What to Know

Why the high drug prices? So shareholders can make more, obviously

The idea that high drug prices (in the U.S. anyway) are needed to fund the pharma companies’ research and development has been debunked before, but here’s another bit of proof: They spend more paying dividends and buying back their own stock than they do on R&D.

But it’s easy to verify that “high prices = innovation” argument. Just look at the numbers. And some researchers did just that. Turns out the real reason for high U.S. drug prices is something else:

In the name of “maximizing shareholder value” (MSV), pharmaceutical companies allocate the profits generated from high drug prices to massive repurchases, or buybacks, of their own corporate stock for the sole purpose of giving manipulative boosts to their stock prices.

Or, as Stat News put it:

From 2006 through 2015, the 18 drug makers in the Standard & Poor’s 500 index spent $516 billion on buybacks and dividends, outpacing the $465 billion spent on R&D.

The big 50

Drug Store News has released its annual profile of the top 50 pharmacy chains in the country, which account for 80 percent of retail pharmacy sales. No real surprises, but the 50 individual profiles are interesting reading.

Who’s paying? Third-party insurance pays for just over half of prescriptions (51.3%), while Medicare (26.9%) and Medicaid (14.1%) make up the bulk of the rest — which is why pharmacists are keeping an eye on the Obamacare-replacement process. Cash payments account for 7.7% of sales.

Interested in running for national office?

APhA is soliciting candidates for its 2018 Board of Trustees, Academy of Pharmacy Practice and Management, and Academy of Pharmaceutical Research and Science.

Get more info at pharmacist.com/elections.

Canada considering suing Purdue Pharma

Heck, with all the U.S. cities and states (and the Cherokee Nation) suing opioid makers, our friends to the north might join in as well. Let’s be honest: Being sued by Canada is like being sued by Mr. Rogers. It just doesn’t look good.

CBO scores ‘repeal only’ option

Per the Congressional Budget Office: If the ACA is repealed without a replacement, 17 million Americans would lose coverage almost immediately (in 2018), and 10 million more would lose it within three years. Premiums for individual policies would go up 50 percent in two years and would double within a decade.

—Andrew Kantor • Jul. 20, 2017

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Why some asthma treatments don’t work

Severe asthma isn’t just more severe — there’s a different immune response. And that means corticosteroids won’t work for those patients — we’re talking about 10 percent of asthma sufferers.

So says a study from the University of Pittsburgh School of Medicine.

Here comes the science:

Researchers observed that the immune cells, called CD4 T-cells, in the airways of severe asthmatics secreted different inflammatory proteins than those in mild disease, particularly interferon gamma. (Emphasis ours.)

A tomato a day…

keeps the skin cancer away. (Maybe.)

The thing to remember about the whole opioid epidemic

Is that — unlike a lot of recreational drugs — most of the people who become hooked on painkillers don’t start taking the drugs for fun. They get injured, get meds, and then end up chasing that dragon.

When Matt was little, [his mother] Kelly was a Head Start caseworker who patiently taught parents how to manage their autistic children. She loved hosting potlucks with friends and playing Barbie with Matt’s sister, Brianna. There was always music: Tchaikovsky when Kelly was at the piano, or Jimmy Buffett blasting through the speakers while she cooked. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”

Then Kelly had neck surgery and got addicted to OxyContin. By 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, letting the fridge go empty and the house lapse into a den of cigarette butts and dirty dishes. “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”

From “Children of the Opioid Epidemic Are Flooding Foster Homes. America Is Turning a Blind Eye.”

Hudgens says no to 2018 run

Georgia Insurance Commissioner Ralph Hudgens has said he won’t run for re-election in 2018.

Cindy Zeldin, the executive director of Georgians for a Healthy Future, is the first person to announce she will seek the office.

Shocker: “Expired” drugs probably still work

Not that you would ever tell your patients this, but just because a drug is “expired” doesn’t mean it doesn’t work. The expiration date is simply the date the manufacturer can guarantee its effectiveness.

You might think that the drug becomes less effective after that. Not necessarily. Drug makers only check whether a drug is good till that date — they don’t check to see how long it’s actually good for.

In fact, the federal government, which maintains stockpiles of drugs in case of emergency, doesn’t toss them after they “expire.” Instead, they test the drugs to make sure they still work.

Why is this a big deal? Well, imagine you’re in a country that’s spending billions and billions on healthcare and are looking for ways to cut costs….

Don’t forget the demand side

China to drug makers: We have 1.4 billion customers. We’d like a discount.

Drug makers: How’s, oh, 44 to 70 percent sound?

China: That works.

Medication errors are affecting a lot more people

But this time it’s because of mistakes they make at home — the wrong meds, the wrong dose, or taking something twice by mistake.

That’s the finding from a 13-year study of calls to poison control centers.

The most common medications involved were cardiovascular drugs such as beta blockers, calcium antagonists and clonidine; pain medications, including opioids and acetaminophen; and hormonal medications, including insulin.

What can help? A system for preventing multiple caregivers (e.g., parents) from accidentally doubling up. And a conversation with a pharmacist (that’s you!) about when and how to take them.

Haystacks amongst the needles*

More opioid users turn to heroin. So what happens to all those needles they use? “They hide in weeds along hiking trails and in playground grass. They wash into rivers and float downstream to land on beaches. They pepper baseball dugouts, sidewalks and streets.”

*You’re right. That headline makes no sense.

Only 36% of kids got epinephrine when they needed it

A study from the American College of Allergy, Asthma and Immunology (published in the Annals of Allergy, Asthma and Immunology) found that barely more than a third of kids going into anaphylactic shock received epinephrine before they got to the ER.

“We found kids who had a reaction at home were less likely to receive epinephrine than kids who had a reaction at school,” says allergist Melissa Robinson, DO, ACAAI member and lead author of the study. “Treatment with epinephrine is often delayed or avoided by parents and caregivers. And sometimes antihistamines are used even though they are not an appropriate treatment.”

—Andrew Kantor • Jul. 19, 2017

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Hey Augusta, chill!

Augusta was ranked the 9th most-stressed city in the country by WalletHub (which does these kinds of rankings). It’s based on 30 figures including work stress (average work hours, unemployment, etc.), financial stress (income, debt, etc.), family stress (divorce rate, etc.), and health stress.

Of the other 149 cities in the study, Columbus ranked #34 and Atlanta ranked #74 — right in the middle. Newark and Detroit were at the top (or bottom, I suppose), while if you want to relax head to Fremont, Calif., or Plano, Tex.

More about that 340B reimbursement proposal

Yesterday we told you how Medicare is considering cutting hospitals’ 340B reimbursements from six percent above the average price to 22.5 percent below it.

Hospitals that treat lower-income people and those without insurance — many in rural areas — are naturally up in arms.

But Adam Fein at Drug Channels explains the logic, and how it’s not as shocking as it sounds.

According to the Medicare Payment Advisory Commission, 340B hospitals get a minimum discount of 22.5 percent on drug prices. Thus, CMS is saying that its new payment scheme would at worst have hospitals break even on drugs. (Fein thinks most pay even less than that.)

Bottom line: 340B hospitals wouldn’t be losing money on these drugs, but they’ll no longer be making money on them.

Further — according to Fein — because Medicare Part B patients’ co-pay is based on what Medicare pays the hospital, the new reimbursement plan would mean lower out-of-pocket costs for them.

Oh, and of note: This would only affect hospitals, not outside contract pharmacies.

Just in case, though, because this involves both money and politics, here’s your grain of salt:

Reminder about naloxone without a prescription

Even though Dr. Brenda Fitzgerald has left her post in Georgia to head the CMS, her standing order allowing pharmacists to dispense naloxone without a prescription is still in effect. Be sure to have a copy of that order on hand.

Don’t leave the “dispose” out of “disposable”

We can’t not point out this story, in case you missed it: Ophthalmologists doing a routine cataract surgery found a lump of 27 contact lenses in the woman’s eye, the result of wearing disposable contacts for 35 years.

(No, they were not all stacked up over her cornea. They had moved up, under the eyelid. But still.)

“She said she had felt an uncomfortable and gritty eye, ‘like something was inside,’ but she didn’t think it was anything to worry about.”

Community pharmacists, can you give NCPA a hand?

It’s doing its annual Community Pharmacy Impact Census — gathering info to use with legislators, regulators, the media, and patients. Click here to take it, so your data are included.

And don’t forget that NCPA’s annual convention is in Orlando on October 14 – 18. Early-bird registration ($15 discount!) ends July 31.

Salt on the wound

Merck sued Gilead for patent infringement. Merck won $200 million in 2016. But then it turned out that Merck’s former attorney… well, let’s just say he didn’t exactly uphold the standard of ethics expected of a lawyer. The verdict was overturned because of his “unclean hands”:

“Merck’s numerous unconscionable acts, including lying, unethical business conduct, and litigation misconduct, the doctrine of unclean hands barred Merck from asserting the patents against Gilead.”

And now Merck finds it not only lost the suit (after winning it), but it must also pay Gilead’s $14 million in attorney fees.

Elsewhere

20 million sterile male mosquitoes are about to be released in Fresno as part of an eradication scheme. The bugs are sterilized with a bacterium so they can outcompete the existing males and reduce the number of offspring.

Missouri’s governor has had enough. He issued an executive order establishing a prescription drug monitoring program after the state’s legislature couldn’t do it. Missouri is — um, was, the only state without one.

—Andrew Kantor • Jul. 18, 2017

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Pharmacists to be included in opioid REMS: FDA

The FDA is going to require drug makers to have a Risk Evaluation and Mitigation Strategy (REMS) for all opioids, not just extended-release versions. That will include mandatory training for physicians, nurses, and pharmacists.

A REMS is “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

In the case of opioids, the REMS includes additional education. The FDA will be requiring that for both extended- and immediate-release opioids — and for drug manufacturers to pay for it. In May, the agency released a suggested blueprint for that education (and invited industry comment). Check it out — it’s a 10-page PDF.

Recent grads: We can save you a pile of money

We’re gonna skip the marketing jargon here.

If you’re a GPhA member and have a student loan, we can save you a lot of money.

GPhA partners with SoFi, which offers student-loan consolidation. GPhA members get a lower rate than SoFi’s standard.

Here’s the news: From now till September 30, GPhA members who refinance with SoFi get a quarter-percent lower rate below SoFi’s rates.

Here’s the math:

  • SoFi’s refinance rates start at 3.35% (fixed, assuming you have a job and good credit).
  • If you have $100,000 in loans at 6%, you’d pay about $1,110 per month over a 10-year loan.
  • If you have $100,000 at 3.35%, though, you’d pay $981 a month. That’s $129 a month difference — or $15,480 over the loan.

And let’s be real — chances are, if you’re a new PharmD, you owe a bit more than that. (The average 2016 PharmD grad owed $157,425!)

SoFi’s stats show pharmacists save an average of $408 a month over 10 years when they refinance, and that’s without the extra GPhA discount.

Take the two minutes to see what your SoFi rate would be if you refinance. Then the math is easy. (Click here for a loan calculator.

CMS to slash 340B drug payments

Currently, hospitals that treat a large number of lower-income people get deep drug discounts through the 340B program. Medicare reimburses those hospitals the average sales prices for the drugs, plus six percent.

A new proposal from the agency, though, would change that “plus 6%” to “minus 22.5%.”

The idea is to cut Medicare costs, but critics point out that the cost-cutting is going to be borne by hospitals that treat the poor, notably in rural areas.

Vitamin D vs. sunburn

Higher levels of vitamin D might protect from and repair sunburn, according to a study published in the Journal of Investigative Dermatology. (Admit it, that’s a cool title for a journal.)

Participants who consumed the highest doses of vitamin D had long-lasting benefits — including less skin inflammation 48 hours after the burn. Participants with the highest blood levels of vitamin D also had less skin redness and a jump in gene activity related to skin barrier repair.

Downside: The doses involved were up to 200,000 IU — way above the recommended dose of 400 IU per day.

If you want great healthcare, go to Austria

The U.S. once again ranks last among modern Western nations when it comes to healthcare — we spend more and get less than anyone else.

The U.K. ranked first overall, but — despite some major gains lately — it still lags in “Health Care Outcomes”; only the U.S. is worse. (Austria ranks number two overall, and has the best outcomes.)

Where we’re good: preventative measures, and “wellness counseling […] shared decision-making with primary care and specialist providers, chronic disease management, and end-of-life discussions.”

Where we’re bad: access (we knew that already), affordability (ditto), “administrative efficiency” (no shock), and of course outcomes, especially for the money we spend.

Junkyard DNA

A new study from the University of Houston suggests that only 15 to 25 percent of our genome might actually do anything useful. The rest is junk DNA.

The idea is simple: Considering the typical number of mutations, if more of our genome was critical we would see a lot more children born with life-threatening genetic defects.

“If 80 percent of the genome were functional, unrealistically high birth rates would be required to sustain the population,” but if only 25 percent is functional, because most deleterious mutations are in that (useless) 75 percent.

The rainbow connection

Here’s your guide to the colors of your phlegm — and what it means. (Bonus: It also covers textures!)

 

—Andrew Kantor • Jul. 17, 2017

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First gene therapy poised for U.S. approval

The Novartis CAR-T cancer therapy — aka CTL019 — was unanimously approved by an FDA panel. What makes CAR-T interesting? It’s the first cancer therapy that’s custom made for each user, reprogramming his or her immune cells to fight a particular type of leukemia.

To use the technique, a separate treatment must be created for each patient — their cells removed at an approved medical center, frozen, shipped to a Novartis plant for thawing and processing, frozen again and shipped back to the treatment center.

Science-fiction authors, take note

CRISPR can potentially cure diseases and bring woolly mammoths back from extinction, but more importantly — it’s been used to store a movie in a bacteria’s genes. Science!

Brits worry about pharmaceutical ‘chaos’

If you thought the pharma bureaucracy here was bad, imagine what they’re looking at in Britain post-Brexit. The word “chaos” keeps popping up.

It probably depends what else they’re saying

If the voices in your head are saying you don’t need meds, [it ]mightbe OK to listen to them.

[T]here are now “hearing voices” support groups on all five continents, and over 180 in the U.K., alone, anchored by the Hearing Voices Network. The idea has been slower to take hold in the U.S., which has a strong medical model for treating mental illness, but is gaining steam there, too.

Dogs and cats, living together

The Senate is considering the nuclear option to craft an Obamacare replacement: bipartisanship.

—Andrew Kantor • Jul. 14, 2017

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Chapman supports Fitzgerald; Fitzgerald supports pharmacy

GPhA President Liza Chapman told APhA how newly-minted CDC director Brenda Fitzgerald supported pharmacy in her role with the state’s Department of Public Health:

“Under the direction and leadership of Dr. Fitzgerald, the profession of pharmacy in the state of Georgia has advanced in providing immunization services and opioid overdose prevention measures to the citizens of the state.”

USC study: Drinking coffee could make you immortal

Yet Another Study — this one out of USC’s Keck School of Medicine — has found that “People who consumed a cup of coffee a day were 12 percent less likely to die compared to those who didn’t drink coffee.” Two or three cups raised that to 18 percent.

While that sounds like drinking coffee can make you immortal, sadly… no. Rather, the huge study (185,855 people) found that “drinking coffee is associated with reduced risk of several types of cancer, diabetes, liver disease, Parkinson’s disease, Type 2 diabetes and other chronic diseases.”

Rural Georgia and Medicaid cuts

Georgia is the focus of this story on the impact of the proposed Medicaid cuts on rural areas. “Cuts now would cripple rural Georgia,” said Dr. Ben Spitalnick, president of the Georgia chapter of the American Academy of Pediatrics.

Key among those concerns are prenatal care in rural areas. With a maternal mortality rate that is among the worst in the country, OB-GYNs are worried that the cuts would eliminate fragile solutions to doctor shortages that the state has implemented.

Congrats to Mandy Reece

…vice chair and associate professor of pharmacy practice at PCOM’s Georgia Campus — she was just selected as a Fellow of the American Association of Diabetes Educators for “outstanding contributions to diabetes education through clinical practice, research, education or health policy.”

Medical debt? Credit-reporting change gives you a chance to catch up

More than half of Americans’ debt is related to medical expenses, and now a change to credit reporting will give them (that is, us) a better chance to settle that debt before it hurts their (that is, our) credit ratings.

Starting Sept. 15, the three major credit reporting agencies — Experian, Equifax and TransUnion — will set a 180-day waiting period before including medical debt on a consumer’s credit report. The six-month period is intended to ensure there’s enough time to resolve disputes with insurers and delays in payment.

—Andrew Kantor • Jul. 12, 2017

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Keith Richards is following this story

Here comes “snortable chocolate” — yes, it’s exactly what you think (assuming you think it’s a chocolate powder you sniff like snuff that’s marketed as a stimulant). And here comes the first legislator to say that the FDA really needs to get involved.

This is the Brenda Fitzgerald item

Congrats to Georgia’s Dr. Brenda Fitzgerald, officially named to head the CDC (as if you didn’t know by now). You know her, of course, as the head of the Department of Public Health. She’s got a combination of medical chops, Republican connections, and a reputation as a moderate.

“Dr. Fitzgerald is more than prepared to face the health challenges of our time, including climate change, Zika, Ebola, and our growing burden of chronic disease,” said Dr. Georges Benjamin, executive director of the American Public Health Association.

H2 beats PPI

If you’re looking to treat stomach acid, H2 blockers look to be a better choice than proton-pump inhibitors. Why? A study of 275,00 people found that PPIs lead to an increased risk of death.

“No matter how we sliced and diced the data from this large data set, we saw the same thing: There’s an increased risk of death among PPI users.”

Snerxkdle bophaizyq

A shocking study finds that handwritten prescriptions — notably for opioids — have more errors than electronic ones.

“Overall, the investigators found that 92 percent of handwritten prescriptions either failed to meet ideal practice standards, contained such errors as the absence of at least two patient identifiers, or failed to comply with federal opioid prescription rules.”

Could be worse, though. Could be a Russian prescription:

And you thought walruses were rare

CDC: When you cook walrus, please make sure it’s well done.

Here’s your 10-second ACA update

The potential overhaul/replacement of the ACA is still up in the air. The Senate is back from its July recess no closer to an agreement — and it only has a few weeks before its August recess.

—Andrew Kantor • Jul. 10, 2017

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What oughta be a law? Tell us

Each year we ask GPhA members for their ideas on laws that need to be enacted or changed. And those member ideas get turned into results.

  • Fighting (and beating) PBM abuses? That was a member idea.
  • Clarifying “direct supervision”? That was a member idea.
  • Immunizations without a prescription? Member idea.

    You get the picture.

We’re about to look at the issues we’ll be working on in the 2018 legislative session.

If there’s a law or policy issue you want to see changed — something that will improve patient care or the practice of pharmacy — tell us about it!

E-mail a brief explanation of the issue to our VP of public policy, Greg Reybold, at greybold@gpha.org. Yes, it’s that simple.

Deadline: Thursday, July 27 by 5:00 p.m.

Greg compiles all your ideas. The best ones — chosen by our legislative policy committee and board of directors — will become part of our 2018 legislative agenda.

GPhA is your association. Our legislative agenda needs to reflect your idea and your needs. We want your opinion heard. So get e-mailing!

Remember when those pills killed four Georgians?

Here’s the story of how Georgia and other states are trying to keep up with all the new opioids appearing on the streets.

At the Georgia Bureau of Investigation’s forensic lab outside Macon, [lab director Brian] Hargett assigned the tablets to one of his forensic chemists. She threw on her gown and gloves, weighed a pill, and dropped it in a skinny vial to soak in ethanol. Then she ran a test designed to separate and identify each substance in the pill. Two synthetic opioids showed up — including one never before seen in Georgia.

Their best guess: the little-known, and lethal, compound known as cyclopropyl.

Speaking of deadly street drugs…

The Georgia Board of Pharmacy passed an emergency rule regulating a new kind of synthetic opioid — tetrahydrofuran fentanyl — as a Schedule 1 substance. This is the kind that is quickly absorbed through the skin and is resistant to naloxone, too.

Kudos to the BoP for giving police the authority to seize it.

Don’t wait to eat that chocolate

It can improve your cognitive function within hours.

Elsewhere

Oklahoma is the latest state to join the Sue the Opioid Manufacturers Club™.

In New Hampshire, opioid manufacturers argued (and won) that the state couldn’t hire outside contractors to sift through paperwork to look for deceptive marketing practices. But the state’s supreme court just overturned that ruling, saying the pharma companies have no say in the state’s contracts with contractors.

—Andrew Kantor • Jul. 05, 2017

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Opioids in Augusta

The Augusta Chronicle has a weekend op-ed: The opioid crisis/epidemic is hitting home.

Georgia’s Brenda Fitzgerald could head the CDC

Trump is expected to assign her to the post soon; it doesn’t require confirmation. She’s headed Georgia’s Department of Public Health since 2011.

Tick season, 2017

Back in 2014, trees decided to produce more acorns and other seeds the next year. (It’s something trees do called “masting,” and scientists aren’t sure what makes the trees choose one year over another*.) In 2015 they did, leading to a booming rodent population in 2016.

Those rodents had babies, which were ripe for spreading all sorts of wonderful tick-borne illnesses — in 2017.

So 2017 is going to be one of the worst years for ticks in recent memory. That means you and your patients need to be on the lookout for tick bites and signs of Lyme disease and West Nile Virus.

You know the drill: DEET is the best repellent you can get, and treating clothes with permethrin is even better. Tell your patients and customers not to mess with natural remedies, random essential oils, or Aunt Martha’s proven repellent. This isn’t the year to take chances.

*This is what you learn reading the awesome The Hidden Life of Trees

—Andrew Kantor • Jul. 03, 2017

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Medicaid switchover to CareSource this weekend

On July 1 — that’s Saturday — more than 200,000 Georgians on Medicaid are switching to CareSource as their Medicaid provider.

Governor names Board of Pharmacy appointees

Congratulations to Mike Faulk  and Bill Prather, both of whom were reappointed today to the Board of Pharmacy by Governor Deal. They do terrific work for the board and for the profession (and that’s one reason GPhA members at our annual membership meeting voted unanimously to support their reappointment). We’re looking forward to working with them both.

Here comes Immunize Georgia

Check it out: The 2017 Immunize Georgia Conference is offering 6.25 pharmacy credit hours in a single day. It’s in Columbus, Ga., on September 15.

You can get more info at immunizegeorgia.com, but take note: They aren’t accepting on-site registrations this year. You’ve got to register in advance.

What’s on the agenda, you ask. Click here to check out a draft of the program (one-page PDF).

FDA looks to speed approval of generics

A simple solution: the Drug Competition Action Plan, which will speed the approval process for generics where the patent has expired on the branded drug, but there is yet no competition. “The FDA will expedite the review of generic drug applications until there are three approved generics for a given drug product.”

It’s part of FDA commish Scott Gottlieb’s plan to use the agency’s power to help lower drug prices, even if it can’t directly affect them.

J&J wanted us to clarify this….

A few days ago we told you about “free diabetes CPE from Johnson & Johnson.” The company wants to be clear — it’s actually the American Association of Diabetes Educators that developed the course and is offering the program. The Johnson & Johnson Institute simply provided an educational grant so you don’t have to pay for it.

Click here for more info, and grab some no-cost CPE.

Awaiting the flying pigs

The Senate’s health committee is suspending its investigation into the high cost of prescription drugs until there is “more of a bipartisan attitude.”

ACA replacement news

The Congressional Budget Office estimates that the GOP’s Senate bill to replace the Affordable Care Act would cut Medicaid by 35 percent over the next 20 years. This contradicts Trump’s promise not to cut the program, and it adds complication to the Republican’s efforts to craft a compromise between the party’s conservative and moderate factions.

The Valdosta Daily Times reports “Health bill cuts could hit South Georgia hard.” Specifically,

The AHCA would cut $4 billion in Medicaid funding to Georgia during 10 years, according to a policy paper by the Georgia Budget and Policy Institute, an Atlanta-based nonprofit group. Georgia’s southeast region, including Lowndes County, would lose $125 million, the paper claims.

“South Georgia would be hit hard because of a higher reliance on Medicaid,” said Laura Harker, a GBPI policy analyst.

—Andrew Kantor • Jun. 30, 2017

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