Legislature(2023 - 2024)DAVIS 106
03/30/2023 03:00 PM House HEALTH & SOCIAL SERVICES
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| Audio | Topic |
|---|---|
| Start | |
| Presentation(s): Opportunities to Grow the Health Workforce, Apprenticeship and Beyond | |
| HB96 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | TELECONFERENCED | ||
| *+ | HB 96 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
HB 96-LICENSING:DRUGS/DEVICES FOR HOME DIALYSIS
4:15:30 PM
VICE CHAIR RUFFRIDGE announced that the final order of business
would be HOUSE BILL NO. 96, "An Act relating to licensing and
registration requirements for certain wholesale drug
distributors; and providing for an effective date."
4:15:50 PM
CHAIR PRAX, as prime sponsor, presented the sponsor statement on
HB 96 [copy included in the committee packet], which read as
follows [original punctuation provided]:
In Alaska, the Pharmacy Board requires a pharmacy that
only distributes dialysis supplies and solutions to
the home of dialysis patients, to comply with the same
arduous requirements as retail pharmacies (e.g.,
Walgreens, CVS) that handle controlled substances,
compounds, and dispense medications with varying
safety profiles. Pharmacies that deliver dialysis
supplies and solutions only offer a limited product
portfolio and follow all Quality and FDA requirements;
additional retail pharmacy mandates are onerous to the
operations.
Currently 24 states allow manufacturers that are
registered as wholesale drug distributors and who
distribute dialysis supplies and solutions, to deliver
directly to home dialysis patients. An additional 8
states provide for some form of special licensure for
the distribution of these products which ensures that
the dialysis supplies are available for delivery to
patients. Both Hawaii and Nevada have bills pending
this session to accomplish the same goal.
HB 96 would amend the pharmacy practice act to allow
manufacturers of home dialysis drugs, supplies and
devices to be exempted from pharmacy if they maintain
control of all products from manufacturing to the
patient. This would still require the pharmacy to
maintain any additional licenses such as a wholesaler
license.
4:18:26 PM
CHADWICK VANCE, Staff, Representative Mike Prax, Alaska State
Legislature, on behalf of Representative Prax, prime sponsor,
presented the sectional analysis for HB 96 [copy included in the
committee packet], which read as follows [original punctuation
provided]:
Section 1: This section amends AS 08.80.157(h) to
provide wholesale drug distributors the ability to
legally deliver dialysate drugs and devices directly
to patients.
4:19:14 PM
ELIZABETH STOLL, Director, State and Government Affairs, Baxter
International Incorporated, on behalf of Representative Prax,
prime sponsor, gave a PowerPoint presentation, titled "Alaska
House Bill 96" [hardcopy included in committee packet]. She
began on slide 2, which addressed the treatment of end state
renal disease (ESRD) in Alaska. She pointed out that there are
1,086 ESRD patients in the state, of which 154 are home dialysis
patients.
MS. STOLL moved to slide 3 and addressed how patients receive
dialysis products at home. She pointed out that for ESRD
patients who elect to receive dialysis in the home, they must
receive monthly home shipments of supplies. The slide lists the
details of the supplies, which when shipping, weighs between 500
and 1,000 pounds. She pointed out that because of this, home
delivery is an essential service for the home patient. She
moved to slide 4, which continued how patients receive dialysis
products at home. She stated that patients must be trained on
using the dialysis kits, while the physician would determine the
monthly supply needed and send this to the pharmacy where the
monthly shipment order is determined. This will then be shipped
to a nearby distribution center, where employees organize each
patient's monthly supplies into deliveries. After several
compliance checks the orders are delivered directly to the
patient's home.
4:25:01 PM
MS. STOLL advanced to slide 5 and addressed why the law needs to
be changed. The slide read as follows [original punctuation
provided].
The Alaska Pharmacy Board requires a pharmacy that
only distributes dialysis supplies and solutions to
the home of dialysis patients, to comply with the same
arduous requirements as retail pharmacies that handle
controlled substances, compounds, and dispense
medications with varying safety profiles.
These Pharmacies that deliver dialysis supplies and
solutions only offer a limited product portfolio and
follow all Quality and FDA requirements.
The law also requires a licensed pharmacist (above and
beyond the Alaska licensed out of state central
pharmacy that has processed the order) to physically
view the boxes before they can leave the warehouse,
which is onerous and unnecessary.
MS. STOLL moved to slide 6, which read as follows [original
punctuation provided]:
What does the Bill DO?
This bill will:
Amend the pharmacy practice act to allow manufacturers
of home dialysis drugs, supplies and devices to be
exempted from being licensed as a pharmacy if they
maintain control of all products from manufacturing to
the patient.
This would still require the location to maintain any
additional licenses, such as an Alaska wholesaler
license.
This means the Alaska Board of Pharmacy still has
jurisdiction over the location and its operations.
MS. STOLL moved to slide 7, which read as follows [original
punctuation provided]:
Why Is this Change Ok for Alaskans?
In Alaska, we believe the requirement to require a
pharmacist to review and place a second label onto the
boxes prior to leaving the warehouse is onerous and
unnecessary.
This bill will mirror what the National Board of
Pharmacy's Model Act outlines for these pharmacies and
distribution centers.
There are 24 states that currently operate under the
model and an additional 8 states provide for some form
of special licensure for the distribution of these
products with zero instances of harm to any patient.
4:26:36 PM
MS. STOLL moved to slide 8 and pointed out that this is the
standard of practice in 32 other states. She advanced to slide
9 to present a map of states that exempt ESRD distribution and
those which require minimal pharmacy audits. She transitioned
to slide 10, which addressed things to consider, including that
the proposed legislation would not include diabetes supplies or
any other type of device, no compounding or manipulation of
products would occur, and solutions would be under the
manufacturers control from the licensed manufacturing plant to
the patient's home.
4:28:08 PM
REPRESENTATIVE SUMNER asked why the change is good for Alaskans.
MS. STOLL answered that the change simplifies the distribution
model and removes unnecessary regulations. She added that this
therapy would save money for Medicaid recipients.
4:29:19 PM
VICE CHAIR RUFFRIDGE inquired as to what the distribution model
looks like for rural Alaska.
MS. STOLL responded that nothing of what currently happens would
change. She explained that there is an Anchorage distribution
facility with a system of boat and air transport that would move
orders to rural Alaska.
VICE CHAIR RUFFRIDGE questioned whether the Anchorage
distribution center or the facility in North Carolina is
licensed.
MS. STOLL explained that Baxter International has a
manufacturing license in North Carolina, and the Anchorage
distribution center is licensed as a wholesaler and a pharmacy.
She added that with the proposed legislation, Baxter
International would be removing the pharmacy license at the
Anchorage distribution center.
4:30:53 PM
REPRESENTATIVE PRAX questioned the dialysis kits.
MS. STOLL explained the contents of a dialysis kit. In response
to a follow-up question, she elaborated that the process is
overseen by a physician or a dialysis center.
4:34:21 PM
VICE CHAIR RUFFRIDGE announced that HB 96 was held over.
| Document Name | Date/Time | Subjects |
|---|---|---|
| HB 96 Fiscal Note DCCED.pdf |
HHSS 3/30/2023 3:00:00 PM |
HB 96 |
| HB 96 Presentation Slides v.2.pptx |
HHSS 3/30/2023 3:00:00 PM |
HB 96 |
| HB 96 Sectional Analysis.pdf |
HHSS 3/30/2023 3:00:00 PM |
HB 96 |
| HB 96 Sponsor statement.pdf |
HHSS 3/30/2023 3:00:00 PM |
HB 96 |
| HB0096A.PDF |
HHSS 3/30/2023 3:00:00 PM |
HB 96 |
| APCA Workforce Panel AkLeg 20230328.pdf |
HHSS 3/30/2023 3:00:00 PM |
APCA Presentation |
| HB96- Licensing-Drugs.Devices for Home Dialysis- Letter of Opposition from AK Board of Pharmacy.pdf |
HHSS 3/30/2023 3:00:00 PM |
HB 96 |
| 2023_0330_Health Care Apprenticeships in Alaska.pptx |
HHSS 3/30/2023 3:00:00 PM |
Cathy Munoz |