safe harbor provisions of the Anti-Kickback Statute

2021.2.1: pol/healthcare/

safe harbor provisions of the Anti-Kickback Statute:

to the HHS Office of Inspector General (OIG):

https://www.regulations.gov/comment?D=HHSIG_FRDOC_0001-0440

Thank you for the opportunity to provide comments on 

abuse of safe harbors to the anti-kickback statute (AKS).

. this letter is a revision of the aapsonline response.

https://aapsonline.org/alert-and-special-legislative-update-pharmacy-benefits-managers/

Physicians Against Drug Shortages estimates that 

http://www.physiciansagainstdrugshortages.com/ 

safe harbor facilitated kickbacks increase 

"annual supplies costs by at least 30%, 

or upwards of $100 billion 

... and the prices of drugs ... 

by at least $100 billion annually as well." 

I urge HHS to move forward with the Part D rebate rule 

instead of delaying it further. 

. that regulation would replace protections for

drug rebates in Medicare Part D

with protections for discounts 

provided directly to consumers. 

. the Biden administration agreed to delay this rule

in response to suit challenging it brought by

the Pharmaceutical Care Management Association.

https://www.fiercehealthcare.com/payer/a-win-for-pbms-biden-administration-delays-rebate-rule

It is past time that discounts on drugs

are passed along directly to patients 

instead of being kicked back to middlemen.

In addition, the Office of Inspector General (OIG) 

must not sidestep its responsibility to investigate and end 

abuse of current AKS safe harbors, 

for example 42 CFR § 1001.952(j) and related regulations. 

This safe harbor for Group Purchasing Organizations (GPOs) 

has unleashed an epidemic of kickbacks

in the medical supply chain 

which has spread into pharmaceuticals 

through similar exploitation by 

Pharmacy Benefits Managers (PBMs).

HHS should further work to stop both

GPO and PBM misuse of safe harbors

by encouraging Congress to repeal 42 U.S.C. § 1320a-7b(b)(3)(C), 

a key statute that shelters harmful schemes. 

Shortages, unaffordability, and improper steering of patients 

to the most profitable product, instead

of the one that best meets patients' needs, 

are driven in part by this AKS safe harbor. 

For example,

sole-source contracts, facilitated by kickbacks, 

are an anti-competitive feature of

many GPO arrangements with hospitals and manufacturers, 

which increase the risk of shortages and push prices higher.  

For more details see 

http://jpands.org/vol23no2/singleton.pdf

-- This year the comment window is open until 

February 16 at 5pm Eastern.

my Comment Tracking Number: 1k5-9lk3-v0h4

feasting, drinking, and getting stoned in ancient #Israel #judaism

2020.12.24..25: relig/judaism/

feasting, drinking, and getting stoned in ancient Israel:

. this is my commentary on:

biblical archaeology review 2020:

https://www.biblicalarchaeology.org/daily/biblical-archaeology-review-winter-2020/

46#5; p52: Gluttony and Drunkenness in Ancient Israel

by Rebekah Welton.

my covid-19 antibody test is negative in November after feeling hit in March

 20.11.30: web,aq.med/redcross/

health/immunity/covid-19/my covid-19 antibody test is negative:

summary:

. I got a covid-19 antibody test 

from giving blood to the redcross;

and it came back negative,

but while that could mean I never got exposed,

it could also mean I had a mild case of covid-19

where my immune response made very few antibodies,

and within 8 months, I make undetectable levels.

Dr.Sinclair xenohormesis in contrast to hormesis

20.10.15: news.health/diet/

Dr.Sinclair`xenohormesis in contrast to hormesis:

Dr.Sinclair 2020:

. hormesis means the use of stressors

to activate our longevity defenses;

such as exercise, intermittent fasting, 

low protein diets, and being hot or cold:

see the paper:

"The 'Metabolic Winter' Hypothesis: 

A Cause of the Current Epidemics of 

Obesity and Cardiometabolic Disease"

METABOLIC SYNDROME AND RELATED DISORDERS 2014

which suggests that we have benefited from

a life without air conditioning.

[ that paper also clarifies 

what the author says about xenohormesis

in contrast to hormesis:

"(

. a reduction in calories by 30%–40% triggers a 

network of genes that evolved to protect organisms

during times of food scarcity (i.e., "longevity" genes). 

This "longevity survival network" includes 

insulin/insulin-like growth factor-1 (IGF-1) signaling, 

mammalian target of rapamycin (mTOR), 

AMPactivated protein kinase (AMPK), 

and the seven sirtuins (SIRT1–7), 

a family of cellular energetics and defense enzymes.44–46 

In fact, sirtuin-activating compounds (STACs),

such as resveratrol and fisetin, 

and other calorie restriction mimetics, such as metformin, 

are thought to derive the majority of their health benefits

not from antioxidant properties 

nor by inducing a cellular damage response (hormesis),

but rather from interacting with conserved regions in enzymes

that have evolved to sense molecules in the environment.47,48 

The "xenohormesis hypothesis" suggests that 

STACs act as an advance warning generated by plants

in times of stressful environmental conditions,

and that these stress-signaling molecules may coordinate

sirtuin-mediated defenses across species.49–52

)-'Metabolic Winter' Hypothesis.

]

. some supplements can be helpful by

being hormesis-mimicking; such as resveratrol, 

and more recently in the news: NAD boosters;

but metformin is controversial; most recently

it inhibits your ability to build muscle

with resistance training.

. similar to how certain stresses make us healthier,

plants under stress can make more of the 

health-promoting "Xenohormetic" nutraceuticals.

When plants are stressed with too much sunlight, 

they often add extra color with anthocyanins

and they are produced not only by radiation damage

but drought, adverse temperatures, nutrient restriction, 

pathogens, and wounding. 

. the wines at "Dry Farm Wines" (and Stressed Vines)

especially the pinot noir, have higher levels resveratrol 

because they are stressed;

[ for instance, they don't use irrigation,

and they do use organic farming

which can add fungal stresses.]

dryfarmwines test their wines:

"By law, wine is not required to have a contents label

on the bottle. This is based on a old agreement 

between the wine lobby and the US government. 

As one of the only major food groups 

without a content label, consumers are

left in the dark about what is in their wine.

Since there are 76 legal additives approved for use

in winemaking by the government,"

testing can ensure that a wine minimizes additives.

@scifri Virologist @angie_rasmussen claims CDC appears "compromised" and has lost "respect"

2020.9.4: news.pol/healthcare/covid-19/
@scifri Virologist @angie_rasmussen claims
CDC appears "compromised" and has lost "respect":

@scifri radio factchecker guest Virologist @angie_rasmussen
claims CDC appears "compromised" and has lost "respect"
after issuing #covid19 policy that seems
"politically motivated" rather than scientific:
stop testing asymptomatic people
even if they believe they've been exposed.

the radio segment is recorded here:
sciencefriday fact-check.
partial transcript:

Rabbi Adin Steinsaltz the Talmud in Hebrew

2020.8.16: news.relig/judaism/

Rabbi Adin Steinsaltz`the Talmud in Hebrew:

. after Rabbi Adin Steinsaltz passed away,

Rabbi Sam Cohon of TooJewish radio

especially recommended 2 of his many books:

the reference guide to the Steinsaltz Talmud,

[Rabbi Adin Steinsaltz 2014`Reference Guide to the Talmud

 2nd Revised Ed].

and his book about Kabbalah and Jewish mysticism:

[Rabbi Adin Steinsaltz 1980..2006`The Thirteen Petalled Rose:

A Discourse On The Essence Of Jewish Existence And Belief]

. he is best known for translating the Talmud

from Aramaic into Hebrew (Israel's language).

Steinsaltz Talmud:

. Steinsaltz Talmud is the most accessible edition available

of the Talmud, the nearly 2,000-year-old, 

central text of the Jewish people. 

Translated from the Aramaic to modern Hebrew

(with editions in English, French & Russian), 

with explanations and commentary by one of the 

great Talmud scholars of all time, Rabbi Adin Steinsaltz.

. he died in Jerusalem on 7 August 2020, 

from acute pneumonia at age 83.

the meaning of the Cain and Abel story

20.7.9: relig/judaism/the meaning of the Cain and Abel story:
. in the story of Cain and Abel
two brothers give gifts to their god;
but the god showed favoritism toward Abel's gift;
and then Cain feeling cheated by the god,
murdered his brother.
. coincidentally,
the preferred gift was that of raising meat,
rather than relying on plants which offer far less protein
and usually have anti-nutrients that require special processing.
. this story may have been a warning to
the elites who design our gods (the priestly caste)
not to create a god who causes injustices and hurt feelings:
we need a god that says our tribe is better than outsiders,
and within the tribe, each is equal to self.

#health #dental Pedram and dental Dr Elmira Shojai's $194 Gateway to Health:Healing Secrets of the Oral Biome

20.7.5: news.health/dental/
Pedram and dental Dr Elmira Shojai's $194 
Gateway to Health:Healing Secrets of the Oral Biome:
. a Dr.Mark Hyman emailing promoted
Pedram Shojai's $194 Gateway to Health:
Healing Secrets of the Oral Biome
(Pedram's wife is a dentist: Dr Elmira Shojai DDS)