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Start Printed Page 63977 Executive Order 13954 of October 3, 2020 By the website link authority vested in me as President by the Constitution and the laws of the United States of America, it is how to buy cheap levitra online hereby ordered as follows. Section 1. Purpose. My Administration is committed to how to buy cheap levitra online preventing the tragedy of suicide, ending the opioid crisis, and improving mental and behavioral health.

Before the erectile dysfunction treatment levitra, these urgent issues were prioritized through significant initiatives, including the President's Roadmap to Empower Veterans and End a National Tragedy of Suicide (PREVENTS), expanded access to medication-assisted treatment and life-saving naloxone, and budget requests for significant investments in the funding of evidence-based treatment for mental- and behavioral-health needs. During the erectile dysfunction treatment levitra, the Federal Government has dedicated billions of dollars and thousands of hours in resources to help Americans, including approximately $425 million in emergency funds to address mental and substance use disorders through the Substance Abuse and Mental Health Services Administration. The levitra has also exacerbated mental- and behavioral-health conditions as a result of stress how to buy cheap levitra online from prolonged lockdown orders, lost employment, and social isolation. Survey data from the Centers for Disease Control and Prevention show that during the last week of June, 40.9 percent of Americans struggled with mental-health or substance-abuse issues and 10.7 percent reported seriously considering suicide.

We must enhance the ability of the Federal Government, as well as its State, local, and Tribal partners, to appropriately address these ongoing mental- and behavioral-health concerns. Sec how to buy cheap levitra online. 2. Policy.

It is the policy of the United States to prevent suicides, drug-related deaths, and poor behavioral-health outcomes, particularly how to buy cheap levitra online those that are induced or made worse by prolonged State and local erectile dysfunction treatment shutdown orders. I am therefore issuing a national call to action to. (a) Engage the resources of the Federal Government to address the mental- and behavioral-health needs of vulnerable Americans, including by. (i) providing crisis-intervention services to treat those in immediate how to buy cheap levitra online life-threatening situations.

And (ii) increasing the availability of and access to quality continuing care following initial crisis resolution to improve behavioral-health outcomes. (b) Permit and encourage safe in-person mentorship programs. Support-group participation how to buy cheap levitra online. And attendance at communal facilities, including schools, civic centers, and houses of worship.

(c) Increase the availability of telehealth and online mental-health and substance-use tools and services. And (d) Marshal public and private resources to address deteriorating mental health, such as factors that contribute to prolonged unemployment and social isolation. Sec how to buy cheap levitra online. 3.

Establishment of a erectile dysfunction Mental Health Working Group. The erectile dysfunction Mental Health Working Group (Working how to buy cheap levitra online Group) is hereby established to facilitate an “all-of-government” response to the mental-health conditions induced or exacerbated by the levitra, including issues related to suicide prevention. The Working Group will be co-chaired by the Secretary of Health and Human Services, or his designee, and the Assistant to the Start Printed Page 63978President for Domestic Policy, or her designee. The Working Group shall be composed of representatives from the Department of Defense, the Department of Justice, the Department of Agriculture, the Department of Labor, the Department of Housing and Urban Development, the Department of Education, the Department of Veterans Affairs, the Small Business Administration, the Office of National Drug Control Policy, the Office of Management and Budget (OMB), and such representatives of other executive departments, agencies, and offices as the Co-Chairs may, from time to time, designate with the concurrence of the head of the department, agency, or office concerned.

All members how to buy cheap levitra online of the Working Group shall be full-time, or permanent part-time, officers or employees of the Federal Government. Sec. 4. Responsibilities of the erectile dysfunction Mental how to buy cheap levitra online Health Working Group.

(a) As part of the Working Group's efforts, it shall consider the mental- and behavioral-health conditions of those vulnerable populations affected by the levitra, including. Minorities, seniors, veterans, small business owners, children, and individuals potentially affected by domestic violence or physical abuse. Those living how to buy cheap levitra online with disabilities. And those with a substance use disorder.

The Working Group shall examine existing protocols and evidence-based programs that may serve as models to better support these at-risk groups, including implementation and broader application of the PREVENTS, and the Department of Labor's Employer Assistance and Resource Network on Disability Inclusion's Mental Health Toolkit and Centralized Accommodation Programs. (b) Within 45 days of the date of this order, the Working Group shall develop and submit to the President a report that outlines a plan for improved service coordination between all relevant public and private stakeholders and executive departments and agencies (agencies) to assist individuals in crisis so that they receive effective treatment and recovery services. Sec. 5.

Grant Funding for States and Organizations that Permit In-Person Treatment and Recovery Support Activities for Mental and Behavioral Health.

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The NSW Government is investing an additional $4 million to fast-track the redevelopment of Shoalhaven District Memorial Hospital to begin in 2020-21.Minister for Health Brad Hazzard said the funding boost will bring the total spend for the project to $438 million, which will also support the acquisition of nearby Nowra Park.“The NSW Government is committed to investing in regional hospitals to ensure patients receive high-quality healthcare closer to home,” Mr Hazzard said.“The land acquisition of Nowra Park is necessary to provide for the expansion of clincial services at Shoalhaven Hospital.”The existing hospital site with expansion into the adjacent Nowra Park has been identified as the best solution for the redeveloped hospital.Clinical services planning is already well underway to best price for levitra 20mg identify the range of health services the Illawarra Shoalhaven community will require into the future. The additional funding best price for levitra 20mg will allow planning activities to progress including:Detailed site investigations, including in-ground investigations. Enabling works, including services diversion and best price for levitra 20mg potential in-ground works. And Design works for the redevelopment, including best price for levitra 20mg clinical design.

Member for the South Coast Shelley Hancock released new artist impressions and said residents will benefit from the hospital expansion, with new and upgraded health facilities to be delivered sooner.“Additionally, as we can see in these stunning images, the completed hospital will return green space back to the community, with an inclusive playground a key component of the park,” Mrs Hancock said.Member for Kiama Gareth Ward said he’s pleased work can get underway on the expanded hospital as soon as possible.“With the ongoing investments we have already put into the Shoalhaven District Memorial Hospital, this is the next big step after the completion of the $11.8 million hospital car park project this year,” Mr Ward said.Construction will start on the redeveloped hospital in this term of Government, prior to March 2023The SDMH redevelopment is one of 29 health projects announced before the 2019 election and is a part of the NSW Government’s record $10.7 billion investment in health infrastructure over the next 4 years.In the Illawarra Shoalhaven, other health projects include $700 million for a new Shellharbour Hospital, $37.1 million towards the Bulli Hospital and Aged Care Centre, and the Dapto and Ulladulla HealthOne projects, delivered as part of the $100 million HealthOne program.Artist impressions are available. best price for levitra 20mg.

The NSW Government is investing an additional $4 million to fast-track the redevelopment how to buy cheap levitra online of Shoalhaven District Memorial Hospital to begin in 2020-21.Minister for Health Brad Hazzard said the funding boost will bring the total spend for the project to $438 million, which will also support the acquisition of nearby Nowra Park.“The NSW Government is committed to investing in regional hospitals to ensure patients receive high-quality healthcare closer to home,” Mr Hazzard said.“The land acquisition of Nowra Park is necessary Can i buy ventolin over the counter in ireland to provide for the expansion of clincial services at Shoalhaven Hospital.”The existing hospital site with expansion into the adjacent Nowra Park has been identified as the best solution for the redeveloped hospital.Clinical services planning is already well underway to identify the range of health services the Illawarra Shoalhaven community will require into the future. The additional how to buy cheap levitra online funding will allow planning activities to progress including:Detailed site investigations, including in-ground investigations. Enabling works, including services diversion and how to buy cheap levitra online potential in-ground works.

And Design how to buy cheap levitra online works for the redevelopment, including clinical design. Member for the South Coast Shelley Hancock released new artist impressions and said residents will benefit from the hospital expansion, with new and upgraded health facilities to be delivered sooner.“Additionally, as we can see in these stunning images, the completed hospital will return green how to buy cheap levitra online space back to the community, with an inclusive playground a key component of the park,” Mrs Hancock said.Member for Kiama Gareth Ward said he’s pleased work can get underway on the expanded hospital as soon as possible.“With the ongoing investments we have already put into the Shoalhaven District Memorial Hospital, this is the next big step after the completion of the $11.8 million hospital car park project this year,” Mr Ward said.Construction will start on the redeveloped hospital in this term of Government, prior to March 2023The SDMH redevelopment is one of 29 health projects announced before the 2019 election and is a part of the NSW Government’s record $10.7 billion investment in health infrastructure over the next 4 years.In the Illawarra Shoalhaven, other health projects include $700 million for a new Shellharbour Hospital, $37.1 million towards the Bulli Hospital and Aged Care Centre, and the Dapto and Ulladulla HealthOne projects, delivered as part of the $100 million HealthOne program.Artist impressions are available..

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There are not enough health workers in California to meet the buy levitra jelly needs of the state’s increasingly diverse, growing, and aging population, and the situation is getting worse. In 2019, 39 percent of Californians identified as Latinx, but only 14 percent of medical school students and 6 percent of active patient care physicians in California were Latinx.Researchers from Mathematica, with support from the California Health Care Foundation, recently reviewed evidence from key health workforce policy interventions to determine their impact on access to health care, the diversity of the health workforce, and providers’ ability to deliver services in a language other than English (“language concordance”). The evidence review included academic literature and interviews of key experts in the buy levitra jelly field. It focused on health professions that require an advanced degree, because it has been particularly challenging to improve access, diversity, and language concordance through these jobs.“There have been many public and private efforts in California to increase the number and diversity of health professionals, but they have not been sufficient to alleviate the crisis,” said Diane Rittenhouse, a senior fellow at Mathematica.

€œIn a year with a state budget surplus, this report reviews evidence and presents options for public investment to improve health care access and health workforce diversity.” Mathematica’s researchers concluded that a blended approach is necessary to achieve better health care access and improve the diversity of the health workforce. For example, loan repayment in exchange for a commitment to serve in a medically underserved area of California is a quick way to improve buy levitra jelly access to primary care, behavioral health, and dentistry in those areas. Improving the diversity of the workforce, however, requires support for a diverse array of college students to succeed in California’s health professional training programs. Ultimately, underserved rural and urban areas are more likely to retain health professionals who are from those areas, and interventions that seek to engage those professionals will likely have the greatest buy levitra jelly impact.

Read the report here. For more information on the report or on health workforce challenges in California, please contact Todd Kohlhepp..

There are not enough health workers in California to meet the needs how to buy cheap levitra online of the state’s increasingly diverse, growing, and aging population, and the situation how to get levitra without a doctor is getting worse. In 2019, 39 percent of Californians identified as Latinx, but only 14 percent of medical school students and 6 percent of active patient care physicians in California were Latinx.Researchers from Mathematica, with support from the California Health Care Foundation, recently reviewed evidence from key health workforce policy interventions to determine their impact on access to health care, the diversity of the health workforce, and providers’ ability to deliver services in a language other than English (“language concordance”). The evidence review how to buy cheap levitra online included academic literature and interviews of key experts in the field.

It focused on health professions that require an advanced degree, because it has been particularly challenging to improve access, diversity, and language concordance through these jobs.“There have been many public and private efforts in California to increase the number and diversity of health professionals, but they have not been sufficient to alleviate the crisis,” said Diane Rittenhouse, a senior fellow at Mathematica. €œIn a year with a state budget surplus, this report reviews evidence and presents options for public investment to improve health care access and health workforce diversity.” Mathematica’s researchers concluded that a blended approach is necessary to achieve better health care access and improve the diversity of the health workforce. For example, loan repayment in exchange for how to buy cheap levitra online a commitment to serve in a medically underserved area of California is a quick way to improve access to primary care, behavioral health, and dentistry in those areas.

Improving the diversity of the workforce, however, requires support for a diverse array of college students to succeed in California’s health professional training programs. Ultimately, underserved rural and urban areas are more how to buy cheap levitra online likely to retain health professionals who are from those areas, and interventions that seek to engage those professionals will likely have the greatest impact. Read the report here.

For more information on the report or on health workforce challenges in California, please contact Todd Kohlhepp..

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Putnam County is calling on more detailed erectile dysfunction treatment data from the state as new cases of the levitra surge across the country during the holiday season.With Thanksgiving levitra patentschutz in the rearview mirror and more holidays fast approaching, county officials issued an alert cautioning families to modify plans to help curtail the spread of the levitra.Officials are also working with New York State health officials to get more information to residents, businesses, and schools, broken down by zip code.Putnam County Executive MaryEllen Odell noted that with more areas in the Hudson Valley and New York being designated as erectile dysfunction treatment “micro-cluster” hotspots, it’s even more important now important site than ever to provide the most detailed and specific data.“The majority of our residents continue to make responsible choices that keep their community safe,” she said. €œHowever, we do rely on the state data to keep people informed– which is why we continue to push for the state to provide us with a town or zip code breakdown of their metrics. “The governor’s mention of Brewster ‘nearing yellow zone designation’ confirms that our request to view Putnam County on a hyper-local level is a necessity,” she added noting that New York Gov. Andrew Cuomo mentioned the town earlier this month during a erectile dysfunction treatment briefing on the state’s micro-cluster strategy.There are currently 167 active erectile dysfunction treatment cases in Putnam County, with eight hospitalized for treatment of levitra patentschutz the levitra.

There have been a total of 2,722 erectile dysfunction treatment cases in Putnam and 64 levitra-related deaths. The latest breakdown of erectile dysfunction treatment cases in Putnam, by town, according to the county Department of Health, is as follows. Carmel. 962 (107 new);Southeast.

625 (57);Kent http://www.ec-prot-obermodern-zutzendorf.ac-strasbourg.fr/?p=2672. 384 (34);Putnam Valley. 291 (18);Patterson. 282 (54);Philipstown.

178 (9).“We continue to encourage all residents of our county to adhere to the recommendations that helped us flatten the curve earlier this year,” County Health Commissioner Michael Nesheiwat stated. €œPutnam County has seen a sharp rise in positive cases related to social gatherings and parties. €œThe spike that is occurring locally is a result of our actions,” Nesheiwat continued. €œWhether you are in closer proximity to Brewster, or you are further west, nearer to Peekskill, it is clear that our numbers are rising, and we all must make responsible choices to keep our families and our neighbors safe.” Click here to sign up for Daily Voice's free daily emails and news alerts..

Putnam County is calling on more detailed erectile dysfunction treatment data from the state as new cases of the levitra surge across the country during the holiday season.With Thanksgiving in the rearview mirror and more holidays fast approaching, county officials issued an alert cautioning families to modify plans to help curtail the spread of the levitra.Officials are also working with New York State health officials to get more information to residents, businesses, and how to buy cheap levitra online schools, broken down by zip code.Putnam County Executive MaryEllen Odell noted that with more areas in the Hudson Valley and New York being designated as erectile dysfunction treatment “micro-cluster” hotspots, it’s even more important now than ever to provide the most detailed and specific data.“The majority of our residents continue to make responsible choices that keep their community safe,” she said. €œHowever, we do rely on the state data to keep people informed– which is why we continue to push for the state to provide us with a town or zip code breakdown of their metrics. “The governor’s mention of Brewster ‘nearing yellow zone designation’ confirms that our request to view Putnam County on a hyper-local level is a necessity,” she added noting that New York Gov.

Andrew Cuomo mentioned the town earlier this month during a erectile dysfunction treatment briefing on the state’s micro-cluster strategy.There are currently 167 active erectile dysfunction treatment cases in Putnam how to buy cheap levitra online County, with eight hospitalized for treatment of the levitra. There have been a total of 2,722 erectile dysfunction treatment cases in Putnam and 64 levitra-related deaths. The latest breakdown of erectile dysfunction treatment cases in Putnam, by town, according to the county Department of Health, is as follows.

Carmel. 962 (107 new);Southeast. 625 (57);Kent.

384 (34);Putnam Valley. 291 (18);Patterson. 282 (54);Philipstown.

178 (9).“We continue to encourage all residents of our county to adhere to the recommendations that helped us flatten the curve earlier this year,” County Health Commissioner Michael Nesheiwat stated. €œPutnam County has seen a sharp rise in positive cases related to social gatherings and parties. €œThe spike that is occurring locally is a result of our actions,” Nesheiwat continued.

€œWhether you are in closer proximity to Brewster, or you are further west, nearer to Peekskill, it is clear that our numbers are rising, and we all must make responsible choices to keep our families and our neighbors safe.” Click here to sign up for Daily Voice's free daily emails and news alerts..

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Over 12,000 home health agencies levitra pill price served 5 million disabled and older Americans in 2018. Home health aides help their clients with the tasks of daily living, like eating and showering, as well as with clinical tasks, like taking blood pressure and leading physical therapy exercises. Medicare relies on home health care services because they help patients discharged from the hospital and skilled nursing facilities recover but at a much lower levitra pill price cost. Together, Medicare and Medicaid make up 76% of all home health spending.Home health care workers serve a particularly important role in rural areas.

As rural areas lose physicians and hospitals, home health agencies levitra pill price often replace primary care providers. The average age of residents living in rural counties is seven years older than in urban counties, and this gap is growing. The need for home health agencies serving the elderly in rural areas will continue to grow over the coming decades.Rural home health agencies face unique challenges. Low concentrations of people are dispersed over large geographic areas leading to long travel levitra pill price times for workers to drive to clients’ homes.

Agencies in rural areas also have difficulties recruiting and maintaining a workforce. Due to these difficulties, agencies may not be able to serve all rural beneficiaries, initiate care on time, or deliver all covered services.Congress has supported measures to levitra pill price encourage home health agencies to work in rural areas since the 1980s by using rural add-on payments. A rural add-on is a percentage increase on top of per visit and episode-of-care payments. When a home health aide works in a rural county, Medicare pays their home health agency a standard fee plus a rural levitra pill price add-on.

With a 5% add-on, Medicare would pay $67.78 for an aide home visit in a city and $71.17 for the same care in a rural area.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health agencies often replace primary care providers.Rural add-on payments have fluctuated based on Congressional budgets and political priorities. From 2003 to 2019, the amount Medicare paid agencies changed eight levitra pill price times. For instance, the add-on dropped from 10% to nothing in April 2003.

Then, in April 2004, Congress set the rural add-on to 5%.The variation in payments created a natural experiment for researchers levitra pill price. Tracy Mroz and colleagues assessed how rural add-ons affected the supply of home health agencies in rural areas. They asked if the number of agencies in urban and rural counties varied depending on the presence and dollar amount of rural add-ons between 2002 and 2018. Though rural add-ons have been in place for over 30 years, levitra pill price researchers had not previously investigated their effect on the availability of home healthcare.The researchers found that rural areas adjacent to urban areas were not affected by rural add-ons.

They had similar supply to urban areas whether or not add-ons were in place. In contrast, isolated levitra pill price rural areas were affected substantially by add-ons. Without add-ons, the number of agencies in isolated rural areas lagged behind those in urban areas. When the add-ons were at least 5%, the availability of home health in isolated rural areas was comparable to urban areas.In 2020, Congress implemented a system of payment reform that reimburses home health agencies in rural counties levitra pill price by population density and home health use.

Under the new system, counties with low population densities and low home health use will receive the greatest rural add-on payments. These payments aim to increase and maintain the availability of care in the most vulnerable rural home health markets. Time will tell if this approach gives sufficient incentive to ensure access to quality care in the nation’s most isolated areas.Photo via Getty ImagesStart Preamble Correction In proposed rule document 2020-13792 beginning on page 39408 in the issue of Tuesday, June levitra pill price 30, 2020, make the following correction. On page 39408, in the first column, in the DATES section, “August 31, 2020” should read “August 24, 2020”.

End Preamble [FR Doc levitra pill price. C1-2020-13792 Filed 7-17-20. 8:45 am]BILLING CODE 1301-00-D.

Over 12,000 home health agencies served 5 million Buy generic levitra disabled and older Americans how to buy cheap levitra online in 2018. Home health aides help their clients with the tasks of daily living, like eating and showering, as well as with clinical tasks, like taking blood pressure and leading physical therapy exercises. Medicare relies on home how to buy cheap levitra online health care services because they help patients discharged from the hospital and skilled nursing facilities recover but at a much lower cost.

Together, Medicare and Medicaid make up 76% of all home health spending.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health how to buy cheap levitra online agencies often replace primary care providers. The average age of residents living in rural counties is seven years older than in urban counties, and this gap is growing.

The need for home health agencies serving the elderly in rural areas will continue to grow over the coming decades.Rural home health agencies face unique challenges. Low concentrations of people are dispersed how to buy cheap levitra online over large geographic areas leading to long travel times for workers to drive to clients’ homes. Agencies in rural areas also have difficulties recruiting and maintaining a workforce.

Due to these difficulties, agencies may not be able to serve all rural beneficiaries, initiate care on time, or deliver all covered services.Congress has supported measures to encourage how to buy cheap levitra online home health agencies to work in rural areas since the 1980s by using rural add-on payments. A rural add-on is a percentage increase on top of per visit and episode-of-care payments. When a home health aide works in a rural county, Medicare pays how to buy cheap levitra online their home health agency a standard fee plus a rural add-on.

With a 5% add-on, Medicare would pay $67.78 for an aide home visit in a city and $71.17 for the same care in a rural area.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health agencies often replace primary care providers.Rural add-on payments have fluctuated based on Congressional budgets and political priorities. From 2003 to 2019, the amount how to buy cheap levitra online Medicare paid agencies changed eight times.

For instance, the add-on dropped from 10% to nothing in April 2003. Then, in April 2004, Congress set the rural add-on to 5%.The variation in payments created a how to buy cheap levitra online natural experiment for researchers. Tracy Mroz and colleagues assessed how rural add-ons affected the supply of home health agencies in rural areas.

They asked if the number of agencies in urban and rural counties varied depending on the presence and dollar amount of rural add-ons between 2002 and 2018. Though rural add-ons have been in place for over 30 years, researchers had not previously investigated their effect on the availability of home healthcare.The researchers found that rural areas adjacent to urban areas were not how to buy cheap levitra online affected by rural add-ons. They had similar supply to urban areas whether or not add-ons were in place.

In contrast, isolated rural how to buy cheap levitra online areas were affected substantially by add-ons. Without add-ons, the number of agencies in isolated rural areas lagged behind those in urban areas. When the add-ons were at least how to buy cheap levitra online 5%, the availability of home health in isolated rural areas was comparable to urban areas.In 2020, Congress implemented a system of payment reform that reimburses home health agencies in rural counties by population density and home health use.

Under the new system, counties with low population densities and low home health use will receive the greatest rural add-on payments. These payments aim to increase and maintain the availability of care in the most vulnerable rural home health markets. Time will tell if this approach gives sufficient incentive to ensure access to quality how to buy cheap levitra online care in the nation’s most isolated areas.Photo via Getty ImagesStart Preamble Correction In proposed rule document 2020-13792 beginning on page 39408 in the issue of Tuesday, June 30, 2020, make the following correction.

On page 39408, in the first column, in the DATES section, “August 31, 2020” should read “August 24, 2020”. End Preamble [FR how to buy cheap levitra online Doc. C1-2020-13792 Filed 7-17-20.

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Start Preamble Centers for Medicare & levitra 10mg online Buy levitra online uk. Medicaid Services (CMS), HHS. Extension of timeline for publication of levitra 10mg online final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October levitra 10mg online 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021.

Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician levitra 10mg online self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients levitra 10mg online over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care.

In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of levitra 10mg online cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also levitra 10mg online provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.

This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance levitra 10mg online with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June levitra 10mg online 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021 levitra 10mg online. Start Signature Dated. August 24, 2020. Wilma M levitra 10mg online.

Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc levitra 10mg online. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration levitra 10mg online or use of the Covered Countermeasures.

This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert levitra 10mg online P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882.

End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the levitra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak.

Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any treatment that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended treatments).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only erectile dysfunction treatment caused by erectile dysfunction or a levitra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a levitra mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric treatment ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of treatment-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other erectile dysfunction treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to erectile dysfunction treatment during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the erectile dysfunction treatment levitra. The survey, which was limited to practices participating in the treatments for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the erectile dysfunction treatment levitra, including.

Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other -control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by erectile dysfunction treatment. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable s in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of erectile dysfunction treatment. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer treatments to children of any age.[] Other States permit pharmacists to administer treatments to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those treatments.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.

For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza treatment to nearly a third of all adults who received the treatment.[] Given the potential danger of serious influenza and continuing erectile dysfunction treatment outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the erectile dysfunction treatment levitra, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza treatment to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers treatments to individuals ages three through 18 pursuant to the following requirements. The treatment must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer treatments to children and permit licensed or registered pharmacy interns acting under their supervision to administer treatments to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the treatment.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended treatments according to ACIP's standard immunization schedule.

All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended treatments and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended treatments ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified levitra and epidemic products that “limit the harm such levitra or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140erectile dysfunction treatment as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by erectile dysfunction treatment.

The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction or a levitra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a levitra mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C.

247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction or a levitra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a levitra mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

Start Preamble how to buy cheap levitra online Centers for Medicare &. Medicaid Services (CMS), HHS. Extension of how to buy cheap levitra online timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until how to buy cheap levitra online August 31, 2021.

Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info how to buy cheap levitra online End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the how to buy cheap levitra online Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care.

In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of how to buy cheap levitra online cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by how to buy cheap levitra online the physician self-referral statute and regulations.

This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the how to buy cheap levitra online complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda how to buy cheap levitra online (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the how to buy cheap levitra online timeline for publication of the final rule until August 31, 2021. Start Signature Dated. August 24, 2020. Wilma M how to buy cheap levitra online.

Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR how to buy cheap levitra online Doc. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons how to buy cheap levitra online and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert how to buy cheap levitra online P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882.

End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the levitra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak.

Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any treatment that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended treatments).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only erectile dysfunction treatment caused by erectile dysfunction or a levitra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a levitra mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric treatment ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of treatment-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other erectile dysfunction treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to erectile dysfunction treatment during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the erectile dysfunction treatment levitra. The survey, which was limited to practices participating in the treatments for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the erectile dysfunction treatment levitra, including.

Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other -control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by erectile dysfunction treatment. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable s in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of erectile dysfunction treatment. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer treatments to children of any age.[] Other States permit pharmacists to administer treatments to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those treatments.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.

For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza treatment to nearly a third of all adults who received the treatment.[] Given the potential danger of serious influenza and continuing erectile dysfunction treatment outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the erectile dysfunction treatment levitra, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza treatment to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers treatments to individuals ages three through 18 pursuant to the following requirements. The treatment must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer treatments to children and permit licensed or registered pharmacy interns acting under their supervision to administer treatments to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the treatment.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended treatments according to ACIP's standard immunization schedule.

All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended treatments and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended treatments ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified levitra and epidemic products that “limit the harm such levitra or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140erectile dysfunction treatment as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by erectile dysfunction treatment.

The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction or a levitra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a levitra mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C.

247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction or a levitra mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a levitra mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.