The Money Snapshot: A Government Worker Shares Thoughts on Pensions, Retirement, and Rapid Income Growth

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Presenting our fifth money snapshot, this time with a government worker in the Northeast! She notes: “Our income has grown rapidly in the last several years — in 2011 we made $ 32,000 (together), in 2014 we made $ 135,000, and in 2018 we will make approximately $ 235,000. Because of the timing of my husband’s schooling, we were in a position of playing catch-up on our retirement accounts, specifically his accounts, but we look to grow our overall financial portfolio in the coming years.”

By way of background: We got a few requests from readers to launch our own “money diary” series, so we’ve asked willing readers to fill out a form with lots of details about debt, spending, saving and more! If you’d like to fill out the form and be considered for a future personal money snapshot, please click here to submit your response! You can see a PDF of the questions if you want to review them ahead of time. See others in the Personal Money Snapshot series here.

Please remember that this is is a real person who has feelings and isn’t gaining anything from this, unlike your usual friendly (soul-deadened, thick-skinned, cold-hearted, money-grubbing) blogger — so please be kind with any comments. Thank you! — Kat

Name: Clementine
Location: MCOL medium-sized city in the Northeast
Age: 33
Occupation: Government  
Income: $ 92,000
Family members: Husband, 37 (engineer with extensive work travel), and a 3-year-old who recently told me they are planning on being a dinosaur when they grow up.
Household income:
$ 235,000
Net worth: Outside of retirement accounts, our net worth is approximately $ 100,000. My husband has approximately $ 250,000 in retirement accounts plus a small pension account, while I have a defined benefit pension.
Net worth when started working: I started working at 14, used scholarships and worked through college and grad school, and graduated at 23 with approximately $ 25,000 in debt (not bad for no parental support!). My husband had been in the military and went to school utilizing the GI Bill, graduating at 30 with approximately $ 20,000 in debt. While he was in school, my career was in a holding pattern, but I was quickly able to build my career once he graduated and we relocated.
How much debt do you have? $ 5,000 in student loan debt that will be paid at the end of the year [2018], $ 35,000 car note with a low interest rate, $ 300,000 left on our mortgage. 
Living situation: Own — mortgage + taxes + insurance is $ 2,200/month.
How much do/did you spend for childcare and/or education? $ 1,000/month
Is there anything else we should know about you?
Our income has grown rapidly in the last several years — in 2011 we made $ 32,000 (together), in 2014 we made $ 135,000, and in 2018 we will make approximately $ 235,000. Because of the timing of my husband’s schooling, we were in a position of playing catch-up on our retirement accounts, specifically his accounts, but we look to grow our overall financial portfolio in the coming years.

Debt

What does your debt picture look like?
We are down to minimal student loans (subsidized only, we utilized the snowball method of paying off our highest interest loans first). We do not carry credit card debt as a habit, but do have a car note which we were able to get at a lower interest rate than the average return on our investments for the past few years. Our mortgage interest rate is also very low; however, it is psychologically important to my husband that we pay that off sooner rather than later.

We asked Clementine how she and her husband handle differing opinions on finances, such as the mortgage question: 

My husband and I are both very rational people — we joke that because we’re both Libras, we just talk and talk an issue until we reach balance. We also do a very good job of picking our battles and understanding the other person’s needs.

How much money are you spending each month to pay down debt?
We have prioritized student loan debt and have paid (on average) an additional $ 1,000/month for the last two years to eliminate it. Our next priority is paying off our car note; however, the interest rate is low enough where it made more sense to invest those dollars elsewhere and take out the loan.

How did you pay for school?
I didn’t go to my “dream school.” Instead, I took a five-year, full-tuition scholarship at a well regarded state school. I worked as an RA during college to get a free room and a monthly paycheck and worked summers and retail jobs to pay my car insurance and for my meal plan. That being said, I still walked away with $ 25,000 in student loan debt, largely owing to the few semesters I chose not to (or was unable to) RA.

Have you paid off any major debt?
We are so close to paying off our student loan debt I can taste it! I am so tempted to just take money from our emergency fund to pay it off.

Home debt: 
We have a fixed, 30-year mortgage that was a VA mortgage. We were offered the option of reducing our interest rate without paying any closing costs or extending our term and took that option, so our interest rate is 3.5%. We could have been approved for more, but were able to buy a home in our ideal neighborhood for what we felt was a reasonable monthly payment. We make biweekly payments, meaning that we make an extra principal payment annually. It is important to my husband that we pay off our mortgage ASAP; however, I acknowledge that from a financial standpoint it doesn’t make sense.

Have you ever done anything noteworthy to avoid or lessen debt?
We have worked and worked and worked some more. We replaced a 20-year-old car only when it began to have safety/reliability issues and choose experiences and time over material items.

Savings, Investments & Retirement

How much do you save for retirement?
Annually (outside of pensions), we aim for $ 35,000; however, the majority of our retirement accounts are pensions.

How much money do you allocate to other tax-savvy investments/accounts?
$ 1,200 annually (currently) to 529, $ 5,000 to our Dependent Care Advantage Account (for daycare).

How much do you save outside of retirement accounts?
That amount varies based on our ongoing expenses. We do not currently have significant automatic transfers going on; however, we do have a combination of money market accounts (minimum 24 hours to access funds but high rate of return) and linked savings accounts.

Talk to us about investments.
We have a financial planner as well as utilize index funds. We have chosen to diversify our investments at this time so as to not “put all our eggs in one basket.”

Do you have an end goal for saving or are you just saving for a rainy day?
Our financial goal is that if either one of us chooses to leave our jobs and be either a stay-at-home parent or take a major pay cut, that option is on the table.

Here’s what Clementine said when we asked her to elaborate on this goal:

I don’t think it’s likely; however, it’s our security blanket. My husband would be the better stay-at-home parent, and his job is also the job that is harder on our lifestyle (extensive and extended work travel). Ultimately though, he loves what he does and I’ve accepted that as my “price of admission.”

What’s the #1 thing you’re doing to save money, limit spending, or live frugally?
Both parents are still working rather than taking one parent out of the workforce.

When did you start saving seriously? How has your savings strategy changed over the years?
We started saving seriously in 2012, then paid for a wedding (taking out no debt but using those savings), then saved for a house (purchased in 2014), then had some income loss related to maternity leave in 2015, and really started to seriously rebuild our savings accounts in 2016.

Have you ever made a big money move or investment with savings in mind?
We moved our “orphaned” 401K accounts into an employer-subsidized deferred compensation plan, ensuring that we were actively managing all accounts.

How much do you have in cash that’s available today?
$ 18,000

How much do you have in cash that’s available in a week?
$ 50,000

How much is in your “emergency fund,” and where do you keep it?
$ 80,000 (included above), a combination of checking/savings/money market accounts. I did not include any accounts I would incur a penalty for withdrawing (e.g., retirement).

How much do you have in retirement savings?
I have a defined benefit pension plan plus $ 20,000 in an additional retirement account. My pension will pay me 60% of my three highest years of pay plus health benefits. My husband has a small pension (expected to pay approximately $ 1,000/month) plus currently $ 250,000 in retirement savings.

How much do you have in long-term investments and savings (CDs, index funds, stocks) that are not behind a retirement wall?
$ 68,000

If property values (home, car) are included in your net worth, how much are those worth?
Car is worth $ 10,000 more than is owed (included), home is worth approximately $ 100,000 more than is owed. Note that I may not have included that full amount in our net worth.

Spending 

How much do you spend on the following categories on a monthly basis?

Groceries: $ 600
Restaurants, bars, takeout, and delivery:
$ 240
Clothing and accessories: $ 200
Transportation: $ 900
Rent/living expenses: $ 4,000
Kid-related expenses:
$ 1,500
Entertainment: various
Health care — premiums and other costs: $ 150 in monthly premiums, $ 1,000 outside of that, but has varied drastically in prior years.

What’s your spending range for these things? What’s your average?

Vacations – Range: $ 20–$ 12,000
Vacations – Average:
$ 3,000

Individual items of clothing – Range: $ 20–$ 80
Individual items of clothing – Average: tops $ 30, pants $ 40, dresses $ 60

Apartment or house – Range: $ 400–$ 2,200
Apartment or house – Current main residence:
$ 2,200 monthly mortgage (house cost $ 355,000)

Car or other vehicle – Range: $ 0–$ 50,000
Car or other vehicle – Last purchase / current main vehicle: $ 50,000. It was a splurge but chosen for size and safety.

Fill in the blank on this question: I could save _____ if I stopped ______, but I don’t because _______.

We could save a drastically large sum of money if we cut out vacations and several items that are “luxury’ items” (e.g., house cleaner, organic food, etc.); however, I actively choose not to because I have known multiple people in my life who never spent, planning on having a fabulous retirement, and then died suddenly before they got to enjoy that retirement.

If you’re married: When was your wedding, how much did it cost (total), and how much did YOU pay? 
2012, $ 15,000, and we paid $ 14,000 of that.

Tell us about your wedding!
It was great! We focused on what mattered to us and had a fun but elegant party.

Have any large medical expenses for yourself or others played a role in your financial picture?
Yes. We lost a significant amount of income related to pregnancy-related complications and then had approximately $ 13,000 in out-of-pocket costs on top of that lost income.

Are there any other large expenses in your life, now or previously?
We own an older home on which all repairs seem to cost $ 8,000.

At any point in your life to date, has inheritance played a role in your money situation? 
I got $ 10,000 from a grandparent, which I used to pay for some living expenses during graduate school.  

Money Strategy

Do you have a general money strategy? 
Work hard. Make smart choices. Buy less stuff.

What are your favorite resources for personal finance?
NPR’s Marketplace

What advice would you give your younger self about personal finance?
Don’t stress so much about money.

Photo credit: icons via Stencil. 

The post The Money Snapshot: A Government Worker Shares Thoughts on Pensions, Retirement, and Rapid Income Growth appeared first on Corporette.com.

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How To Survive The Government Shutdown

Where do we currently stand on the government shutdown? 

As of today, the federal government has been partially shutdown for 31 days and counting – the longest stretch in history. While most of us know about the shutdown, not everyone understands how it is playing out for workers, for millions of Americans who rely on federal programs, and for the economy. Today I want to talk about how we got here, what to expect in the days and perhaps weeks to come if the federal government remains shutdown, as well as some options for those affected.

First, let’s talk about the basics: why did it happen, how long could it last, and who has been affected?

 This shutdown started last month when Congress and the president failed to reach an agreement to appropriate money to operate several sectors of the federal government, including everything from the departments of Urban Development, Interior, State, Agriculture, Treasury, Commerce, and Homeland Security, to national parks and the Peace Corps. The sticking point is funding President Trump requested for a border wall. Here we are a month later, and the president has said this impasse could last months.

The lack of funding is affecting millions of Americans. Roughly 380,000 federal employees have been furloughed without pay, and 420,000 people are working without receiving paychecks because they provide “essential” services. Nearly 4 million government contractors are also furloughed, and are likely to go uncompensated for the time they did not work during the shutdown. On top of this, millions of people rely on numerous federal programs could be in for pain if an agreement is not reached, and the economy is starting to show signs of damage.

 What can workers who have been affected do?

For those workers, there are a few things I would suggest. If you have not already done so, reach out to your creditors and inquire about leniency or about programs they available for situations like this. Some lenders have options specifically for furloughed workers. If they do not offer that option, ask what if anything they can do for you in the short-term that will allow you to prioritize the most important costs such as food and housing.

YOU CAN CLICK HERE FOR INFO ON RESOURCES FOR FURLOUGHED WORKERS. 

You can also visit 211.org, a website that helps connect people to local social services, like help with prescriptions or other medical issues, and childcare.

If you are not getting a paycheck, consider no-interest or low-interest loans. Some credit unions and banks are offering them to those affected. Several lenders have been working to lessen the blow in other ways, by waiving fees or postponing payment deadlines. Credit card and mortgage late charges might also be dropped. Some banks are waiving some fees for government employees who have direct-deposit set up.

Finally, if you have been furloughed, you are likely to be eligible for unemployment benefits in your state, though it varies. It is certainly worth exploring. Just remember, employees who receive unemployment benefits and also later receive a retroactive payment from their employer for the same time period, will be required to repay the ui benefits received.

Beyond the labor force, how is the shutdown playing out?

Federal programs that millions of low-income Americans depend on are already being affected. Contracts for more than 1,000 government-funded properties that house low-income renters have already expired, and over 1000 more set to do so by February. The Supplemental Nutrition Assistance Program (SNAP) will also run out of funding at the end of next month. The National School Lunch Program (NSLC), a federally funded initiative that provides more than 30 million at-need youth with nutritious meals, could be at risk if the shutdown continues. Some districts are already cutting back on fresh fruits and vegetables.

Most Americans will feel the effects on air travel, as the nation’s airport security screening system battles high absenteeism as a result of TSA workers going unpaid. Some airports have started closing terminals due to staffing issues. The federal court system is running out of money. Vacationers are missing out as many national parks and museums have been shuttered.

Disaster relief is likely be hampered, as thousands of emergency responders are missing courses in firefighting and emergency response. There were concerns that 6 million Americans expecting tax refunds would not be receiving them during the shutdown. However, the IRS has said it has called over 40,000 employees back to work without pay and it will be processing tax returns, though we can expect delays.

When it comes to the economy, the ripple effects are also starting to show. The agriculture, real estate, and energy industries are all looking years of setbacks caused by pauses in federal loans, permits and other regulatory permissions. Investors are looking at delayed deal-making approval. Retailers that depend on consumers spending – particularly in states with concentrations of federal workers like Virginia and Maryland – are certain to suffer.

Even the analysis from the President’s Council of Economic Advisers suggests that the shutdown has already weighed significantly on growth and could ultimately push the United States economy into a contraction. So, while the workings of the federal government can seem far away to some, its import to remember how important they actually are.

What about the rest of us Americans who rely on the government for services?

We have never had a shutdown last this long, so we are in unknown territory. For those affected by the lack of funding for programs for low-income Americans, the consequences of a shutdown through February could be dire. It is hard to say if states will step in, or if leaders in DC will pass smaller bills to address some of these issues piecemeal. Right now, we just have to hope we do not reach that point.

Mellody Hobson is President of Ariel Investments, a Chicago-based money management firm that serves individual investors and retirement plans through its no-load mutual funds and separate accounts. Additionally, she is a regular financial contributor and analyst for CBS News.

 


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Coalition Pressures Amazon, Microsoft, and Google to Keep Facial Recognition Surveillance Away From Government

A coalition of more than 85 activist groups sent letters to Microsoft, Amazon, and Google pressuring them not to sell their facial surveillance technology to the government.

In its letters sent Jan. 15, the coalition–which comprises groups including the American Civil Liberties Union, National Lawyers Guild chapters, and Freedom of the Press Foundation–warned the companies that a decision to supply government with the technology “threatens the safety of community members and will also undermine public trust.” That’s because facial recognition software gives the government the power to target immigrants, religious minorities, and people of color, thereby exacerbating a historical bias, according to the coalition.

“Companies can’t continue to pretend that the ‘break-then-fix’ approach works,” Nicole Ozer, technology and civil liberties director for the ACLU of California, said in a statement. ” … We are at a crossroads with face surveillance, and the choices made by these companies now will determine whether the next generation will have to fear being tracked by the government for attending a protest, going to their place of worship, or simply living their lives.”

The letter adds pressure to technology companies, whose sentiment toward selling the new technologies range from cautious to eager.

Google, at least, appears to be treading lightly. In December, the company committed not to sell its facial recognition surveillance software until the technology’s potential dangers are addressed.

That came a couple of months after several Google employees quit in protest of the company’s $ 10 billion bid for a contract with the Pentagon over cloud data center services. Ultimately, Google withdrew its bid for the project, called the Joint Enterprise Defense Infrastructure cloud, citing uncertainty that the project aligned with its principles for the use of artificial intelligence. Google bans the use of its AI software in weapons and services that violate international norms for surveillance and human rights.

Similarly, Microsoft employees also pressured executives to pull its bid for the JEDI project. At the time, however, Microsoft said it had no intentions of dropping out.

In a December blog post, Brad Smith, president of Microsoft, acknowledged the risks associated with facial recognition surveillance technology and its obligation to address those concerns internally. He also pushed for government regulation in regards to the use of the technology.

And on the other end of the spectrum, Amazon continues to sell its facial recognition software to government agencies. Last year, CEO Jeff Bezos told CNN that society would eventually take care of any bad uses of the technology.

Earlier this month, the FBI reportedly began piloting Amazon software called Rekognition to help sift through surveillance footage collected during an investigation. Amazon also reportedly met with U.S. Immigration and Customs Enforcement to discuss Rekognition.

The ACLU is particularly concerned about Amazon and its technology, as a test it conducted last year showed that Rekognition falsely matched 28 members of Congress with images in a database of people arrested by police, with members of color disproportionately being identified incorrectly.

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Government shutdown hits breweries

Associated Press

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California’s economy could suffer if the government shutdown drags into February

The partial federal government shutdown comes at a time when California's agriculture sector is already reeling from President Donald Trump's trade war with China.
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Why robocalls have gotten worse since the government shutdown

Don’t pick up that phone. Americans have been plagued with an increasing number of robocalls — and the government can’t do anything about it. Both the Federal Trade Commission (FTC) and Federal Communications Commission (FCC) are closed due to the government shutdown, which means Americans can’t file complaints on FCC or FTC websites and regulators…
Technology News & Reviews | New York Post

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Government Shutdown Forces Houston Airport to Close TSA Checkpoint

David J. Phillip

The government shutdown dealt yet another blow to airport security on Sunday, with officials at Houston’s George Bush Intercontinental Airport announcing they have been forced to close the security checkpoint in one terminal due to a shortage of TSA agents to screen passengers.

The decision comes two days after airport officials in Miami took similar precautions over the weekend, announcing that one of the smaller terminals at Miami International Airport would close early each day starting on Saturday.

In Houston, officials at the main airport serving the nation’s fourth largest city announced that “due to staffing issues associated with the partial shutdown of the federal government,” a TSA checkpoint and the ticketing counter in Terminal B closed at 3:30 p.m and would remain closed for the rest of the day. After assessing the situation, authorities said Sunday night that the terminal would remain closed at least into Monday. The officials encouraged passengers to “arrive early and give themselves extra time to check in for their flights and to clear the security checkpoints.”  

Read more at The Daily Beast.

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Longest government shutdown in history hits 22-day mark

ABC News

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The government just made applying for student aid easier

Many people who apply for college financial aid are forced to go through an audit-like process in which they must prove that the information they provided is accurate.
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Partial government shutdown timeline: From Trump’s demands to Democrats’ proposals

The partial government shutdown continues with seemingly no end in sight as President Trump and Democratic lawmakers refuse to compromise and pass a spending bill – with funding for a border wall at the crux of the fight.
FOX News

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Trump pledges not to cave on border wall as he heads to Texas amid government shutdown

As a partial government shutdown entered its 20th day, Trump showed no signs of relenting on his promise to secure more than $ 5 billion to build the barrier.
Politics

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WATCH: World News 01/02/19: Government Shutdown Enters Day 12

Manhunt still underway for Houston shooter; Toddler slips between bars at Florida zoo
ABC News: World News Tonight

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Here’s how the government shutdown affects health care

Funding for "big-ticket" health programs is already in place.
ABC News: Health

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WATCH: World News 12/31/18: New Signs of Movement in the Government Shutdown Stalemate

Thousands of Police officers on duty in and around Times Square; The video raising new questions about the treatment of migrant children in US custody
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WATCH: World News 12/29/18: No End In Sight For the Partial Government Shutdown

Suspected California cop killer had help trying to escape back to Mexico; Hollywood tallies a blockbuster year at the box office
ABC News: World News Tonight

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No end in sight for the partial government shutdown

ABC News

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Government shutdown looks set to drag on to 2019 after House and Senate adjourn until next week

The House and Senate on Thursday both adjourned until next week after pro forma sessions that lasted less than three minutes.


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Partial Government Shutdown Takes Effect Amid Dispute Over Border Wall

A partial shutdown of the U.S. government took effect at midnight on Friday after lawmakers failed to negotiate an agreement over funding for President Donald Trump’s controversial border wall. The government shutdown, the third of the year, comes as Trump has demanded $ 5 billion for construction of the wall on the border with Mexico.
RTT – Top Story

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Partial government shutdown likely to continue until after Christmas

ABC News

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Here’s who the partial government shutdown affects

More than 420,000 federal employees across numerous agencies could continue to work without receiving their paychecks, and hundreds of thousands more could be furloughed, according to Senate Democrats' projections.
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Government Shutdown Likely To Continue Through Christmas

A partial shutdown of the U.S. government is likely to continue until after Christmas, as President Donald Trump and Democratic lawmakers remain “far apart” on the issue of funding for the president’s controversial border wall. The Senate adjourned Saturday without a deal to re-open the shut down parts of the federal government.
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The Senate adjourns with little expectation of passing a deal to reopen the government soon


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Partial government shutdown likely to continue until after Christmas

Lawmakers are expected to convene Saturday on Capitol Hill, as a plan to fund the government has yet to come to fruition. This comes just a day after members of Congress and President Donald Trump failed to come to an agreement on a deal, resulting in the third government shutdown this year.


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Government shutdown begins

ABC News

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Government partially shuts down for third time in a year after Congress adjourns for the night

While negotiations continue in Congress to reach a deal to avert a partial government shutdown, there is virtually no chance a vote will happen Friday night — all but assuring there will be a government shutdown at midnight.


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Despite Government Shutdown, Homeland Security Border Patrol Remains on the Job. And Unpaid

With the shutdown in effect, the borders remain guarded and ships, planes, and trains–as well as merchandise–will still be allowed to enter and leave the U.S. under a contingency plan set by the Department of Homeland Security. Nearly 88% of its workers will be required to report to work, but will not receive a paycheck for the duration of the funding lapse.

About 53,000 TSA employees, 54,000 Customs and Border Protection agents and officers, and 42,000 Coast Guard members and staff must work without pay, according to research from the Senate Appropriation Committee’s vice chair, Democrat Patrick Leahy. Essential employees also include anyone involved in counter-terrorism efforts, intelligence gathering, or providing telecommunications support for DHS workers.

The 88% of all DHS employees who must remain on the job are part of about 420,000 federal workers also forced to perform their duties at agencies for whom no budget or stopgap measure has been approved. Some may receive payment if funds remain in certain accounts or their positions or work are funded by agencies unaffected by the partial shutdown. The other 12% of DHS workers, and 380,000 employees across government, will be furloughed–and also not paid for the duration.

DHS and other federal workers required to report to their jobs will receive back pay when a funding measure finally gets approved. Furloughed workers will almost certainly also receive pay for the period they were not working, as has happened routinely following previous shutdowns, such as a brief one in January 2018.

Federal agencies generally cannot spend money ahead of appropriations, requiring this suspension of non-essential operations and all pay. But workers who fit certain exemptions have to report to work during government shutdowns. The DHS noted in a contingency plan prepared for the shutdown, “An employee who refuses to report for work after being ordered to do so will be considered to be in an absence without leave status and may be subject to administrative or disciplinary action for not reporting for work.”

In that plan, updated Dec. 17, DHS spelled out the many exemptions that apply to its employees. That includes members of the active military, those engaged in foreign relations essential to national security, and most significantly, workers who are “necessary for the safety of human life or protection of property.” That sweeps in most DHS employees outside of those involved in planning, research, auditing, training, and areas related to regulatory and public policy work.

Fortune

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McConnell Introduces Short-Term Government Spending Bill

With a partial government shutdown looming, Senate Majority Leader Mitch McConnell, R-Ken., has introduced another short-term government spending bill. McConnell said the continuing resolution introduced on Wednesday would “provide the resources necessary to continue normal operations through February 8th.”
RTT – Political News

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Don’t trust the government to make Big Tech behave

The social-media wars are heating up. Congress has grilled Google’s CEO, and the British Parliament wants to hear from Facebook’s Mark Zuckerberg. Across the political spectrum, there are calls for the government to do something about Big Tech’s seemingly unaccountable power. Since we live our lives increasingly on social media, it’s understandable. But it’s a…
Opinion | New York Post

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Congress Passes Stopgap Spending Bill To Avert Government Shutdown

With a potential government shutdown looming, members of Congress voted Thursday to approve a short-term spending bill amid an ongoing disagreement over funding for President Donald Trump’s proposed border wall. The two-week spending bill extends funding for several government agencies.
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Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is “streamlining our processes.” The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $ 147,308 in 2017 compared with $ 30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $ 5.4 billion in sales and $ 184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $ 10 billion drugs, even though they are for rare diseases.”

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News

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Amazon Web Services Just Opened a New Cloud for the U.S. Government

Amazon Web Services has opened a new region of interconnected data centers specifically for the U.S. government and its various contractors.

Amazon’s cloud computing arm said Monday that its so-called GovCloud region is now operating live in an unspecified area on the East Coast. The new government cloud region comes seven years after Amazon’s first West Coast government cloud region debuted in 2011.

Unlike traditional data centers, cloud computing and big Internet companies like Microsoft and Facebook typically operate clusters of interconnected data centers that essentially act as one big facility.

Teresa Carlson, AWS vice president of the worldwide public sector, said that one of the reasons the company built a new government cloud was to let government agencies and their third-party contractors maintain duplicate copies of their data and apps. In the case that a problem occurs in one facility, the other data center facility can pick up the slack.

Having a second data center region will also reduce the latency, or delays, that might occur when East Coast federal agencies have to use Amazon’s cloud services from the West Coast, Carlson explained. She declined to say where the facilities are physically located, citing security reasons.

Amazon’s opening of a new government cloud highlights the efforts of big tech companies to score big federal contracts as the government attempts to modernize to newer IT technologies. For instance, Amazon built the CIA its own separate cloud data center region, and is in the process of bidding against companies like Oracle and Microsoft for a $ 10 billion Joint Enterprise Defense Infrastructure (JEDI) cloud contract with the Pentagon.

Carlson said that the new government cloud data center region is separate from Amazon’s bidding on the JEDI contract.

Some of Amazon’s competitors in selling on-demand computing resources to the federal government include Microsoft, IBM, and Google, said Adelaide O’Brien, International Data Corporation’s research director of government digital transformation strategies.

Although Amazon’s government cloud business is likely to be much smaller compared to its enterprise cloud business, Carlson said Amazon is building more government data center facilities to keep up with demand. She said the government cloud business has a compound annual growth rate of 185%, but declined to say from what number.

When Carlson first began pitching Amazon Web Services back in 2010 and 2011, she said that federal employees were unfamiliar with the online retail giant’s information technology business.

“Oh, you want to talk about books?” Carlson said federal workers would ask her.

No so anymore. “There is not anyone out there today that does not know what cloud computing is,” Carlson said in regards to how the service has become more mainstream with businesses and government agencies.

Carlson also echoed recent comments made by Amazon CEO Jeff Bezos, who said that Amazon and his Blue Origin rocket company would continue pursuing Pentagon contracts, regardless if it upsets employees or critics who don’t want the tech giant to supply the U.S. military with war-fighting or surveillance technologies.

“They got to make sure that when they commit to you, you commit to them,” Carlson said of supplying the U.S. military with unspecified technologies.

As for the idea that the government should potentially regulate the use of artificial intelligence technologies, because the technologies could lead to unforeseen consequences, Carlson believes that too much regulation could stifle the tech industry from innovating. It’s a contrast to Microsoft President Brad Smith, who has urged the government to regulate the use of facial-recognition technology and that both the public and private sector should develop standards around how to use the tech.

Amazon executives have previously said that the government should specify the regulation’s guidelines, and that the company would follow.

“I would say any time you’re trying to regulate something, we really push back on that,” Carlson said. “Because history has taught us that any time you try to regulate, you just might as well stomp it out, because it kind of stagnates everything.”

Fortune

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GOP Gubernatorial Candidate John Cox: Limit Government In Health Care

John Cox stood on a presidential debate stage and told the audience that he was glad abortion wasn’t legal in 1955.

If it had been, he said, he wouldn’t have been born.

“I wouldn’t be standing here before you today. This is personal to me,” Cox said in the 2007 GOP presidential primary debate, explaining that his biological father walked out on his mother.

“My mother took responsibility for me,” he said. “She’s glad she did, and I’m glad she did.”

Cox, California’s Republican candidate for governor, frequently invoked his anti-abortion views during his unsuccessful political bids for Congress and president. He unapologetically framed himself as the anti-abortion candidate – a Christian who believes in the right to life, and whose “absolute opposition to abortion on demand” was born from his mother’s circumstances.

Cox has been less vocal about his abortion views in blue-state California, where Republicans, Democrats and independents overwhelmingly favor a woman’s right to choose. But his argument that it is an issue of personal responsibility provides a window into Cox’s thinking when it comes to health care overall: He contends that free markets, combined with people taking responsibility for their actions, ought to guide health care policy — and that government should mostly stay out of it.

His views on health care contrast starkly with those of the Democratic gubernatorial nominee, Lt. Gov. Gavin Newsom, who calls for health care coverage for all Californians, and supports the creation of a single-payer, government-run health care system financed by taxpayers. In the latest Public Policy Institute of California poll released in late September, Cox trailed Newsom by 12 percentage points among California’s likely voters, with 7 percent undecided.

As a candidate for governor, Cox has not released detailed health care positions. Nor would he agree to an interview with California Healthline to explain his views or allow those closest to him to comment.

On Monday, with less than a month before the election, Cox issued a statement following a live gubernatorial debate saying that he supports affordable health care for everyone, including those with preexisting conditions. He again failed to provide any specifics.

A review of his statements, old and current campaign websites, and interviews with previous campaign aides portrays a successful businessman who believes in limiting government in health care and in general — a political philosophy inspired by Jack Kemp’s focus on free enterprise, fiscal conservatism and family values during the 1988 presidential campaign.

Cox, who grew up in a Chicago suburb he describes as lower-middle class, became a successful tax attorney, investor and developer before getting involved in Illinois Republican politics. He didn’t do as well in that arena: He ran unsuccessfully for Congress — the House in 2000 and the Senate in 2002 — and for Cook County Recorder of Deeds in 2004 and president in 2008.

“John is a principled guy. He didn’t come from much and he did very well,” said Nicholas Tyszka, who was Cox’s campaign manager in his U.S. Senate bid. “He’s certainly more of a limited-government guy who believes if you give people an opportunity to do good things, they will.”

Cox, 63, settled in California permanently in 2011, and now lives in the affluent San Diego suburb of Rancho Santa Fe.

He has spent much of his campaign lamenting California’s high cost of living, along with the recent gas tax increase that he is encouraging voters to repeal in November.

Cox’s mindset of limited government, combined with his conviction of personal responsibility, feeds his argument that competition is the answer to rising health care costs, high prescription drug prices and nurse shortages.

“I’ve heard him say many times health care should be run more by the free markets and the federal government should have less involvement,” said Phil Collins, a Republican county treasurer candidate in Nevada who worked on two of Cox’s campaigns in Illinois.

In Monday’s statement, Cox complained that “our current system was designed by political insiders and health care corporate lobbyists to protect their monopoly profits, not to provide decent health care at a reasonable price.”

Cox said previously that, if elected governor, he isn’t interested in defending the Affordable Care Act, and that if Congress and the Trump administration were to repeal the law, the millions of Californians who now have coverage could go into high-risk insurance pools. That could increase the ranks of the uninsured.

In the hour-long debate Monday hosted by KQED, a San Francisco National Public Radio affiliate, Newsom challenged Cox’s desire to repeal the ACA and criticized his abortion views when asked how the confirmation of Brett Kavanaugh to the U.S. Supreme Court could affect California.

“It could have a profound impact on Californians, on their reproductive rights, which you believe a woman does not have a right to choose, regardless whether or not they are raped or a tragic incident of incest,” Newsom said.

Cox, who has dodged questions about his views on abortion during the gubernatorial campaign, did so again during the debate, saying only that he would appoint justices in California who will respect the U.S. and state constitutions.

“The things I’ve seen him say are very much aligned with what we hear coming out of the Trump administration and the Republican leadership of Congress,” said Dr. Andy Bindman, a primary care doctor at Zuckerberg San Francisco General Hospital and professor at the Philip R. Lee Institute for Health Policy Studies at the University of California-San Francisco who helped draft the Affordable Care Act.

When the state legislature this year considered bills that would have opened Medi-Cal, California’s Medicaid program, to unauthorized immigrants between ages 19 and 25, as well as those 65 and older, Cox went on national television to call the Democratic plans a “freebie” and told Fox News that “our government has been grabbed by a bunch of people who believe that government is the most important thing.” The bills died in the legislature.

Cox has also criticized Newsom for advocating both a single-payer system, which he says would destroy California’s economy, and health coverage for unauthorized immigrants.

“Gavin Newsom wants to make problems even worse, by increasing the costs of health care of Californians and then rewarding those who cut in line,” Cox said in an August news release. “If we want to see how Newsom’s government health care would work, just look at the DMV.”

If elected governor, Cox said in his post-debate statement, he “will break up the health care corporate monopolies, make insurance companies compete and turn patients into consumers with power over their health care dollars.”

He declined to provide any details in response to questions submitted to his campaign.

Bindman said Cox is taking a page out of the national Republican playbook — bash the Affordable Care Act without offering solutions.

“John Cox is not talking a lot about health care other than saying what he’s against because he doesn’t have any viable alternatives that ensure people retain coverage,” Bindman said.

But over the years, Cox has made suggestions that display his confidence in free markets to solve problems. What exists now, he argued in his 2006 book, “Politic$ , Inc.,” is an “illogical system” where insurance companies and government have taken over individual patient care.

The solution, Cox argued both in his book and on his website as a presidential candidate, would be to end the federal tax deduction for employee health insurance, opening the door to more competition and lower prices. Like auto insurance, consumers ought to be able to choose their own health insurance plans in a free market, he said.

The poor could benefit from a limited government voucher program, he proposed, one with incentives to save money and get preventive care, as well as health savings accounts that encourage consumers to find care at the most reasonable cost.

“Wealthier people may well have better choices, but that should be one of the awards for upward mobility,” he wrote.


This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Kaiser Health News

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