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€œIf countries order viagra from canada are serious about opening, they must be serious about suppressing transmission and saving lives”, said WHO chief Tedros Adhanom Ghebreyesus, briefing reporters from Geneva. “Opening up without having control, is a recipe for disaster.”We are 8 months into the #erectile dysfunction treatment19 viagra & order viagra from canada. We understand that people are tired &. Yearn to order viagra from canada get on with their lives, but no country can just pretend the viagra is over. This viagra spreads easily, &.

We all must remain serious about suppressing order viagra from canada its transmission &. Saving lives. Pic.twitter.com/1d2jR5FfvE— Tedros Adhanom Ghebreyesus (@DrTedros) August 31, 2020 While this may seem an impossible balance, order viagra from canada it can be done if countries are in control of transmission, he said. The more control they have, the more they can open. The reality is that erectile dysfunction spreads easily, he order viagra from canada said.

It can be fatal for people of all ages and most people remain susceptible.Prevention, prevention, preventionTo control transmission, he said it is essential to prevent events that lead to outbreaks. erectile dysfunction treatment spreads efficiently among clusters of people, with explosive outbreaks linked to gatherings at places such order viagra from canada as sports stadiums, nightclubs and places of worship. At the same time, there are ways to hold gatherings safely, Tedros said. Decisions about how and when must be made order viagra from canada with a risk-based approach, tailored to local conditions. Tedros said countries experiencing significant community transmission may need to postpone such events.

Those seeing sporadic cases or small clusters, on the other hand, can find creative ways to hold events while minimizing risk.He advocated a focus on reducing deaths by protecting the elderly, people with underlying conditions and essential workers order viagra from canada. Countries that do this well may be able to cope with low levels of transmission as they open.Individuals must play their part by staying at least one metre away from others, cleaning their hands regularly, practicing respiratory etiquette by wearing a mask and avoiding close-contact settings.For governments, widespread stay-at-home orders can be avoided if they take temporary, geographically targeted interventions. It is important to find, isolate, test and care for erectile dysfunction treatment cases – and both trace and order viagra from canada quarantine contacts. WHO guidance for safe reopeningThe UN health agency chief said WHO has a range of evidence-based guidance that can be applied in different transmission scenarios, most recently for hotels, cargo ships and fishing vessels.Meanwhile, the agency is working with its partners through the ACT Accelerator and COVAX Global treatments Facility to ensure that a treatment, once developed, is available equitably to all communities. He thanked the European Commission, which announced today it would join the COVAX Facility, order viagra from canada for its €400 million contribution.Health systems under pressureTo be sure, all countries are under extreme pressure, he declared.

A WHO survey on the impact of erectile dysfunction treatment on health systems in 105 countries found that 90 per cent of those surveyed have experienced disruption to their health services, with low- and middle-income countries reporting the greatest difficulties. Most nations reported that routine and elective services have been suspended, while critical care – such as cancer screenings and treatment, and HIV therapies – have seen high-risk interruptions in low-income countries.While many countries are now implementing WHO-recommended strategies to mitigate service disruptions, only 14 per cent have reported the removal of user fees, which WHO recommends, offsetting potential financial difficulties for patients.He said WHO is also developing the erectile dysfunction treatment Health Services Learning Hub, a web-based platform that will allow countries to share their experiences.Aftermath of Beirut explosionTedros also touched on WHO’s response to the 4 August blast in Beirut, which injured 6,500 people, left more than 300,000 homeless and severely damaged health infrastructure.He order viagra from canada said the agency is ensuring access to basic health and mental health care for the injured. It is also expanding erectile dysfunction treatment testing and treatments, buying medicines and protecting health workers.To sustain these efforts, Tedros said WHO had launched a $76 million appeal. The WHO Foundation on Monday launched a campaign into which any individual order viagra from canada or organization can contribute.“This viagra thrives when we are divided,” he said. “When we are united, we can defeat it.”“Despite a new wave which began on 25 July which Viet Nam is now also in the process of bringing under effective control, it is globally recognized that Viet Nam demonstrated one of the world’s most successful responses to the erectile dysfunction treatment viagra between January and April 16.

After that date, no cases of local transmission were recorded for 99 consecutive days.There were less than 400 cases of across order viagra from canada the country during that period, most of them imported, and zero deaths, a remarkable accomplishment considering the country’s population of 96 million people and the fact that it shares a 1,450 km land border with China.Long-term planning pays offKamal Malhotra is the UN Resident Coordinator in Viet Nam. , by UN Viet Nam/Nguyen Duc HieuViet Nam’s success has drawn international attention because of its early, proactive, response, led by the government, and involving the whole political system, and all aspects of the society. With the support of theWorld Health Organization (WHO) and other partners, Viet Nam had already put a long-term plan in place, to enable it to cope with public health emergencies, building on its experience dealing with previous disease outbreaks, such as SARS, which it also handled remarkably well.Viet Nam’s order viagra from canada successful management of the erectile dysfunction treatment outbreak so far can, therefore, be at least partly put down to the its investment during “peacetime”. The country has now demonstrated that preparedness to deal with infectious disease is a key ingredient for protecting people and securing public health in times of viagras such as erectile dysfunction treatment.As early as January 2020, Viet Nam conducted its first risk assessment, immediately after the identification of a cluster of cases of “severe pneumonia with unknown etiology” in Wuhan, China. From the time that the first two erectile dysfunction treatment cases were confirmed in Viet Nam in the second half of January 2020, the government order viagra from canada started to put precautionary measures into effect by strengthening entry-screening measures and extending the Tết (Lunar New Year) holiday for schools.

© UNICEFTeachers and students were able to return to school in Lao Cai, Viet Nam, in May.By 13 February 2020, the number of cases had climbed to 16 with limited local transmission detected in a village near the capital city, Hanoi. As this had the potential to cause a further spread of the viagra in Viet Nam, the country implemented a targeted three-week order viagra from canada village-wide quarantine, affecting 11,000 people. There were then no further local cases for three weeks.But Viet Nam had simultaneously developed its broader quarantine and isolation policy to control erectile dysfunction treatment. As the next wave began in early March, through an imported case from the UK, the government knew that it was crucial to contain viagra transmission as fast as possible, in order also to safeguard its economy.Viet Nam therefore closed its borders and suspended international flights from mainland China in February, extending this to UK, Europe, the US and order viagra from canada then the rest of the world progressively in March, whilst requiring all travelers entering the country, including its nationals, to undergo 14-day mandatory quarantine on arrival.This helped the authorities keep track of imported cases of erectile dysfunction treatment and prevent further local transmission which could have then led to wider community transmission. Both the military and local governments were mobilized to provide testing, meals and amenity services to all quarantine facilities which remained free during this period.No lockdown requiredWhile there was never a nationwide lockdown, some restrictive physical distancing measures were implemented throughout the country.

On 1 April 2020, the Prime Minister issued a nationwide two week physical distancing directive, which was extended by a week order viagra from canada in major cities and hotspots. People were advised to stay at home, non-essential businesses were requested to close, and public transportation was limited.Such measures were so successful that, by early May, following two weeks without a locally confirmed case, schools and businesses resumed their operations and people could return to regular routines. Green One UN House, the home of most UN agencies in Viet Nam, remained open throughout this period, with the Resident Coordinator, WHO Representative and approximately 200 UN staff and consultants physically in the office throughout this period, to provide vital support to the Government and people of Viet Nam.Notably, the Vietnamese public had been exceptionally compliant with government directives and advice, partly as a result of trust built up thanks to real time, transparent communication order viagra from canada from the Ministry of Health, supported by the WHO and other UN agencies. Innovative methods were used to keep the public informed and safe. For instance, order viagra from canada regular text updates were sent by the Ministry of Health, on preventive measures and erectile dysfunction treatment’s symptoms.

A erectile dysfunction treatment song was released, with lyrics raising public awareness of the disease, which later went viral on social media with a dance challenge on Tik Tok initiated by Quang Dang, a local celebrity.. UN Viet Nam/Nguyen Duc order viagra from canada HieuYoung people in Viet Nam take part in International Youth Day 2020 festivities in June. Protecting the vulnerableStill, challenges remain to ensure that the people across the country, especially the hardest hit people, from small and medium-sized enterprises (SMEs) and poor and vulnerable groups, are well served by an adequately resourced and effectively implemented social protection package. The UN in Viet Nam is keen to help the government support clean technology-based order viagra from canada SMEs, with the cooperation of international financial institutions, which will need to do things differently from the past and embrace a new, more inclusive and sustainable, perspective on growth.Challenges remainAs I write, Viet Nam stands at a critical point with respect to erectile dysfunction treatment. On 25 July, 99 days after being erectile dysfunction treatment-free in terms of local transmission, a new case was confirmed in Da Nang, a well-known tourist destination.

Hundreds of order viagra from canada thousands of people flocked to the city and surrounding region over the summer.The government is once again demonstrating its serious commitment to containing local viagra transmission. While there have been a few hundred new local transmission cases and 24 deaths, all centered in a major hospital in Danang (sadly, all the deaths were of people with multiple pre-conditions) aggressive contact tracing, proactive case management, extensive quarantining measures and comprehensive public communication activities are taking place.I am confident that the country will be successful in its efforts to once again successfully contain the viagra, once more over the next few weeks.”.

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If you are using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of the Federal how to use viagra for best results Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 &. 1507. Learn more here..

This document is unpublished order viagra from canada how can i get viagra. It is scheduled to be published on 05/05/2021. Once it is published order viagra from canada it will be available on this page in an official form. Until then, you can download the unpublished PDF version.

Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text. If you order viagra from canada are using public inspection listings can i buy viagra online for legal research, you should verify the contents of documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 & order viagra from canada.

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Do not take Viagra with any of the following:

• cisapride
• methscopolamine nitrate
• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• nitroprusside
• other sildenafil products (Revatio)

Viagra may also interact with the following:

• certain drugs for high blood pressure
• certain drugs for the treatment of HIV or AIDS
• certain drugs used for fungal or yeast s, like fluconazole, itraconazole, ketoconazole, and voriconazole
• cimetidine
• erythromycin
• rifampin

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Malheur County, Oregon, is one what does viagra do to men of 10 counties in the state considered frontier areas because it has six or fewer people per square mile. By Addy Hatch, WSU College of NursingGiving nurse practitioners the authority to prescribe buprenorphine has brought that gold standard treatment for opioid addiction to people who might not have had access to it before, according to a new study led what does viagra do to men by Tracy Klein, PhD, associate professor at the Washington State University College of Nursing in Vancouver.Klein and her colleagues Dan Hartung, PharmD, and Jonah Geddes, MPH, used prescription drug monitoring data to look at prescription and dispensing patterns in Oregon before and after nurse practitioners and physician assistants gained the authority to prescribe buprenorphine in 2017. Before that time, only physicians were allowed to prescribe the medication nationally.Her study found that nurse practitioners almost immediately had an impact on access to buprenorphine in rural Oregon, especially in the sparsely populated areas known as frontier regions – counties with six or fewer people per square mile.By the end of 2018, nurse practitioners what does viagra do to men accounted for nearly 1 in 5 buprenorphine prescriptions in rural Oregon, according to the study, published in the Journal of Rural Health.

In frontier areas – 10 of Oregon’s 36 counties what does viagra do to men – nurse practitioners accounted for more than a third of buprenorphine prescriptions dispensed, it said.Nurse practitioners are sometimes the only healthcare provider in these very rural areas, Klein said.Tracy Klein“It’s not surprising that having nurse practitioners be able to do this would increase access to buprenorphine in rural areas,” she said. €œIt was surprising the extent to which people were reliant on nurse practitioners for this service and that nurse practitioners were stepping up to the plate and providing it.”Opioid addiction “continues to be an enormous public health crisis that claimed over 46,000 lives in 2018,” the study notes.Implementation of the Comprehensive Addiction and Recovery Act in early 2017 was what does viagra do to men intended to expand availability of medication-assisted treatment, which includes prescribing buprenorphine in an office or clinic.Klein said her study “offers a good opportunity to look at whether changing a law has an impact on patient care,” especially in little-studied frontier areas.Said Klein, “This is one of the few studies that’s really looked at the impact of nurse practitioners in frontier areas. Most studies look at urban versus rural, but it’s important to consider frontier areas that are even more isolated and underserved, and the contribution nurse practitioners make to this very important aspect of health care.”Media contact:Tracy Klein, PhD, associate professor, Washington State University College of Nursing-Vancouver, 360-546-9142, taklein@wsu.edu.

Malheur County, Oregon, is one of 10 counties in the state considered frontier areas because it has six or fewer people per square mile order viagra from canada. By Addy Hatch, WSU College of NursingGiving nurse practitioners the authority to prescribe buprenorphine has brought that gold standard treatment for opioid addiction to people who might not have had access to it before, according to a new study led by Tracy order viagra from canada Klein, PhD, associate professor at the Washington State University College of Nursing in Vancouver.Klein and her colleagues Dan Hartung, PharmD, and Jonah Geddes, MPH, used prescription drug monitoring data to look at prescription and dispensing patterns in Oregon before and after nurse practitioners and physician assistants gained the authority to prescribe buprenorphine in 2017. Before that time, only physicians were allowed to prescribe the medication nationally.Her study found that nurse practitioners almost immediately had an impact on access to buprenorphine in rural Oregon, especially in the sparsely populated areas known as frontier regions order viagra from canada – counties with six or fewer people per square mile.By the end of 2018, nurse practitioners accounted for nearly 1 in 5 buprenorphine prescriptions in rural Oregon, according to the study, published in the Journal of Rural Health.

In frontier areas – 10 of Oregon’s 36 counties – nurse practitioners accounted for more than a third of buprenorphine prescriptions dispensed, it said.Nurse practitioners are sometimes the only healthcare provider in these very rural order viagra from canada areas, Klein said.Tracy Klein“It’s not surprising that having nurse practitioners be able to do this would increase access to buprenorphine in rural areas,” she said. €œIt was surprising the extent to which people were reliant on nurse practitioners for this service and that nurse practitioners were stepping up to the plate and providing it.”Opioid addiction “continues to be an enormous public health crisis that claimed over 46,000 lives in 2018,” the study notes.Implementation of the Comprehensive Addiction and Recovery Act in early 2017 was intended to expand availability of medication-assisted treatment, which includes prescribing buprenorphine in an office or clinic.Klein said her study “offers a good opportunity to look at whether changing a law has an impact on patient care,” especially in little-studied frontier areas.Said Klein, “This is one of the few studies that’s really looked order viagra from canada at the impact of nurse practitioners in frontier areas. Most studies look at urban versus rural, but it’s important to consider frontier areas that are even more isolated and underserved, and the contribution nurse practitioners make to this very important aspect of health care.”Media contact:Tracy Klein, PhD, associate professor, Washington State University College of Nursing-Vancouver, 360-546-9142, taklein@wsu.edu.

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Medicaid Services, Department of discount viagra Health what is the active ingredient in viagra and Human Services, Attention. CMS-2482-P2, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close what is the active ingredient in viagra of the comment period. 3.

By express or overnight mail. You may send written what is the active ingredient in viagra comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-2482-P2, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD what is the active ingredient in viagra 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Christine Hinds, (410) 786-4578. Wendy Tuttle, (410) 786-8690 what is the active ingredient in viagra. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the applicable comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment.

We post all comments received before the close of the applicable comment period on the following website as soon as possible after they what is the active ingredient in viagra have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual what is the active ingredient in viagra. CMS continues to encourage individuals not to submit duplicative comments.

We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.Start Printed Page 28743 I. Background A what is the active ingredient in viagra. Proposed Delays in Effective and Inclusion Dates of Certain Regulation Provisions CMS is proposing to delay the January 1, 2022 effective date for amendatory instruction 10.a. Of the final rule entitled, “Medicaid Program. Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for what is the active ingredient in viagra Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” (85 FR 87000), for 6 months to July 1, 2022, and to delay the April 1, 2022, inclusion date in the amended regulatory definitions of “States” and “United States”, adopted in the interim final rule with comment period entitled “Medicaid Program.

Covered Outpatient Drugs. Further Delay of Inclusion of Territories in Definitions of States and United States” (84 FR 64783), for 2 years until April 1, 2024, or in the alternative, to a date earlier than April 1, 2024, but not before January 1, 2023. B. Proposed Delay of Effective Date of Amendatory Instruction 10.a. On December 31, 2020, we published a final rule in the Federal Register entitled “Medicaid Program.

Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” [] (85 FR 87000) (hereinafter referred to as the December 31, 2020 final rule). The December 31, 2020 final rule advanced CMS' efforts to support state flexibility to enter into innovative value-based purchasing (VBP) arrangements with drug manufacturers for new and innovative, and often costly therapies, such as gene therapies, and codified new approaches required by section 1004 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) and the existing Medicaid DUR program to improve the clinical use of opioids and reduce the potential for abuse in Medicaid patients. In addition, it codified in regulation several changes made in recent legislation and clarified other provisions of regulations relating to the Medicaid Drug Rebate Program (MDRP).

The regulations included in the December 31, 2020 final rule went into effect on March 1, 2021, except for certain amendatory instructions, including instruction 10.a., which is effective on January 1, 2022. We are proposing to delay the January 1, 2022 effective date for amendatory instruction 10.a. Of the December 31, 2020 final rule on manufacturer reporting of multiple best prices connected to a VBP arrangement, to July 1, 2022, and are seeking public comment on the proposed delay as outlined in section I.A. Of this proposed rule. As discussed in greater detail in section II.

Of this proposed rule, we believe a delay of 6 months is warranted to assure that stakeholders have the ability to implement the new VBP policy in a manner that assures that patient access and quality of care is protected. We seek public comments on this proposed delay in the effective date, including the impact of this delay on affected beneficiaries. The primary reason for the original delay, and the new proposed delay, is to provide more time for CMS, states, and manufacturers to make the complex system changes necessary to implement the new best price and VBP program, and assure patient access and quality of care, given the current need to devote resources to the public health emergency (PHE) relating to erectile dysfunction treatment that has been in effect, and will likely remain in effect through 2021. C. Proposed Delay of Inclusion Date in Amended Regulatory Definitions of “States” and “United States” The Covered Outpatient Drug (COD) final rule, published in the February 1, 2016 Federal Register (81 FR 5170), amended the regulatory definitions of “States” and “United States” to include the U.S.

Territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) for the purposes of the MDRP with a delayed inclusion date of April 1, 2017. We stated in the preamble to the final rule that U.S. Territories may use existing waiver authority to elect not to participate in the MDRP consistent with the statutory waiver standards. Specifically, the Northern Mariana Islands and American Samoa may seek to opt out of participation under the broad waiver that has been granted to them in accordance with section 1902(j) of the Act. The territories of Puerto Rico, the Virgin Islands, and Guam may use waiver authority under section 1115 of the Act to waive section 1902(a)(54) of the Act, which requires state compliance with the applicable requirements of section 1927 of the Act (81 FR 5203 through 5204).

The change to the definition of “States” and “United States” under the COD final rule to include the territories would also impact the quarterly calculation of average manufacturer price (AMP) and best price by manufacturers. That is, the change requires manufacturers to include prices paid by entities in the U.S. Territories in the same manner in which they include prices paid by entities located in one of the 50 states and District of Columbia (81 FR 5224) in AMP and best price. It requires manufacturers to include eligible sales and associated discounts, rebates, and other financial transactions that take place in the U.S. Territories in their calculations of AMP and best price once the revised definitions of “States” and “United States” take effect, regardless of whether the U.S.

Territories seek to waive participation in the MDRP. Once the COD final rule became effective, CMS began discussions with the territories regarding their participation in the MDRP. Based on those discussions, it became evident that interested territories would not be ready to participate in the MDRP by April 1, 2017. Stakeholders also reiterated the concerns in the comments to the COD final rule (81 FR 5224) that drug manufacturers will likely need to increase drug prices paid by U.S. Territory Medicaid programs once the territories are included in the definitions of “States” and “United States” in order to avoid setting a new, lower best price.

That is because if prices for drugs in the territories are lower than those in the states, then those prices could become the Medicaid best price for that drug in the entire Medicaid program. The manufacturers may then increase their drug prices in the territories to avoid this outcome, and an increase in drug prices in the territories could result in an increase in territory Medicaid drug spending without the offsetting benefit of receiving Medicaid rebates. Furthermore, the increase in Medicaid drug spending could adversely impact the availability of drugs to patients in the territories because of their Medicaid funding cap. As a result of these initial and subsequent discussions on preparedness, the potential for increased Medicaid drug prices in certain territories, and later, due to additional impacts of natural disasters in several of the territories, CMS issued two interim final rules with comment period (IFC) to further delay the Start Printed Page 28744inclusion date for the U.S. Territories in the regulatory definitions of “States” and “United States” for purposes of the MDRP.

The first, the “Medicaid Program. Covered Outpatient Drug. Delay in Change in Definitions of States and United States” IFC, was issued on November 15, 2016, amending the regulatory definitions of “States” and “United States” to include the U.S. Territories beginning April 1, 2020, rather than to April 1, 2017 (81 FR 80003). The second, the “Medicaid Program.

Covered Outpatient Drug. Further Delay of Inclusion of Territories in Definitions of States and United States” IFC, was published on November 25, 2019, and further delayed the inclusion date for the regulatory definitions of “States” and “United States” to include the U.S. Territories beginning April 1, 2022, rather than April 1, 2020 (84 FR 64783). For similar reasons, in addition to ensuring continued beneficiary access and quality of care protections, we are proposing to amend § 447.502 to delay the April 1, 2022 inclusion date for the amended regulatory definitions of “States” and “United States” to April 1, 2024, and are seeking public comment on the proposed delay as outlined in section I.A. Of this proposed rule.

As discussed in greater detail in section II. Of this proposed rule, we believe an additional delay of 2 years may be warranted because it would allow the territories to focus their human and financial resources on ensuring the health and well-being of their beneficiaries during this PHE, rather than having to divert those resources to the development of systems required to participate in the MDRP, which can take several years to implement from start to finish, and seek public comments on this proposal. However, if we determine based on public comments received from interested parties that the territories that want to participate in MDRP can do so sooner than April 1, 2024, and those that do not want to participate are able to complete the necessary waiver process, then we are proposing in the alternative to finalize a date that is sooner than April 1, 2024, but not earlier than January 1, 2023. II. Proposed Delay in Effective and Inclusion Dates of Certain Regulation Provisions Due to Ongoing Public Health Emergency (PHE) On April 21, 2021, the Secretary of Health and Human Services (the Secretary) renewed the PHE initially declared on January 31, 2020, to continue giving CMS programs (including Medicaid) flexibility to support beneficiaries during the erectile dysfunction treatment viagra.

This PHE is expected to last through 2021. In response to the PHE, CMS put in place its own viagra plan (https://www.cms.gov/​files/​document/​erectile dysfunction treatment-viagra-plan.pdf) to address the needs of its stakeholders, as well as the beneficiaries of its various programs including Medicaid. As part of that plan, CMS provided that it may approve waivers, amendments, and flexibilities for U.S. States, including the District of Columbia, and U.S. Territories to allow Medicaid and CHIP programs to adapt their operations as necessary to respond to the viagra.

The viagra plan also provided that it may make adjustments to the agency's value-based payment initiatives to allow health providers, healthcare facilities, Medicare Advantage and Part D plans, and States to focus on providing needed care to beneficiaries. In addition to the flexibilities granted to states under the PHE, the President signed into law on March 11, 2021 the American Rescue Plan Act of 2021 (ARP) (Pub. L. 117-2) to address the health care and economic needs of the country during the viagra. This law is one of the most significant expansions of Medicaid since enactment of the Affordable Care Act of 2010, and includes several new mandatory benefit requirements on states that will take time to implement.

We acknowledged in the December 31, 2020 final rule that the changes to the reporting of multiple best prices by manufacturers under the MDRP (a VBP policy) adopted under the amendatory instruction 10.a would require additional time to provide operational guidance and complex system changes to implement. Thus, we delayed the effective date of the VBP provision until January 1, 2022. States that opt to participate in VBP models offered by manufacturers under the multiple best price approach must ensure that beneficiaries have appropriate access to care under such arrangements by developing systems and methods to track beneficiaries and their outcomes, retrieving and evaluating the patient-specific outcomes data, and securing the cooperation of providers and beneficiaries to enter into some of the more complex outcome-based arrangements offered by the manufacturers. Thus, there will be requirements on states to develop significant capabilities to build an infrastructure that will be able to implement VBP. We also want to be sure that our own technology infrastructure will be ready to receive multiple VBP offers from manufacturers that will report them to CMS, and subsequently report them to states.

We are currently developing a new Medicaid Drug Program (MDP) system. This MDP system will replace CMS' current legacy system with certain aspects of the system expected to be transitioned in the summer of 2021. However, because of other events that have transpired since the regulation was published in December 2020, we do not believe that certain aspects of the system necessary for states and manufacturers to operationalize the VBP multiple best price program will be transitioned at that time, making a January 1, 2022 infeasible. We believe that it is important to have a technically up-to-date system that is ready to support the data requirements necessary for states and manufacturers to operationalize the VBP multiple best price program. However, we may have a delay with operationalizing that part of the MDP system by July 2021, which may mean we will not have the necessary CMS components in place by later this year to implement the program by January 1, 2022, and believe July 1, 2022, is a realistic target date.

Furthermore, the demands on researching, producing, and distributing erectile dysfunction treatment drug treatments and treatments have likely diverted some manufacturer financial and human resources from developing and implementing system changes that would be required to enter multiple best price offers in the MDP system. We understand that there is interest among patient and consumer groups, states, and manufacturers in the new multiple best price policy, and we are committed to implementing the VBP multiple best price policy in a manner that assures that Medicaid beneficiaries have access to medications and therapies that are appropriately administered and monitored. However, we are concerned that there are several challenges the states, providers, and manufacturers are facing during the PHE. These include, in addition to those resulting from the passage of the ARP, those relating to implementing expanded eligibility and mandatory benefit requirements under Medicaid (as described below). In sum, states, providers and manufacturers, as well as CMS, will need additional time to operationalize the multiple best prices policy under amendatory instruction 10.a.

Therefore, given the possible delay in the MDP system and the recent developments around the PHE and ARP, we believe more time is critical to permit CMS and our partners—states, providers, and manufacturers—to successfully implement the multiple best prices approach so that Medicaid Start Printed Page 28745patients benefit from these programs to full extent possible. Specifically, CMS and all the parties involved with the multiple best prices policies will want to make sure Medicaid patients receive the drug therapies under the VBP approach that are prescribed for them in a timely manner. That the VBP program does not create unnecessary barriers or requirements on the patient to access the drug. That they receive appropriately scheduled doses of a therapy if the patient treatment under the VBP arrangement is based on multiple doses. And that patient outcomes are tracked so that optimal patient care is provided.

And, the states can obtain any additional discounts due to them from manufacturers under the VBP arrangement. At this time, we believe it is in the best interest of the Medicaid program and Medicaid beneficiaries, in particular, that states prioritize the Medicaid eligibility and benefit requirements under the ARP (for example, expanded optional Medicaid coverage for postpartum women, expansion of erectile dysfunction treatment testing and treatment services, and expansion of treatment administration to limited benefit groups), resulting from enactment of the ARP to address beneficiary needs during the erectile dysfunction treatment viagra, and therefore, propose a delay to the effective date for amendatory instruction 10.a. (the multiple best price approach) by 6 months (effective July 1, 2022). By allowing more time to address the needs of Medicaid beneficiaries during the PHE, states, CMS, providers, and manufacturers will also have more time to put in place appropriate beneficiary protections as part of the multiple best price approach. Therefore, we propose to delay the amendment associated with multiple best price requirements for 6 months, which if finalized, would make amendatory instruction 10.a effective beginning July 1, 2022.

We also expect to issue additional guidance before that time on operational and policy aspects of the new VBP program, including specifications relating to beneficiary protections. For the same reasons discussed above, we believe that in light of the viagra and the resource demands stemming from the PHE (including those established under the ARP) on the Medicaid program and its beneficiaries, it is imperative that the territories prioritize the Medicaid eligibility and mandatory benefit requirements brought about by the ARP to address beneficiary needs during the erectile dysfunction treatment. Therefore, we believe that a further delay in the inclusion date of the U.S. Territories in the regulatory definitions of “States” and “United States” is warranted and are proposing that they be included in those definitions beginning April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received.

By delaying the inclusion date to April 1, 2024, or in the alternative, a date earlier than April 1, 2024, but not before January 1, 2023, we are allowing the territories additional time to develop needed systems and policy changes, in order to avoid unintended increases in drug costs and access concerns. The needed systems must be capable of collecting, reporting, validating, and tracking drug utilization on an ongoing basis. In addition, they require extensive advance planning and budgeting. The delay in inclusion date would also benefit those territories that choose not to participate in the MDRP, and therefore, would be required to use human and financial resources to complete the section 1115 and section 1902(j) waiver applications that are required to waive out of MDRP participation should the current April 1, 2022 date remain in effect. Moreover, should the amended regulatory definitions of “States” and “United States” go into effect on April 1, 2022, all manufacturers' sales to the territories and prices paid would be included in the AMP and best price calculations at that time, regardless of whether the territory is participating in the MDRP.

As discussed in the COD final rule (81 FR 5224), we heard from various stakeholders who expressed concerns that drug manufacturers would likely be prompted to increase drug prices, including prices paid by the U.S. Territory Medicaid programs, once the territories are included in the definitions of “States” and “United States.” This is because, as currently drafted, section 1927 of the Act requires that eligible sales of drugs within the United States be included in the drug manufacturers calculation of Average Manufacturer Price (AMP) and best price. The inclusion of these prices in AMP and best price would result in the territories that receive a waiver realizing an increase in their Medicaid drug costs without the offsetting benefit of receiving Medicaid rebates. Furthermore, the increase in Medicaid costs could adversely affect territories because of their Medicaid funding cap. As noted above, that could result in an increase in drug prices in the territories, making drugs less affordable, and making it more difficult for the territories to address their own public health needs during the PHE.

We believe this provides further rationale for delaying the inclusion date of territories in the regulatory definitions of “States” and “United States.” It will ensure that during this PHE, which has the potential to extend into 2022, those territories that opt to waive participation from the MDRP will not face the additional financial burdens associated with increased Medicaid drug costs from drug manufacturers increasing drug prices to the territories. We are proposing a new inclusion date of April 1, 2024 for the amended regulatory definitions of “States” and “United States” to include the U.S. Territories for purposes of the MDRP. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. Thus, we are specifically requesting comments from all interested parties on whether April 1, 2024, or an earlier inclusion date, but not earlier than January 1, 2023, would be more appropriate for the amended regulatory definitions.

More specifically, we are requesting public comments that will assist us in understanding all relevant concerns related to establishing a new inclusion date, including whether territories are ready to participate in the MDRP, and whether CMS is able to execute appropriate and necessary waivers for territories that do not want to participate. In any case, manufacturers would be required to include their sales to the territories in their AMP and best price calculations based on the inclusion date finalized in a final rule, which we are proposing to be April 1, 2024, or possibly earlier, but no earlier than January 1, 2023 based on public comments. Therefore, we are requesting comment on our proposal to amend § 447.502 to delay the inclusion date for the the U.S. Territories into the regulatory definitions of “States” and “United States” until April 1, 2024. We are also requesting comments on an alternative proposal, which is to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received.

III. Response to Comments Because of the significant number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble for each applicable comment period, and, if and when we Start Printed Page 28746proceed with a subsequent document, we will respond to the applicable comments in the preamble to that document, as appropriate. I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &. Medicaid Services, approved this document on May 18, 2021.

Start List of Subjects AccountingAdministrative practice and procedureDrugsGrant programs—healthHealth facilitiesHealth professionsMedicaidReporting and recordkeeping requirementsRural areas End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 447 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302 and 1396r-8. End Authority Start Amendment Part2. Amend § 447.502 by revising the definitions of “States” and “United States” to read as follows. End Amendment Part Definitions. * * * * * States means the 50 States and the District of Columbia and, beginning April 1, 2024, also includes the Commonwealth of Puerto Rico, the Virgin Islands of the United States, Guam, the Commonwealth of the Northern Mariana Islands, and American Samoa.

United States means the 50 States and the District of Columbia and, beginning April 1, 2024, also includes the Commonwealth of Puerto Rico, the Virgin Islands of the United States, Guam, the Commonwealth of the Northern Mariana Islands, and American Samoa. * * * * * Start Signature Dated. May 21, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc.

2021-11160 Filed 5-26-21. 4:15 pm]BILLING CODE 4120-01-PStart Preamble Start Printed Page 26849 Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS). Final rule. This final rule delays the effective date of the final rule titled, “Medicare Program.

Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary' ” published in the January 14, 2021 Federal Register. As of May 14, 2021, the effective date of the final rule amending 42 CFR part 405, published at 86 FR 2987, January 14, 2021, and delayed at 86 FR 14542, March 17, 2021, is further delayed until December 15, 2021. Start Further Info Lori Ashby at (410)-786-6322 or MCIT@cms.hhs.gov. End Further Info End Preamble Start Supplemental Information I. Background A.

Introduction In the January 14, 2021 Federal Register, we published a final rule titled “Medicare Program. Medicare Coverage of Innovative Technology (MCIT) and Definition of `Reasonable and Necessary' ” (86 FR 2987) (hereinafter referred to as MCIT/R&N final rule). The January 2021 final rule established a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). Under the final rule as currently written, MCIT would result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. The MCIT/R&N final rule would also implement regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Medicare Parts A and B.

B. March 17, 2021 Interim Final Rule (IFC) In response to the January 20, 2021 memorandum from the Assistant to the President and Chief of Staff titled “Regulatory Freeze Pending Review” (“Regulatory Freeze Memorandum”) (86 FR 7424, January 28, 2021) and guidance on implementation of the memorandum issued by the Office of Management and Budget (OMB) in Memorandum M-21-14 dated January 20, 2021, we determined that a 60-day delay of the effective date of the MCIT/R&N final rule was appropriate to ensure that. (1) The rulemaking process was procedurally adequate. (2) the agency properly considered all relevant facts. (3) the agency considered statutory or other legal obligations.

(4) the agency had reasonable judgment about the legally relevant policy considerations. And (5) the agency adequately considered public comments objecting to certain elements of the rule, including whether interested parties had fair opportunities to present contrary facts and arguments. Therefore, in an interim final rule that took effect on March 12, 2021, and appeared in the March 17, 2021 Federal Register (86 FR 14542), we (1) delayed the MCIT/R&N final rule effective date until May 15, 2021 (that is, 60 days after the original effective date of March 15, 2021). And (2) opened a 30-day public comment period on the facts, law, and policy underlying the MCIT/R&N final rule. C.

Review of Public Comments on the Delay of the MCIT/R&N Final Rule We received approximately 215 timely pieces of correspondence in response to the interim final rule delaying the effective date of the MCIT/R&N final rule. In this section of this final rule, we summarize our response to comments on the delay of the MCIT/R&N final rule. To the extent applicable, we intend to also consider these comments for future rulemaking. Comment. Some manufacturers, in particular those with FDA designated breakthrough devices that have been market authorized, as well as the industry groups representing them commented that the MCIT/R&N final rule should be implemented without further delay.

Although they acknowledged certain operational issues remain, specifically coding and payment for applicable devices and/or the services in which they are used, these commenters suggested those issues could be overcome by adapting existing processes such as inpatient new technology add on payment (NTAP) and outpatient hospital transitional pass-through payment to determine coding and payment, at least when these devices are used in the hospital setting. These commenters also expressed that they believe patient safety provisions in the final rule are sufficient to protect beneficiaries. Other manufacturers that have FDA breakthrough designated devices but generally have yet to receive market authorization were supportive of a MCIT policy that would be more comprehensive and that includes specified guidance and expedited processes for benefit category determination, coding, and payment. These manufacturers support a delay of the MCIT/R&N final rule to the extent that such a delay would lead to a more comprehensive policy than the one that would be effective in May 2021. Response.

The current MCIT/R&N final rule solely relates to coverage of certain devices under Medicare. It does not establish a benefit category determination https://eingrext.at/shop-neu/hausgemachte-vegane-zucchinicremesuppe/ (BCD), medical coding, nor payment rates for any devices. While we recognize that some commenters support a different policy that would address benefit category determinations, coding, and payment, in addition to coverage, the MCIT/R&N final rule was not designed to address factors beyond Medicare coverage. Further, while the rule eliminates coverage uncertainty early after FDA market authorization for those devices with a clear benefit category, the rule did not directly address the operational issues, such as how the agency would establish coding and payment. Comment.

Several individual physicians and members of the public submitted comments supporting implementation of the MCIT/R&N final rule given the promise of breakthrough devices for their specialties or disease states of concern. Chronic obstructive pulmonary disease (COPD), prostate care, heart failure, stroke, opioid use disorder, oncology, and sleep disorders. On the other hand, some commenters suggested that the final MCIT/R&N rule provided automatic coverage for breakthrough devices without adequate evidentiary support. Response. We are aware that breakthrough devices span numerous clinical specialties.

We note that MCIT would be one of several coverage pathways (that is, claim-by-claim adjudication, local coverage, National Coverage Determination (NCD)) for breakthrough devices. Even without the MCIT/R&N final rule in effect, a review of claims data showed that breakthrough devices have received and are receiving Medicare coverage when medically Start Printed Page 26850necessary. CMS reviewed fee-for-service claims data for several recent market-authorized breakthrough devices. The majority of the FDA market authorized breakthrough devices that would have been eligible for the MCIT pathway were already paid through an existing mechanism or were predominantly directed to a pediatric population. Of those that would be separately payable by Medicare on a claim-by-claim basis, the reviewed devices, were covered and paid under the applicable Medicare payment system.

Regarding commenters' concerns about automatic coverage without evidentiary support, we share commenters' concerns that guaranteeing coverage for all breakthrough devices receiving market-authorization for any Medicare patient with possibly minimal or no evidence on the Medicare population and no requirement to develop evidence on the Medicare population could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries. For example, a breakthrough device may only be beneficial in a subset of the Medicare population or when used only by specialized clinicians to ensure benefit. Without additional clinical evidence on the device's clinical utility for the Medicare population, it is challenging to determine appropriate coverage of these newly market-authorized devices. Comment. Multiple stakeholders (manufacturers, physicians, associations) commented that CMS should modify the MCIT policy in some way.

A substantial number of comments from a variety of stakeholders expressed evidentiary concerns with MCIT as currently designed, including that the current MCIT/R&N final rule's pathway establishes an open-ended coverage commitment for all breakthrough devices without demonstrating a health benefit in the Medicare population. Additionally, commenters were concerned that the current MCIT/R&N final rule does not specify, nor can it require, coverage criteria beyond the FDA indication(s) for use, and that evidence development under MCIT is voluntary, and narrowing coverage after MCIT expires will be challenging for devices that do not have a documented, proven benefit for Medicare patients. Many of these stakeholders recommend that CMS leverage or broaden the existing coverage with evidence development (CED) pathway to provide more timely and appropriate access to new technologies. These commenters encouraged CMS to require post market studies and data collection as part of MCIT to ensure that beneficiaries are gaining access to new technologies that improve health outcomes. Several breakthrough device manufacturers suggested that, for inclusion in MCIT, a portion of FDA pivotal studies should include a portion of Medicare beneficiaries.

One breakthrough device manufacturer suggested that 25 percent of patients in the pivotal study should be Medicare beneficiaries for MCIT. Otherwise, CED would be more appropriate. Response. We agree that for breakthrough devices for which studies did not include Medicare populations or populations with characteristics similar to the Medicare population CED or a similar evidence development process would strengthen the evidence base relevant to Medicare patients. In past NCDs, we have leveraged FDA required post-market studies in CED decisions.

In contrast to the NCD process which involves a robust review of available clinical evidence, especially for the Medicare population, to determine whether the item or service is reasonable and necessary for Medicare beneficiaries, the current MCIT pathway in the MCIT/R&N final rule establishes a 4-year coverage commitment for all breakthrough devices that have a benefit category without a specific requirement that the device must demonstrate a health benefit or that the benefits outweigh harms in the Medicare population. In general, Medicare patients have more comorbidities and often require additional and higher acuity clinical treatments which may impact the outcomes differently than the usual patients enrolled in early studies. Medicare has also focused on real world data or implementation studies to understand how items and services perform when more broadly used in general practice in the Medicare population. These considerations are often not addressed in the early device development process. We also note that FDA grants breakthrough designation early in a device's product lifecycle.

In part, the FDA considers “whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current standard of care (SOC) in the U.S. A complete set of clinical data is not required for designation.” [] At the time a device is granted breakthrough status by the FDA, little may be known about the benefits and harms of the device. We recognize the importance of breakthrough technologies that provide for more effective treatment of life-threatening and irreversibly debilitating diseases and conditions when no effective treatment exists. In cases where there is greater uncertainty surrounding the benefit-risk profile of a breakthrough device, some commenters have suggested that more relevant evidence is needed for Medicare patients to determine health benefit, to mitigate harms that may not be apparent in initial studies with small sample sizes, and to understand the balance of benefits and harms when breakthrough devices are used more broadly in Medicare patients. The additional delay announced in this rule will provide an opportunity to ensure that the objections to the rule are adequately considered.

We will consider ways to diminish uncertainty with respect to Medicare coverage by building upon the evidence foundation established during the market authorization process or combining that evidence with other approaches like CED to expedite coverage in appropriate instances. For CMS, the evidence base underlying the FDA's decision to approve or clear a device for particular indications for use has been crucial for determining Medicare coverage through the NCD process. CMS looks to the evidence supporting FDA market authorization and the device indications for use for evidence generalizable to the Medicare population, data on improvement in health outcomes, and durability of those outcomes. If there are no data on those elements, it is difficult for CMS to make an evidence-based decision whether the device is reasonable and necessary for the Medicare population. The current MCIT/R&N final rule does not specify any coverage criteria beyond the FDA indication(s) for use for which FDA has approved or cleared the device.

The current final rule would provide coverage when a device is used according to approved or cleared indication(s) for use. A device's approved or cleared indications for use may not include information that is important or particularly relevant for Medicare patients and clinicians when making treatment decisions. With breakthrough devices, as mentioned by some commenters, the patients included in device studies generally are not Medicare beneficiaries who often have multiple comorbidities and higher acuity of illness. The data used to determine whether a device meets applicable FDA safety Start Printed Page 26851and effectiveness requirements for its approved or cleared indication(s) for use may not be able to answer questions such as the following. Does the benefit differ for older and/or frailer patients with specific comorbidities?.

Are clinician experience or facility requirements needed to ensure good health outcomes or to prevent certain harms in those patients?. These guidelines and recommendations have often been part of NCDs, but were not included in the MCIT policy. When making NCDs, CMS sometimes develops clinician and institutional requirements after careful review of expert physicians' specialty society guidelines and clinical study results. Additional rulemaking may provide a further opportunity for the public to opine on whether these types of restrictions are needed when covering breakthrough devices. Comment.

Manufacturers acknowledged the need to develop evidence to achieve long-term coverage, and many indicated their intent to develop real world evidence (RWE). Some stated that MCIT would incentivize manufacturers to develop RWE following market authorization and sought guidance from CMS on desired elements. Response. Whether evidence development is voluntary or required for coverage, we value manufacturer, CMS, and FDA coordination on RWE development for coverage and/or post-market studies. Establishing the RWE guidance sought by manufacturers and some physicians would be beneficial and that further stakeholder engagement would best inform the guidance.

CMS has multiple pathways to facilitate engagement such as the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) and the public input process through the Federal Register. We are also receptive to informal engagement with stakeholders, including with manufacturers who pursue this evidence development approach. We are aware that best practices for RWE generation are in development by some stakeholders. However, when a device receives breakthrough designation by the FDA, there is currently no clinical study requirement for market-authorization that Medicare patients must be included. Without relevant Medicare data, including RWE, under the MCIT/R&N final rule, CMS may be covering devices with no data demonstrating that Medicare patients will not be harmed or will benefit from the device.

Currently, when CMS sees a trend indicative of a potentially harmful device, we are sometimes able to deny coverage through Medicare Administrative Contractors. Under the MCIT/R&N final rule, this authority has been removed as we may only remove a breakthrough device from the MCIT coverage pathway for limited reasons, including if FDA issues a safety communication, warning letter, or removes the device from the market. Further, under the current final rule, if CMS is seeing a trend of higher risk specifically in the Medicare population, CMS' authority with respect to coverage for Medicare determinations is limited without an FDA action, which would not just take the Medicare population experience into account. That is, the FDA's review of devices is for the entirety of the intended patient population rather than within the narrower Medicare population. Comment.

Some stakeholders continued to express concern that reliance on breakthrough designation ceded decision-making authority on what is reasonable and necessary for Medicare patients to an FDA decision very early in the product lifecycle. A number of physician commenters with experience in clinical evidence noted a number of compelling evidentiary concerns, including their assertion that the MCIT policy is flawed because of a lack of evidence that breakthroughs benefit Medicare beneficiaries. One manufacturer suggested that pivotal studies should have to demonstrate patient benefit in the Medicare population in order to obtain MCIT coverage. Response. The FDA criteria to determine whether a device is designated as a breakthrough is different from the criteria and evidence CMS reviews to determine appropriateness for the Medicare population.

The FDA does not routinely require data on Medicare patients. The relevant data is key for Medicare national coverage decision-making to ensure that Medicare is paying for devices that are beneficial to Medicare patients. While the goal of the MCIT/R&N final rule was to expedite coverage to speed access to innovative treatments, the immediacy of coverage must be balanced with ensuring that the Medicare program is covering appropriate devices for the Medicare population. Without any data or minimal clinical data to make this determination, it is challenging to ensure that breakthrough devices are beneficial to the Medicare population. We will further consider public comments seeking modifications to MCIT that might allow for expedited coverage while seeking to ensure devices are safe for Medicare patients even when those breakthrough devices do not have an evidence base that is generalizable to Medicare beneficiaries.

Comment. Medical specialty societies also sought modifications to the MCIT/R&N final rule regarding evidence development, specifically the addition of RWE requirements and a clarification of CMS' CED authorities. Commenters specifically recommended post market studies, data collection, and recommended CED as a potential pathway to address uncertainty in health outcomes. In lieu of MCIT, commenters recommended using the Parallel Review program for devices with a broad evidence base and a CED for devices with a developing evidence base. Response.

We appreciate these comments and refer to our earlier responses addressing similar issues regarding evidence development and RWE-related comments. CED has been utilized for many years to allow beneficiary access while simultaneously fostering evidence development. The public comments suggest there is an interest in additional guidance on CED. Knowing where there are gaps in clinical evidence for a device or type of devices is a preliminary question asked and researched by CMS and FDA. This gap analysis with respect to the Medicare reasonable and necessary criteria is a precursor to CED parameters for a given item or service.

We are aware that manufacturers are interested in more input from CMS on what evidence needs to be developed for coverage, including a discussion of the gap analysis. Based on the comments from manufacturers that indicated they were already developing or would develop evidence following market authorization, we believe there is also interest in coordination with CMS to create an evidence development plan that is fit-for-purpose in line with manufacturer coverage goals to ensure that Medicare patients are protected. Comment. Several health plans participating in Medicare Advantage (MA) and their advocacy associations submitted comments that raised concerns with the MCIT/R&N final rule. Associations specifically indicated that the final rule should be rescinded and not implemented.

In general, they recommend post market data collection and use of existing coverage pathways. One health plan noted several concerns for the MA plans if the MCIT/R&N final rule is implemented specific to bids and plan payment rates and related downstream effects for beneficiaries such as increased out of pocket costs, fewer benefits, and perhaps even fewer plan offerings.Start Printed Page 26852 Response. There is not a substantive discussion on how the MCIT pathway would affect MA plans in the MCIT/R&N final rule. Under current law, MA plans are required to offer coverage of reasonable and necessary items and services covered under part A and part B on terms at least as favorable as those adopted by fee for service Medicare. CMS did not fully consider the MA effects in the MCIT/R&N final rule.

Specifically, the cost implications for MA plans of blanket national coverage and all of the associated costs to the breakthrough device was not fully explored. For example, if a breakthrough device was implanted, Medicare would pay not just for the device, but also for the reasonable and necessary procedures and related care and services such as the surgery, and related visits to prepare for surgery and follow up. These non-device costs were not considered in the regulatory impact analysis (RIA). Comment. Some commenters noted that the MCIT/R&N final rule could potentially lead to increased fraud, waste and abuse.

A commenter noted that, under the final rule, the current MCIT construct offering guaranteed Medicare payment for 3 to 4 years with broad-based coverage criteria and minimal limitations for a massive patient population is a strong scenario for fraud. Response. We believe the commenters are suggesting that the expanded coverage may encourage greater use of these devices than they believe is warranted. Because these determinations would depend on specific facts, CMS would follow its normal process in the event there was a concern of fraud or abuse. Comment.

Another stakeholder raised concerns that the MCIT/R&N final rule as currently constructed only considers industry's perspective and does not take into account physician and patient perspectives. They further noted that for MCIT there is no established mechanism in place for those stakeholders to provide comments regarding their concerns about using these technologies on the Medicare population. To that end, they claim that the current MCIT/R&N final rule lacks the transparency and accountability found in the existing NCD and LCD processes. Response. We appreciate these comments.

We acknowledge that the MCIT/R&N final rule as currently designed does not provide the same level of opportunities for public participation as stakeholders have become accustomed to with the established NCD and LCD processes where, for each item or service considered for coverage, stakeholders have an opportunity to comment. Comment. Regarding operational issues for MCIT, manufacturers commented that the existing processes in place for BCD, coding, and payment should work for MCIT, and that early coordination with CMS shortly after breakthrough designation should allow for time for these processes to play out. Commenters, including several manufacturers, recommended that CMS establish provisional codes and payment for breakthrough devices as part of the MCIT pathway to ensure availability of codes and payment at the time of FDA approval. They also recommended that CMS formalize an operational framework with a predictable timeline to conduct evidence reviews, develop benefit category determinations, codes, and payment.

Response. We will take these suggestions under consideration for future rulemaking. Comment. Commenters indicated that the newly public information about the volume increase in the Breakthrough Device volume [] was not a concern and that it should not impede implementation of the MCIT/R&N final rule. Others stated that the RIA was sufficient because not all devices designated as breakthrough would ultimately achieve market authorization after the 4-year period.

Still others believed the RIA was insufficient because they believe there would be more breakthrough devices market authorized than included in the estimate. In light of the increase in volume, a commenter suggested considering mechanisms, such as establishing user fees, to increase resources through dedicated appropriation or other mechanisms. Response. We must take into consideration the number of possible devices that will be approved through the MCIT pathway. Further, under the MCIT/R&N final rule any breakthrough device that receives FDA market-authorization is potentially covered for any Medicare patient without evidence of its benefit generated in the Medicare population.

Beyond limits in the indications for use for which FDA approves or clears a device, CMS does not have the authority under the finalized MCIT policy to further define clinical parameters to narrow or expand national coverage. In addition, all related care and services associated with the device are covered which could include additional visits and maintenance of the device. CMS did not factor these costs in the RIA. This analysis has an impact on ensuring there are sufficient resources for the program to run efficiently. As with any program, sufficient resources are key to efficient and timely operations.

Comment. Most manufacturers commented that the patient protections in place in the final rule, specifically the reliance on FDA safety and efficacy requirements to grant coverage to breakthrough devices under MCIT, were sufficient to prevent beneficiary harm. Response. As finalized in the MCIT/R&N final rule, devices could be used on Medicare patients without any evidence of the devices' clinical utility in the Medicare population. To remove a device from Medicare coverage under MCIT, FDA must issue a safety communication, warning letter, or remove the device from the market.

Under the MCIT/R&N final rule, if CMS observes a trend of higher risk, specifically in the Medicare population, CMS authority to deny coverage is limited. For example, if a CMS contractor (for example, a Medicare Administrative Contractor (MAC)) identifies a pattern or trend of significant patient harm or death related to an MCIT device, there is no procedure to quickly remove coverage for the device until and unless the FDA acts. We believe that the public should have an additional opportunity to comment on this policy. Comment. A commenter recommends that MCIT coverage could be offered to the class of the breakthrough device including device iterations and follow-on competitive devices.

The commenter suggested that CMS direct an evidence review at the end of the 4 years of MCIT coverage for a particular device determine which coverage pathway would be most appropriate to ensure the most benefit to Medicare patients. Response. Clinical evidence development that includes Medicare beneficiaries is central to ensuring that Medicare patients are receiving optimal clinical care and minimizing risk when possible. While examining data on a group of similar breakthrough devices and identifying gaps in the evidence base may be a greater effort initially than the evidence review for one device, it could result in efficiencies across several components within CMS and inform coverage in a more comprehensive manner than MCIT, which is one device at a time. We will Start Printed Page 26853seek additional public comments on this topic when considering any proposed changes.

Comment. Some stakeholders supported defining “reasonable and necessary” in regulation while others do not believe a codified definition is necessary. Commenters expressed concerns about transparency of commercial coverage polices and believed the rule could unnecessarily restrict coverage by relying on commercial insurer policies designed for a different population with different incentives. Furthermore, the majority of public comments from patient advocates, policy “think tanks,” health insurance advocates and manufacturers did not support including commercial insurer criteria in the definition. Most public comments noted that CMS can (and has) reviewed commercial policies in recent years as part of a national coverage analysis.

Other commenters suggested separating and reissuing separate rules for the definition of “reasonable and necessary” and MCIT because they were viewed as too distinct. Response. We will consider this comment for future rulemaking. C. Impracticability of Implementation by May 15, 2021 As noted previously, many commenters on the March 2021 IFC supported delaying the MCIT/R&N final rule.

Based upon the public comments expressing significant evidentiary concerns, we do not believe that it is in the best interest of Medicare beneficiaries for the MCIT/R&N final rule to become effective May 15, 2021. Under the current rule, there no requirement for evidence that MCIT devices will specifically benefit the Medicare target population. Additionally, the final rule takes away tools the CMS has to deny coverage when it becomes apparent that a particular device can be harmful to the Medicare population. If the rule goes into effect, and a device is later found to be harmful to Medicare recipients is approved under the MCIT pathway, CMS would be limited in the actions it can take to withdraw or modify coverage to protect beneficiaries. As was noted by some commenters, early and unrestricted adoption of devices may have consequences that may not be easy to reverse.

Commenters referenced publications that highlight the relationship between manufacturers and physicians and claimed that the potential for manufacturers to influence physician behavior will persist if coverage is guaranteed under MCIT. Guaranteed coverage under MCIT may further stimulate providers to adopt these technologies and could potentially lead to these technologies being prematurely viewed as standard of care which could adversely impact beneficiaries if a product does not ultimately receive Medicare coverage. Additionally, providers may make capital and capacity investments that could pose challenges to withdrawing coverage. A common theme among some commenters is that, under the MCIT/R&N final rule as currently written, the evidence used to support FDA clearance or approval of a breakthrough device is not generalizable to the Medicare population since the Medicare population is often not adequately represented in clinical trials. Commenters noted that existing Medicare coverage paradigms rely on careful consideration of the tradeoffs between benefits and risks for the Medicare population and adequate evidence that demonstrates improved health outcomes.

Commenters expressed concerns that devices covered under MCIT would not achieve that standard. Additionally, commenters cited several published studies that noted that approval of many breakthrough devices relied upon intermediate endpoints which do not always translate into real world improved health outcomes. Multiple commenters also pointed out that a major limitation of the MCIT pathway under the MCIT/R&N final rule is that manufacturers are not required or incentivized to conduct clinical trials to generate additional evidence, and contended that it is unlikely that manufacturers will voluntarily choose to do so. Further, the shift of the burden of evidence development entirely to manufacturers undermines CMS' ability to support evidence development or establish the coverage criteria (for example, provider experience, location of service, availability of supporting services) that are central to delivery of high-quality, evidence-based care for devices with insufficient evidence of a health benefit for Medicare patients. An additional delay in the effective date would allow time for CMS to address the evidentiary concerns raised by stakeholders and consider how to better balance the needs of all stakeholders and beneficiaries in particular.

Additionally, there is significant uncertainty surrounding coding and payment for new MCIT devices since these issues were not addressed in the MCIT/R&N final rule. If the MCIT/R&N final rule goes into effect, we believe there could be confusion and disruption stemming from devices receiving MCIT approval without a clear path for appropriate coding and payment. The delay will allow CMS time to ensure the public has a clear understanding of the pathways to coverage, coding, and payment. Further, the delay gives CMS time to evaluate stakeholders' recommendation of whether the reasonable and necessary definition should be a separate rule. There were a number of stakeholder comments supporting delaying defining “reasonable and necessary” in regulation.

Commenters did not believe a codified definition was necessary or thought the rule could unnecessarily restrict coverage by relying on commercial insurer policies. Furthermore, the majority of public comments from patient advocates, policy think tanks, health insurance advocates and manufactures did not support including commercial insurer criteria in the definition. Most public comments noted that CMS can (and has) reviewed commercial policies in recent years as part of a national coverage analysis. Future rulemaking will provide an opportunity for us to fully consider the significant objections to the rule, and will provide another opportunity for the public to present contrary facts and arguments. II.

Provisions of the Final Rule This final rule would further delay the effective date of the MCIT/R&N final rule until December 15, 2021, to provide CMS an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment as noted previously. During the delay, we will determine appropriate next steps that are in the best interest of all Medicare stakeholders, and beneficiaries in particular. This final rule delays the effective date of the January 2021 MCIT/R&N final rule as specified in the DATES section of this final rule. III. Waiver of the 30-Day Delay in Effective Date The Administrative Procedure Act, 5 U.S.C.

553(d), and section 1871(e)(1)(B)(i) of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. The purpose of the 30-day delay is to allow the public to prepare to implement the new final rule. We find good cause to waive the 30-day delay in the effective date because the further extension will maintain the status quo, so the public does not need notice to adjust their Start Printed Page 26854behavior as a result of the additional delay. Moreover, allowing the prior rule to go into effect would defeat the purpose of the delay rule and result in the same difficulties that were identified regarding reversing course once the rule was in place and would be contrary to the public interest. Start Signature Dated.

May 13, 2021. Xavier Becerra, Secretary, Department of Health and Human Services.

Medicaid Services (CMS), Department of Health and Human Services (HHS) order viagra from canada. Proposed rule. This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, “Medicaid Program. Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in order viagra from canada Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements”, published in the December 31, 2020 Federal Register.

This proposed rule also proposes to delay for 2 years the April 1, 2022 effective date of inclusion (inclusion date) for U.S. Territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of “States” and “United States” for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, “Medicaid Program. Covered Outpatient order viagra from canada Drug. Further Delay of Inclusion of Territories in Definitions of States and United States”, published in the November 25, 2019 Federal Register to April 1, 2024.

In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. We are requesting public comment on the order viagra from canada proposed delays of applicable effective date and inclusion date discussed in greater detail below. To be assured consideration, comments on the proposals must be received at one of the addresses provided below by June 28, 2021. In commenting, please refer to file code CMS-2482-P2.

Comments, including mass comment submissions, must be submitted in one of order viagra from canada the following three ways (please choose only one of the ways listed). 1. Electronically. You may submit order viagra from canada electronic comments on this regulation to http://www.regulations.gov.

Follow the “Submit a comment” instructions. 2. By regular mail order viagra from canada. You may mail written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department order viagra from canada of Health and Human Services, Attention. CMS-2482-P2, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for order viagra from canada mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may order viagra from canada send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-2482-P2, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850 order viagra from canada. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info Christine Hinds, (410) 786-4578. Wendy Tuttle, order viagra from canada (410) 786-8690. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the applicable comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment.

We post order viagra from canada all comments received before the close of the applicable comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not order viagra from canada post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual.

CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.Start Printed Page 28743 I. Background A order viagra from canada. Proposed Delays in Effective and Inclusion Dates of Certain Regulation Provisions CMS is proposing to delay the January 1, 2022 effective date for amendatory instruction 10.a.

Of the final rule entitled, “Medicaid Program. Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs order viagra from canada Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” (85 FR 87000), for 6 months to July 1, 2022, and to delay the April 1, 2022, inclusion date in the amended regulatory definitions of “States” and “United States”, adopted in the interim final rule with comment period entitled “Medicaid Program. Covered Outpatient Drugs. Further Delay of Inclusion of Territories in Definitions of States and United States” (84 FR 64783), for 2 years until April 1, 2024, or in the alternative, to a date earlier than April 1, 2024, but not before January 1, 2023.

B. Proposed Delay of Effective Date of Amendatory Instruction 10.a. On December 31, 2020, we published a final rule in the Federal Register entitled “Medicaid Program. Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” [] (85 FR 87000) (hereinafter referred to as the December 31, 2020 final rule).

The December 31, 2020 final rule advanced CMS' efforts to support state flexibility to enter into innovative value-based purchasing (VBP) arrangements with drug manufacturers for new and innovative, and often costly therapies, such as gene therapies, and codified new approaches required by section 1004 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) and the existing Medicaid DUR program to improve the clinical use of opioids and reduce the potential for abuse in Medicaid patients. In addition, it codified in regulation several changes made in recent legislation and clarified other provisions of regulations relating to the Medicaid Drug Rebate Program (MDRP).

The regulations included in the December 31, 2020 final rule went into effect on March 1, 2021, except for certain amendatory instructions, including instruction 10.a., which is effective on January 1, 2022. We are proposing to delay the January 1, 2022 effective date for amendatory instruction 10.a. Of the December 31, 2020 final rule on manufacturer reporting of multiple best prices connected to a VBP arrangement, to July 1, 2022, and are seeking public comment on the proposed delay as outlined in section I.A. Of this proposed rule.

As discussed in greater detail in section II. Of this proposed rule, we believe a delay of 6 months is warranted to assure that stakeholders have the ability to implement the new VBP policy in a manner that assures that patient access and quality of care is protected. We seek public comments on this proposed delay in the effective date, including the impact of this delay on affected beneficiaries. The primary reason for the original delay, and the new proposed delay, is to provide more time for CMS, states, and manufacturers to make the complex system changes necessary to implement the new best price and VBP program, and assure patient access and quality of care, given the current need to devote resources to the public health emergency (PHE) relating to erectile dysfunction treatment that has been in effect, and will likely remain in effect through 2021.

C. Proposed Delay of Inclusion Date in Amended Regulatory Definitions of “States” and “United States” The Covered Outpatient Drug (COD) final rule, published in the February 1, 2016 Federal Register (81 FR 5170), amended the regulatory definitions of “States” and “United States” to include the U.S. Territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) for the purposes of the MDRP with a delayed inclusion date of April 1, 2017. We stated in the preamble to the final rule that U.S.

Territories may use existing waiver authority to elect not to participate in the MDRP consistent with the statutory waiver standards. Specifically, the Northern Mariana Islands and American Samoa may seek to opt out of participation under the broad waiver that has been granted to them in accordance with section 1902(j) of the Act. The territories of Puerto Rico, the Virgin Islands, and Guam may use waiver authority under section 1115 of the Act to waive section 1902(a)(54) of the Act, which requires state compliance with the applicable requirements of section 1927 of the Act (81 FR 5203 through 5204). The change to the definition of “States” and “United States” under the COD final rule to include the territories would also impact the quarterly calculation of average manufacturer price (AMP) and best price by manufacturers.

That is, the change requires manufacturers to include prices paid by entities in the U.S. Territories in the same manner in which they include prices paid by entities located in one of the 50 states and District of Columbia (81 FR 5224) in AMP and best price. It requires manufacturers to include eligible sales and associated discounts, rebates, and other financial transactions that take place in the U.S. Territories in their calculations of AMP and best price once the revised definitions of “States” and “United States” take effect, regardless of whether the U.S.

Territories seek to waive participation in the MDRP. Once the COD final rule became effective, CMS began discussions with the territories regarding their participation in the MDRP. Based on those discussions, it became evident that interested territories would not be ready to participate in the MDRP by April 1, 2017. Stakeholders also reiterated the concerns in the comments to the COD final rule (81 FR 5224) that drug manufacturers will likely need to increase drug prices paid by U.S.

Territory Medicaid programs once the territories are included in the definitions of “States” and “United States” in order to avoid setting a new, lower best price. That is because if prices for drugs in the territories are lower than those in the states, then those prices could become the Medicaid best price for that drug in the entire Medicaid program. The manufacturers may then increase their drug prices in the territories to avoid this outcome, and an increase in drug prices in the territories could result in an increase in territory Medicaid drug spending without the offsetting benefit of receiving Medicaid rebates. Furthermore, the increase in Medicaid drug spending could adversely impact the availability of drugs to patients in the territories because of their Medicaid funding cap.

As a result of these initial and subsequent discussions on preparedness, the potential for increased Medicaid drug prices in certain territories, and later, due to additional impacts of natural disasters in several of the territories, CMS issued two interim final rules with comment period (IFC) to further delay the Start Printed Page 28744inclusion date for the U.S. Territories in the regulatory definitions of “States” and “United States” for purposes of the MDRP. The first, the “Medicaid Program. Covered Outpatient Drug.

Delay in Change in Definitions of States and United States” IFC, was issued on November 15, 2016, amending the regulatory definitions of “States” and “United States” to include the U.S. Territories beginning April 1, 2020, rather than to April 1, 2017 (81 FR 80003). The second, the “Medicaid Program. Covered Outpatient Drug.

Further Delay of Inclusion of Territories in Definitions of States and United States” IFC, was published on November 25, 2019, and further delayed the inclusion date for the regulatory definitions of “States” and “United States” to include the U.S. Territories beginning April 1, 2022, rather than April 1, 2020 (84 FR 64783). For similar reasons, in addition to ensuring continued beneficiary access and quality of care protections, we are proposing to amend § 447.502 to delay the April 1, 2022 inclusion date for the amended regulatory definitions of “States” and “United States” to April 1, 2024, and are seeking public comment on the proposed delay as outlined in section I.A. Of this proposed rule.

As discussed in greater detail in section II. Of this proposed rule, we believe an additional delay of 2 years may be warranted because it would allow the territories to focus their human and financial resources on ensuring the health and well-being of their beneficiaries during this PHE, rather than having to divert those resources to the development of systems required to participate in the MDRP, which can take several years to implement from start to finish, and seek public comments on this proposal. However, if we determine based on public comments received from interested parties that the territories that want to participate in MDRP can do so sooner than April 1, 2024, and those that do not want to participate are able to complete the necessary waiver process, then we are proposing in the alternative to finalize a date that is sooner than April 1, 2024, but not earlier than January 1, 2023. II.

Proposed Delay in Effective and Inclusion Dates of Certain Regulation Provisions Due to Ongoing Public Health Emergency (PHE) On April 21, 2021, the Secretary of Health and Human Services (the Secretary) renewed the PHE initially declared on January 31, 2020, to continue giving CMS programs (including Medicaid) flexibility to support beneficiaries during the erectile dysfunction treatment viagra. This PHE is expected to last through 2021. In response to the PHE, CMS put in place its own viagra plan (https://www.cms.gov/​files/​document/​erectile dysfunction treatment-viagra-plan.pdf) to address the needs of its stakeholders, as well as the beneficiaries of its various programs including Medicaid. As part of that plan, CMS provided that it may approve waivers, amendments, and flexibilities for U.S.

States, including the District of Columbia, and U.S. Territories to allow Medicaid and CHIP programs to adapt their operations as necessary to respond to the viagra. The viagra plan also provided that it may make adjustments to the agency's value-based payment initiatives to allow health providers, healthcare facilities, Medicare Advantage and Part D plans, and States to focus on providing needed care to beneficiaries. In addition to the flexibilities granted to states under the PHE, the President signed into law on March 11, 2021 the American Rescue Plan Act of 2021 (ARP) (Pub.

L. 117-2) to address the health care and economic needs of the country during the viagra. This law is one of the most significant expansions of Medicaid since enactment of the Affordable Care Act of 2010, and includes several new mandatory benefit requirements on states that will take time to implement. We acknowledged in the December 31, 2020 final rule that the changes to the reporting of multiple best prices by manufacturers under the MDRP (a VBP policy) adopted under the amendatory instruction 10.a would require additional time to provide operational guidance and complex system changes to implement.

Thus, we delayed the effective date of the VBP provision until January 1, 2022. States that opt to participate in VBP models offered by manufacturers under the multiple best price approach must ensure that beneficiaries have appropriate access to care under such arrangements by developing systems and methods to track beneficiaries and their outcomes, retrieving and evaluating the patient-specific outcomes data, and securing the cooperation of providers and beneficiaries to enter into some of the more complex outcome-based arrangements offered by the manufacturers. Thus, there will be requirements on states to develop significant capabilities to build an infrastructure that will be able to implement VBP. We also want to be sure that our own technology infrastructure will be ready to receive multiple VBP offers from manufacturers that will report them to CMS, and subsequently report them to states.

We are currently developing a new Medicaid Drug Program (MDP) system. This MDP system will replace CMS' current legacy system with certain aspects of the system expected to be transitioned in the summer of 2021. However, because of other events that have transpired since the regulation was published in December 2020, we do not believe that certain aspects of the system necessary for states and manufacturers to operationalize the VBP multiple best price program will be transitioned at that time, making a January 1, 2022 infeasible. We believe that it is important to have a technically up-to-date system that is ready to support the data requirements necessary for states and manufacturers to operationalize the VBP multiple best price program.

However, we may have a delay with operationalizing that part of the MDP system by July 2021, which may mean we will not have the necessary CMS components in place by later this year to implement the program by January 1, 2022, and believe July 1, 2022, is a realistic target date. Furthermore, the demands on researching, producing, and distributing erectile dysfunction treatment drug treatments and treatments have likely diverted some manufacturer financial and human resources from developing and implementing system changes that would be required to enter multiple best price offers in the MDP system. We understand that there is interest among patient and consumer groups, states, and manufacturers in the new multiple best price policy, and we are committed to implementing the VBP multiple best price policy in a manner that assures that Medicaid beneficiaries have access to medications and therapies that are appropriately administered and monitored. However, we are concerned that there are several challenges the states, providers, and manufacturers are facing during the PHE.

These include, in addition to those resulting from the passage of the ARP, those relating to implementing expanded eligibility and mandatory benefit requirements under Medicaid (as described below). In sum, states, providers and manufacturers, as well as CMS, will need additional time to operationalize the multiple best prices policy under amendatory instruction 10.a. Therefore, given the possible delay in the MDP system and the recent developments around the PHE and ARP, we believe more time is critical to permit CMS and our partners—states, providers, and manufacturers—to successfully implement the multiple best prices approach so that Medicaid Start Printed Page 28745patients benefit from these programs to full extent possible. Specifically, CMS and all the parties involved with the multiple best prices policies will want to make sure Medicaid patients receive the drug therapies under the VBP approach that are prescribed for them in a timely manner.

That the VBP program does not create unnecessary barriers or requirements on the patient to access the drug. That they receive appropriately scheduled doses of a therapy if the patient treatment under the VBP arrangement is based on multiple doses. And that patient outcomes are tracked so that optimal patient care is provided. And, the states can obtain any additional discounts due to them from manufacturers under the VBP arrangement.

At this time, we believe it is in the best interest of the Medicaid program and Medicaid beneficiaries, in particular, that states prioritize the Medicaid eligibility and benefit requirements under the ARP (for example, expanded optional Medicaid coverage for postpartum women, expansion of erectile dysfunction treatment testing and treatment services, and expansion of treatment administration to limited benefit groups), resulting from enactment of the ARP to address beneficiary needs during the erectile dysfunction treatment viagra, and therefore, propose a delay to the effective date for amendatory instruction 10.a. (the multiple best price approach) by 6 months (effective July 1, 2022). By allowing more time to address the needs of Medicaid beneficiaries during the PHE, states, CMS, providers, and manufacturers will also have more time to put in place appropriate beneficiary protections as part of the multiple best price approach. Therefore, we propose to delay the amendment associated with multiple best price requirements for 6 months, which if finalized, would make amendatory instruction 10.a effective beginning July 1, 2022.

We also expect to issue additional guidance before that time on operational and policy aspects of the new VBP program, including specifications relating to beneficiary protections. For the same reasons discussed above, we believe that in light of the viagra and the resource demands stemming from the PHE (including those established under the ARP) on the Medicaid program and its beneficiaries, it is imperative that the territories prioritize the Medicaid eligibility and mandatory benefit requirements brought about by the ARP to address beneficiary needs during the erectile dysfunction treatment. Therefore, we believe that a further delay in the inclusion date of the U.S. Territories in the regulatory definitions of “States” and “United States” is warranted and are proposing that they be included in those definitions beginning April 1, 2024.

In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. By delaying the inclusion date to April 1, 2024, or in the alternative, a date earlier than April 1, 2024, but not before January 1, 2023, we are allowing the territories additional time to develop needed systems and policy changes, in order to avoid unintended increases in drug costs and access concerns. The needed systems must be capable of collecting, reporting, validating, and tracking drug utilization on an ongoing basis. In addition, they require extensive advance planning and budgeting.

The delay in inclusion date would also benefit those territories that choose not to participate in the MDRP, and therefore, would be required to use human and financial resources to complete the section 1115 and section 1902(j) waiver applications that are required to waive out of MDRP participation should the current April 1, 2022 date remain in effect. Moreover, should the amended regulatory definitions of “States” and “United States” go into effect on April 1, 2022, all manufacturers' sales to the territories and prices paid would be included in the AMP and best price calculations at that time, regardless of whether the territory is participating in the MDRP. As discussed in the COD final rule (81 FR 5224), we heard from various stakeholders who expressed concerns that drug manufacturers would likely be prompted to increase drug prices, including prices paid by the U.S. Territory Medicaid programs, once the territories are included in the definitions of “States” and “United States.” This is because, as currently drafted, section 1927 of the Act requires that eligible sales of drugs within the United States be included in the drug manufacturers calculation of Average Manufacturer Price (AMP) and best price.

The inclusion of these prices in AMP and best price would result in the territories that receive a waiver realizing an increase in their Medicaid drug costs without the offsetting benefit of receiving Medicaid rebates. Furthermore, the increase in Medicaid costs could adversely affect territories because of their Medicaid funding cap. As noted above, that could result in an increase in drug prices in the territories, making drugs less affordable, and making it more difficult for the territories to address their own public health needs during the PHE. We believe this provides further rationale for delaying the inclusion date of territories in the regulatory definitions of “States” and “United States.” It will ensure that during this PHE, which has the potential to extend into 2022, those territories that opt to waive participation from the MDRP will not face the additional financial burdens associated with increased Medicaid drug costs from drug manufacturers increasing drug prices to the territories.

We are proposing a new inclusion date of April 1, 2024 for the amended regulatory definitions of “States” and “United States” to include the U.S. Territories for purposes of the MDRP. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. Thus, we are specifically requesting comments from all interested parties on whether April 1, 2024, or an earlier inclusion date, but not earlier than January 1, 2023, would be more appropriate for the amended regulatory definitions.

More specifically, we are requesting public comments that will assist us in understanding all relevant concerns related to establishing a new inclusion date, including whether territories are ready to participate in the MDRP, and whether CMS is able to execute appropriate and necessary waivers for territories that do not want to participate. In any case, manufacturers would be required to include their sales to the territories in their AMP and best price calculations based on the inclusion date finalized in a final rule, which we are proposing to be April 1, 2024, or possibly earlier, but no earlier than January 1, 2023 based on public comments. Therefore, we are requesting comment on our proposal to amend § 447.502 to delay the inclusion date for the the U.S. Territories into the regulatory definitions of “States” and “United States” until April 1, 2024.

We are also requesting comments on an alternative proposal, which is to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. III. Response to Comments Because of the significant number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble for each applicable comment period, and, if and when we Start Printed Page 28746proceed with a subsequent document, we will respond to the applicable comments in the preamble to that document, as appropriate.

I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &. Medicaid Services, approved this document on May 18, 2021. Start List of Subjects AccountingAdministrative practice and procedureDrugsGrant programs—healthHealth facilitiesHealth professionsMedicaidReporting and recordkeeping requirementsRural areas End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below.

Start Part End Part Start Amendment Part1. The authority citation for part 447 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1396r-8.

End Authority Start Amendment Part2. Amend § 447.502 by revising the definitions of “States” and “United States” to read as follows. End Amendment Part Definitions. * * * * * States means the 50 States and the District of Columbia and, beginning April 1, 2024, also includes the Commonwealth of Puerto Rico, the Virgin Islands of the United States, Guam, the Commonwealth of the Northern Mariana Islands, and American Samoa.

United States means the 50 States and the District of Columbia and, beginning April 1, 2024, also includes the Commonwealth of Puerto Rico, the Virgin Islands of the United States, Guam, the Commonwealth of the Northern Mariana Islands, and American Samoa. * * * * * Start Signature Dated. May 21, 2021. Xavier Becerra, Secretary, Department of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2021-11160 Filed 5-26-21. 4:15 pm]BILLING CODE 4120-01-PStart Preamble Start Printed Page 26849 Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS).

Final rule. This final rule delays the effective date of the final rule titled, “Medicare Program. Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary' ” published in the January 14, 2021 Federal Register. As of May 14, 2021, the effective date of the final rule amending 42 CFR part 405, published at 86 FR 2987, January 14, 2021, and delayed at 86 FR 14542, March 17, 2021, is further delayed until December 15, 2021.

Start Further Info Lori Ashby at (410)-786-6322 or MCIT@cms.hhs.gov. End Further Info End Preamble Start Supplemental Information I. Background A. Introduction In the January 14, 2021 Federal Register, we published a final rule titled “Medicare Program.

Medicare Coverage of Innovative Technology (MCIT) and Definition of `Reasonable and Necessary' ” (86 FR 2987) (hereinafter referred to as MCIT/R&N final rule). The January 2021 final rule established a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). Under the final rule as currently written, MCIT would result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. The MCIT/R&N final rule would also implement regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Medicare Parts A and B.

B. March 17, 2021 Interim Final Rule (IFC) In response to the January 20, 2021 memorandum from the Assistant to the President and Chief of Staff titled “Regulatory Freeze Pending Review” (“Regulatory Freeze Memorandum”) (86 FR 7424, January 28, 2021) and guidance on implementation of the memorandum issued by the Office of Management and Budget (OMB) in Memorandum M-21-14 dated January 20, 2021, we determined that a 60-day delay of the effective date of the MCIT/R&N final rule was appropriate to ensure that. (1) The rulemaking process was procedurally adequate. (2) the agency properly considered all relevant facts.

(3) the agency considered statutory or other legal obligations. (4) the agency had reasonable judgment about the legally relevant policy considerations. And (5) the agency adequately considered public comments objecting to certain elements of the rule, including whether interested parties had fair opportunities to present contrary facts and arguments. Therefore, in an interim final rule that took effect on March 12, 2021, and appeared in the March 17, 2021 Federal Register (86 FR 14542), we (1) delayed the MCIT/R&N final rule effective date until May 15, 2021 (that is, 60 days after the original effective date of March 15, 2021).

And (2) opened a 30-day public comment period on the facts, law, and policy underlying the MCIT/R&N final rule. C. Review of Public Comments on the Delay of the MCIT/R&N Final Rule We received approximately 215 timely pieces of correspondence in response to the interim final rule delaying the effective date of the MCIT/R&N final rule. In this section of this final rule, we summarize our response to comments on the delay of the MCIT/R&N final rule.

To the extent applicable, we intend to also consider these comments for future rulemaking. Comment. Some manufacturers, in particular those with FDA designated breakthrough devices that have been market authorized, as well as the industry groups representing them commented that the MCIT/R&N final rule should be implemented without further delay. Although they acknowledged certain operational issues remain, specifically coding and payment for applicable devices and/or the services in which they are used, these commenters suggested those issues could be overcome by adapting existing processes such as inpatient new technology add on payment (NTAP) and outpatient hospital transitional pass-through payment to determine coding and payment, at least when these devices are used in the hospital setting.

These commenters also expressed that they believe patient safety provisions in the final rule are sufficient to protect beneficiaries. Other manufacturers that have FDA breakthrough designated devices but generally have yet to receive market authorization were supportive of a MCIT policy that would be more comprehensive and that includes specified guidance and expedited processes for benefit category determination, coding, and payment. These manufacturers support a delay of the MCIT/R&N final rule to the extent that such a delay would lead to a more comprehensive policy than the one that would be effective in May 2021. Response.

The current MCIT/R&N final rule solely relates to coverage of certain devices under Medicare. It does not establish a benefit category determination (BCD), medical coding, nor payment rates for any devices. While we recognize that some commenters support a different policy that would address benefit category determinations, coding, and payment, in addition to coverage, the MCIT/R&N final rule was not designed to address factors beyond Medicare coverage. Further, while the rule eliminates coverage uncertainty early after FDA market authorization for those devices with a clear benefit category, the rule did not directly address the operational issues, such as how the agency would establish coding and payment.

Comment. Several individual physicians and members of the public submitted comments supporting implementation of the MCIT/R&N final rule given the promise of breakthrough devices for their specialties or disease states of concern. Chronic obstructive pulmonary disease (COPD), prostate care, heart failure, stroke, opioid use disorder, oncology, and sleep disorders. On the other hand, some commenters suggested that the final MCIT/R&N rule provided automatic coverage for breakthrough devices without adequate evidentiary support.

Response. We are aware that breakthrough devices span numerous clinical specialties. We note that MCIT would be one of several coverage pathways (that is, claim-by-claim adjudication, local coverage, National Coverage Determination (NCD)) for breakthrough devices. Even without the MCIT/R&N final rule in effect, a review of claims data showed that breakthrough devices have received and are receiving Medicare coverage when medically Start Printed Page 26850necessary.

CMS reviewed fee-for-service claims data for several recent market-authorized breakthrough devices. The majority of the FDA market authorized breakthrough devices that would have been eligible for the MCIT pathway were already paid through an existing mechanism or were predominantly directed to a pediatric population. Of those that would be separately payable by Medicare on a claim-by-claim basis, the reviewed devices, were covered and paid under the applicable Medicare payment system. Regarding commenters' concerns about automatic coverage without evidentiary support, we share commenters' concerns that guaranteeing coverage for all breakthrough devices receiving market-authorization for any Medicare patient with possibly minimal or no evidence on the Medicare population and no requirement to develop evidence on the Medicare population could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries.

For example, a breakthrough device may only be beneficial in a subset of the Medicare population or when used only by specialized clinicians to ensure benefit. Without additional clinical evidence on the device's clinical utility for the Medicare population, it is challenging to determine appropriate coverage of these newly market-authorized devices. Comment. Multiple stakeholders (manufacturers, physicians, associations) commented that CMS should modify the MCIT policy in some way.

A substantial number of comments from a variety of stakeholders expressed evidentiary concerns with MCIT as currently designed, including that the current MCIT/R&N final rule's pathway establishes an open-ended coverage commitment for all breakthrough devices without demonstrating a health benefit in the Medicare population. Additionally, commenters were concerned that the current MCIT/R&N final rule does not specify, nor can it require, coverage criteria beyond the FDA indication(s) for use, and that evidence development under MCIT is voluntary, and narrowing coverage after MCIT expires will be challenging for devices that do not have a documented, proven benefit for Medicare patients. Many of these stakeholders recommend that CMS leverage or broaden the existing coverage with evidence development (CED) pathway to provide more timely and appropriate access to new technologies. These commenters encouraged CMS to require post market studies and data collection as part of MCIT to ensure that beneficiaries are gaining access to new technologies that improve health outcomes.

Several breakthrough device manufacturers suggested that, for inclusion in MCIT, a portion of FDA pivotal studies should include a portion of Medicare beneficiaries. One breakthrough device manufacturer suggested that 25 percent of patients in the pivotal study should be Medicare beneficiaries for MCIT. Otherwise, CED would be more appropriate. Response.

We agree that for breakthrough devices for which studies did not include Medicare populations or populations with characteristics similar to the Medicare population CED or a similar evidence development process would strengthen the evidence base relevant to Medicare patients. In past NCDs, we have leveraged FDA required post-market studies in CED decisions. In contrast to the NCD process which involves a robust review of available clinical evidence, especially for the Medicare population, to determine whether the item or service is reasonable and necessary for Medicare beneficiaries, the current MCIT pathway in the MCIT/R&N final rule establishes a 4-year coverage commitment for all breakthrough devices that have a benefit category without a specific requirement that the device must demonstrate a health benefit or that the benefits outweigh harms in the Medicare population. In general, Medicare patients have more comorbidities and often require additional and higher acuity clinical treatments which may impact the outcomes differently than the usual patients enrolled in early studies.

Medicare has also focused on real world data or implementation studies to understand how items and services perform when more broadly used in general practice in the Medicare population. These considerations are often not addressed in the early device development process. We also note that FDA grants breakthrough designation early in a device's product lifecycle. In part, the FDA considers “whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current standard of care (SOC) in the U.S.

A complete set of clinical data is not required for designation.” [] At the time a device is granted breakthrough status by the FDA, little may be known about the benefits and harms of the device. We recognize the importance of breakthrough technologies that provide for more effective treatment of life-threatening and irreversibly debilitating diseases and conditions when no effective treatment exists. In cases where there is greater uncertainty surrounding the benefit-risk profile of a breakthrough device, some commenters have suggested that more relevant evidence is needed for Medicare patients to determine health benefit, to mitigate harms that may not be apparent in initial studies with small sample sizes, and to understand the balance of benefits and harms when breakthrough devices are used more broadly in Medicare patients. The additional delay announced in this rule will provide an opportunity to ensure that the objections to the rule are adequately considered.

We will consider ways to diminish uncertainty with respect to Medicare coverage by building upon the evidence foundation established during the market authorization process or combining that evidence with other approaches like CED to expedite coverage in appropriate instances. For CMS, the evidence base underlying the FDA's decision to approve or clear a device for particular indications for use has been crucial for determining Medicare coverage through the NCD process. CMS looks to the evidence supporting FDA market authorization and the device indications for use for evidence generalizable to the Medicare population, data on improvement in health outcomes, and durability of those outcomes. If there are no data on those elements, it is difficult for CMS to make an evidence-based decision whether the device is reasonable and necessary for the Medicare population.

The current MCIT/R&N final rule does not specify any coverage criteria beyond the FDA indication(s) for use for which FDA has approved or cleared the device. The current final rule would provide coverage when a device is used according to approved or cleared indication(s) for use. A device's approved or cleared indications for use may not include information that is important or particularly relevant for Medicare patients and clinicians when making treatment decisions. With breakthrough devices, as mentioned by some commenters, the patients included in device studies generally are not Medicare beneficiaries who often have multiple comorbidities and higher acuity of illness.

The data used to determine whether a device meets applicable FDA safety Start Printed Page 26851and effectiveness requirements for its approved or cleared indication(s) for use may not be able to answer questions such as the following. Does the benefit differ for older and/or frailer patients with specific comorbidities?. Are clinician experience or facility requirements needed to ensure good health outcomes or to prevent certain harms in those patients?. These guidelines and recommendations have often been part of NCDs, but were not included in the MCIT policy.

When making NCDs, CMS sometimes develops clinician and institutional requirements after careful review of expert physicians' specialty society guidelines and clinical study results. Additional rulemaking may provide a further opportunity for the public to opine on whether these types of restrictions are needed when covering breakthrough devices. Comment. Manufacturers acknowledged the need to develop evidence to achieve long-term coverage, and many indicated their intent to develop real world evidence (RWE).

Some stated that MCIT would incentivize manufacturers to develop RWE following market authorization and sought guidance from CMS on desired elements. Response. Whether evidence development is voluntary or required for coverage, we value manufacturer, CMS, and FDA coordination on RWE development for coverage and/or post-market studies. Establishing the RWE guidance sought by manufacturers and some physicians would be beneficial and that further stakeholder engagement would best inform the guidance.

CMS has multiple pathways to facilitate engagement such as the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) and the public input process through the Federal Register. We are also receptive to informal engagement with stakeholders, including with manufacturers who pursue this evidence development approach. We are aware that best practices for RWE generation are in development by some stakeholders. However, when a device receives breakthrough designation by the FDA, there is currently no clinical study requirement for market-authorization that Medicare patients must be included.

Without relevant Medicare data, including RWE, under the MCIT/R&N final rule, CMS may be covering devices with no data demonstrating that Medicare patients will not be harmed or will benefit from the device. Currently, when CMS sees a trend indicative of a potentially harmful device, we are sometimes able to deny coverage through Medicare Administrative Contractors. Under the MCIT/R&N final rule, this authority has been removed as we may only remove a breakthrough device from the MCIT coverage pathway for limited reasons, including if FDA issues a safety communication, warning letter, or removes the device from the market. Further, under the current final rule, if CMS is seeing a trend of higher risk specifically in the Medicare population, CMS' authority with respect to coverage for Medicare determinations is limited without an FDA action, which would not just take the Medicare population experience into account.

That is, the FDA's review of devices is for the entirety of the intended patient population rather than within the narrower Medicare population. Comment. Some stakeholders continued to express concern that reliance on breakthrough designation ceded decision-making authority on what is reasonable and necessary for Medicare patients to an FDA decision very early in the product lifecycle. A number of physician commenters with experience in clinical evidence noted a number of compelling evidentiary concerns, including their assertion that the MCIT policy is flawed because of a lack of evidence that breakthroughs benefit Medicare beneficiaries.

One manufacturer suggested that pivotal studies should have to demonstrate patient benefit in the Medicare population in order to obtain MCIT coverage. Response. The FDA criteria to determine whether a device is designated as a breakthrough is different from the criteria and evidence CMS reviews to determine appropriateness for the Medicare population. The FDA does not routinely require data on Medicare patients.

The relevant data is key for Medicare national coverage decision-making to ensure that Medicare is paying for devices that are beneficial to Medicare patients. While the goal of the MCIT/R&N final rule was to expedite coverage to speed access to innovative treatments, the immediacy of coverage must be balanced with ensuring that the Medicare program is covering appropriate devices for the Medicare population. Without any data or minimal clinical data to make this determination, it is challenging to ensure that breakthrough devices are beneficial to the Medicare population. We will further consider public comments seeking modifications to MCIT that might allow for expedited coverage while seeking to ensure devices are safe for Medicare patients even when those breakthrough devices do not have an evidence base that is generalizable to Medicare beneficiaries.

Comment. Medical specialty societies also sought modifications to the MCIT/R&N final rule regarding evidence development, specifically the addition of RWE requirements and a clarification of CMS' CED authorities. Commenters specifically recommended post market studies, data collection, and recommended CED as a potential pathway to address uncertainty in health outcomes. In lieu of MCIT, commenters recommended using the Parallel Review program for devices with a broad evidence base and a CED for devices with a developing evidence base.

Response. We appreciate these comments and refer to our earlier responses addressing similar issues regarding evidence development and RWE-related comments. CED has been utilized for many years to allow beneficiary access while simultaneously fostering evidence development. The public comments suggest there is an interest in additional guidance on CED.

Knowing where there are gaps in clinical evidence for a device or type of devices is a preliminary question asked and researched by CMS and FDA. This gap analysis with respect to the Medicare reasonable and necessary criteria is a precursor to CED parameters for a given item or service. We are aware that manufacturers are interested in more input from CMS on what evidence needs to be developed for coverage, including a discussion of the gap analysis. Based on the comments from manufacturers that indicated they were already developing or would develop evidence following market authorization, we believe there is also interest in coordination with CMS to create an evidence development plan that is fit-for-purpose in line with manufacturer coverage goals to ensure that Medicare patients are protected.

Comment. Several health plans participating in Medicare Advantage (MA) and their advocacy associations submitted comments that raised concerns with the MCIT/R&N final rule. Associations specifically indicated that the final rule should be rescinded and not implemented. In general, they recommend post market data collection and use of existing coverage pathways.

One health plan noted several concerns for the MA plans if the MCIT/R&N final rule is implemented specific to bids and plan payment rates and related downstream effects for beneficiaries such as increased out of pocket costs, fewer benefits, and perhaps even fewer plan offerings.Start Printed Page 26852 Response. There is not a substantive discussion on how the MCIT pathway would affect MA plans in the MCIT/R&N final rule. Under current law, MA plans are required to offer coverage of reasonable and necessary items and services covered under part A and part B on terms at least as favorable as those adopted by fee for service Medicare. CMS did not fully consider the MA effects in the MCIT/R&N final rule.

Specifically, the cost implications for MA plans of blanket national coverage and all of the associated costs to the breakthrough device was not fully explored. For example, if a breakthrough device was implanted, Medicare would pay not just for the device, but also for the reasonable and necessary procedures and related care and services such as the surgery, and related visits to prepare for surgery and follow up. These non-device costs were not considered in the regulatory impact analysis (RIA). Comment.

Some commenters noted that the MCIT/R&N final rule could potentially lead to increased fraud, waste and abuse. A commenter noted that, under the final rule, the current MCIT construct offering guaranteed Medicare payment for 3 to 4 years with broad-based coverage criteria and minimal limitations for a massive patient population is a strong scenario for fraud. Response. We believe the commenters are suggesting that the expanded coverage may encourage greater use of these devices than they believe is warranted.

Because these determinations would depend on specific facts, CMS would follow its normal process in the event there was a concern of fraud or abuse. Comment. Another stakeholder raised concerns that the MCIT/R&N final rule as currently constructed only considers industry's perspective and does not take into account physician and patient perspectives. They further noted that for MCIT there is no established mechanism in place for those stakeholders to provide comments regarding their concerns about using these technologies on the Medicare population.

To that end, they claim that the current MCIT/R&N final rule lacks the transparency and accountability found in the existing NCD and LCD processes. Response. We appreciate these comments. We acknowledge that the MCIT/R&N final rule as currently designed does not provide the same level of opportunities for public participation as stakeholders have become accustomed to with the established NCD and LCD processes where, for each item or service considered for coverage, stakeholders have an opportunity to comment.

Comment. Regarding operational issues for MCIT, manufacturers commented that the existing processes in place for BCD, coding, and payment should work for MCIT, and that early coordination with CMS shortly after breakthrough designation should allow for time for these processes to play out. Commenters, including several manufacturers, recommended that CMS establish provisional codes and payment for breakthrough devices as part of the MCIT pathway to ensure availability of codes and payment at the time of FDA approval. They also recommended that CMS formalize an operational framework with a predictable timeline to conduct evidence reviews, develop benefit category determinations, codes, and payment.

Response. We will take these suggestions under consideration for future rulemaking. Comment. Commenters indicated that the newly public information about the volume increase in the Breakthrough Device volume [] was not a concern and that it should not impede implementation of the MCIT/R&N final rule.

Others stated that the RIA was sufficient because not all devices designated as breakthrough would ultimately achieve market authorization after the 4-year period. Still others believed the RIA was insufficient because they believe there would be more breakthrough devices market authorized than included in the estimate. In light of the increase in volume, a commenter suggested considering mechanisms, such as establishing user fees, to increase resources through dedicated appropriation or other mechanisms. Response.

We must take into consideration the number of possible devices that will be approved through the MCIT pathway. Further, under the MCIT/R&N final rule any breakthrough device that receives FDA market-authorization is potentially covered for any Medicare patient without evidence of its benefit generated in the Medicare population. Beyond limits in the indications for use for which FDA approves or clears a device, CMS does not have the authority under the finalized MCIT policy to further define clinical parameters to narrow or expand national coverage. In addition, all related care and services associated with the device are covered which could include additional visits and maintenance of the device.

CMS did not factor these costs in the RIA. This analysis has an impact on ensuring there are sufficient resources for the program to run efficiently. As with any program, sufficient resources are key to efficient and timely operations. Comment.

Most manufacturers commented that the patient protections in place in the final rule, specifically the reliance on FDA safety and efficacy requirements to grant coverage to breakthrough devices under MCIT, were sufficient to prevent beneficiary harm. Response. As finalized in the MCIT/R&N final rule, devices could be used on Medicare patients without any evidence of the devices' clinical utility in the Medicare population. To remove a device from Medicare coverage under MCIT, FDA must issue a safety communication, warning letter, or remove the device from the market.

Under the MCIT/R&N final rule, if CMS observes a trend of higher risk, specifically in the Medicare population, CMS authority to deny coverage is limited. For example, if a CMS contractor (for example, a Medicare Administrative Contractor (MAC)) identifies a pattern or trend of significant patient harm or death related to an MCIT device, there is no procedure to quickly remove coverage for the device until and unless the FDA acts. We believe that the public should have an additional opportunity to comment on this policy. Comment.

A commenter recommends that MCIT coverage could be offered to the class of the breakthrough device including device iterations and follow-on competitive devices. The commenter suggested that CMS direct an evidence review at the end of the 4 years of MCIT coverage for a particular device determine which coverage pathway would be most appropriate to ensure the most benefit to Medicare patients. Response. Clinical evidence development that includes Medicare beneficiaries is central to ensuring that Medicare patients are receiving optimal clinical care and minimizing risk when possible.

While examining data on a group of similar breakthrough devices and identifying gaps in the evidence base may be a greater effort initially than the evidence review for one device, it could result in efficiencies across several components within CMS and inform coverage in a more comprehensive manner than MCIT, which is one device at a time. We will Start Printed Page 26853seek additional public comments on this topic when considering any proposed changes. Comment. Some stakeholders supported defining “reasonable and necessary” in regulation while others do not believe a codified definition is necessary.

Commenters expressed concerns about transparency of commercial coverage polices and believed the rule could unnecessarily restrict coverage by relying on commercial insurer policies designed for a different population with different incentives. Furthermore, the majority of public comments from patient advocates, policy “think tanks,” health insurance advocates and manufacturers did not support including commercial insurer criteria in the definition. Most public comments noted that CMS can (and has) reviewed commercial policies in recent years as part of a national coverage analysis. Other commenters suggested separating and reissuing separate rules for the definition of “reasonable and necessary” and MCIT because they were viewed as too distinct.

Response. We will consider this comment for future rulemaking. C. Impracticability of Implementation by May 15, 2021 As noted previously, many commenters on the March 2021 IFC supported delaying the MCIT/R&N final rule.

Based upon the public comments expressing significant evidentiary concerns, we do not believe that it is in the best interest of Medicare beneficiaries for the MCIT/R&N final rule to become effective May 15, 2021. Under the current rule, there no requirement for evidence that MCIT devices will specifically benefit the Medicare target population. Additionally, the final rule takes away tools the CMS has to deny coverage when it becomes apparent that a particular device can be harmful to the Medicare population. If the rule goes into effect, and a device is later found to be harmful to Medicare recipients is approved under the MCIT pathway, CMS would be limited in the actions it can take to withdraw or modify coverage to protect beneficiaries.

As was noted by some commenters, early and unrestricted adoption of devices may have consequences that may not be easy to reverse. Commenters referenced publications that highlight the relationship between manufacturers and physicians and claimed that the potential for manufacturers to influence physician behavior will persist if coverage is guaranteed under MCIT. Guaranteed coverage under MCIT may further stimulate providers to adopt these technologies and could potentially lead to these technologies being prematurely viewed as standard of care which could adversely impact beneficiaries if a product does not ultimately receive Medicare coverage. Additionally, providers may make capital and capacity investments that could pose challenges to withdrawing coverage.

A common theme among some commenters is that, under the MCIT/R&N final rule as currently written, the evidence used to support FDA clearance or approval of a breakthrough device is not generalizable to the Medicare population since the Medicare population is often not adequately represented in clinical trials. Commenters noted that existing Medicare coverage paradigms rely on careful consideration of the tradeoffs between benefits and risks for the Medicare population and adequate evidence that demonstrates improved health outcomes. Commenters expressed concerns that devices covered under MCIT would not achieve that standard. Additionally, commenters cited several published studies that noted that approval of many breakthrough devices relied upon intermediate endpoints which do not always translate into real world improved health outcomes.

Multiple commenters also pointed out that a major limitation of the MCIT pathway under the MCIT/R&N final rule is that manufacturers are not required or incentivized to conduct clinical trials to generate additional evidence, and contended that it is unlikely that manufacturers will voluntarily choose to do so. Further, the shift of the burden of evidence development entirely to manufacturers undermines CMS' ability to support evidence development or establish the coverage criteria (for example, provider experience, location of service, availability of supporting services) that are central to delivery of high-quality, evidence-based care for devices with insufficient evidence of a health benefit for Medicare patients. An additional delay in the effective date would allow time for CMS to address the evidentiary concerns raised by stakeholders and consider how to better balance the needs of all stakeholders and beneficiaries in particular. Additionally, there is significant uncertainty surrounding coding and payment for new MCIT devices since these issues were not addressed in the MCIT/R&N final rule.