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Abstract The erectile dysfunction treatment kamagra has emerged as a major stressor of a global scale, buy kamagra gel affecting all aspects of our lives, and is likely to contribute to a surge of mental http://natalievartanian.com/buy-cheap-kamagra-oral-jelly/ ill health. Ancient Hindu scriptures, notably the Bhagavad Gita, have a wealth of insights that can help approaches to build psychological resilience for individuals at risk, those affected, as well as for caregivers. The path of knowledge (Jnana yoga) promotes accurate awareness of nature of the self, and can buy kamagra gel help reframe our thinking from an “I” to a “we mode,” much needed for collectively mitigating the spread of the erectile dysfunction.

The path of action (Karma yoga) teaches the art of selfless action, providing caregivers and frontline health-care providers a framework to continue efforts in the face of uncertain consequences. Finally, the path of buy kamagra gel meditation (Raja yoga) offers a multipronged approach to healthy lifestyle and mindful meditation, which may improve resilience to the illness and its severe consequences. While more work is needed to empirically examine the potential value of each of these approaches in modern psychotherapy, the principles herein may already help individuals facing and providing care for the erectile dysfunction treatment kamagra.Keywords.

Bhagavad Gita, erectile dysfunction treatment, YogaHow to cite this article:Keshavan MS. Building resilience in the erectile dysfunction treatment buy kamagra gel era. Three paths in the Bhagavad Gita.

Indian J buy kamagra gel Psychiatry 2020;62:459-61The erectile dysfunction treatment crisis has changed our world in just a matter of months, thrusting us into danger, uncertainty, fear, and of course social isolation. At the time of this writing, over 11 million individuals have been affected worldwide (India is fourth among all countries, 674,515) and over half a million people have died. The erectile dysfunction treatment kamagra has been an unprecedented global stressor, not only because of the disease burden and mortality but also buy kamagra gel because of economic upheaval.

The very fabric of the society is disrupted, affecting housing, personal relationships, travel, and all aspects of lifestyle. The overwhelmed health-care system is among the most major stressors, leading to a heightened sense of vulnerability. No definitive treatments or treatment is buy kamagra gel on the horizon yet.

Psychiatry has to brace up to an expected mental health crisis resulting from this global stressor, not only with regard to treating neuropsychiatric consequences but also with regard to developing preventive approaches and building resilience.Thankfully, there is a wealth of wisdom to help us in our ancient scriptures such as the Bhagavad Gita[1] for building psychological resilience. The Bhagavad Gita is a dialog between the Pandava prince Arjuna and his charioteer Krishna in the epic Mahabharata, the great tale of buy kamagra gel the Bharata Dynasty, authored by Sage Vyasa (c. 4–5 B.C.E.).

The dialog occurs in the 6th buy kamagra gel chapter of the epic and has over 700 verses. In this epic story, Arjuna, the righteous Pandava hero was faced with the dilemma of waging a war against his cousins, the Kauravas, for territory. Arjuna is confused and has no will to initiate the war.

In this context, Krishna, his charioteer and buy kamagra gel spiritual mentor, counsels him. The key principles of this spiritual discourse in the Gita are embodied in the broad concept of yoga, which literally means “Yog” or “to unite.” Applying three tenets of yoga can greatly help developing resilience at individual, group, and societal levels. A fourth path, Bhakti yoga, is a spiritual approach in the Gita which emphasizes loving devotion toward a higher power or principle, which may or may not involve a personal god buy kamagra gel.

In this editorial, I focus on three paths that have considerable relevance to modern approaches to reliance-focused psychotherapy that may be especially relevant in the erectile dysfunction treatment era. Path of Knowledge The first concept in the Gita is buy kamagra gel the path of knowledge (Jnana Yoga, chapter 2). The fundamental goal of Jnana yoga is to liberate oneself from the limited view of the individual ego, and to develop the awareness of one's self as part of a larger, universal self.

Hindu philosophers were among the earliest to buy kamagra gel ask the question of “who am I” and concluded that the self is not what it seems. The self as we all know is a collection of our physical, mental, and social attributes that we create for ourselves with input from our perceptions, and input by our families and society. Such a world view leads to a tendency to crave for the “I” and for what is mine, and not consider the “We.” As Krishna in the Bhagavad Gita points out, the person who sees oneself in others, and others in oneself, really “sees.” Such awareness, which guides action in service of self as well as others, is critically important in our goals of collectively preventing the spread of the erectile dysfunction.

A glaring example is the use of face masks, known to buy kamagra gel effectively slow the viral . Using the mask is as important to protecting oneself from the kamagra as well as protecting others from oneself. Nations such as the USA (and their leaders), who have given mixed messages to the public about the need to wear masks, have been showing a strikingly buy kamagra gel high number of cases as well as mortality.

Unfortunately, such reluctance to wear masks (and thus model protective hygiene for the population), as in the case of the US leader, has stemmed from ego or vanity-related issues (i.e., how he would appear to other leaders!. ). This factor may at least partly underlie the worse erectile dysfunction treatment outcome in the buy kamagra gel USA.

The simple lesson here is that it is important to first flatten the ego if one wants to flatten the kamagra curve!. Path of Action The second key concept is the path of action (Karma yoga, chapter buy kamagra gel 3). Karma yoga is all about taking action without thinking, “what's in it for me.” As such, it seeks to mainly let go of one's ego.

In the Bhagavad Gita, Arjuna is ambivalent about fighting because of the conflict regarding the outcome brought buy kamagra gel on by waging the war, i.e., having to kill some of his own kith and kin. Krishna reminds him that he should not hesitate, because it is his nature and duty (or Dharma), as a warrior, to protect the larger good, though it will have some downside consequences. The frontline health-care worker caring for severely ill patients with erectile dysfunction treatment is likely to have a similar emotional reaction as Arjuna, facing a lack of adequate treatments, high likelihood of mortality and of unpredictable negative outcomes, and risk to him/herself.

Compounding this, especially buy kamagra gel when resources such as ventilators are limited, the doctor may have to make tough decisions of whose life to save and whose not. Adding to this are personal emotions when facing with the death of patients, having to deliver bad news, and dealing with grieving relatives.[2] All these are likely to result in emotional anguish and guilt, leading to burnout and a war “neurosis.”So, what should the frontline health-care provider should do?. Krishna's counsel would be buy kamagra gel that the doctor should continue to perform his/her own dharma, but do so without desire or attachment, thereby performing action in the spirit of Karma yoga.

Such action would be with detachment, without a desire for personal gain and being unperturbed by success or failure. Such “Nishkaama Karma” (or selfless action) may help doctors working today in the erectile dysfunction treatment outbreak to carry forward their work with compassion, and accept the results of their actions with equanimity and without buy kamagra gel guilt. Krishna points out that training one's mind to engage in selfless action is not easy but requires practice (Abhyasa).

Krishna is also emphatic about the need to protect oneself, in order to be able to effectively carry out one's duties. Path of Meditation The third core concept in the Gita is the path of meditation and self-reflection (Raja yoga, or buy kamagra gel Dhyana yoga, chapter 6). It is considered the royal path (Raja means royal) for attaining self-realization, and often considered the 8-fold path of yoga (Ashtanga yoga) designed to discipline lifestyle, the body and mind toward realizing mindfulness and self-reflection.

These techniques, which originated in India over two millennia ago, have evolved over recent decades and anticipate several approaches to contemplative psychotherapy, including dialectical behavior therapy, acceptance and commitment therapy, and mindfulness-based stress reduction.[3] These approaches are of particular relevance for stress reduction and resilience building in individuals faced buy kamagra gel by erectile dysfunction treatment-related emotional difficulties as well as health-care providers.[4]The majority of people affected by the erectile dysfunction treatment kamagra recover, but about 20% have severe disease, and the mortality is around 5%. Older individuals, those with obesity and comorbid medical illnesses such as diabetes and lung disease, are particularly prone to developing severe disease. It is possible that a state of chronic low-grade inflammation which underlies each of these conditions may increase the risk of disproportionate host immune reactions (with excessive release of cytokines), characterizing severe disease in those with erectile dysfunction treatment.[4] With this in mind, it is important to note that exercise, some forms of meditation, anti-inflammatory and antioxidant diet (such as turmeric and melatonin), and yoga have known benefits in reducing inflammation.[5],[6],[7],[8],[9] Sleep buy kamagra gel loss also elevates inflammatory cytokines.

Healthy sleep may reduce inflammation.[10] Clearly, a healthy lifestyle, including healthy sleep, exercise, and diet, may be protective against developing erectile dysfunction treatment-related severe complications. These principles of healthy living are beautifully summarized in the Bhagavad Gita.Yuktahara-viharasya yukta-cestasya karmasuYukta-svapnavabodhasya yogo bhavati duhkha-haHe who is temperate in his habits of eating, sleeping, working and recreation can mitigate all sorrows by practicing the yoga system.–Bhagavad Gita, Chapter 6, verse 17.The relevance of the Bhagavad Gita for modern psychotherapy has been widely reviewed.[11],[12] However, relatively little empirical literature exists on the effectiveness of versus spiritually integrated psychotherapy incorporating Hindu psychotherapeutic insights. Clearly, more work is needed, and erectile dysfunction treatment may provide an opportunity for buy kamagra gel conducting further empirical research.[13] In the meantime, using the principles outlined here may already be of benefit in helping those in need, and may be rapidly enabled in the emerging era of telehealth and digital health.[14]Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest.

References 1.Pandurangi AK, Shenoy S, Keshavan MS. Psychotherapy in the Bhagavad Gita, the Hindu scriptural buy kamagra gel text. Am J Psychiatry 2014;171:827-8.

2.Arango buy kamagra gel C. Lessons learned from the erectile dysfunction health crisis in Madrid, Spain. How erectile dysfunction treatment has changed our lives in the last 2 weeks [published online ahead of print, 2020 Apr 8].

Biol Psychiatry 2020;26:S0006-3223 (20) 31493-1 buy kamagra gel. [doi. 10.1016/j.biopsych.

2020.04.003]. 3.Keshavan MS, Gangadhar GN, Hinduism PA. In.

Spirituality and Mental Health Across Cultures, Evidence-Based Implications for Clinical Practice. Oxford, England. Oxford University Press.

In Press. 4.Habersaat KB, Betsch C, Danchin M, Sunstein CR, Böhm R, Falk A, et al. Ten considerations for effectively managing the erectile dysfunction treatment transition.

Nat Hum Behav 2020;4:677-87. Doi. 10.1038/s41562-020-0906-x.

Epub 2020 Jun 24. 5.Kumar K. Building resilience to erectile dysfunction treatment disease severity.

J Med Res Pract 2020;9:1-7. 6.Bushell W, Castle R, Williams MA, Brouwer KC, Tanzi RE, Chopra D, et al. Meditation and Yoga practices as potential adjunctive treatment of erectile dysfunction and erectile dysfunction treatment.

A brief overview of key subjects [published online ahead of print, 2020 Jun 22]. J Altern Complement Med 2020;26:10.1089/acm. 2020.0177.

7.Gupta H, Gupta M, Bhargava S. Potential use of turmeric in erectile dysfunction treatment [published online ahead of print, 2020 Jul 1]. Clin Exp Dermatol.

2020;10.1111/ced.14357. Doi:10.1111/ced.14357. 8.Damiot A, Pinto AJ, Turner JE, Gualano B.

Immunological implications of physical inactivity among older adults during the erectile dysfunction treatment kamagra [published online ahead of print, 2020 Jun 25]. Gerontology 2020:26;1-8. [doi.

10.1159/000509216]. 9.El-Missiry MA, El-Missiry ZM, Othman AI. Melatonin is a potential adjuvant to improve clinical outcomes in individuals with obesity and diabetes with coexistence of erectile dysfunction treatment [published online ahead of print, 2020 Jun 29].

Eur J Pharmacol 2020;882:173329. 10.Mullington JM, Simpson NS, Meier-Ewert HK, Haack M. Sleep loss and inflammation.

Best Pract Res Clin Endocrinol Metab 2010;24:775-84. 11.Balodhi JP, Keshavan MS. Bhagavad Gita and psychotherapy.

Asian J Psychiatr 2011;4:300-2. 12.Bhatia SC, Madabushi J, Kolli V, Bhatia SK, Madaan V. The Bhagavad Gita and contemporary psychotherapies.

Indian J Psychiatry 2013;55:S315-21. 13.Keshavan MS. kamagras and psychiatry.

Repositioning research in context of erectile dysfunction treatment [published online ahead of print, 2020 May 7]. Asian J Psychiatr 2020;51:102159. [doi.

10.1016/j.ajp. 2020.102159]. 14.Torous J, Keshavan M.

erectile dysfunction treatment, mobile health and serious mental illness. Schizophr Res 2020;218:36-7. Correspondence Address:Matcheri S KeshavanRoom 542, Massachusetts Mental Health Center, 75 Fenwood Road, Boston, MA 02115 USASource of Support.

None, Conflict of Interest. NoneDOI. 10.4103/psychiatry.IndianJPsychiatry_829_20.

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This includes honey for allergies and sore throats, cinnamon for blood sugar control and blood thinning, chili peppers for pain relief, and aloe vera for skin burns. Here are five popular natural remedies. Chamomile Credit:(George Dolgikh/Shutterstock)Many people find what does kamagra do a hot cup of tea before bed relaxing.

But one tea stands out aboveall others as a natural sleep aid — chamomile. That’s because apigenin, a chemicalproperty found in green tea binds to GABA receptors in the brain, creating a sedative effect. Having a what does kamagra do cup of chamomile tea about 45 minutes before going to sleep gives your body enough time for the chemicals to work.

One study showed that when chamomile extract capsules were given to elderly people for 28 days in a row, their sleep quality improved. Although considered quite what does kamagra do safe, chamomile should be avoided two weeks before surgery and can interfere with sedatives, blood thinners, or NSAIDs.GingerCredit. (Photoongraphy/Shutterstock)Ginger root has been used to treat nausea (and related symptoms) for more than two millennia— primarily in Indian, Asian, and Arabic cultures.

This thick and knotty stem,called a rhizome, can be made into supplements, teas, lozenges, extracts and even pickled or crystallized. Studies support ginger as a remedy for nausea related to motion sickness, what does kamagra do migraines and other causes. Research found ginger to be effective at controlling nausea and vomiting in pregnancy and chemotherapy when tested against placebo, as well as when compared to B6 — a common nausea treatment.

There’s also reason to believe ginger could aid in reducing inflammatory pain, what does kamagra do blood sugar, and cholesterol. It’s also a delicious, flavorful addition to many recipes. You can even make your own spicy and sweet candied ginger with a few simple steps.

Magnesium Credit what does kamagra do. (Tatjana Baibakova/Shutterstock) Migraine headaches can be debilitating, especially for the 12 percent of the population who suffer from them—making migraine the third most prevalent illness in the world, according to the Migraine Research Foundation. Although there are a variety ofmedications available, they can carry risks and have unpleasant side effects.

Magnesium offers an inexpensive, drug-free, safe way to address migraines what does kamagra do. The American Academy ofNeurology and the American Headache Society gave magnesium a “B” rating, indicating it was “probably effective” as a migraine treatment It seems to be especially helpful with migraine with headaches with aura. The relationship between magnesium and migraine isn’t fully understood, although migraines sufferers do seem to have lower magnesium levels.

Some scientists think what does kamagra do that magnesium can block pain chemicals. Lower magnesium may cause blood vessel narrowing in the brain, which could also be connected to migraines. Although you can get magnesium what does kamagra do from certain foods, including pumpkin seeds, almonds, and spinach, most people need a supplement to reach levels that would help with their migraines.PeppermintCredit.

(Arina_B/Shutterstock) For people with irritable bowel syndrome (IBS), peppermint can be a natural way to treat symptoms, such as pain, bloating, and constipation. Peppermint can be ingested either through tea or peppermint oil capsules. It appears to work as an what does kamagra do antispasmodic, meaning it calms spasms and relaxes intestinal muscles.

While people may enjoy the taste of peppermint tea, the real benefits are reaped from the oil. One study of irritable bowel syndrome (IBS) patients found that after a month of treatment with peppermint oil capsules, 75% saw a reduction of more than half of their symptoms. This is not a new use of peppermint—ancient what does kamagra do Egyptians, Romans, and Greeks used it for digestive conditions.

Peppermint is not recommended for pregnant or breastfeeding women. TurmericCredit. (SOMMAI/Shutterstock) Turmeric is an Indian spice often used in curry.

Aside from powder form, it’s also made into capsules, extracts, and teas. The main chemical ingredient in turmeric is curcumin, which contains anti-inflammatory and pain-relieving properties. Research obtained from multiple studies supports turmeric’s effectiveness in reducing arthritis pain.

One study found its effect to be comparable to ibuprofen. Another study found that turmeric provided as much relief for their osteoarthritis knee as they did from a prescription NSAIDs.mInterestingly, curcumin comprises only about 5% of turmeric, so to enhance the amount your body can absorb (called bioavailability), combine black pepper with turmeric. Even just 1/20 of a teaspoon of black pepper increases the bioavailability of curcumin.

Another way to boostabsorption is to make sure your turmeric is taken with foods that have fat in them. These are easy methods to adapt, as turmeric is great in stews, on veggies roasted in olive oil, or as part of a spice blend on salmon or chicken.Run an Internet search on “longest living humans” and you’ll be met with an impressive list of people who reached 117, 118 and even 122 years of age. However, with the global life expectancy at birth hovering around 72, many of us would likely be happy to make it to 90 in good health.

Often, genetics and other factors beyond our control affect the amount of time we have on this Earth, but healthy habits such as a good diet, regular exercise and seeing your doctor regularly can go a long way too, experts say. While all factors affecting longevity would be too numerous to list in one article (and include everything from one’s education level to the quality of sleep you’re getting), we focused on a few key areas to explore. GenesResearch in humans and animals indicates that being born into a family whose members regularly make it into their 90s and beyond can be a key factor for determining your lifespan.

€œGenes are for sure very important, particularly to get to extreme longevity,” says Valter D. Longo, director of the Longevity Institute at the University of Southern California. Particularly for that “extreme” longevity, where members of the same family make it into their 100s, Longo says.

If you’re not born with the ideal gene set, then you have to work harder to reach these longer years. However, Longo cautions that having these long-living genes on its own is not an excuse to eat poorly or take other chances with your health.Studies report that genes take on a roughly 20 to 30 percent factor for predicting longevity. DietThe prevalence of obesity and disease like diabetes really hurt our ability to experience a healthy longevity, says Neil Charness, director of the Institute for Successful Longevity at Florida State University.

And our preference for high-fat, high-sugar diets isn’t helping the matter. If healthy longevity is the goal, Charness recommends sticking to a Mediterranean-style diet that goes light on meat, heavier on seafood, vegetables, fruits and nuts. Longo has done extensive study on diet and its relationship to longevity.

Like Charness, he generally recommends a primarily plant-based diet with seafood options two or three times per week, though suggests that there are other factors to consider such as a person’s ancestry. For example, a person from Japan is more likely to be lactose intolerant vs. A person whose family originated from Norway, he says.

Also, fasting for a period of 12 hours each day (for example, between 8 p.m. And 8 a.m.) is important too, the researcher notes. While it’s ideal to be eating healthfully around the clock, Longo recently published a study with other researchers that involved putting mice on a high-fat, high-calorie diet for 25 days out of the month, with the remaining five days consisting of lower-calorie, more healthful foods.

This was enough, Longo says, to get the mice back on track to a healthierlifestyle.“The five days a month — at least in mice — was completely sufficient to wipe outthis 25 days a month of bad food,” Longo says. A similar principle is applied in Longo’s book, The Longevity Diet, which calls for readers to go on a “fasting mimicking” diet four times per year for five days. In this period, readers are instructed to eat lower calorie, vegetable and nut-rich foods.ExerciseExercise, along with diet and genetics, is one of the top factors for longevity, experts say.

Longo says people who have lived to 100 have typically lived very active lifestyles. Maybe they weren’t athletes, the researcher notes, but they lived their lives as farmers or shepherds — a lifestyle with plenty of physical activity built into their routines. Charness points to research on the so-called “Blue Zones” that indicate where in the world people are living the longest and exercise has been a consistent factor there.

€œWe’re pretty sedentary here in the U.S.,” says Charness. €œVery few people get the recommended amount of exercise … maybe a quarter of the general population does, even less of the older population.” According to the Centers for Disease Control and Prevention, adults should be getting 150 minutes of exercise per week, which involves a combination of aerobic exercise and muscle strengthening. Medical Advances and TechnologyFrom treatments to pacemakers, various medical interventions have gone a long way toward extending our life spans by warding off disease.

However, technology can play a part in enhancing the quality and potentially the length of our lives, too. For example, setting seniors up with email and other ways to connect with people online can help combat feelings of isolation, which improves quality of life in an aging population. Charness also points to advancements such as self-driving cars, which could extend seniors’ lives by ultimately reducing the types of accidents they are more likely to be involved in, such as crashes caused by misjudged distance gaps and missed stop signs and traffic lights, Charness says.

PersonalityPersonality has a role to play in lifespan as well, experts say. For example, conscientious people — meaning individuals who are more likely to be organized, responsible, and disciplined — tend to live longer, says Angelina Sutin, a professor in the behavioral sciences and social medicine department at Florida State University. Sutin, whose lab has doneextensive research on the topic of personality and lifespan says this particular trait works in the person’s favor in a number of ways.

First, because conscientious people tend to engage in healthier behaviors such as exercising regularly, not smoking, and seeing their doctors for preventative care.“In fact, prior to mortality, conscientiousness is associated with less risk of developing chronic disease,” says Sutin. Sutin adds that the trait is further associated with lower stresslevels and healthier social relationships, which all contribute to both a higher quality life and a longer lifespan..

People have been turning to nature for medicinal and health http://www.stonestage.at/eventareal/ benefits since buy kamagra gel ancienttimes. Health-related plant usage has been mentioned in the Bible and the Jewish Talmud, as well as in Homer’s The Iliad and The Odyssey. Ingredients found in the natural world have been used as home remedies to address a wide buy kamagra gel range of conditions.

This includes honey for allergies and sore throats, cinnamon for blood sugar control and blood thinning, chili peppers for pain relief, and aloe vera for skin burns. Here are five popular natural remedies. Chamomile Credit:(George Dolgikh/Shutterstock)Many people find a hot cup of tea buy kamagra gel before bed relaxing.

But one tea stands out aboveall others as a natural sleep aid — chamomile. That’s because apigenin, a chemicalproperty found in green tea binds to GABA receptors in the brain, creating a sedative effect. Having a cup of chamomile tea about 45 minutes before going to buy kamagra gel sleep gives your body enough time for the chemicals to work.

One study showed that when chamomile extract capsules were given to elderly people for 28 days in a row, their sleep quality improved. Although considered quite safe, chamomile should be avoided two weeks before surgery and can interfere buy kamagra gel with sedatives, blood thinners, or NSAIDs.GingerCredit. (Photoongraphy/Shutterstock)Ginger root has been used to treat nausea (and related symptoms) for more than two millennia— primarily in Indian, Asian, and Arabic cultures.

This thick and knotty stem,called a rhizome, can be made into supplements, teas, lozenges, extracts and even pickled or crystallized. Studies support ginger as buy kamagra gel a remedy for nausea related to motion sickness, migraines and other causes. Research found ginger to be effective at controlling nausea and vomiting in pregnancy and chemotherapy when tested against placebo, as well as when compared to B6 — a common nausea treatment.

There’s also reason buy kamagra gel to believe ginger could aid in reducing inflammatory pain, blood sugar, and cholesterol. It’s also a delicious, flavorful addition to many recipes. You can even make your own spicy and sweet candied ginger with a few simple steps.

Magnesium Credit buy kamagra gel. (Tatjana Baibakova/Shutterstock) Migraine headaches can be debilitating, especially for the 12 percent of the population who suffer from them—making migraine the third most prevalent illness in the world, according to the Migraine Research Foundation. Although there are a variety ofmedications available, they can carry risks and have unpleasant side effects.

Magnesium offers an inexpensive, drug-free, safe buy kamagra gel way to address migraines. The American Academy ofNeurology and the American Headache Society gave magnesium a “B” rating, indicating it was “probably effective” as a migraine treatment It seems to be especially helpful with migraine with headaches with aura. The relationship between magnesium and migraine isn’t fully understood, although migraines sufferers do seem to have lower magnesium levels.

Some scientists think that magnesium can block pain buy kamagra gel chemicals. Lower magnesium may cause blood vessel narrowing in the brain, which could also be connected to migraines. Although you can get magnesium from certain foods, including pumpkin seeds, almonds, and spinach, buy kamagra gel most people need a supplement to reach levels that would help with their migraines.PeppermintCredit.

(Arina_B/Shutterstock) For people with irritable bowel syndrome (IBS), peppermint can be a natural way to treat symptoms, such as pain, bloating, and constipation. Peppermint can be ingested either through tea or peppermint oil capsules. It appears buy kamagra gel to work as an antispasmodic, meaning it calms spasms and relaxes intestinal muscles.

While people may enjoy the taste of peppermint tea, the real benefits are reaped from the oil. One study of irritable bowel syndrome (IBS) patients found that after a month of treatment with peppermint oil capsules, 75% saw a reduction of more than half of their symptoms. This is not a new use of peppermint—ancient Egyptians, Romans, and Greeks used buy kamagra gel it for digestive conditions.

Peppermint is not recommended for pregnant or breastfeeding women. TurmericCredit. (SOMMAI/Shutterstock) Turmeric is an Indian spice often used in curry.

Aside from powder form, it’s also made into capsules, extracts, and teas. The main chemical ingredient in turmeric is curcumin, which contains anti-inflammatory and pain-relieving properties. Research obtained from multiple studies supports turmeric’s effectiveness in reducing arthritis pain.

One study found its effect to be comparable to ibuprofen. Another study found that turmeric provided as much relief for their osteoarthritis knee as they did from a prescription NSAIDs.mInterestingly, browse this site curcumin comprises only about 5% of turmeric, so to enhance the amount your body can absorb (called bioavailability), combine black pepper with turmeric. Even just 1/20 of a teaspoon of black pepper increases the bioavailability of curcumin.

Another way to boostabsorption is to make sure your turmeric is taken with foods that have fat in them. These are easy methods to adapt, as turmeric is great in stews, on veggies roasted in olive oil, or as part of a spice blend on salmon or chicken.Run an Internet search on “longest living humans” and you’ll be met with an impressive list of people who reached 117, 118 and even 122 years of age. However, with the global life expectancy at birth hovering around 72, many of us would likely be happy to make it to 90 in good health.

Often, genetics and other factors beyond our control affect the amount of time we have on this Earth, but healthy habits such as a good diet, regular exercise and seeing your doctor regularly can go a long way too, experts say. While all factors affecting longevity would be too numerous to list in one article (and include everything from one’s education level to the quality of sleep you’re getting), we focused on a few key areas to explore. GenesResearch in humans and animals indicates that being born into a family whose members regularly make it into their 90s and beyond can be a key factor for determining your lifespan.

€œGenes are for sure very important, particularly to get to extreme longevity,” says Valter D. Longo, director of the Longevity Institute at the University of Southern California. Particularly for that “extreme” longevity, where members of the same family make it into their 100s, Longo says.

If you’re not born with the ideal gene set, then you have to work harder to reach these longer years. However, Longo cautions that having these long-living genes on its own is not an excuse to eat poorly or take other chances with your health.Studies report that genes take on a roughly 20 to 30 percent factor for predicting longevity. DietThe prevalence of obesity and disease like diabetes really hurt our ability to experience a healthy longevity, says Neil Charness, director of the Institute for Successful Longevity at Florida State University.

And our preference for high-fat, high-sugar diets isn’t helping the matter. If healthy longevity is the goal, Charness recommends sticking to a Mediterranean-style diet that goes light on meat, heavier on seafood, vegetables, fruits and nuts. Longo has done extensive study on diet and its relationship to longevity.

Like Charness, he generally recommends a primarily plant-based diet with seafood options two or three times per week, though suggests that there are other factors to consider such as a person’s ancestry. For example, a person from Japan is more likely to be lactose intolerant vs. A person whose family originated from Norway, he says.

Also, fasting for a period of 12 hours each day (for example, between 8 p.m. And 8 a.m.) is important too, the researcher notes. While it’s ideal to be eating healthfully around the clock, Longo recently published a study with other researchers that involved putting mice on a high-fat, high-calorie diet for 25 days out of the month, with the remaining five days consisting of lower-calorie, more healthful foods.

This was enough, Longo says, to get the mice back on track to a healthierlifestyle.“The five days a month — at least in mice — was completely sufficient to wipe outthis 25 days a month of bad food,” Longo says. A similar principle is applied in Longo’s book, The Longevity Diet, which calls for readers to go on a “fasting mimicking” diet four times per year for five days. In this period, readers are instructed to eat lower calorie, vegetable and nut-rich foods.ExerciseExercise, along with diet and genetics, is one of the top factors for longevity, experts say.

Longo says people who have lived to 100 have typically lived very active lifestyles. Maybe they weren’t athletes, the researcher notes, but they lived their lives as farmers or shepherds — a lifestyle with plenty of physical activity built into their routines. Charness points to research on the so-called “Blue Zones” that indicate where in the world people are living the longest and exercise has been a consistent factor there.

€œWe’re pretty sedentary here in the U.S.,” says Charness. €œVery few people get the recommended amount of exercise … maybe a quarter of the general population does, even less of the older population.” According to the Centers for Disease Control and Prevention, adults should be getting 150 minutes of exercise per week, which involves a combination of aerobic exercise and muscle strengthening. Medical Advances and TechnologyFrom treatments to pacemakers, various medical interventions have gone a long way toward extending our life spans by warding off disease.

However, technology can play a part in enhancing the quality and potentially the length of our lives, too. For example, setting seniors up with email and other ways to connect with people online can help combat feelings of isolation, which improves quality of life in an aging population. Charness also points to advancements such as self-driving cars, which could extend seniors’ lives by ultimately reducing the types of accidents they are more likely to be involved in, such as crashes caused by misjudged distance gaps and missed stop signs and traffic lights, Charness says.

PersonalityPersonality has a role to play in lifespan as well, experts say. For example, conscientious people — meaning individuals who are more likely to be organized, responsible, and disciplined — tend to live longer, says Angelina Sutin, a professor in the behavioral sciences and social medicine department at Florida State University. Sutin, whose lab has doneextensive research on the topic of personality and lifespan says this particular trait works in the person’s favor in a number of ways.

First, because conscientious people tend to engage in healthier behaviors such as exercising regularly, not smoking, and seeing their doctors for preventative care.“In fact, prior to mortality, conscientiousness is associated with less risk of developing chronic disease,” says Sutin. Sutin adds that the trait is further associated with lower stresslevels and healthier social relationships, which all contribute to both a higher quality life and a longer lifespan..

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There is kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women. 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 kamagra effects on women.

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 kamagra effects on women. 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 kamagra effects on women LCD processes. Response. We appreciate these comments. We acknowledge that the MCIT/R&N final rule kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women. 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women.

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 kamagra effects on women 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 kamagra effects on women. 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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 kamagra effects on women 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.

End Signature I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &. Medicaid Services, Approved This Document on May 12, 2021 End Supplemental Information [FR Doc. 2021-10466 Filed 5-14-21. 4:15 pm]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &. Medicaid Services, Health and Human Services (HHS).

Notice. The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Comments must be received by July 19, 2021. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1. Electronically.

You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number. CMS-P-0015A, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1.

Access CMS' website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

CMS-R-185—Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory CMS-10166—Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program CMS-10178—Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information CMS-10184—Payment Error Rate Measurement—State Medicaid and CHIP Eligibility CMS-10417—Medicare Fee-for-Service Prepayment Review of Medical Records CMS-372(S)—Annual Report on Home and Community Based Services Waivers and Supporting Regulations Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval.

To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request. Extension of currently approved collection. Title of Information Collection.

Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs. Use. The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). If an accreditation organization is approved, the laboratories that it accredits are “deemed” to meet the Start Printed Page 26922CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements.

The information collected will be used by HHS to. Determine comparability/equivalency of the accreditation organization standards and policies or State licensure program standards and policies to those of the CLIA program. To ensure the continued comparability/equivalency of the standards. And to fulfill certain statutory reporting requirements. Form Number.

CMS-R-185 (OMB control number. 0938-0686). Frequency. Occasionally. Affected Public.

Private Sector—Business or other for-profits and Not-for-profit institutions. Number of Respondents. 9. Total Annual Responses. 9.

Total Annual Hours. 5,464. (For policy questions regarding this collection contact Arlene Lopez at 410-786-6782.) 2. Type of Information Collection Request. Reinstatement without change of a currently approved collection.

Title of Information Collection. Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program. Use. The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP FFS data processing and medical record reviews on which State-specific improper payment rates will be calculated. The quarterly FFS claims and payments will provide the contractor with the actual claims to be sampled.

The systems manuals, provider policies, and other supporting documentation will be used by the federal contractor when conducting the FFS data processing and medical record reviews. Further, the FFS claims and payments sampled for data processing and medical record reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the FFS claim or payments will have their underlying eligibility reviewed. In addition to the Federal Review Contractor conducting a data processing and medical record review of the FFS claims and payments, the FFS sample selected from the state-submitted universe will also be leveraged to support the PERM eligibility reviews. The Federal Eligibility Review Contractor will review the underlying eligibility of individuals whose FFS claims and payments were sampled as part of the PERM FFS sample.

Form Number. CMS-10166 (OMB control number. 0938-0974). Frequency. Quarterly.

Affected Public. State, Local, or Tribal Governments. Number of Respondents. 17. Total Annual Responses.

34. Total Annual Hours. 56,100. (For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 3. Type of Information Collection Request.

Reinstatement without change of a currently approved collection. Title of Information Collection. Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information. Use. The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP managed care data processing reviews on which State-specific improper payment rates will be calculated.

The quarterly capitation payments will provide the contractor with the actual claims to be sampled. The managed care contracts, rate schedules, and updates to both, will be used by the federal contractor when conducting the managed care claims reviews. Further, the managed care capitation payments sampled for data processing reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the managed care capitation will have their underlying eligibility reviewed. Section 2(b)(1) of IPERA clarified that, when meeting IPIA and IPERA requirements, agencies must produce a statistically valid estimate, or an estimate that is otherwise appropriate using a methodology approved by the Director of the OMB.

IPERIA further clarified requirements for agency reporting on actions to reduce improper payments and recover improper payments. The collection of information is necessary for CMS to produce national improper payment rates for Medicaid and CHIP as required by Public Law 107-300. Form Number. CMS-10178 (OMB control number. 0938-0994).

Frequency. Quarterly. Affected Public. State, Local, or Tribal Governments. Number of Respondents.

17. Total Annual Responses. 34. Total Annual Hours. 19,550.

(For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 4. Type of Information Collection Request. Reinstatement with change of a previously approved collection. Title of Information Collection. Payment Error Rate Measurement—State Medicaid and CHIP Eligibility.

Use. The Payment Error Rate Measurement (PERM) program was developed to implement the requirements of the Improper Payments Information Act (IPIA) of 2002 (Pub. L. 107-300), which requires the head of federal agencies to annually review all programs and activities that it administers to determine and identify any programs that are susceptible to significant erroneous payments. If programs are found to be susceptible to significant improper payments, then the agency must estimate the annual amount of erroneous payments, report those estimates to the Congress, and submit a report on actions the agency is taking to reduce improper payments.

IPIA was amended by Improper Payments Elimination and Recovery Act of 2010 (IPERA) (Pub. L. 111-204), the Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA) (Pub. L. 112-248), and the Payment Integrity Information Act of 2019 (PIIA) (Pub.

L. 116-117). The eligibility case documentation collected from the States, through submission of hard copy case files and through access to state eligibility systems, will be used by CMS and its federal contractors to conduct eligibility case reviews on individuals who had claims paid on their behalf in order to determine the improper payment rate associated with Medicaid and CHIP eligibility to comply with the IPIA of 2002. Prior to the July 2017 Final Rule being published in response to the Affordable Care Act, states provided CMS only with information about their sampling and review process as well as the final review findings, which CMS has used in each PERM cycle to calculate IPIA-compliant state and federal improper payment rate for Medicaid and CHIP. Given changes brought forth in the July 2017 Final Rule, states will no longer be required to develop eligibility-specific universes, conduct case reviews, and report findings to CMS.

A federal contractor will utilize the claims (fee-for-service and managed care universes) to identify a sample of individuals and will be responsible for conducting case reviews to support the PERM measurement. Form Number. CMS-10184 (OMB control number. 0938-1012). Frequency.

Quarterly. Affected Public. State, Local, or Tribal Governments. Number of Respondents. 17.

Total Annual Responses. 34. Total Annual Hours. 25,500. (For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 5.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection. Medicare Fee-for-Service Prepayment Review of Medical Records. Use.

The Medical Review program is designed to prevent improper payments in the Medicare FFS program. Whenever possible, Medicare Administrative Contractors (MACs) are Start Printed Page 26923encouraged to automate this process. However, it may require the evaluation of medical records and related documents to determine whether Medicare claims are billed in compliance with coverage, coding, payment, and billing policies. Addressing improper payments in the Medicare fee-for-service (FFS) program and promoting compliance with Medicare coverage and coding rules is a top priority for the CMS. Preventing Medicare improper payments requires the active involvement of every component of CMS and effective coordination with its partners including various Medicare contractors and providers.

The information required under this collection is requested by Medicare contractors to determine proper payment, or if there is a suspicion of fraud. Medicare contractors request the information from providers/suppliers submitting claims for payment when data analysis indicates aberrant billing patterns or other information which may present a vulnerability to the Medicare program. Form Number. CMS-10417. Frequency.

Occasionally. Affected Public. Private Sector, State, Business, and Not-for Profits. Number of Respondents. 485,632.

Number of Responses. 485,632. Total Annual Hours. 242,816. (For questions regarding this collection, contact Christine Grose at (410-786-1362).

6. Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection. Annual Report on Home and Community Based Services Waivers and Supporting Regulations.

Use. We use this report to compare actual data to the approved waiver estimates. In conjunction with the waiver compliance review reports, the information provided will be compared to that in the Medicaid Statistical Information System (MSIS) (CMS-R-284. OMB control number. 0938-0345) report and FFP claimed on a state's Quarterly Expenditure Report (CMS-64.

OMB control number. 0938-1265), to determine whether to continue the state's home and community-based services waiver. States' estimates of cost and utilization for renewal purposes are based upon the data compiled in the CMS-372(S) reports. Form Number. CMS-372(S) (OMB control number.

0938-0272). Frequency. Yearly. Affected Public. State, Local, or Tribal Governments.

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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel. 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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 buy kamagra gel 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, buy kamagra gel 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 buy kamagra gel. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &.

Medicaid Services, Approved This Document on May 12, 2021 End Supplemental Information [FR buy kamagra gel Doc. 2021-10466 Filed 5-14-21. 4:15 pm]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &.

Medicaid Services, Health and Human Services buy kamagra gel (HHS). Notice. The Centers for Medicare &.

Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' buy kamagra gel intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Comments must be received by July 19, 2021 buy kamagra gel. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways.

1. Electronically. You may send your comments electronically to http://www.regulations.gov.

Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2. By regular mail.

You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number.

CMS-P-0015A, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1.

Access CMS' website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669.

End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-R-185—Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory CMS-10166—Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program CMS-10178—Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information CMS-10184—Payment Error Rate Measurement—State Medicaid and CHIP Eligibility CMS-10417—Medicare Fee-for-Service Prepayment Review of Medical Records CMS-372(S)—Annual Report on Home and Community Based Services Waivers and Supporting Regulations Under the PRA (44 U.S.C.

3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.

Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1.

Type of Information Collection Request. Extension of currently approved collection. Title of Information Collection.

Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs. Use. The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

If an accreditation organization is approved, the laboratories that it accredits are “deemed” to meet the Start Printed Page 26922CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements. The information collected will be used by HHS to.

Determine comparability/equivalency of the accreditation organization standards and policies or State licensure program standards and policies to those of the CLIA program. To ensure the continued comparability/equivalency of the standards. And to fulfill certain statutory reporting requirements.

Form Number. CMS-R-185 (OMB control number. 0938-0686).

Private Sector—Business or other for-profits and Not-for-profit institutions. Number of Respondents. 9.

Total Annual Responses. 9. Total Annual Hours.

5,464. (For policy questions regarding this collection contact Arlene Lopez at 410-786-6782.) 2. Type of Information Collection Request.

Reinstatement without change of a currently approved collection. Title of Information Collection. Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program.

Use. The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP FFS data processing and medical record reviews on which State-specific improper payment rates will be calculated. The quarterly FFS claims and payments will provide the contractor with the actual claims to be sampled.

The systems manuals, provider policies, and other supporting documentation will be used by the federal contractor when conducting the FFS data processing and medical record reviews. Further, the FFS claims and payments sampled for data processing and medical record reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the FFS claim or payments will have their underlying eligibility reviewed.

In addition to the Federal Review Contractor conducting a data processing and medical record review of the FFS claims and payments, the FFS sample selected from the state-submitted universe will also be leveraged to support the PERM eligibility reviews. The Federal Eligibility Review Contractor will review the underlying eligibility of individuals whose FFS claims and payments were sampled as part of the PERM FFS sample. Form Number.

CMS-10166 (OMB control number. 0938-0974). Frequency.

Quarterly. Affected Public. State, Local, or Tribal Governments.

Number of Respondents. 17. Total Annual Responses.

(For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 3. Type of Information Collection Request. Reinstatement without change of a currently approved collection.

Title of Information Collection. Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information. Use.

The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP managed care data processing reviews on which State-specific improper payment rates will be calculated. The quarterly capitation payments will provide the contractor with the actual claims to be sampled. The managed care contracts, rate schedules, and updates to both, will be used by the federal contractor when conducting the managed care claims reviews.

Further, the managed care capitation payments sampled for data processing reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the managed care capitation will have their underlying eligibility reviewed. Section 2(b)(1) of IPERA clarified that, when meeting IPIA and IPERA requirements, agencies must produce a statistically valid estimate, or an estimate that is otherwise appropriate using a methodology approved by the Director of the OMB.

IPERIA further clarified requirements for agency reporting on actions to reduce improper payments and recover improper payments. The collection of information is necessary for CMS to produce national improper payment rates for Medicaid and CHIP as required by Public Law 107-300. Form Number.

CMS-10178 (OMB control number. 0938-0994). Frequency.

Quarterly. Affected Public. State, Local, or Tribal Governments.

Number of Respondents. 17. Total Annual Responses.

(For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 4. Type of Information Collection Request. Reinstatement with change of a previously approved collection.

Title of Information Collection. Payment Error Rate Measurement—State Medicaid and CHIP Eligibility. Use.

The Payment Error Rate Measurement (PERM) program was developed to implement the requirements of the Improper Payments Information Act (IPIA) of 2002 (Pub. L. 107-300), which requires the head of federal agencies to annually review all programs and activities that it administers to determine and identify any programs that are susceptible to significant erroneous payments.

If programs are found to be susceptible to significant improper payments, then the agency must estimate the annual amount of erroneous payments, report those estimates to the Congress, and submit a report on actions the agency is taking to reduce improper payments. IPIA was amended by Improper Payments Elimination and Recovery Act of 2010 (IPERA) (Pub. L.

111-204), the Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA) (Pub. L. 112-248), and the Payment Integrity Information Act of 2019 (PIIA) (Pub.

L. 116-117). The eligibility case documentation collected from the States, through submission of hard copy case files and through access to state eligibility systems, will be used by CMS and its federal contractors to conduct eligibility case reviews on individuals who had claims paid on their behalf in order to determine the improper payment rate associated with Medicaid and CHIP eligibility to comply with the IPIA of 2002.

Prior to the July 2017 Final Rule being published in response to the Affordable Care Act, states provided CMS only with information about their sampling and review process as well as the final review findings, which CMS has used in each PERM cycle to calculate IPIA-compliant state and federal improper payment rate for Medicaid and CHIP. Given changes brought forth in the July 2017 Final Rule, states will no longer be required to develop eligibility-specific universes, conduct case reviews, and report findings to CMS. A federal contractor will utilize the claims (fee-for-service and managed care universes) to identify a sample of individuals and will be responsible for conducting case reviews to support the PERM measurement.

Form Number. CMS-10184 (OMB control number. 0938-1012).

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The news buy kamagra gel about addiction — rising rates of addiction, record numbers of overdose deaths, and the like — tends to be bleak. As clinicians and researchers, however, we have the good fortune to often see its bright side. Recovery.The narrative has long been that substance use disorder is a hopeless condition that few buy kamagra gel recover from. Grim statistics often thrown around suggest that only a small percentage of people recover from it.

Though there’s some truth to that, the problem is that these statistics are never put into context.There’s no buy kamagra gel question that many people relapse after an addiction recovery attempt. But most people make multiple attempts. Just as with changing any heavily ingrained buy kamagra gel habit, like smoking or unhealthy eating, many people don’t succeed on their first try. But many eventually get there with successive tries.advertisement Around 75% of people seeking recovery from a substance use problem achieve their goal, though it may take them some time to achieve full remission.

The average number of attempts before success is five, though the median number is just two, meaning that a small number of outliers — usually individuals with the greatest addiction severity and other concomitant mental buy kamagra gel health issues — who need five-plus attempts, inflate the numbers, making them look worse than they are. Along with several colleagues, we recently completed a landmark study which, for the first time, comprehensively surveyed Americans who said they had resolved an alcohol or other drug problem.advertisement Some of what we learned from this survey was indeed disheartening — people who have resolved a substance use problem, for instance, are worse off than the rest of the population in terms of health and employment. But the news wasn’t all buy kamagra gel bad. In fact, some major positives emerged from this work.First off, this study found that 22.3 million Americans have overcome an alcohol or other drug problem — that’s 9% of U.S.

Adults at the time we buy kamagra gel did the survey!. That nearly 1 in 10 U.S. Adults have buy kamagra gel overcome a substance use problem is testament to the fact that not only is addiction recovery possible, it’s common. To further contextualize this finding, in the year these data were collected (2015), there were more people who endorsed having resolved an alcohol or other drug problem in the U.S.

Than had an active buy kamagra gel alcohol or other drug use disorder (22.3 million vs. 20.8 million).We also saw significant improvements in quality of life and a decrease in psychological distress over time in recovery, showing that people and their lives get better after resolving a substance use problem. Just about anyone in addiction recovery will tell you as much, but these findings are important because they provide hard evidence that counter the false narrative about substance use disorder being a hopeless condition.And it’s not just that well-being improves. We also found buy kamagra gel that 80% of people who had overcome an alcohol or other drug problem accomplished at least one major achievement associated with self-improvement and family engagement since overcoming a substance use problem — things like getting a new job, completing a university degree, or volunteering.

And as you might expect, accruing such achievements was associated with improvements in quality of life and well-being over time. These results challenge commonly held beliefs about the nature of substance use disorder as a constantly recurring condition with little buy kamagra gel room for improvement. The reality is that this disorder has a good prognosis and is typified by significant improvement over time in recovery.Along these lines, we found that more years in recovery were associated with an increasing number of achievements. This likely represents a reciprocal process, with more years in recovery leading to more achievements and better outcomes which, in buy kamagra gel turn, support continuous recovery.

With time, people continue improving their quality of life and achieve things they weren’t able to before.Starting early appears to be one key to better recovery outcomes. Though addiction recovery is associated with numerous positives regardless of one’s age, data suggest that getting into addiction recovery young, regardless buy kamagra gel of the severity of an individual’s addiction, is associated with better subsequent global functioning and quality of life.Taken together, this research stands in stark contrast to the heavy stigma and pessimism surrounding substance use disorder, which dramatically compound the burden of addiction. For many people, they represent a major barrier to seeking help and achieving recovery.Individuals with addiction are often viewed as unstable and dangerous, and are much less likely to be wanted by others as friends or part of their families compared to people with other mental health conditions. Numerous social and legal barriers also impede individuals’ efforts to rebuild their lives after resolving an alcohol or other drug problem, such as laws preventing people with histories of drug arrest from getting federal loans to go to school, and widespread corporate buy kamagra gel policies forbidding hiring of people with criminal records, even for nonviolent charges related to drug possession.At the end of the day, addiction is a highly treatable disorder from which the majority of people eventually recover.

And our recent study shows that in spite of numerous legal and social barriers, most individuals in addiction recovery go on to rejoin society and contribute to it in numerous meaningful ways.It’s time we provided individuals with the resources they need to rebuild their lives in addiction recovery, rather than erecting or maintaining barriers to their success. Doing so benefits not just those seeking addiction recovery, but society as a whole.David Eddie is a research scientist at the Recovery Research Institute and Center for Addiction Medicine at Massachusetts General Hospital, a clinical psychologist in the Department of Psychiatry at Massachusetts General buy kamagra gel Hospital, and an assistant professor of psychology at Harvard Medical School. John Kelly is the director of Recovery Research Institute, associate director of the Center for Addiction Medicine, and professor of psychiatry at Harvard Medical School.Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!. GET STARTED Log In | Learn More What is buy kamagra gel it?.

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What's included?. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr..

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The warning http://dandgparts.com/how-to-buy-cheap-cialis-online/ came from WHO Director-General, Tedros Adhanom Ghebreyesus, speaking to journalists in buy kamagra gel Geneva on Thursday. More than 5 million deaths have now been reported, and WHO believes the real number is higher. More than 50,000 people are losing their lives every week. In the last seven days, 56 countries, from buy kamagra gel all regions, reported an increase in deaths of more than 10 per cent.

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On that topic, Tedros kept pointing out the inequality in the distribution of treatments, saying that most low-income countries are relying on the UN-backed international COVAX initiative. According to him, the initiative has the money and the contracts needed, but “manufacturers haven't played their part." “No more treatments should go to countries that have already vaccinated more buy kamagra gel than 40 per cent of their population, until COVAX has the treatments it needs to help other countries get there too", he argued. He stressed that no more boosters should be administered, except to immunocompromised people, and repeated his call for a moratorium on the extra shots. Familiar new wave According to WHO, every single country in Europe and Central Asia is facing a real threat of erectile dysfunction treatment resurgence, or already fighting it.

In a statement released this Thursday, WHO buy kamagra gel Regional Director for Europe said that the current pace of transmission across the 53 countries of the WHO European Region is “of grave concern.” According to Dr. Hans Kluge, cases are once again approaching record levels, with the more transmissible Delta variant continuing to dominate transmission. Over the past 4 weeks, the continent has seen increase in new cases greater than 55 per cent. Last week, Europe and central Asia accounted for 59 per cent of all cases globally buy kamagra gel and 48 per cent of reported deaths.

“We are, once again, at the epicentre”, Dr. Kluge said, adding that hospitalization admission rates due to erectile dysfunction treatment more than doubled in one week. There are buy kamagra gel increasing trends across all age groups, but 75 per cent of fatal cases are in people aged 65 years and above. One estimate predicts that, if the countries stay on this trajectory, there could be another half million deaths in Europe and Central Asia, by 1 February next year.

treatments and social measures According to WHO’s Regional Director, there are two reasons for this surge. Insufficient vaccination coverage, and relaxation of public health and social measures buy kamagra gel. €œDespite near-record erectile dysfunction treatment cases, new deaths are at approximately half the peak levels. This reflects the life-saving effects of treatments and the Herculean task of health authorities, the health workforce and communities, to develop, administer and accept treatments”, Mr.

Kluge said buy kamagra gel. So far, one billion doses have now been administered in Europe and central Asia. Countries of Europe and Centra Asia are, however, at different stages within the kamagra. On average, only 47 per cent of people buy kamagra gel have completed their vaccination.

While eight countries have now exceeded 70 per cent coverage, in two countries, the rate remains below 10 per cent. €œThe treatments are indeed doing what they were intended to do. Preventing severe illness buy kamagra gel and death”, Mr. Kluge assured.

Regarding public health and social measures, he said that testing, contact tracing, ventilation in indoor spaces, and physical distancing, remain part of the defensive arsenal. €œThese are tried and tested measures that enable lives to continue while controlling the kamagra and avoiding widespread, damaging lockdowns”, he argued..

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