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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.

CMS Takes Further Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment

The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, casirivimab and imdevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab, administered together, may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab regarding the limitations of authorized use when administered together.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) , EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Additional Resources:

USDA Publishes Proposed Rule Maintaining School Meal Flexibilities

In line with USDA’s unwavering promise to serve America’s children well through school meal programs, the department today announced it will publish a proposed rule maintaining flexibility for schools to serve tasty meals their kids will be eager to eat. These proposed changes respond directly to the needs of nutrition professionals who are the experts on-the-ground, hearing from our children every day.

The proposed rule would maintain flexibility in USDA child nutrition program meal requirements related to milk, grains, and sodium, by:

  • Allowing flavored, low-fat milk in the Child Nutrition Programs;
  • Allowing half of the weekly grains offered through the school meal programs to be whole grain-rich; and
  • Providing schools more time for gradual sodium reduction by retaining Sodium Target 1 through the end of SY 2023-2024, continuing to Target 2 in SY 2024-2025, and eliminating the Final Target.

Yesterday, USDA issued a separate rule as an administrative step to ensure the department’s procedural compliance with a court ruling regarding its 2018 final rule on child nutrition program flexibilities. Today’s rule proposes to restore the flexibilities included in the 2018 final rule. Despite this procedural formality, schools do not have to change their meals, thanks to the  meal pattern flexibilities USDA has already provided in all child nutrition programs through June 30, 2021, in response to the COVID-19 national emergency.

The proposed rule announced today will publish in the Federal Register on Nov. 25th, followed by a 30-day public comment period. USDA is committed to listening to and collaborating with customers, partners, and stakeholders to make these reforms as effective as possible, and encourages all those who are interested in school meals to share their comments and recommendations for improvement through regulations.gov.

For information on food insecurity in Pennsylvania throughout the pandemic, visit agriculture.pa.gov/foodsecurity.

CARES Act-Funded Dairy Program Provides $7.6 Million in Direct Relief to 1,550 Pennsylvania Dairy Farmers

Pennsylvania Agriculture Secretary Russell Redding announced that the CARES Act-funded Dairy Indemnity Program has distributed $7.6 million in direct relief payments to 1,550 dairy farmers in the commonwealth. Any dairy farmer who experienced losses due to discarded or displaced milk during the COVID-19 pandemic was eligible to apply.

“Early in the pandemic in Pennsylvania, many of our dairy farmers were forced to dump milk and faced extreme uncertainty due to rapidly changing markets,” said Redding. “In this season of thanks, we are grateful that the legislature saw and met the needs of Pennsylvania’s dairy farmers with this program. These dollars don’t stop at the farm gate. They come back in your communities through grocery stores, schools, food banks, and more.”

Senators Judy Schwank and Elder Vogel, chairs of the Senate Agriculture and Rural Affairs Committee, championed this CARES-Act funding for Pennsylvania’s dairy farmers and joined today’s announcement.

“The dairy indemnity program, funded by the CARES Act, was a great program to help 1,550 of our farmers weather COVID-19,” Schwank said. “But there are nearly 7,000 dairy farms in the Commonwealth. We have to recommit ourselves to doing everything we can to strengthen the industry.”

“During this difficult time, there was an even greater appreciation for the role dairy farmers plays in our economy and to the families of Pennsylvania,” said Vogel. “It is the Commonwealth’s most essential industry and providing the necessary state funding at this time is more critical than ever.”

To qualify for direct relief payments, farmer’s losses must have occurred between March 6, 2020 and September 30, 2020. Farmers were eligible for an immediate $1,500 in direct relief upon applying, followed by additional relief dollars with the remaining funds in the program.

Pennsylvania is home to nearly 7,000 dairy farms with an economic impact of $12 billion and more than 52,000 jobs. The commonwealth’s more than 500,000 cows produce more than 10.2 billion pounds of milk annually, ranking Pennsylvania seventh in the nation for total milk production.

Reminder: December 11 Deadline for 2021 Dairy Safety-Net Enrollment

The U.S. Department of Agriculture reminds dairy producers that the deadline to enroll in Dairy Margin Coverage (DMC) for calendar year 2021 is Friday, Dec. 11, 2020. USDA’s Farm Service Agency (FSA) opened DMC signup in October to help producers manage economic risk brought on by milk price and feed cost disparities.

For DMC enrollment, producers must certify with FSA that the operation is commercially marketing milk, sign all required forms, and pay the $100 administrative fee unless the dairy operation qualifies for a limited resource, beginning, socially disadvantaged, or military veteran farmers and ranchers waiver.

Producers interested in DMC have the option to select a $4.00 catastrophic level of coverage with no premium fee or they can choose to buy-up coverage where the premium is based on margin triggers between $4.50 and $9.50 on 5 to 95 percent of established production history.

To determine the appropriate level of DMC coverage for a specific dairy operation, producers can utilize the recently updated online dairy decision tool. The decision tool is designed to demonstrate the historical performance of DMC and assist producers with calculating total premium costs and administrative fees associated with participation in DMC. An informational video is available, too.

For more information, visit farmers.gov DMC webpage, or contact your local USDA Service Center. To locate your local FSA office, visit farmers.gov/service-center-locator.

 

Pennsylvania Secures $16 Million Pennsylvania Farm Bill, Highlights 2019 Programs that Aided PA Farmers through Pandemic

Pennsylvania Agriculture Secretary Russell Redding applauded the state legislature for once again funding Governor Tom Wolf’s Pennsylvania Farm Bill in the 2020-21 Pennsylvania Budget. The first-ever Pennsylvania Farm Bill was signed into law in July 2019 and was transformative for the commonwealth’s leading industry.

“We began this journey with the Pennsylvania Farm Bill two years ago, when Governor Wolf laid out his vision to strengthen Pennsylvania’s agriculture industry and secure a prosperous future,” said Redding. “And while no one could predict the toils of 2020, the governor’s 2019 multi-million dollar investment to support the industry that sustains life for us all put infrastructure in place that made 2020 a little less painful for some, and put others in a position to pivot and meet radically altered demand.

“That foresight into what this industry and our commonwealth’s food supply chain needed was spot on, and we look forward to using this next round of funding to strengthen the weak links found as we maneuvered a pandemic,” added Redding.

In 2020, the Center for Poultry & Livestock Excellence, created and funded through the Pennsylvania Farm Bill, provided $280,000 in reimbursement to Pennsylvania’s animal ag industry for the purchase of personal protective equipment (PPE) to protect the workforce. The center also provided guidance to the industry on strengthening biosecurity plans to mitigate the spread of COVID-19.

As communities across the commonwealth faced immense challenges with food insecurity as a result of COVID-19 mitigation efforts, urban communities that took advantage of the PA Farm Bill’s Urban Agriculture Grant program had new infrastructure in place to combat food insecurity by growing their own food and improving access to food for their neighborhoods. The 2019 program funded 28 projects with $500,000.

Pennsylvania’s dairy industry was most notably affected by the pandemic, as rapidly changing markets caused farmers to dump fresh, nutritious milk down the drain. However, some dairy farmers had already diversified their markets and found new opportunities through the PA Farm Bill’s $5 million Dairy Investment Program. The program offered dairy farmers an opportunity to sustain and grow their business through on-farm innovation, organic transition, and diversification through value-added products such as cheese, yogurt, and ice cream. The 2019 program funded 46 projects.

A full review of accomplishments from the 2019 Pennsylvania Farm Bill can be found in The PA Farm Bill in Review, an article on the department’s blog.

 The $16 million 2020 Pennsylvania Farm Bill includes:

Resources for Business Development & Succession Planning

  • PA Agricultural Business Development Center, funded at $2 million, to serve as a resource to create business, transition, or succession plans.
  • Realty Transfer Tax Exemption for any transfer of preserved farmland to a qualified beginning farmer.

 Creating More Processing Capabilities

  • Center for Poultry & Livestock Excellence, funded at $1 million, to support the animal ag industry with biosecurity planning and disease prevention, processing capacity, and food safety and quality assurance.
  • Incentivizing Access to Meat Processing Inspections, funded at $500,000, to encourage access to new and expanded markets for small or new producers.

 Removing Regulatory Burdens

  • Resource Enhancement and Protection Tax Credits, expanded by $3 million, to increase the lifetime cap and increase availability.
  • Conservation Excellence Grant Program, funded at $2 million, to provide financial and technical assistance to farmers to install and implement best management practices.
  • Agriculture Linked Investment Program, funded at $500,000, to re-establish this low interest loan program for the implementation of best management practices.

 Strengthening the Ag Workforce

  • Agriculture and Youth Grant Program, funded at $500,000, to reestablish this program to fund agricultural and youth organizations to help increase knowledge and awareness of agriculture in the commonwealth.
  • The PA Farm to School Grant Program, funded at $500,000, to improve childhood nutrition while increasing exposure to agriculture.

 Protecting Agricultural Infrastructure

  • PA Rapid Response Disaster Readiness Account, funded at $3 million, to allow for quick response to agricultural disasters, such as Spotted Lanternfly or Avian Influenza; or providing an immediate response to a foodborne illness.

 Increasing Market Opportunities

  • PA Preferred Organic, funded at $1.6 million, to make Pennsylvania the nation’s leading organic state by further enhancing the growth of the organic industry.
  • PA Preferred Program, funded at an additional $1 million, to support the program and to bolster enrollment in Homegrown by Heroes.
  • State-level Specialty Crop Block Grant Program, funded at $500,000, to invest in and encourage farming of high-priority horticultural crops like hemp, hops, and hardwoods.
  • Urban Agriculture, funded at $500,000, to improve agriculture infrastructure in urban areas, the aggregation of product, sharing of resources, and support development efforts.

“As we close what will be known in history books as one of the most challenging years for Pennsylvania agriculture, we look forward to cultivating a brighter tomorrow through this next round of PA Farm Bill funding,” said Redding. “We’ll work to make this industry whole again, using our experiences from 2020 to strengthen our programs for the industry we so clearly rely on.”

For more about the Pennsylvania Farm Bill visit agriculture.pa.gov/pafarmbill. The department is actively working to roll out grant programs for the 2020 funding and will make announcements as programs are available for applications.