- Q&A: Angela Gonzales (Hopi), on New Indigenous Health Research Dashboard
- Not All Expectant Moms Can Reach a Doctor's Office. This Kentucky Clinic Travels to Them.
- Hawaiʻi's Physician Shortage Hits Maui Hardest
- Choctaw Nation Found a Better Way to Deliver Harm Reduction. It's Working.
- In Rural America, Heart Disease Is Increasingly Claiming Younger Lives
- HHS Launches Healthy Border 2030 Framework Highlighting Health Priorities and Actions to Support Border Communities and Populations
- Gaps in Mental Health Training, Rural Access to Care Compound Az's Maternal Mortality Crisis
- Enticing Rural Residents to Practice Where They Train
- New Round of Federal Funding Open for Rural Health Initiatives
- UAA Training for Health Care Providers Keeps Victims of Violent Crimes from Falling Through the Cracks
- Helene Exacerbated Rise in Homelessness Across Western North Carolina
- 'It's a Crisis': How the Shortage of Mental Health Counselors Is Affecting the Rural Northwest
- FCC Launches New Maternal Health Mapping Platform
- How Mobile Clinics Are Transforming Rural Health Access for Cochise County Farmworkers
- Struggling to Adapt
Pennsylvania Announces Temporary Change to SNAP Benefit Issuance Schedule
Pennsylvania Department of Human Services (DHS) Secretary Teresa Miller announced that DHS is altering payment schedules for the Supplemental Nutrition Assistance Program (SNAP) for the month of December to allow all benefits to be issued without risk of delay in case of a federal government shutdown. SNAP is a federally funded program and the federal government is currently funded through December 11, 2020.
“SNAP is a critical resource for the nearly 1.9 million Pennsylvanians who use it to purchase fresh food and groceries for themselves and their families. Particularly as Pennsylvania and our nation are in the midst of a growing public health crisis, we cannot risk a lapse in benefits that help meet this most basic, essential need,” said Secretary Miller. “Some SNAP recipients may receive their monthly benefit and emergency allotments earlier than usual, but we need Pennsylvanians to know that this is not in error or an additional payment. This is their normal December payment, and there will be no additional payment.”
SNAP benefits are typically issued during the first 10 business days of the month and emergency allotments, which are authorized by the Families First Coronavirus Response Act and currently go to about 60 percent of SNAP households, in the second 10 business days after this issuance. Because SNAP is entirely federally funded, a delay in authorizing new funding could disrupt benefit issuance. To avoid any potential disruption, recipients may receive their benefits earlier than anticipated and in one payment as opposed to two issuances. All December SNAP benefits will be available on EBT cards by December 11, 2020.
SNAP helps nearly 1.9 million Pennsylvanians purchase fresh food and groceries, helping families with limited or strained resources be able to keep food on the table while meeting other needs. Inadequate food and chronic nutrient deficiencies have profound effects on a person’s life and health, including increased risks for chronic diseases, higher chances of hospitalization, poorer overall health, and increased health care costs. As the nation faces the COVID-19 pandemic, access to essential needs like food is more important than ever to help keep vulnerable populations healthy and mitigate co-occurring health risks.
SNAP recipients can also use online purchasing to use SNAP funds for grocery delivery or for prepayment of curbside pick-up at certain retailers. Earlier this year, Pennsylvania joined a federal pilot program allowing SNAP recipients to purchase food online through certain approved retailers: Walmart, Amazon, the Fresh Grocer, Shoprite, and, most recently, Aldi. Funds can only be used for food products and not processing fees, delivery charges, or tips.
Applications for SNAP and other public assistance programs can be submitted online at www.compass.state.pa.us. Those who prefer to submit paper documentation can print from the website or request an application by phone at 1-800-692-7462 and mail it to their local County Assistance Office (CAO) or place it in a CAO’s secure drop box, if available. You do not need to know your own eligibility in order to apply. While CAOs remain closed, work processing applications, determining eligibility, and issuing benefits continues. Clients should use COMPASS or the MyCOMPASS PA mobile app to submit necessary updates to their case files while CAOs are closed.
For more information about food assistance resources for people around Pennsylvania impacted by COVID-19 and the accompanying economic insecurity, visit the Department of Agriculture’s food security guide.
For more information on public assistance programs, visit www.dhs.pa.gov.
Pennsylvania Governor Sends Letter Urging Congress to Extend Federal Programs for Unemployed Workers
With hundreds of thousands of workers in Pennsylvania relying on several federal unemployment programs that are set to expire at the end of the month, Governor Tom Wolf sent a letter today to the state’s Congressional delegation urging the federal government to continue the programs through 2021.
“The number of COVID-19 cases is surging now and expected to continue increasing in the weeks to come, endangering both the public and economy,” said Gov. Wolf. “I strongly urge you, our congressional delegation, to consider how important the CARES Act has been to our nation and our state in helping businesses and workers and in preventing further contraction of the economy, and to act swiftly to extend these programs.”
The governor’s letter outlines four recommended actions:
- Extend Pandemic Unemployment Assistance (PUA) Through 2021: PUA provides unemployment benefits to workers who are self-employed, seeking part-time employment, lack sufficient work history, or otherwise do not qualify for regular Unemployment Compensation (UC) or Extended Benefits (EB). PUA has provided more than $6.5 billion to Pennsylvania households and the economy.
- Extend Pandemic Emergency Unemployment Compensation (PEUC) Through 2021: PEUC provides up to 13 weeks of additional unemployment assistance to those who exhausted their benefits. PEUC has added $846.1 million to households in Pennsylvania.
- Renew Federal Pandemic Unemployment Compensation (FPUC): FPUC, which expired on July 31, 2020, provided $16.1 billion to eligible individuals through an additional $600 per week on top of their weekly UC benefit.
- Extend No-interest Loans to the UC Trust Fund Through 2021: Many states are borrowing from the federal government to pay the increased need for UC benefits. Pennsylvania has borrowed $618 million in loans that will begin accruing interest on Jan. 1, 2021 if the no-interest loan program expires. Extending the no-interest loans to states is critical to avoid significant increases in employer taxes and assessments as more Pennsylvanians are expected to need the benefits to afford housing, food and other basic needs.
Since March, the Department of Labor & Industry has paid more than $31.6 billion in total unemployment benefits.
Pennsylvania Capitol Complex will Close to Public Due to Rising COVID-19 Cases
With the surge in COVID-19 cases continuing, starting Monday, Dec. 7, the Pennsylvania Capitol Complex will close to the public until further notice. All operations of the Governor’s Office and General Assembly will continue, but access to the Capitol Complex will be limited to employees and people with badge keycard credentials.
The cancelation of visits and events applies to all interior venues in the Capitol Complex and will affect rallies, school or group tours, choir performances, receptions, and other public gatherings. The Capitol Complex includes, but is not limited to, the Main Capitol Rotunda, East Wing Rotunda, Keystone Building Atrium, Forum Auditorium and The State Museum of Pennsylvania.
To further support public health, the Department of General Services is encouraging Pennsylvanians to add their phone to the fight against COVID-19 by downloading the COVID Alert PA app. The free and voluntary mobile app can notify those who opt-in if you have had a potential exposure to someone who tested positive for COVID-19. In addition, the app provides timely alerts that can help you get advice on how to help yourself and protect others as well as determine when to get testing. It can help reduce your risk of unknowingly spreading the virus to your friends, family, and larger community. The free app can be found in the Google Play Store Opens In A New Window and the Apple App Store Opens In A New Window by searching for “covid alert pa.”
Pennsylvania Governor Announces Life Sciences Partnership to Create Jobs, Develop COVID-19 Vaccine
On December 3, Pennsylvania Governor Tom Wolf announced that U.S. Specialty Formulations (USSF), LLC, a pharmaceutical manufacturing company, will expand its operations in Allentown, Lehigh County to continue its work developing a COVID-19 vaccine in partnership with VaxForm, LLC. This project will create at least 97 new, high-paying positions at the site.
“There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”
USSF will expand its 41,000-square-foot facility in Allentown and will request an FDA Emergency Use Authorization (EUA) approval to release a COVID-19 oral and injectable vaccine in mid-2021. In order to meet its schedule, the company must make renovations, acquire equipment, and hire new employees.
There is currently a global shortage of pharmaceutical manufacturing capacity, further exacerbated by the COVID-19 pandemic, and very limited capacity for clinical investigators to obtain appropriately documented clinical grade materials. USSF has been able to address both of these market challenges. USSF has also partnered with fellow Ben Franklin Technology Partners company VaxForm, LLC, to adapt an emergent oral vaccine platform technology to act as a vaccine for SARS-CoV-2 (COVID-19).
This oral platform was originally designed and has been successfully tested to show that it produces the antibodies required to generate immunity to Diphtheria, Tetanus (Lockjaw) and Pertussis (Whooping cough). After the COVID-19 genomic structure was identified, this oral platform was modified to generate the appropriate proteins to produce the proper immune response in mammals. USSF will be providing clinical materials from its Allentown plant for the human phase one clinical safety trials scheduled to begin in February 2021.
USSF received a funding proposal from the Department of Community and Economic Development (DCED) for a $291,000 Pennsylvania First grant and was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority loan. The company has committed to invest at least $5.2 million into the project and company will create 97 new, high-paying jobs and retain 14 more positions.
The project was coordinated by the Governor’s Action Team, an experienced group of economic development professionals who report directly to the governor and work with businesses that are considering locating or expanding in Pennsylvania.
“Completion of the USSF expansion will add a significant capability and capacity for our offerings and specifically to the oral Vaccine Platforms. As we continue the ramp for our Generation 1 and Generation 2 oral platforms, USSF will have the manufacturing space and human resources to deploy vaccines throughout PA and the world,” said USSF CEO Dr. Kyle Flanigan. “This is expected to have a dramatic positive impact on world health. The jobs created focus on biotechnology and advanced manufacturing capabilities, which are resilient to economic downturn. Further, the strategic location of this facility also allows USSF to support other vaccine formulation companies as the industry focuses on bringing this pandemic under control.”
The company also received more than $225,000 in funding from DCED through the COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program to support the rapid advancement of vaccines, treatments and therapies by qualified biotechnology entities in response to the COVID-19 pandemic. The program, announced in July, was made available to Pennsylvania-based entities that demonstrate both a financial need and a well-defined pathway to the accelerated commercialization of a new vaccine, treatment or therapy in direct response to fight against COVID-19.
“We are pleased to welcome USSF to the growing life sciences sector in the Lehigh Valley,” said Don Cunningham, president and CEO of the Lehigh Valley Economic Development Corporation (LVEDC). “USSF is on the front lines of the fight against COVID-19 and we’re glad to be home to its expanding operations. We appreciate the work of Governor Wolf and the Commonwealth to support the growth of this important company.”
USSF was founded in 2013 and produces a variety of pharmaceuticals in a state-of-the-art facility that exceeds quality standards outlined in U.S. Pharmacopeia (USP) and FDA guidelines, and adheres to the Current Good Manufacturing Practice (cGMP) and thereby lowers the total risk of using Outsourced Facility pharmaceuticals. The company utilizes a small batch disposable model to support healthcare providers and investigational new drug sponsors on a global scale. By registering some formulations under its FDA Outsourced Facility designation, USSF addresses the need caused by interruptions in the availability of specialty pharmaceuticals. USSF focuses on high-value formulations, allowing the company to provide a much larger portfolio of products to customers at both global and regional levels. USSF’s portfolio has expanded to include injectables and nasal presentations as well as tropical pharmaceuticals as a response to customer demands. The company is also the global single source of four prescription medications.
For more information about the Governor’s Action Team or DCED, visit dced.pa.gov, and be sure to stay up to date with all of our agency news on Facebook, Twitter, and LinkedIn.
Pennsylvania Opens Hemp Grower, Processor Permit Applications for 2021 Season; Invites Stakeholders to 2020 Hemp Summit
Pennsylvania Agriculture Secretary Russell Redding announced today that Pennsylvania’s 2021 hemp program applications for commercial growers and processors open Saturday, December 5 for mail-in applicants only. Online applications are expected to open in January 2021.
“Hemp production represents a return to our heritage and a wealth of new opportunities,” said Redding. “Hemp has seemingly endless uses as sustainable building materials, fabrics, paper and resins, plus scores of food products all spell out a bright future for growers and processors alike. Pennsylvania is committed to creating a commercial hemp program that works for small and large growers, new and established businesses, and urban and traditional agriculture.”
In 2020, the second year of the state’s commercial growing program, following a two-year research pilot, the department issued permits for more than 500 growing sites and 60 processors statewide. Permits for the 2020 season are valid through February 2021.
Redding also encouraged growers, processors and anyone interested in pursuing business opportunities in the emerging industry to attend the Pennsylvania Hemp Summit Interactive Virtual Summit December 8 and 9, 2020. Sessions will include:
- Navigating Rules and Regulations: An Update from Federal and State Leaders
- Filling Processing Needs and Building Lasting Agricultural Infrastructure
- Grow Local, Process Local, Buy Local – Building Our Supply Chains
Register online at pahempsummit.com. Students and Pennsylvania permit holders are eligible for a special registration rate, and call-in options are available for those without internet access. Contact HempSummit@TeamPA.com for details. For information about call-in options for attending the Virtual Summit, please call (717) 233-1375.
Applications for 2021 Hemp permits will be accepted from December 5, 2020 through April 1, 2021. The 2021 program, similar to the 2020 program, is operating under the requirements of the 2018 Federal Farm Bill and the USDA Interim Final Rule for hemp production. Processor permits were new in 2020 and continue in 2021. Information about permit holders will again be on the department website to inform business decisions and help connect growers and processors.
New or aspiring growers are encouraged to review application instructions and information on new minimum plant limits and opportunities for written exemptions for qualified commercial projects including planting for removing soil contaminants.
Each property where hemp is grown requires a separate permit. An initial permit costs $150. Permit renewals are $50. Applicants interested in easier application, renewal and online payment are encouraged to wait until January, when the upgraded system is expected to be available.
Hemp was grown in Pennsylvania and throughout the United States until after World War II but became regulated along with marijuana and its cultivation was prohibited under federal law. Hemp and marijuana are different varieties of the same species of plant. Unlike marijuana, hemp is grown mainly for fiber and seed and must maintain a concentration of the psychoactive chemical delta-9 tetrahydrocannabinol, or THC, below the .3 percent legal threshold. As a result of the 2019 and 2020 commercial growing seasons, the department has provided a list of prohibited crop varieties of concern that yield THC levels above the legal threshold.
For more information on Pennsylvania’s hemp program, visit agriculture.pa.gov/hemp or contact the hemp program staff at 1- 223-666-2561.
HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.
“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” said HHS Secretary Alex Azar. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.”
You can read the full press release here
HHS Outlines New Plans and a Partnership to Reduce U.S. Pregnancy-related Deaths
The U.S. Department of Health and Human Services (HHS) released an important HHS Action Plan and announced a partnership to reduce maternal deaths and disparities that put women at risk prior to, during, and following pregnancy. The U.S. Surgeon General Jerome M. Adams issued a complementary Call to Action to Improve Maternal Health outlining the critical roles everyone can play to improve maternal health.
Approximately 700 women die each year in the United States as a result of pregnancy-related complications. In addition, every year more than 25,000 women suffer unintended outcomes of labor and delivery that can result in significant short- or long-term consequences to their health. The Centers for Disease Control and Prevention estimates that two out of three pregnancy-related deaths are preventable.
“Maternal mortality should be a ‘never’ event,” said HHS Secretary Alex Azar. “We now have laid out a plan for all Americans to work together to cut maternal deaths dramatically and improve the long-term health of mothers and their children.”
In the newly released Action Plan, HHS provides a roadmap for addressing risk factors before and during pregnancy, improving the quality of and access to maternity and postpartum care, and supporting a research agenda to fill gaps in current evidence. The Call to Action provides a list of strategies and specific actions to optimize women’s health. HHS is also announcing a public-private partnership with the March of Dimes to address the disparity gap in maternal health outcomes for black women through the implementation of evidence-based best practices to improve healthcare quality in hospital settings.
“The health of our nation depends on the health of our mothers, and making the U.S. the safest place in the world to give birth is one of my top priorities,” said Vice Adm. Jerome M. Adams, Surgeon General. “A mother or mother-to-be dies every 12 hours in the U.S. These tragedies are unacceptable. We cannot truly improve maternal health — until we acknowledge and address the disparate outcomes many women of color face.”
For more information:
The Press Release can be found here.
The HHS Maternal Health Initiative can be found here.
Trump Administration Finalizes Policies to Give Medicare Beneficiaries More Choices around Surgery
Outpatient Prospective Payment System and Ambulatory Surgical Center final rule empowers beneficiary choices and unleashes competition to lower costs and improve innovation
On December 2, CMS finalized policy changes that will give Medicare patients and their doctors greater choices to get care at a lower cost in an outpatient setting. The Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) final rules will increase value for Medicare beneficiaries and reflect the agency’s efforts to transform the health care delivery system through competition and innovation. These changes implement the Trump Administration’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors, and will take effect on January 1, 2021.
“President Trump’s term in office has been marked by an unrelenting drive to level the playing field and boost competition at every turn,” said CMS Administrator Seema Verma. “Today’s rule is no different. It allows doctors and patients to make decisions about the most appropriate site of care, based on what makes the most sense for the course of treatment and the patient without micromanagement from Washington.”
In this final rule, CMS will begin eliminating the Inpatient Only (IPO) list of 1,700 procedures for which Medicare will only pay when performed in the hospital inpatient setting over a three-year transitional period, beginning with some 300 primarily musculoskeletal-related services. The IPO list will be completely phased out by CY 2024. This will make these procedures eligible to be paid by Medicare when furnished in the hospital outpatient setting when outpatient care is appropriate, as well as continuing to be payable when furnished in the hospital inpatient setting when inpatient care is appropriate, as determined by the physician. In the short term, as hospitals face surges in patients with complications from COVID-19, being able to provide treatment in outpatient settings will allow non-COVID-19 patients to get the care they need.
In addition to putting decisions on the best site of care in the hands of physicians, allowing more procedures to be done in an outpatient setting also provides for lower-cost options that benefit the patient.
For example, thromboendarterectomy (HCPCS code 35372) is a surgical procedure that removes chronic blood clots from the arteries in the lung. If this procedure is performed in an inpatient setting, a patient who has not had other health care expenses that year would have a deductible of about $1500. In contrast, the copayment for this procedure for the same patient in the outpatient setting would be about $1150. Patient safety and quality of care will be safeguarded by the doctor’s assessment of the risk of a procedure or service to the individual beneficiary and their selection of the most appropriate setting of care based on this risk. This is in addition to state and local licensure requirements, accreditation requirements, hospital conditions of participation, medical malpractice laws, and CMS quality and monitoring initiatives and programs.
Beginning January 1, 2021, we are adding eleven procedures to the ASC Covered Procedures List (CPL), including total hip arthroplasty (CPT 27130), under our standard review process. Additionally, we are revising the criteria we use to add surgical procedures to the ASC CPL, providing that certain criteria we used to add surgical procedures to the ASC CPL in the past will now be factors for physicians to consider in deciding whether a specific beneficiary should receive a covered surgical procedure in an ASC. Using our revised criteria, we are adding an additional 267 surgical procedures to the ASC CPL beginning January 1, 2021. Finally, we are adopting a notification process for surgical procedures the public believes can be added to the ASC CPL under the criteria we are retaining.
CMS is announcing that it will continue its policy of paying for 340B-acquired drugs at average sales price minus 22.5% after the July 31, 2020, decision of the Court of Appeals for the D.C. Circuit upholding the current policy. This policy lowers out-of-pocket drug costs for Medicare beneficiaries by letting them share in the discount that hospitals receive under the 340B program. Since this policy went into effect in 2018, Medicare beneficiaries have saved nearly $1 billion on drug costs, with expected Medicare beneficiary drug cost savings of over $300 million in CY 2021.
As part of the agency’s Patients Over Paperwork Initiative, which is aimed at reducing burden for health care providers, CMS is establishing a simple updated methodology to calculate the Overall Hospital Quality Star Rating (Overall Star Rating). The Overall Star Rating summarizes a variety of quality measures published on the Medicare.gov Care Compare tool (the successor to Hospital Compare) for common conditions that hospitals treat, such as heart attacks or pneumonia. Along with publicly reported data on Care Compare, the Overall Star Rating helps patients make better-informed health care decisions. Veterans Health Administration hospitals will be added to CMS’ Care Compare, which will help veterans understand hospital quality within the VA system. Overall, these changes will reduce provider burden, improve the predictability of the star ratings, and make it easier for patients to compare ratings between similar hospitals.
In response to stakeholder feedback about the current methodology used to calculate the Overall Star Rating, CMS is not finalizing its proposal to stratify readmission measures under the new methodology based on dually eligible patients, but will continue to study the issue to find the best way to convey quality of care for this vulnerable population.
Finally, in order to address the ongoing public health emergency, CMS is finalizing a new requirement for the nation’s 6,200 hospitals and critical access hospitals to report information about their inventory of therapeutics to treat COVID-19. This reporting will provide the information needed to track and accurately allocate therapeutics to the hospitals that need additional inventory to care for patients and meet surge needs.
For More Information:
CMS COVID-19 Stakeholder Engagement Calls-December
CMS hosts varied recurring stakeholder engagement sessions to share information related to the agency’s response to COVID-19. These sessions are open to members of the healthcare community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.
Call details are below. Conference lines are limited so we highly encourage you to join via audio webcast, either on your computer or smartphone web browser. You are welcome to share this invitation with your colleagues and professional networks. These calls are not intended for the press.
Calls recordings and transcripts are posted on the CMS podcast page at: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts
CMS COVID-19 Office Hours Calls (twice a month on Tuesday at 5:00 – 6:00 PM Eastern)
Office Hour Calls provide an opportunity for hospitals, health systems, and providers to ask questions of agency officials regarding CMS’s temporary actions that empower local hospitals and healthcare systems to:
- Increase Hospital Capacity – CMS Hospitals Without Walls;
- Rapidly Expand the Healthcare Workforce;
- Put Patients Over Paperwork; and
- Further Promote Telehealth in Medicare
Next Office Hours:Tuesday, December 8th at 5:00 – 6:00 PM Eastern
Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 3129517
Audio Webcast link: https://engage.vevent.com/rt/cms2/index.jsp?seid=2766
Tuesday, December 22nd at 5:00 – 6:00 PM Eastern
Toll Free Attendee Dial In: 833-614-0820; Access Passcode: 3968359
Audio Webcast link: https://engage.vevent.com/rt/cms2/index.jsp?seid=2771
For the most current information including call schedule changes, please click here
To keep up with the important work the White House Task Force is doing in response to COVID-19 click here: https://protect2.fireeye.com/url?k=36fa2226-6aae0b0d-36fa1319-0cc47a6d17cc-2d06c219f858d641&u=http://www.coronavirus.gov/. For information specific to CMS, please visit the Current Emergencies Website.
COVID-19 Vaccines and Monoclonal Antibody Infusion: Enforcement Discretion Relating to SNF Consolidated Billing
To facilitate the efficient administration of COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising enforcement discretion with respect to statutory provisions requiring consolidated billing by SNFs as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance. Through the exercise of this discretion, we will allow Medicare-enrolled immunizers working within their scope of practice and subject to applicable state law, including, but not limited to, pharmacies working with the United States, as well as infusion centers, and home health agencies, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare Part A SNF residents. This enforcement discretion, and accordingly the ability for entities other than the SNF to submit claims for these monoclonal antibody products and their administration furnished to Medicare Part A SNF residents, is limited to the period described in the above-cited enforcement discretion notice.