83 FR 62869 - Notice of Hearing: Reconsideration of Disapproval Washington Medicaid State Plan Amendment (SPA) 17-0002
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 234 (December 6, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 234 (December 6, 2018)
| Page Range | 62869-62870 | |
| FR Document | 2018-26495 |
[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)] [Notices] [Pages 62869-62870] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26495] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval Washington Medicaid State Plan Amendment (SPA) 17-0002 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of hearing: reconsideration of disapproval. ----------------------------------------------------------------------- SUMMARY: This notice announces an administrative hearing to be held on January 15, 2019, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid and Children's Health, Seattle Regional Office, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104 to reconsider CMS' decision to disapprove Washington's Medicaid SPA 17-0002. DATES: Requests to participate in the hearing as a party must be received by the presiding officer by December 20, 2018. FOR FURTHER INFORMATION CONTACT: Benjamin R. Cohen, Presiding Officer, CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244, Telephone: (410) 786-3169. SUPPLEMENTARY INFORMATION: This notice announces an administrative hearing to reconsider CMS' decision to disapprove Washington's Medicaid state plan amendment (SPA) 17-0002, which was submitted to the Centers for Medicare & Medicaid Services (CMS) on June 26, 2017 and disapproved on September 10, 2018. This SPA requested CMS approval to: Bring Washington into compliance with the pharmacy reimbursement requirements in the Covered Outpatient Drugs final rule with comment period (CMS- 2345-FC) (Final Rule). Specifically, SPA 17-0002 proposed to revise the current pharmacy reimbursement methodology from reimbursing for ingredient costs based on Estimated Acquisition Cost (EAC), plus a tiered dispensing fee (High-volume pharmacies $4.24/Rx, Mid-volume pharmacies $4.56/Rx, Low-volume pharmacies $5.25/Rx, and Unit Does System $5.25/Rx), to reimbursing for ingredient cost based on Actual Acquisition Cost (AAC), using the National Average Drug Acquisition Cost (NADAC) without a change in the new requirements for a professional dispensing fee. In addition, SPA 17-0002 included proposed changes to reimbursement for 340B drugs, physician-administered drugs, clotting factor, federal supply schedule, and drugs purchased at nominal price. The issues to be considered at the hearing are whether Washington SPA 17-0002 is inconsistent with the requirements of:Section 1902(a)(30)(A) of the Social Security Act (the Act) which requires, in part, that states have a state plan that provides such methods and procedures to assure that payment rates are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area. Federal regulations at 42 CFR 447.502, 447.512 and 447.518 which provide that payments for drugs are to be based on the ingredient cost of the drug based on AAC and a Professional Dispensing Fee (PDF). Section 1116 of the Act and federal regulations at 42 CFR part 430 establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a state plan or plan amendment. CMS is required to publish in the Federal Register a copy of the notice to a state Medicaid agency that informs the agency of the time and place of the hearing, and the issues to be considered. If we subsequently notify the state Medicaid agency of additional issues that will be considered at the hearing, we will also publish that notice in the Federal Register. Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as amicus curiae must petition the presiding officer before the hearing begins in accordance with the requirements contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the presiding officer will notify all participants. The notice to Washington announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows: Ms. MaryAnne Lindeblad Director State of Washington, Health Care Authority 626 8th Avenue PO Box 45502 Olympia, WA 98504-5050 Dear Ms. Lindeblad: I am responding to your November 5, 2018 request for reconsideration of the decision to disapprove Washington's State Plan amendment (SPA) 17- 0002. Washington SPA 17-0002 was submitted to the Centers for Medicare & Medicaid Services (CMS) on June 26, 2017, and disapproved on September 10, 2018. I am scheduling a hearing on your request for reconsideration to be held on January 15, 2019, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid and Children's Health, Seattle Regional Office, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104. I am designating Mr. Benjamin R. Cohen as the presiding officer. If these arrangements present any problems, please contact Mr. Cohen at (410) 786-3169. In order to facilitate any communication that may be necessary between the parties prior to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. If the hearing date is not acceptable, Mr. Cohen can set another date mutually agreeable to the parties. The hearing will be governed by the procedures prescribed by federal regulations at 42 CFR part 430. This SPA requested CMS approval to bring Washington into compliance with the pharmacy reimbursement requirements in the Covered Outpatient Drugs final rule with comment period (CMS-2345-FC) (Final Rule). Specifically, SPA 17-0002 proposed to revise the current pharmacy reimbursement methodology from reimbursing for ingredient costs based on Estimated Acquisition Cost (EAC), plus a tiered dispensing fee (High-volume pharmacies $4.24/Rx, Mid-volume pharmacies $4.56/Rx, Low- volume pharmacies $5.25/Rx, and Unit Does System $5.25/Rx), to reimbursing for ingredient cost based on Actual Acquisition Cost (AAC), using the National Average Drug Acquisition Cost (NADAC) without a change in the new requirements for a professional dispensing fee. In addition, SPA 17-0002 included proposed changes to reimbursement for 340B drugs, physician-administered drugs, clotting factor, federal supply schedule, and drugs purchased at nominal price. [[Page 62870]] The issues to be considered at the hearing are whether Washington SPA 17-0027 is inconsistent with the requirements of: Section 1902(a)(30)(A) of the Social Security Act (the Act) which requires, in part, that states have a state plan that provides such methods and procedures to assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area. Federal regulations at 42 CFR 447.502, 447.512 and 447.518 which provide that payments for drugs are to be based on the ingredient cost of the drug based on AAC and a Professional Dispensing Fee (PDF). In the event that CMS and the State come to agreement on resolution of the issues which formed the basis for disapproval, this SPA may be moved to approval prior to the scheduled hearing. Sincerely, Seema Verma Administrator cc: Benjamin R. Cohen Section 1116 of the Social Security Act (42 U.S.C. 1316; 42 CFR 430.18) (Catalog of Federal Domestic Assistance program No. 13.714. Medicaid Assistance Program.) Dated: November 30, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2018-26495 Filed 12-4-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices 62869
Jeffrey M. Zirger, Acquisition Cost (AAC), using the Director
Acting Lead, Information Collection Review National Average Drug Acquisition Cost State of Washington, Health Care
Office, Office of Scientific Integrity, Office (NADAC) without a change in the new Authority
of Science, Centers for Disease Control and requirements for a professional 626 8th Avenue PO Box 45502
Prevention (CDC). dispensing fee. In addition, SPA 17– Olympia, WA 98504–5050
[FR Doc. 2018–26351 Filed 12–4–18; 8:45 am] 0002 included proposed changes to Dear Ms. Lindeblad:
BILLING CODE 4163–18–P reimbursement for 340B drugs, I am responding to your November 5,
physician-administered drugs, clotting 2018 request for reconsideration of the
factor, federal supply schedule, and decision to disapprove Washington’s
DEPARTMENT OF HEALTH AND drugs purchased at nominal price. State Plan amendment (SPA) 17–0002.
HUMAN SERVICES The issues to be considered at the Washington SPA 17–0002 was
hearing are whether Washington SPA submitted to the Centers for Medicare &
Centers for Medicare & Medicaid
17–0002 is inconsistent with the Medicaid Services (CMS) on June 26,
Services
requirements of: 2017, and disapproved on September
Notice of Hearing: Reconsideration of • Section 1902(a)(30)(A) of the Social 10, 2018. I am scheduling a hearing on
Disapproval Washington Medicaid Security Act (the Act) which requires, in your request for reconsideration to be
State Plan Amendment (SPA) 17–0002 part, that states have a state plan that held on January 15, 2019, at the
provides such methods and procedures Department of Health and Human
AGENCY: Centers for Medicare & to assure that payment rates are Services, Centers for Medicare &
Medicaid Services (CMS), HHS. consistent with efficiency, economy, Medicaid Services, Division of Medicaid
ACTION: Notice of hearing: and quality of care and are sufficient to and Children’s Health, Seattle Regional
reconsideration of disapproval. enlist enough providers so that care and Office, 701 Fifth Avenue, Suite 1600,
services are available under the plan at Seattle, WA 98104.
SUMMARY: This notice announces an least to the extent that such care and
administrative hearing to be held on I am designating Mr. Benjamin R.
services are available to the general Cohen as the presiding officer. If these
January 15, 2019, at the Department of population in the geographic area.
Health and Human Services, Centers for arrangements present any problems,
• Federal regulations at 42 CFR please contact Mr. Cohen at (410) 786–
Medicare & Medicaid Services, Division 447.502, 447.512 and 447.518 which
of Medicaid and Children’s Health, 3169. In order to facilitate any
provide that payments for drugs are to communication that may be necessary
Seattle Regional Office, 701 Fifth be based on the ingredient cost of the
Avenue, Suite 1600, Seattle, WA 98104 between the parties prior to the hearing,
drug based on AAC and a Professional please notify the presiding officer to
to reconsider CMS’ decision to Dispensing Fee (PDF).
disapprove Washington’s Medicaid SPA indicate acceptability of the hearing
Section 1116 of the Act and federal date that has been scheduled and
17–0002. regulations at 42 CFR part 430 establish provide names of the individuals who
DATES: Requests to participate in the Department procedures that provide an will represent the State at the hearing.
hearing as a party must be received by administrative hearing for If the hearing date is not acceptable, Mr.
the presiding officer by December 20, reconsideration of a disapproval of a Cohen can set another date mutually
2018. state plan or plan amendment. CMS is agreeable to the parties. The hearing
FOR FURTHER INFORMATION CONTACT: required to publish in the Federal will be governed by the procedures
Benjamin R. Cohen, Presiding Officer, Register a copy of the notice to a state prescribed by federal regulations at 42
CMS, 2520 Lord Baltimore Drive, Suite Medicaid agency that informs the CFR part 430.
L, Baltimore, Maryland 21244, agency of the time and place of the This SPA requested CMS approval to
Telephone: (410) 786–3169. hearing, and the issues to be considered. bring Washington into compliance with
SUPPLEMENTARY INFORMATION: This If we subsequently notify the state the pharmacy reimbursement
notice announces an administrative Medicaid agency of additional issues requirements in the Covered Outpatient
hearing to reconsider CMS’ decision to that will be considered at the hearing, Drugs final rule with comment period
disapprove Washington’s Medicaid state we will also publish that notice in the (CMS–2345–FC) (Final Rule).
plan amendment (SPA) 17–0002, which Federal Register. Specifically, SPA 17–0002 proposed to
was submitted to the Centers for Any individual or group that wants to revise the current pharmacy
Medicare & Medicaid Services (CMS) on participate in the hearing as a party reimbursement methodology from
June 26, 2017 and disapproved on must petition the presiding officer reimbursing for ingredient costs based
September 10, 2018. This SPA requested within 15 days after publication of this on Estimated Acquisition Cost (EAC),
CMS approval to: Bring Washington into notice, in accordance with the plus a tiered dispensing fee (High-
compliance with the pharmacy requirements contained at 42 CFR volume pharmacies $4.24/Rx, Mid-
reimbursement requirements in the 430.76(b)(2). Any interested person or volume pharmacies $4.56/Rx, Low-
Covered Outpatient Drugs final rule organization that wants to participate as volume pharmacies $5.25/Rx, and Unit
with comment period (CMS–2345–FC) amicus curiae must petition the Does System $5.25/Rx), to reimbursing
(Final Rule). Specifically, SPA 17–0002 presiding officer before the hearing for ingredient cost based on Actual
proposed to revise the current pharmacy begins in accordance with the Acquisition Cost (AAC), using the
reimbursement methodology from requirements contained at 42 CFR National Average Drug Acquisition Cost
reimbursing for ingredient costs based 430.76(c). If the hearing is later (NADAC) without a change in the new
khammond on DSK30JT082PROD with NOTICES
on Estimated Acquisition Cost (EAC), rescheduled, the presiding officer will requirements for a professional
plus a tiered dispensing fee (High- notify all participants. dispensing fee. In addition, SPA 17–
volume pharmacies $4.24/Rx, Mid- The notice to Washington announcing 0002 included proposed changes to
volume pharmacies $4.56/Rx, Low- an administrative hearing to reconsider reimbursement for 340B drugs,
volume pharmacies $5.25/Rx, and Unit the disapproval of its SPA reads as physician-administered drugs, clotting
Does System $5.25/Rx), to reimbursing follows: factor, federal supply schedule, and
for ingredient cost based on Actual Ms. MaryAnne Lindeblad drugs purchased at nominal price.
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![62870 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices
The issues to be considered at the Seema Verma Social Security Act (the Act) for each
hearing are whether Washington SPA Administrator public child welfare agency requesting
17–0027 is inconsistent with the cc: Benjamin R. Cohen Federal funding for foster care, adoption
requirements of: assistance and guardianship assistance
Section 1116 of the Social Security Act (42
• Section 1902(a)(30)(A) of the Social U.S.C. 1316; 42 CFR 430.18) (Catalog of under the Act. Section 479B of the Act
Security Act (the Act) which requires, Federal Domestic Assistance program No. provides for an Indian tribe, tribal
in part, that states have a state plan 13.714. Medicaid Assistance Program.) organization or tribal consortium (Tribe)
that provides such methods and to operate a title IV–E program in the
Dated: November 30, 2018.
procedures to assure that payments same manner as a State with minimal
Seema Verma, exceptions. The Tribe must have an
are consistent with efficiency,
Administrator, Centers for Medicare & approved title IV–E Plan. The title IV–
economy, and quality of care and are Medicaid Services.
sufficient to enlist enough providers E plan provides assurances the
[FR Doc. 2018–26495 Filed 12–4–18; 8:45 am] programs will be administered in
so that care and services are available
under the plan at least to the extent
BILLING CODE 4120–01–P conformity with the specific
that such care and services are requirements stipulated in title IV–E.
available to the general population in The plan must include all applicable
DEPARTMENT OF HEALTH AND State or Tribal statutory, regulatory, or
the geographic area. HUMAN SERVICES
• Federal regulations at 42 CFR policy references and citations for each
447.502, 447.512 and 447.518 which requirement as well as supporting
Administration for Children and
provide that payments for drugs are to documentation. A title IV–E agency may
Families
be based on the ingredient cost of the use the pre-print format prepared by the
drug based on AAC and a Professional Submission for OMB Review; Children’s Bureau of the Administration
Dispensing Fee (PDF). Comment Request for Children and Families or a different
format, on the condition that the format
In the event that CMS and the State Title: Plan for Foster Care and used includes all of the title IV–E plan
come to agreement on resolution of the Adoption Assistance: Title IV–E of the requirements of the law.
issues which formed the basis for Social Security Act. Respondents: Title IV–E agencies
disapproval, this SPA may be moved to OMB No.: 0970–0433. administering or supervising the
approval prior to the scheduled hearing. Description: A title IV–E plan is administration of the title IV–E
Sincerely, required by section 471, part IV–E of the programs.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses burden hours Total burden
Instrument respondents per per hours
respondent response
Title IV–E Plan ................................................................................................. 17 1 16 272
Estimated Total Annual Burden of Management and Budget, Paperwork OMB No.: 0970–0177.
Hours: 272. Reduction Project, Email: OIRA_ Description: The information obtained
Additional Information: Copies of the SUBMISSION@OMB.EOP.GOV, Attn: from this form will be used to: (1)
proposed collection may be obtained by Desk Officer for the Administration for Report Child Support Enforcement
writing to the Administration for Children and Families. activities to the Congress as required by
Children and Families, Office of law; (2) calculate incentive measures
Robert Sargis,
Planning, Research and Evaluation, 330 performance and performance
Reports Clearance Officer.
C Street SW, Washington, DC 20201. indicators utilized in the program; and
[FR Doc. 2018–26416 Filed 12–4–18; 8:45 am]
Attention Reports Clearance Officer. All (3) assist the Office of Child Support
requests should be identified by the title BILLING CODE 4184–01–P
Enforcement (OCSE) in monitoring and
of the information collection. Email evaluating State Child Support
address: infocollection@acf.hhs.gov. programs.
DEPARTMENT OF HEALTH AND
OMB Comment: OMB is required to
HUMAN SERVICES OCSE is proposing updates to the
make a decision concerning the
collection of information between 30 OCSE–157 report instructions to update
Administration for Children and and clarify reporting requirements.
and 60 days after publication of this Families
document in the Federal Register. Respondents are encouraged to contact
Therefore, a comment is best assured of Submission for OMB Review; the agency to obtain a copy of the
having its full effect if OMB receives it Comment Request revised instructions for review and
comment.
khammond on DSK30JT082PROD with NOTICES
within 30 days of publication. Written
comments and recommendations for the Title: OCSE–157 Child Support Respondents: State, Local or Tribal
proposed information collection should Enforcement Program Annual Data Government.
be sent directly to the following: Office Report
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Document Created: 2018-12-05 02:36:11
Document Modified: 2018-12-05 02:36:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of hearing: reconsideration of disapproval. | |
| Dates | Requests to participate in the hearing as a party must be received by the presiding officer by December 20, 2018. | |
| Contact | Benjamin R. Cohen, Presiding Officer, CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244, Telephone: (410) 786-3169. | |
| FR Citation | 83 FR 62869 |
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