U.S.C. 360b(a)(5);
322		-
323		-	14. "Distribute" or "distribution" means the sale, purchase,
	518	+	14. “Distribute” or “distribution” means the sale, purchase,
324	519		trade, delivery, handling, storage, or receipt of a product, and
325	520		does not include the dispensing of a product pursua nt to a
326	521		prescription executed in accordance with 21 U.S.C. 353(b)(1) or the
327	522		dispensing of a product approved under 21 U.S.C. 360 b(b); provided,
	523	+
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328	549		taking actual physical possession of a product or title shall not be
329	550		required;
330		-
331		-	15. "Doctor of Pharmacy" means a person licensed by the Board
332		-	to engage in the practice of pharmacy. The terms "pharmacist",
333		-	"D.Ph.", and "Doctor of Pharmacy" shall be interchangeable and s hall
	551	+	15. “Doctor of Pharmacy” means a person licensed by the Board
	552	+	to engage in the practice of pharmacy. The terms “pharmacist”,
	553	+	“D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and s hall
334	554		have the same meaning wherever they appear in the Oklahoma Statutes
335	555		and the rules promulgated by the Board;
336		-
337		-	16. "Drug outlet" means all manufacturers, repackagers,
	556	+	16. “Drug outlet” means all manufacturers, repackagers,
338	557		outsourcing facilities, wholesale distributors, third -party
339	558		logistics providers, pharm acies, and all other facilities which are
340	559		engaged in dispensing, delivery, distribution or storage of
341	560		dangerous drugs;
342		-
343		-	17. "Drugs" means all medicinal substances and preparations
	561	+	17. “Drugs” means all medicinal substances and preparations
344	562		recognized by the United States Pharmacopoeia and National
345	563		Formulary, or any revision thereof, and all substances and
346	564		preparations intended for external and/or internal use i n the cure,
347	565		diagnosis, mitigation, treatment or prevention of disease in humans
348	566		or animals and all substances and preparations, other than food,
349	567		intended to affect the structure or any function of the body of a
350	568		human or animals;
351		-
352		-	18. "Drug sample" means a unit of a prescription drug packaged
	569	+	18. “Drug sample” means a unit of a prescription drug packaged
353	570		under the authority and responsibility of the manufacturer that is
354	571		not intended to be sold and is intended to promote the sale of the
355	572		drug;
356	573
357		-	19. "Durable medical equipment " has the same meaning as
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	592	+	19
	593	+	20
	594	+	21
	595	+	22
	596	+	23
	597	+	24
	598	+
	599	+	19. “Durable medical equipment ” has the same meaning as
358	600		provided by Section 2 of this act;
359		-	ENR. H. B. NO. 2649 Page 9
360		-	20. "Filled prescription" means a packaged prescription
	601	+	20. “Filled prescription” means a packaged prescription
361	602		medication to which a label has been affixed which contain s such
362	603		information as is requi red by the Oklahoma Pharmacy Act;
363		-
364		-	20. 21. "Hospital" means any institution licensed as a hospital
	604	+	20. 21. “Hospital” means any institution licensed as a hospital
365	605		by this state for the care and treatment of patients, or a pharmacy
366	606		operated by the Oklahoma Department of Veterans Affairs;
367		-
368		-	21. 22. "Licensed practitioner " means an allopathic physician,
	607	+	21. 22. “Licensed practitioner ” means an allopathic physician,
369	608		osteopathic physician, podiatric physician, dentist, veterinarian or
370	609		optometrist licensed to practice and authorize d to prescribe
371	610		dangerous drugs within the scope of practice of such practitione r;
372		-
373		-	22. 23. "Manufacturer" or "virtual manufacturer" means with
	611	+	22. 23. “Manufacturer” or “virtual manufacturer” means with
374	612		respect to a product:
375		-
376	613		a. a person that holds an application appr oved under 21
377	614		U.S.C. 355 or a license issued under 42 U.S.C. 262 for
378	615		such product, or if such product is not the subject of
379	616		an approved application or license , the person who
380	617		manufactured the product,
381		-
382	618		b. a co-licensed partner of the person described in
383	619		subparagraph a that obtains the product directly from
384	620		a person described in this subparagraph or
385		-	subparagraph a of this paragraph,
	621	+	subparagraph a,
	622	+
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386	647
387	648		c. an affiliate of a person described in subpara graph a
388	649		or b who receives the product directly from a person
389	650		described in this subparagraph or in subparagraph a or
390		-	b; of this paragraph, or
391		-
	651	+	b;, or
392	652		d. a person who contracts wi th another to manufacture a
393	653		product;
394		-
395		-	23. 24. "Manufacturing" means the production, preparation,
	654	+	23. 24. “Manufacturing” means the production, preparation,
396	655		propagation, compounding, conversion or processing of a device or a
397	656		drug, either directly or indirectly by extraction from substances of
398	657		natural origin or independ ently by means of chemical or biological
399	658		synthesis and includes any pac kaging or repackaging of the
400	659		substances or labeling or relabeling of its container, and the
401	660		promotion and marketing of such drug s or devices. The term
402		-	"manufacturing" also includes the preparation and ~~promoti on~~ of
	661	+	“manufacturing” also includes the preparation and promotion of
403	662		commercially available products from bulk compounds for resale by
404		-	licensed pharmacies, licensed practitioners or other persons; ENR. H. B. NO. 2649 Page 10
	663	+	licensed pharmacies, licensed practitioners or other persons;
	664	+	24. 25. “Medical gas” means those gases including those in
	665	+	liquid state upon which the manufacturer o r distributor has placed
	666	+	one of several cautions, such as “Rx Only”, in compliance with
	667	+	federal law;
	668	+	25. 26. “Medical gas order” means an order for medical gas
	669	+	issued by a licensed prescriber;
	670	+	26. 27. “Medical gas distributor ” means a person licensed to
	671	+	distribute, transfer, wholesale, deliver or sell medical gases on
405	672
406		-	24. 25. "Medical gas" means those gases including those in
407		-	liquid state upon which the manufacturer or distributor has placed
408		-	one of several cautions, such as "Rx Only", in compliance with
409		-	federal law;
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410	697
411		-	25. 26. "Medical gas order" means an order for medical gas
412		-	issued by a licensed prescriber;
413		-
414		-	26. 27. "Medical gas distributor " means a person licensed to
415		-	distribute, transfer, wholesale, deliver or sell medical gases on
416	698		drug orders to suppliers or oth er entities licensed to use,
417	699		administer or distribute medical gas and may also include a patient
418	700		or ultimate user;
419		-
420		-	27. 28. "Medical gas supplier" means a person who dispe nses
	701	+	27. 28. “Medical gas supplier ” means a person who dispe nses
421	702		medical gases on drug orders only to a patient or ultimate user;
422		-
423		-	28. 29. "Medicine" means any drug or combination of drugs which
	703	+	28. 29. “Medicine” means any drug or combination of drugs which
424	704		has the property of curing, preventing, treating , diagnosing or
425	705		mitigating diseases, or which is used for that purpose;
426		-
427		-	29. 30. "Nonprescription drugs " means medicines or drug s which
	706	+	29. 30. “Nonprescription drugs ” means medicines or drug s which
428	707		are sold without a pre scription and which are prepackaged for use by
429	708		the consumer and labeled in accordance with the req uirements of the
430	709		statutes and regulations of this state and the federal governmen t.
431	710		Such items shall also include medical and d ental supplies and
432	711		bottled or nonbulk chemicals which are sold or offered for sale to
433	712		the general public if such articles or pre parations meet the
434	713		requirements of the Federal Food, Drug and Cosmetic Act, 21
435	714		U.S.C.A., Section 321 et seq.;
436		-
437		-	30. 31. "Outsourcing facility", including "virtual outsourcing
438		-	facility" means a facility at one geographic location or address
	715	+	30. 31. “Outsourcing facility”, including “virtual outsourcing
	716	+	facility” means a facility at one geographic location or address
439	717		that:
440		-
441	718		a. is engaged in the compounding of sterile drugs,
442		-
443	719		b. has elected to register as an outsourcing facility,
444	720		and
445		-
446	721		c. complies with all requirem ents of 21 U.S.C. 353b;
447	722
448		-	31. 32. "Package" means the smallest individual saleable unit
449		-	of product for distribution by a manufact urer or repackager that is ENR. H. B. NO. 2649 Page 11
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	747	+
	748	+	31. 32. “Package” means the smallest individual saleable unit
	749	+	of product for distribution by a manufact urer or repackager that is
450	750		intended by the manufacturer for ultimate sale to the dispense r of
451		-	such product. For the purposes of this paragraph, "individual
452		-	saleable unit" means the smallest container of a product introduced
	751	+	such product. For the purposes of this paragraph, “individual
	752	+	saleable unit” means the smallest container of a product introduced
453	753		into commerce by the manufactur er or repackager that is intended by
454	754		the manufacturer or repackager for individual sale t o a dispenser;
455		-
456		-	32. 33. "Person" means an individual, partnership, li mited
	755	+	32. 33. “Person” means an individual, partnership, li mited
457	756		liability company, corporation or association, unless the context
458	757		otherwise requires;
459		-
460		-	33. 34. "Pharmacist-in-charge" or "PIC" means the pharmacist
	758	+	33. 34. “Pharmacist-in-charge” or “PIC” means the pharmacist
461	759		licensed in this state responsible for th e management control of a
462	760		pharmacy and all other aspects of t he practice of pharmacy in a
463	761		licensed pharmacy as defined by Section 353.18 of this title;
464		-
465		-	34. 35. "Pharmacy" means a place regularly licensed by the
	762	+	34. 35. “Pharmacy” means a place regularly licensed by the
466	763		Board of Pharmacy in which prescriptions, drugs, medicines,
467	764		chemicals and poisons are compounded or dispe nsed or such place
468	765		where pharmacists practice the profession of pharmacy, or a pharmacy
469	766		operated by the Oklahoma Department of Veterans Affairs;
470		-
471		-	35. 36. "Pharmacy technician", "technician", "Rx tech", or
472		-	"tech" means a person issued a Technician permit by the State Board
	767	+	35. 36. “Pharmacy technician”, “technician”, “Rx tech”, or
	768	+	“tech” means a person issued a Technician permit by the State Board
473	769		of Pharmacy to assist the pharmacist and perform nonjudgmental,
474	770		technical, manipulative, non-discretionary functions in the
	771	+
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475	797		prescription department under the immediate and direct supervi sion
476	798		of a pharmacist;
477		-
478		-	36. 37. "Poison" means any substance which when introduced into
	799	+	36. 37. “Poison” means any substance which when introduced into
479	800		the body, either directly or by absorption, produces violent, mo rbid
480	801		or fatal changes, or which destroys living tissue with which such
481	802		substance comes into contact;
482		-
483		-	37. 38. "Practice of pharmacy" means:
484		-
	803	+	37. 38. “Practice of pharmacy” means:
485	804		a. the interpretation and evaluation of prescription
486	805		orders,
487		-
488	806		b. the compounding, dispensing, administering and
489	807		labeling of drugs and devices, except labeling by a
490	808		manufacturer, repackager or distributor of
491	809		nonprescription drugs a nd commercially packaged legend
492	810		drugs and devices,
493		-	ENR. H. B. NO. 2649 Page 12
494	811		c. the participation in drug selection and drug
495	812		utilization reviews,
496		-
497	813		d. the proper and safe storage of drugs and devices and
498	814		the maintenance of proper records thereof,
499		-
500	815		e. the responsibility for advising by counseling and
501	816		providing information, where professionally necessary
502	817		or where regulated, of therapeutic values, content,
503	818		hazards and use of dr ugs and devices,
504	819
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505	845		f. the offering or performing of those acts, services,
506	846		operations or transactions necessary in t he conduct,
507	847		operation, management and control of a pharmacy, or
508		-
509	848		g. the provision of those acts or services that are
510	849		necessary to provide pharma ceutical care;
511		-
512		-	38. 39. "Preparation" means an article which may or may not
	850	+	38. 39. “Preparation” means an article which may or may not
513	851		contain sterile products compounded in a licensed pharmacy pursuant
514	852		to the order of a licensed prescriber;
515		-
516		-	39. 40. "Prescriber" means a person licensed in this state who
	853	+	39. 40. “Prescriber” means a person licensed in this state who
517	854		is authorized to prescribe dangerous drugs within the scope of
518		-	practice of the person 's profession;
519		-
520		-	40. 41. "Prescription" means and includes any order for drug or
	855	+	practice of the person ’s profession;
	856	+	40. 41. “Prescription” means and includes any order for drug or
521	857		medical supplies written or signed, or transmitted by word of mouth,
522	858		telephone or other means of com munication:
523		-
524	859		a. by a licensed prescriber,
525		-
526	860		b. under the supervision of an Oklahoma licensed
527	861		practitioner, an Oklahoma licensed advanced practice
528	862		registered nurse or an Oklahoma licensed physician
529	863		assistant, or
530		-
531	864		c. by an Oklahoma licensed wholesaler or distrib utor as
532	865		authorized in Section 353.29.1 of this title;
533		-
534		-	41. 42. "Product" means a prescription drug in a finished
	866	+	41. 42. “Product” means a prescription drug in a finished
535	867		dosage form for administration to a patient w ithout substantial
536	868		further manufacturing, such as capsules, tablets, and lyophilized
537		-	products before reconstitution. "Product" does not include blo od ENR. H. B. NO. 2649 Page 13
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	895	+	products before reconstitution. “Product” does not include blood
538	896		components intended for transfusion, radioactive drugs or biologics
539	897		and medical gas;
540		-
541		-	42. 43. "Repackager", including "virtual repackager", means a
	898	+	42. 43. “Repackager”, including “virtual repackager”, means a
542	899		person who owns or operates an establishment that repac ks and
543	900		relabels a product or package for further sale or distribution
544	901		without further transaction;
545		-
546		-	43. 44. "Sterile drug" means a drug that is intended for
	902	+	43. 44. “Sterile drug” means a drug that is intended for
547	903		parenteral administration, an ophthalmic or oral inhalation drug in
548	904		aqueous format, or a drug that is required to be sterile under state
549	905		and federal law;
550		-
551		-	44. 45. "Supervising physician " means an individual holding a
	906	+	44. 45. “Supervising physician ” means an individual holding a
552	907		current license to practice as a physician from the State Board of
553	908		Medical Licensure and Supervision, pursuant to the provisions of the
554	909		Oklahoma Allopathic Medical and Surgical Licensure and Supervision
555	910		Act, or the State Board of Osteopathic Examiners, pursuant to t he
556	911		provisions of the Oklahoma Osteopathic Medicine Act, who supervises
557	912		an advanced practice registered nurse as defined in Secti on 567.3a
558	913		of this title, and who is not in training as an intern, resident, or
559	914		fellow. To be eligible to supervise an advanced practice registered
560	915		nurse, such physician shall remain in compliance with the rules
561	916		promulgated by the State Board of Medical Li censure and Supervision
562	917		or the State Board of Osteopathic Examiners;
563	918
564		-	45. 46. "Supportive personnel " means technicians and auxil iary
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	943	+
	944	+	45. 46. “Supportive personnel ” means technicians and auxil iary
565	945		supportive persons who are regularly paid employees of a pharmacy
566	946		who work and perform tasks in the pharmacy as authorized by Section
567	947		353.18A of this title;
568		-
569		-	46. 47. "Third-party logistics provider ", including "virtual
570		-	third-party logistics provider " means an entity that provides or
	948	+	46. 47. “Third-party logistics provider ”, including “virtual
	949	+	third-party logistics provider ” means an entity that provides or
571	950		coordinates warehousing, or other logistics services of a product in
572	951		interstate commerce on beh alf of a manufacturer, wholesale
573	952		distributor, or dispenser of a product but does not take ownership
574	953		of the product, nor have res ponsibility to direct the sale or
575	954		disposition of the product. For the purposes of this paragraph,
576		-	"third-party logistics provid er" does not include shippers and the
	955	+	“third-party logistics provid er” does not include shippers and the
577	956		United States Postal Service;
578		-
579		-	47. 48. "Wholesale distributor ", including "virtual wholesale
580		-	distributor" means a person other than a manufacturer, a
581		-	manufacturer's co-licensed partner, a third -party logistics
582		-	provider, or repackager engaged in wholesale distrib ution as defined ENR. H. B. NO. 2649 Page 14
	957	+	47. 48. “Wholesale distributor ”, including “virtual wholesale
	958	+	distributor” means a person other than a manufacturer, a
	959	+	manufacturer’s co-licensed partner, a third -party logistics
	960	+	provider, or repackager engaged in wholesale distribution as defined
583	961		by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security
584	962		Act;
585		-
586		-	48. 49. "County jail" means a facility operated by a county for
	963	+	48. 49. “County jail” means a facility operated by a county for
587	964		the physical detention and correction of persons charged with, or
588	965		convicted of, criminal offenses or ordinance violations or persons
589	966		found guilty of civil or criminal contempt;
590	967
591		-	49. 50. "State correctional facility " means a facility or
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	992	+
	993	+	49. 50. “State correctional facility ” means a facility or
592	994		institution that houses a prisoner population under the jurisdiction
593	995		of the Department of Corrections;
594		-
595		-	50. 51. "Unit dose package" means a package that contains a
	996	+	50. 51. “Unit dose package” means a package that contains a
596	997		single dose drug with the name, strength, control number, and
597	998		expiration date of that drug on the label; and
598		-
599		-	51. 52. "Unit of issue package " means a package that provid es
	999	+	51. 52. “Unit of issue package ” means a package that provid es
600	1000		multiple doses of the same drug, but each drug is individually
601	1001		separated and includes the name, lot number, and expiration da te.
602		-
603	1002		SECTION 7. AMENDATORY 59 O.S. 2021, Section 353.7, is
604	1003		amended to read as follows:
605		-
606		-	Section 353.7 The State Board of Pharmacy shall have the power
	1004	+	Section 353.7. The State Board of Pharmacy shall have the powe r
607	1005		and duty to:
608		-
609	1006		1. Regulate the practice of pharmacy;
610		-
611	1007		2. Regulate the sale and distribution of drugs, medicine s,
612	1008		chemicals and poisons;
613		-
614	1009		3. Regulate the dispensing of drugs and medicines in all places
615	1010		where drugs and medicines are compounded and/or dis pensed;
616		-
617	1011		4. Examine and issue appropriate certificates of licensure as
618	1012		Doctor of Pharmacy to all applicants whom t he Board deems qualified
619	1013		under the provisions of the Oklahoma Pharmacy Act;
620		-
621	1014		5. Issue licenses to manufacturers, repackagers, outsourcing
622	1015		facilities, wholesale distri butors, third-party logistics providers,
	1016	+
	1017	+	ENGR. S. A. TO ENGR. H. B. NO. 2649 Page 21 1
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	1041	+
623	1042		pharmacies and other dispensers, medical gas supp liers and, medical
624	1043		gas distributors, and suppliers of durable medical equipment;
625		-
626	1044		6. Issue sterile compounding and drug supplier permits for
627		-	pharmacies at the fee set by the Board, w ith the expiration date of ~~ENR. H. B. NO. 2649 Page 15~~
	1045	+	pharmacies at the fee set by the Board, w ith the expiration date of
628	1046		such permits to coincide with the pharmacy lice nse annual expiration
629	1047		date;
630		-
631	1048		7. Prescribe minimum standards with respect to floor space and
632	1049		other physical characteristics of pharmacies and hospital dr ug rooms
633	1050		as may be reasonably necessary for the maintenan ce of professional
634	1051		surroundings and for the pro tection of the safety and welfare of the
635	1052		public, and to refuse the issuance of new or re newal licenses for
636	1053		failure to comply with such standards. Minim um standards for
637	1054		hospital drug rooms shall be consistent with the State Department of
638	1055		Health, Hospital Standards, as defined in OAC 310:667;
639		-
640	1056		8. Authorize its inspectors, compliance officers and duly
641	1057		authorized representatives to enter and inspect any and all places
642	1058		including premises, vehicles, equipment, con tents and records, where
643	1059		drugs, medicines, chemic als or poisons are stored, sold, vended,
644	1060		given away, compounded, dispensed, manufactu red, repackaged or
645	1061		transported;
646		-
647	1062		9. Employ the number of inspect ors and pharmacist complian ce
648	1063		officers necessary in the investigation of criminal activity or
649	1064		preparation of administrative actions at an annual salary to be
650	1065		fixed by the Board, and to authori ze necessary expenses. Any
651		-	inspector certified as a peace offic er by the Council of on Law
652		-	Enforcement Education and Training shall have statewide jurisdiction
653		-	to perform the duties authorized by this section. In additio n, the
654		-	inspectors shall be considered pe ace officers and shall have the
655		-	same powers and authority as that granted to peace officers. In
656		-	addition, such inspector s or pharmacist compliance officers shall
657		-	have the authority to take and copy records and the d uty to
658		-	confiscate all drugs, medicines, chemicals or poisons found to be
659		-	stored, sold, vended, given away , compounded, dispensed or
660		-	manufactured contrary to the provisions of the Oklahoma Pharmacy
661		-	Act;
662	1066
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	1091	+
	1092	+	inspector certified as a peace offic er by the Council of Enforc ement
	1093	+	Education and Training shall have statewide jurisdiction to perform
	1094	+	the duties authorized by this section. In additio n, the inspectors
	1095	+	shall be considered pea ce officers and shall have the same powers
	1096	+	and authority as that granted to peace officers. In addition, such
	1097	+	inspectors or pharmacist compliance officers shall have the
	1098	+	authority to take and copy records and the d uty to confiscate all
	1099	+	drugs, medicines, chemicals or poisons found to be stored, sold,
	1100	+	vended, given away, compounded, dispensed or manufactured contrary
	1101	+	to the provisions of the Oklahoma Pharmacy Act;
663	1102		10. Investigate complaints, subpoena witnesses and re cords,
664	1103		initiate prosecution and hold hearings;
665		-
666	1104		11. Administer oaths in all manners pertaining to the af fairs
667	1105		of the Board and to take evidence and compel the attendance of
668	1106		witnesses on questions pertaining to th e enforcement of the Oklahoma
669	1107		Pharmacy Act;
670		-
671	1108		12. Reprimand, place on probation, susp end, revoke permanently
672		-	and levy fines not to exceed Three Thous and Dollars ($3,000.00) for ~~ENR. H. B. NO. 2649 Page 16~~
	1109	+	and levy fines not to exceed Three Thous and Dollars ($3,000.00) for
673	1110		each count for which any person charged with violating the Oklahoma
674	1111		Pharmacy Act or Oklahoma Board of Pharmacy administrativ e rules has
675	1112		been convicted in Board hear ings. The Board also may take other
676	1113		disciplinary action. The B oard may impose as part of any
677	1114		disciplinary action th e payment of costs expended by the Board for
678	1115		any legal fees and costs including, but not limited to , staff time,
	1116	+
	1117	+	ENGR. S. A. TO ENGR. H. B. NO. 2649 Page 23 1
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	1141	+
679	1142		salary and travel expense , witness fees and attorney fees. The
680	1143		Board may also require ad ditional continuing educ ation including
681	1144		attendance at a live continuing education program, and may require
682	1145		participation in a rehabilitation program for the impaired. The
683	1146		Board may take such actions singly or in combination, as the nature
684	1147		of the violation requires;
685		-
686	1148		13. Adopt and establish rules of profes sional conduct
687	1149		appropriate to the establishment and mainte nance of a high standard
688	1150		of integrity and dignity in the profession of pharmacy. Such rules
689	1151		shall be subject to amendment or repeal by the Board as the need may
690	1152		arise;
691		-
692	1153		14. Make and publish rules such as may be necessary for
693	1154		carrying out and enforcing the provisions of the Oklahoma Pharmacy
694	1155		Act, Oklahoma drug laws and rules, federal dr ug laws and
695	1156		regulations, and make such other rules as in its dis cretion may be
696	1157		necessary to protect the health, saf ety and welfare of the public;
697		-
698	1158		15. Establish and collect a ppropriate fees for licenses,
699	1159		permits, inspections and services provided; and su ch fees shall be
700	1160		nonrefundable. Such fees shall be promulgated to implement the
701	1161		provisions of the Oklahoma Pharmacy Act and the Oklahoma Abortion -
702	1162		Inducing Drug Certification P rogram Act under the provisions of the
703	1163		Administrative Procedures Act ;
	1164	+	16. Regulate:
704	1165
705		-	16. Regulate:
	1166	+	ENGR. S. A. TO ENGR. H. B. NO. 2649 Page 24 1
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706	1190
707	1191		a. personnel working in a pharmacy, such as interns and
708	1192		supportive personnel including technicians, and issue
709	1193		pharmacy technician permits and intern licenses,
710		-
711	1194		b. interns, preceptors and training areas through whic h
712	1195		the training of applicants occurs f or licensure as a
713	1196		pharmacist, and
714		-
715	1197		c. such persons regarding all aspects relating to the
716	1198		handling of drugs, medicines, chemicals and poisons;
717		-	ENR. H. B. NO. 2649 Page 17
718	1199		17. Acquire by purchase, lease, gif t, solicitation of gift or
719	1200		by any other manner, and to maintain, use and opera te or to contract
720	1201		for the maintenance, use and operation of or l ease of any and all
721	1202		property of any kind, real, personal or mixed or any interest
722	1203		therein unless otherwise provide d by the Oklahoma Pharmacy Act;
723	1204		provided, all contracts for real property shal l be subject to the
724	1205		provisions of Section 63 of Title 74 of the Oklahoma Statutes;
725		-
726	1206		18. Perform other such duties, exercise other such powers and
727	1207		employ such personnel as the pro visions and enforcement of the
728	1208		Oklahoma Pharmacy Act may require; and
729		-
730	1209		19. Approve pilot projects designed to utilize new or expanded
731	1210		technology or processes and provide patients with better pharmacy
732	1211		products or provide pharmacy services in a more safe and efficient
733	1212		manner. Such approvals may in clude provisions granting exemptions
734	1213		to any rule adopted by the Board.
735	1214
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	1239	+
736	1240		SECTION 8. NEW LAW A new section of law to be codified
737	1241		in the Oklahoma Statutes as Section 353.7a of Title 59, unless th ere
738	1242		is created a duplication in numbering, reads as follows:
739		-
740	1243		The State Board of Pharmacy shall assess the following licensure
741	1244		fees for the stated entities:
742		-
743	1245		1. For a medical gas distributor , Four Hundred Dollars
744	1246		($400.00) for an initial license and Two Hundred Dollars ($200.00)
745	1247		for a license renewal;
746		-
747	1248		2. For a supplier of durable medical equipment , Four Hundred
748	1249		Dollars ($400.00) for an initial license and Two Hundred Dollars
749	1250		($200.00) for a license renewal;
750		-
751	1251		3. For a combined license for a medical gas distributor and
752	1252		supplier of durable medical equipment , Six Hundred Dollars ($600.00)
753	1253		for an initial license and Three Hundred Dollars ($300.00) for a
754	1254		license renewal; and
755		-
756	1255		4. For a medical gas supplier, an amount determined by the
757	1256		Board in rule.
	1257	+	SECTION 9. This act shall become effective November 1, 2022. ”
758	1258
759		-	SECTION 9. This act shall become effective November 1, 2022. ENR. H. B. NO. 2649 Page 18
760	1259
761		-	Passed the House of Representatives the 16th day of May, 2022.
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	1284	+
	1285	+	Passed the Senate the 28th day of April, 2022.
	1286	+
	1287	+
	1288	+
	1289	+	Presiding Officer of the Senate
	1290	+
	1291	+
	1292	+	Passed the House of Representatives the ____ day of __________,
	1293	+	2022.
	1294	+
	1295	+
	1296	+
	1297	+	Presiding Officer of the House
	1298	+	of Representatives
	1299	+
	1300	+	ENGR. H. B. NO. 2649 Page 1 1
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	1324	+
	1325	+	ENGROSSED HOUSE
	1326	+	BILL NO. 2649 By: Echols of the House
	1327	+
	1328	+	and
	1329	+
	1330	+	Dugger of the Senate
	1331	+
	1332	+
	1333	+
	1334	+
	1335	+
	1336	+
	1337	+	An Act relating to durable medical equipment;
	1338	+	creating the Oklahoma Durable Medical Equipment
	1339	+	Licensing Act; defining terms; requiring a license;
	1340	+	providing for effective date of license; authorizing
	1341	+	certain inspections; requiring promul gation of rules;
	1342	+	construing provision ; providing for licensing
	1343	+	qualifications; providing for license revocation or
	1344	+	suspension; listing exceptions; providing for
	1345	+	codification; and providing an effective date .
	1346	+
	1347	+
	1348	+
	1349	+
	1350	+
	1351	+	BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
	1352	+	SECTION 10. NEW LAW A new section of law to be codified
	1353	+	in the Oklahoma Statutes as Section 375 of Title 59, unless there is
	1354	+	created a duplication in numbering, reads as follows:
	1355	+	This act shall be known and may be cited as the "Oklahoma
	1356	+	Durable Medical Equipment Licensing Act ".
	1357	+	SECTION 11. NEW LAW A new section of law to be codified
	1358	+	in the Oklahoma Statutes as Section 376 of T itle 59, unless there is
	1359	+	created a duplication in numbering, reads as follow s:
	1360	+	As used in the Oklahoma Durable Medical Equipment Licensing A ct:
	1361	+	1. "Board" means the State Board of Pharmacy;
	1362	+
	1363	+	ENGR. H. B. NO. 2649 Page 2 1
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	1387	+
	1388	+	2. a. "Durable medical equipment" means equipment for which
	1389	+	a prescription is required, including for repair and
	1390	+	replacement parts, and tha t:
	1391	+	(1) can stand repeated use,
	1392	+	(2) has an expected useful life of at least three (3)
	1393	+	years,
	1394	+	(3) is primarily and customarily used to serve a
	1395	+	medical purpose,
	1396	+	(4) is not generally useful to a person in the
	1397	+	absence of illness or injury,
	1398	+	(5) is appropriate for use in the home, and
	1399	+	(6) is intended for use by the consumer .
	1400	+	b. Durable medical equipment includes, but is not limited
	1401	+	to:
	1402	+	(1) ambulating assistance equipment,
	1403	+	(2) mobility equipment,
	1404	+	(3) rehabilitation seating,
	1405	+	(4) oxygen care and oxygen delivery syste ms,
	1406	+	(5) respiratory equipment and respiratory disease
	1407	+	management devices,
	1408	+	(6) rehabilitation environmental control equipment,
	1409	+	(7) ventilators,
	1410	+	(8) apnea monitors,
	1411	+	(9) diagnostic equipment,
	1412	+
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	1437	+
	1438	+	(10) feeding pumps,
	1439	+	(11) beds prescribed by physicians to alleviate
	1440	+	medical conditions,
	1441	+	(12) transcutaneous electrical nerve stimulators, and
	1442	+	(13) sequential compression devices; and
	1443	+	3. "Supplier" means any person or entity that provides durable
	1444	+	medical equipment services or products and that currently bills or
	1445	+	plans to bill a claim for reimbursement of services or products to a
	1446	+	third party.
	1447	+	SECTION 12. NEW LAW A new section of law to be codified
	1448	+	in the Oklahoma Statutes as Section 377 of Title 59, unless there is
	1449	+	created a duplication in numbering, reads as follows:
	1450	+	A. Any supplier of durable medical equipment to a consumer in
	1451	+	Oklahoma shall possess a durable medical equipment supplier license
	1452	+	issued by the Board pursuant t o this act.
	1453	+	B. Licenses issued by the Board pursuant to this act shall be
	1454	+	effective for twelve (12) months from the date of issuance and shall
	1455	+	not be transferable or assignable.
	1456	+	C. The Board shall have the authority to initially and
	1457	+	periodically inspect the applicant's office or place of business.
	1458	+	D. The Board shall promulgate rules necessary to implement the
	1459	+	provisions of this act. Such rules shall prioritize patient safety
	1460	+	and quality of durable medical equipment. The Board may provide by
	1461	+	rule that any person or entity accredited by organizations
	1462	+
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	1487	+
	1488	+	recognized by the Centers fo r Medicare and Medicaid Services is
	1489	+	deemed to meet all or some of the requirements of this act.
	1490	+	E. Nothing in this section shall be construed to restrict or
	1491	+	prohibit private trans actions between two parties.
	1492	+	SECTION 13. NEW LAW A ne w section of law to be codified
	1493	+	in the Oklahoma Statutes as Section 378 of Title 59, unless there is
	1494	+	created a duplication in numbering, reads as follows:
	1495	+	A. The Board shall be au thorized to issue a license to an
	1496	+	applicant for licensure as a supplier of d urable medical equipment
	1497	+	if the applicant:
	1498	+	1. Submits an application in a form prescribed by the Board;
	1499	+	2. Maintains a physical office or place of business within this
	1500	+	state;
	1501	+	3. Pays a license fee established by the Board;
	1502	+	4. Meets all state and federa l accreditation requirements; and
	1503	+	5. Meets all safety standards established by the Board, which
	1504	+	shall include, but not be limited to:
	1505	+	a. ensuring that all personnel e ngaged in delivery,
	1506	+	maintenance and repair of durable medical equipment
	1507	+	receive annual continuing education,
	1508	+	b. instructing the patient or patient 's caregiver about
	1509	+	how to use the durable medical equipment provided ,
	1510	+	c. receiving and responding to complaints from patien ts,
	1511	+
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	1537	+	d. maintaining records of all patients receiving durable
	1538	+	medical equipment, and
	1539	+	e. managing, maintaining and servicing durable medical
	1540	+	equipment.
	1541	+	B. The Board may issue a license to a Medicare or Medicaid
	1542	+	enrolled out-of-state supplier who has at leas t one accredited
	1543	+	facility within one hundred (100) miles of any Oklahoma res ident
	1544	+	being served by the supplier.
	1545	+	C. The Board may revoke or suspend a license for:
	1546	+	1. Violation of state or federal law;
	1547	+	2. Violation of rules promulgated pursuant to this act;
	1548	+	3. Permitting, aiding or abetting any illegal act;
	1549	+	4. Failing to meet the safety standards established by the
	1550	+	Board pursuant to this act;
	1551	+	5. Engaging in conduct or practices found by the Board to be
	1552	+	detrimental to the health, safety or welfare of patients; or
	1553	+	6. Failing to renew a license.
	1554	+	SECTION 14. NEW LAW A new section of law to be codified
	1555	+	in the Oklahoma Statutes as Section 379 of Title 59, unless there is
	1556	+	created a duplication in numbering, reads as follows:
	1557	+	The Oklahoma Durable Medical Equipment Licensing Act shall not
	1558	+	apply to:
	1559	+	1. Pharmacies and pharmacists;
	1560	+	2. Hospitals;
	1561	+
	1562	+	ENGR. H. B. NO. 2649 Page 6 1
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	1586	+
	1587	+	3. Ambulatory surgical centers;
	1588	+	4. Health care facilities owned or operated by the state or
	1589	+	federal government;
	1590	+	5. Skilled nursing facilities;
	1591	+	6. Assisted living facilities;
	1592	+	7. Prosthetic or orthotic practitioners;
	1593	+	8. Health care practitioners who are licensed to practice
	1594	+	health care in the State of Oklahoma and who provide durable medical
	1595	+	equipment within the scope of their health care practice;
	1596	+	9. Manufacturers or wholesale distributors that do not sell or
	1597	+	rent durable medical equipment directly to consumers; or
	1598	+	10. Suppliers of insulin infusion pumps and related supplies or
	1599	+	services.
	1600	+	SECTION 15. This act shall become effectiv e November 1, 2021.
	1601	+	Passed the House of Representatives the 9th day of March, 2021.
762	1602
763	1603
764	1604
765	1605
766	1606		Presiding Officer of the House
767	1607		of Representatives
768	1608
769	1609
770		-	Passed the Senate the ~~28th~~ day of ~~April~~, ~~2022~~.
	1610	+	Passed the Senate the ___ day of __________, 2021.
771	1611
772	1612
773	1613
774	1614
775	1615		Presiding Officer of the Senate
776	1616
777	1617
778	1618
779		-	OFFICE OF THE GOVERNOR
780		-	Received by the Office of the Governor this ____________________
781		-	day of ___________________, 20_______, at _______ o'clock _______ M.
782		-	By: _________________________________
783		-	Approved by the Governor of the State of Oklahoma this _____ ____
784		-	day of ___________________, 20_______, at _______ o'clock _______ M.
785		-
786		-
787		-	_________________________________
788		-	Governor of the State of Oklahoma
789		-
790		-	OFFICE OF THE SECRETARY OF STATE
791		-	Received by the Office of the Secretary of State this __________
792		-	day of ___________________, 20_______, at _______ o 'clock _______ M.
793		-	By: _________________________________