October 9, 2020 |  Issue 20-34 Missed Last Week's Washington Report? Click Here to Visit our Archives!
UPCOMING EVENTS
  

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Top Story
TopStoryHRSA Holds Listening Session with Tribal Leaders Regarding Coverage of 340B Drug Pricing Program
On October 7th, the Health Resources and Services Administration (HRSA) held a listening session in response to correspondence that they received from Tribal leaders regarding recent actions taken by pharmaceutical manufacturers to limit the access of covered entities to 340B drugs. The 340B program allows certain safety-net health care providers, specified in statute, to obtain discounts on covered outpatient drugs from drug manufacturers. Manufacturers participating in the Medicaid Drug Rebate Program agree to charge covered entities a price that will not exceed the amount determined under the statute (ceiling price) when selling covered outpatient drugs to covered entities. Covered entities are supposed to receive these drugs at reduced prices. However, the recent actions by the pharmaceutical industry threatens the availability of these drugs at the reduced price. 

HRSA is working closely with impacted covered entities and is actively investigating the matter in order to make a final determination as to any potential action.  To the extent that your organization is experiencing any issue with receiving the 340B ceiling price, HRSA asks that you contact them directly. The 340B Prime Vendor Program has a tool to assist covered entities in reporting these issues to HRSA. The link to the tool is: https://www.340bpvp.com/resource-center/340b-tools. You may also access the applicable form directly by clicking here.
In This Issue:

TOP STORY
FEDERAL ADMINISTRATION AND STATE GOVERNMENT UPDATES 
UPCOMING EVENTS, CALLS, AND WEBINARS
CAPITOL HILL UPDATES
SDPITestNIHB Submits Testimony to Senate Committee on Indian Affairs in Support of the Special Diabetes Program for Indians
In response to a September 23rd legislative hearing held by the Senate Committee on Indian Affairs, the National Indian Health Board (NIHB) submitted testimony in support of several bills including S. 3937, the Special Diabetes programs for Indians (SDPI) Reauthorization Act of 2020. Despite significant bipartisan, and bicameral support for SDPI, it is currently slated to only be reauthorized for the extent of the current budget continuing resolution, through December 11. This would be the fifth short-term extension of all of these programs since September 2019, and the third during the devastating COVID-19 pandemic. 
Additionally NIHB expressed support for S. 3126, the Native Behavioral Health Access Improvement Act of 2019 and for S. 4556 for the Director of IHS to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California.

NIHB's written testimony for the record may be read 
here.
  
For any questions, please contact NIHB Director of Congressional Relations, Shervin Aazami, at [email protected]
CommentsDrugTop Republicans Call for Input to Improve the 340B Drug Pricing Program
On Friday, October 9, House Energy & Commerce Ranking Member Greg Walden (R-OR) and Senate Health, Education, Labor, and Pensions (HELP) Chairman Lamar Alexander (R-TN) called for stakeholders to submit input for improvements to he 340B Drug Pricing Program. 
Said Walden and Lamar,"While we hear reports of the program benefiting low-income patients, there remains significant confusion about the program's requirements and lack of data necessary for effective oversight to maintain the integrity of the program." Recently, the Health Resources and Services Administration's (HRSA) held a listening session with Tribal leader regarding recent action taken by pharmaceutical manufacturers to limit access of covered entities to 340B drugs. 

Ranking Member Walden and Chairman Alexander are asking for comments and recommendations to be submitted by October 30th to the following email addresses: [email protected] and 3[email protected]
FEDERAL ADMINISTRATION AND STATE GOVERNMENT UPDATES
Changes340BUpdate on 340B Program Changes Following Manufacturers Limiting Covered Entity's Access to Drug Discounts
On October 7th, the Health Resources and Services Administration (HRSA) held a listening session in response to correspondence that they received from Tribal leaders regarding recent actions taken by pharmaceutical manufacturers to limit the access of covered entities to 340B drugs. The 340B program allows certain safety-net health care providers, specified in statute, to obtain discounts on covered outpatient drugs from drug manufacturers. Manufacturers participating in the Medicaid Drug Rebate Program agree to charge covered entities a price that will not exceed the amount determined under the statute (ceiling price) when selling covered outpatient drugs to covered entities. Covered entities are supposed to receive these drugs at reduced prices. However, the recent actions by the pharmaceutical industry threatens the availability of these drugs at the reduced price. 

HRSA is working closely with impacted covered entities and is actively investigating the matter in order to make a final determination as to any potential action.  To the extent that your organization is experiencing any issue with receiving the 340B ceiling price, HRSA asks that you contact them directly. The 340B Prime Vendor Program has a tool to assist covered entities in reporting these issues to HRSA. The link to the tool is: https://www.340bpvp.com/resource-center/340b-tools. You may also access the applicable form directly by clicking here.
ExecutiveOrderImplementation of an Executive Order on Access to Affordable Life Saving Medications
On September 28, HHS and HRSA released a joint notice of proposed rulemaking on an executive order titled "Access to Affordable Life-Saving Medications." This order involves entities in the 340B Drug Pricing Program who receive grants under section 330(e) of the Public Health Service Act. Through this order, these entities have the opportunity to establish and provide access to insulin and injectable epinephrine to low income patients, who do not have access before through commercial insurance or Federal programs, like Medicare and Medicaid, at the price originally purchased by the health center through the 340 Drug Pricing Program. Individuals with low incomes are determined by the Secretary to have; high cost sharing requirements for either insulin or injectable epinephrine, high unmet deductibles or no health insurance. This proposed rulemaking would apply to both new grants and new project periods for certain service areas, new access point, supplemental and expanded service awards. 

Comments on this rule making are due October 28, 2020. 
InfoRequestThree Information Collection Notices from CMS on Data Collection, Monitoring and Establishment of Exchange
On September 28, CMS published a notice on an information collection request for the Beneficiary and Family Centered Data Collection, which requests changes for beneficiaries to now have the ability to directly provide feedback on the services they receive under the Quality Improvement Organization (QIO) program, allow access for the quality improvement data for QIOs, and provide evaluation metrics for CMS to use in assessing performance of QIO contractors. The second collection request involves Programs of All-Inclusive Care for the Elderly (PACE) Quality Data Monitoring and continuing mandatory monitoring and reporting. The third request reinstates the Reporting and the Establishment of an Exchange by a State and Qualified Health Plans. This exchange will assist in the certification and offering of state Qualified Health Plans. 

Comments on all three of these information collection requests are due October 28, 2020. 
HomeHealthCMS Home Health Agency Accreditation Program Continuation of Approval
On September 28, CMS published a proposed notice on the acknowledgement of an application from the Accreditation Commission for Healthcare for continued recognition as a national accrediting organization authorized to continue participation in Medicare and Medicaid programs. This certification as a national accrediting organization allows home health agencies to participate in a provider agreement as well as assist eligible beneficiaries covered services as long as they maintain certain requirements. 

Comments on this proposed notice are due October 28, 2020
CodingAnnouncement of Public Meeting from CMS on Healthcare Procedure Coding Systems
On September 28, CMS released a notice on the virtual Healthcare Common Procedure Coding System (HCPCS) public meeting. Meeting topics will include coding recommendations for new public requests of revisions to the HCPCS level 2 code set for durable medical equipment as well as supplies for non-drug and non-biological items and services. The meeting will be held on October 27 and 28. Written comments about these revisions can be emailed to [email protected]
LowIncomeBroadband Providers in Rural Areas Working with the FCC to Help Low Income Students
On October 1, the FCC released an announcement of "Rural Broadband Providers Working with the FCC to Meet Internet Needs of Students in Low-Income Families." Specifically, the FCC will now have hundreds of carries providing discounts and service upgrades to help families who need better broadband services. Specifically, tariff revisions will help provide eligible new customers of rural carriers a 25% discount on certain broadband services as well as offer faster connections at no cost to existing eligible customers. The effect date of the revised tariffs was October 1, 2020, while the promotional offerings will be in effect till June 30, 2021.  
SUDCMS and ACF information Bulletin on Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment in Patients and Communities
On October 5, CMS announced the release of an informational bulletin in collaboration with the ACF on requirements for states to follow in regard to the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment in Patients and Communities Act (SUPPORT ACT). Some information in the bulletin includes new flexibilities and opportunities states may have when receiving Medicaid funding in relation to substance use disorder treatment, as well as how states can use funding provided under the Medicaid program to support placing children with their parents in specific residential treatment programs. This bulletin also outlines existing opportunities and flexibilities under Medicaid and state coordination of funds between Medicaid and the foster care program. 
UPCOMING EVENTS, CALLS, AND WEBINARS
NTHCRegister Now for NIHB's National Tribal Health Conference
In response to COVID-19, and in respect to the health of our communities, the National Indian Health Board (NIHB) decided to host its annual National Tribal Health Conference on a virtual platform.
NIHB is committed to providing the same world-class information to support Tribal health systems and opportunities for attendees to network with colleagues from across Indian Country. Tribal consultation and listening consultation sessions with our government partners, hosted by NIHB, will remain free and open to the public during specific, designated times.
NIHB believes this year's virtual conference brings a real opportunity to add new stakeholders to the conversation, especially those who may not have been able to join us in previous years due to travel costs or scheduling conflicts. NIHB is excited to have you join this year's virtual National Tribal Health Conference!

hrsaconsultHRSA Tribal Consultation Scheduled During NIHB Virtual Conference: October 13, 2020
The National Indian Health Board is offering a platform during its upcoming virtual conference for the Health Resources and Services Administration (HRSA) to host its annual Tribal Consultation. The HRSA consultation, which is in support of the agency's ongoing commitment to partner with Tribes, is free and open to the public and will take place on Tuesday, October 13, 2020 from 1:00 PM to 3:00 PM (EDT). Tribals official may submit written comments to [email protected] by September 28, 2020. 
 
 
To participate in this HRSA Tribal Consultation, please dial in at least 10 minutes before the appointed time to:
Conference number: 800-779-7169; Participant passcode: 6122629
GRANTS & RESOURCES
COVIDResourcesCall for Tribal COVID-19 Resources
The National Indian Health Board (NIHB) is seeking to create a pool of resources which Tribes can access when planning or implementing their own COVID-19 response. To this end, NIHB is asking Tribes to share with us any tools, operational plans, guides, policies, communication products, etc. that has helped your Tribe combat this pandemic. The materials can be de-identified, if needed. These resources will be placed online within NIHB's COVID-19 Tribal Response Center alongside other community health materials. We hope this aids Tribes to build on successes and support each other in the collective effort to mitigate the impact of the pandemic on Indian Country.

To submit any materials or resources, please email Courtney Wheeler (c[email protected]). If you have any questions, please contact Courtney Wheeler.

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