FDA Finds the Right Note in Mobile Medical Apps

I’ve been critical of the FDA in the past. But now that the FDA has released its long-awaited guidance for “Mobile Medical Applications,”  I’m pleasantly surprised at the stance the agency has taken. Basically, the FDA has done exactly what it should do–gotten out of the way of innovation, while reserving the right to jump back in if circumstances warrant.

To put it a different way,  rather than being annoyingly ambiguous, the FDA has marked a big section of the beach and said “go play in the water, kiddies! Have fun, and we’ll be watching to make sure that no one drowns.” This is the right approach to maximizing both progress and safety. In fact, other regulators should follow the same path.

The issue when it came to mobile medical apps was in some sense simple. Clearly some mobile apps worked just like regulated devices, and therefore needed to come under the same scrutiny. No one disagreed with that. But then there was a whole set of other apps–including ones that provide simple coaching and prompting to diabetics and other people who needed to follow regular schedules–which could have been regulated as medical devices under a strict interpretation of the rules.

But in the guidance, the FDA was extremely clear that it would exercise “enforcement discretion” for these sorts of medical apps. The agency was even kind enough to give a long list of such apps, opening up a clear pathway for innovators. Some examples:

  • “Apps that provide simple tools for patients with specific conditions or chronic disease (e.g., obesity, anorexia, arthritis, diabetes, heart disease) to log, track, or trend their events or measurements (e.g., blood pressure measurements, drug intake times, diet, daily routine or emotional state) and share this information with their health care provider as part of a disease-management plan.”
  • “Apps specifically intended for medical uses that utilize the mobile device’s builtin camera or a connected camera for purposes of documenting or transmitting pictures (e.g., photos of a patient’s skin lesions or wounds) to supplement or augment what would otherwise be a verbal description in a consultation between healthcare providers or between healthcare providers and patients/caregivers.”
  • “Mobile apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks;”

And so forth and so on. You get the idea.

Other regulatory agencies should adopt the same tack. In a world of rapid innovation, regulators cannot and should not engage in pre-emptive regulation. Instead, they should stand back and watch closely, stepping in as necessary. That’s the best way to insure the

 

 

 

 

 

A Test of Republican Loyalties

How much do congressional Republicans hate Obamacare? How determined are they to see it fail?

We may soon find out. For the first time, a constituency group to whom the GOP normally pays close attention—religious institutions—is asking for a legislative “fix” of the Affordable Care Act to make it work as intended. If the recent past is any indication, conservatives will resist any such effort on grounds that Obamacare must be repealed root and branch, not repaired or reformed.

Months of outreach to Republican Senate offices by religious leaders have yielded no official GOP support to an appeal from a broad coalition of religious denominations to ensure that church-sponsored health plans can participate in the ACA’s health insurance exchanges. Worse yet, from a partisan Republican point of view, two Democratic senators, Mark Pryor and Chris Coons, were the first responders to this call, introducing legislation late last week. Pryor is widely viewed as the GOP’s number one senatorial target in 2014.

Without the requested “fix,” as many as one million clergy members and church employees now enrolled in church-sponsored health plans could soon face the choice of leaving these plans (designed to meet their unique needs, such as the frequent reassignment of clergy across state lines) or losing access to the tax subsidies provided by the ACA to help lower-to-middle income Americans purchase insurance. Continue reading “A Test of Republican Loyalties”

“Cut and Invest” vs. Austerity

President Obama’s new budget attempts to define a progressive alternative to conservative demands for a politics of austerity. Having just returned from a gathering of center-left parties in Copenhagen, I can report that European progressives are wrestling with the same challenge, and are reaching similar conclusions.

There was wide agreement that the wrong answer is to revert to “borrow and spend” policies that have mired transatlantic economies in debt, while failing to stimulate sustained economic growth. The right answer is a “cut and invest” approach that shifts spending from programs that support consumption now to investments that will make our workers and companies more productive and competitive down the road.

“You can only have a Nordic model if you’re competitive,” declared conference host Helle Thorning-Schmidt, prime minister of Denmark. “In this country, we cannot tax more; it’s that simple,” she added. “If you like the welfare state, if you want to sustain it, you have to take the tough decisions.” Continue reading ““Cut and Invest” vs. Austerity”

State of the Union 2013: Right Direction, Wrong Speed

President Obama got off on the right foot in last night’s State of the Union address by putting America’s economic revival at the center of his second-term agenda. That was reassuring, since his second inaugural strangely neglected this crucial subject.

There’s no more urgent national challenge than building new economic foundations for shared prosperity. More than anything else, what happens to the U.S. economy over the next four years will decisively shape history’s judgment of Barack Obama’s presidency.

Last night, the president certainly got the goal right. But it’s fair to ask whether the modest means he proposed are adequate to the task.

On the plus side, the president’s endorsement of corporate tax reform was welcome. Eliminating tax loopholes and subsidies will make for better investment decisions, and bringing down the corporate rate will make doing business in the United States more attractive. We also need to overhaul a worldwide tax system that encourages companies to offshore activities and leaves profits stranded abroad.

Continue reading “State of the Union 2013: Right Direction, Wrong Speed”

Tracking Healthcare Cost Growth Through a New Measure of Productivity

This brief provides a new explanation for why healthcare cost growth is showing restraint. Specifically, we find evidence that the healthcare sector is finally managing to use its workers more productively.

In this policy brief we define a new measure of healthcare productivity, Gross Medical Productivity (GMP). We define GMP as the number of potential patients per healthcare worker, where the pool of potential patients is the entire population. GMP measures healthcare productivity by looking at how effectively the sector uses its workers. So, if the potential patient population grows faster than the number of healthcare workers, GMP rises.

We argue GMP is a reasonable proxy for healthcare productivity, and could be a leading indicator for trends in healthcare cost growth going forward. Research shows labor accounts for over half of total healthcare costs1, suggesting a strong relationship between labor productivity and cost growth. Indeed, historically GMP has been falling at a rapid rate, corresponding to rapid growth in healthcare costs. That suggests a rise in GMP, or a rise in the number of potential patients per worker, will place downward pressure on healthcare cost growth. And because we can see changes in GMP well before official healthcare cost data is available, we believe GMP can provide early insight on the direction of cost growth.

From this approach we find evidence to suggest healthcare cost growth continued to show restraint in 2012, especially for the elderly population. We found that GMP rose considerably in 2012 for the 65 and over population, one of the largest drivers of healthcare cost growth, as healthcare workers became more productive in treating older patients. However, we also note that GMP for the entire potential patient population continues to fall.

Download the policy brief.

Democrats Must Step Up on Entitlement Reform for Fiscal Cliff Deal

PPI President Will Marshall speaks to The Daily Beast regarding the compromises needed from the left to avoid the fiscal cliff:

‘It appears President Obama is serious about slowing the growth of public health and retirement costs, which is the key to bending down the curve of federal spending,’ says Will Marshall, president and founder of the Progressive Policy Institute. ‘The big question now is whether leading Democrats in Congress will stand up to the Norquists of the left and put real entitlement reform on the table.’

That is the big question. Labor unions rightly believe that they were essential to the president’s winning coalition and ground-game effort in the November election. They and many liberal partisans will insist that now is not the time to make any concessions, especially on core philosophic policies like Social Security and Medicaid. They will find comfort in the arguments of some party activists and pundits who say there is no problem, that the fiscal cliff is a myth, and that current levels of deficits and debt are perfectly sustainable, especially if we just soak the rich. They are, like their conservative corollaries, embracing a feel-good reality distortion field.

Math isn’t partisan. The Congressional Budget Office has projected that because of our aging population, cumulative spending on Social Security, Medicare, Medicaid, and interest on the debt could gobble all federal revenues by the end of the next decade. The status quo is unsustainable. We cannot simply tax or spend or borrow our way out of this problem. Striking the right decisive balance is critical to our long-term economic strength as a nation.

Read the entire article at The Daily Beast.

The Real Meaning of Obamacare

Back in 1996, I wrote a book called The High-Risk Society. The book was based on the vision that Americans had to embrace risk and innovation in order to achieve faster growth and long-term prosperity.

An essential part of that vision, however, is the creation of a much stronger safety net.  If we are going to ask Americans to take risks for growth, to accept disruption in return for innovation, they have to be protected from the worst consequences of failure.

In particular, it becomes much harder to take a chance on growth if it means you might lose your healthcare. That’s why Obamacare, despite being ungainly and awkward, is an essential step towards a high-growth economy. People who want to start a new company or join an innovative new enterprise shouldn’t have to worry about whether they will be able to get healthcare. People who want to work halftime and go back to school shouldn’t have to worry about whether a sudden medical problem will throw them in the poorhouse.

Obamacare is a step towards unleashing the creative juices of Americans.  There are lots of problems, of course. We need to ensure that the new Obamacare bureaucracies don’t strangle innovative company. But now that the basic mechanisms are in place, we can move onto the more important task of empowering innovative and hardworking Americans.

This piece was cross-posted from Innovation and Growth.

Why Romney’s Medicare Taxes Are So Low

As the presidential candidates debate the fate of Medicare, it’s worth noting a very simple fact: Mitt Romney paid only 0.07% of his income in Medicare taxes in 2010. By comparison, the typical American worker paid 1.45% of his or her income in Medicare taxes plus an equal amount paid by the employer. In other words, Romney’s Medicare tax rate was about one-fortieth of the norm.

How did he manage this trick? The key is that investment income, which made up 97% of Romney’s total income in 2010, is not subject to payroll taxes that pay for Medicare or Social Security. That means he only paid Medicare taxes on his speaking and directing fees. If Romney had paid the full Medicare tax rate on all of his income, he would have paid about $628,000. Instead he paid $15,908.

Oddly enough, despite his relatively meager contribution, Mitt is also likely eligible for free Medicare coverage. Current Medicare rules stipulate that as long as he paid into the system for 10 years, he can still receive full coverage.

Because Romney is self-employed, he is paying both the employer and employee shares of the Medicare tax. We therefore compared his tax rate to the combined employer-employee rate for wage and salary workers (2.9% for Medicare taxes). And because he is self-employed Romney got to deduct a portion of his Medicare taxes to calculate his adjusted total income for tax purposes.

A new 3.8% Medicare tax on investment income for high income Americans, scheduled to go into effect in 2013 as part of healthcare reform, would dramatically boost the Medicare taxes paid by people with Romney-like returns. However, there are efforts underway in Congress to get it repealed.

GOP Guts Teen Pregnancy Prevention

If U.S. conservatives have made any useful contribution to anti-poverty policy, it’s driving home this crucial point: family structure matters. The whole vicious cycle of intergenerational poverty usually begins with teen pregnancy and unwed births.

Yet House Republicans this week proposed to gut federal programs that aim at reducing teen pregnancies. How do conservatives square their antipathy to such programs with their understanding of the risks and disadvantages of growing up in poor families headed by unmarried mothers?

You might think the answer is obvious: Mistrustful of government in general, Republicans don’t believe it knows how to do anything as complicated as promoting responsible sexual behavior.  Ok, but the same Republicans who called for cutting spending on prevention programs also voted to boost spending on federal abstinence programs.

So let me get this straight: Republicans believe that Washington is hopelessly incompetent when it comes to encouraging young girls to take every precaution against an unwanted pregnancy, but masterful in persuading them not to have sex at all. There’s little evidence to support this view, but in the GOP of Norquist and Bachmann, facts are no match for dogma.

Continue reading “GOP Guts Teen Pregnancy Prevention”

Prescription for Decline

PPI President Will Marshall writes for Foreign Policy on the impact healthcare costs are having on the US economy and the “American decline.

Lost in all the uproar over the U.S. Supreme Court’s June 28 “Obamacare” ruling was the crucial link between health-care reform and the issue voters care most about: the economy. America’s current health-care “system” isn’t just an ungainly, costly, and unjust mess. It also undercuts the United States’ ability to compete and win in world markets.

Amid the debate over “American decline,” this connection deserves a lot more attention than it’s getting. To revive U.S. international competitiveness, the country clearly needs to rein in runaway health-care costs. But it has to be done in the right way — not just by clamping down on spending, but also by boosting medical innovation and productivity.

Now that the court has upheld the individual mandate requiring most citizens to obtain health insurance, U.S. policymakers would ideally turn to the challenge of medical cost containment. This is unlikely to happen, however, because Republicans have vowed to make the repeal of the Affordable Care Act a centerpiece of their 2012 campaign message. Republican presidential candidate Mitt Romney dutifully promised Thursday to kill the “bad law,” even though it’s conceptually identical to the Massachusetts health plan he backed while governor of the state.

Read the entire article HERE

Election Watch: All Eyes on Supreme Court, Obama Pushes GOP on Immigration

Ed Kilgore is a PPI senior fellow, as well as managing editor of The Democratic Strategist, an online

This week’s skirmishing in the presidential campaign revolved around the president’s immigration initiative and preparations for the Supreme Court’s decision on the Affordable Care Act, due to be handed down next week.

The executive order (technically issued by the Department of Homeland Security) offered the children of undocumented workers a two-year, renewable immunity from prosecution if they had entered the country prior to the age of 16 and are currently under 30; have a high-school diploma or GED or a record of military service; and have no serious criminal record. It’s basically a “Lite” version of the DREAM Act, which Obama also supports, in that it provides no path to citizenship. And most importantly, from a political point of view, the administration initiative is very close to what Sen. Marco Rubio (R-Fla.) has reportedly been working on in the form of legislation that could free Republicans (and the Republican presidential candidate in particular) from the taint of being hostile to any remedial action to help children here illegally.

Continue reading “Election Watch: All Eyes on Supreme Court, Obama Pushes GOP on Immigration”

Keep Drug Bill Pro-Innovation

PPI believes in the importance of smart regulation as part of a well-functioning economy. But we’ve also repeatedly advocated that regulation and legislation should aim to boost innovation, not get in its way.

Unfortunately, not all politicians in DC have gotten the message. Over the next couple of days Congress will be voting to reauthorize the Prescription Drug User Fee Act (PDUFA), which speeds up the process of reviewing new drugs by using fees collected from manufacturers.

On net, this is a pro-innovation bill which is strongly worth supporting. But it’s worth noting that one amendment, submitted by Senator Bernie Sanders (I-VT), would gratuitously undercut the incentives for innovation. The amendment, as I read it, would take away marketing exclusivity for a drug if a company was found guilty of any one of a long list of criminal or civil violations related to the drug, including illegal marketing.

Continue reading “Keep Drug Bill Pro-Innovation”

How Rising Health Costs Slow Wage Growth

How Rising Health Costs Slow Wage GrowthMost Americans are painfully aware that their health care premiums are rising faster than other necessities of life. Many also know that their earnings are growing slowly or not at all, despite apparent increases in worker productivity. These problems have been widely reported, but are seldom linked.

Yet they are directly connected. The costs of health benefits has gotten so large in recent years, and has been growing so fast, that they are now contributing to the slowdown in workers’ pay and income growth. In economic terms, more of the productivity generated by each worker is being used to pay their health insurance premiums, so less gets paid out in wages.

This shift in compensation helps to explain a mystery that has puzzled economists for nearly a decade: Why have workers’ wages stagnated as their productivity has been increasing? In theory, the two are supposed to rise in tandem.

Download the Report

Will Marshall on Wyden-Ryan Medicare Plan

PPI President Will Marshall breaks down the merits of the Wyden-Ryan plan for Medicare reform in Politico:

An honest debate over Medicare’s future may be too much to hope for in an election year. But candidates should think twice before staking out positions that could tie their hands in next year’s unavoidable showdown over public debts and Medicare spending.

After all, 50 percent will win and actually have to govern. That’s why it’s a big mistake to allow the leading bipartisan proposal for Medicare reform — the Wyden-Ryan plan — to fall victim to election-year Medagoguery.

It’s the brainchild of Democratic Sen. Ron Wyden, a progressive Medicare champion who once led a Gray Panthers chapter in Oregon, and Rep. Paul Ryan (R-Wis.), chairman of the Budget Committee and darling of tea party conservatives. If this political odd couple can agree on a balanced way to slow the unsustainable growth of Medicare costs, there may be hope for real entitlement reform yet.

Read the full article here.

Welcome Back, Gang of Six

Not a moment too soon, the Gang of Six has resurfaced in the U.S. Senate, breathing new life into hopes for a bipartisan “grand bargain” on deficit reduction.

Even if Eric Cantor were abducted by aliens, there’s no way that Congress could pass the Gang’s elaborate plan to solve the debt crisis before Aug. 2. But the Gang’s resurgence, with growing support from GOP Senators, adds to mounting public pressure on House Republicans to end their self-isolating intransigence on taxes.

Several weeks ago, the Gang looked moribund after a key member, Senator Tom Coburn (R-Okla.) went on walkabout. To their immense credit, however, Gang leaders Mark Warner (D-Va.) and Saxby Chambliss (R-Ga.) persevered, got Coburn back in the fold, and unveiled their new plan before 46 Republican and Democratic Senators this week. President Obama, who has stood strangely aloof from the Gang’s efforts to find common ground, pronounced the new package “consistent” with his views.

The new blueprint, like the original, is based on the Bowles-Simpson fiscal commission plan. It envisions two steps: First, an immediate, $500 billion “down payment” on deficit reduction; followed by more comprehensive reform. Altogether, the Gang calls for $3.7 trillion in debt reduction over the next decade. That’s about what budget experts say is necessary to first stabilize, then start shrinking, the national debt.

Another Gang leader, Sen. Kent Conrad (D-Mont.), said today there is talk on Capitol Hill of using the $500 billion cut to win a short-term extension of the debt limit. That could give lawmakers more time to hammer out a permanent solution to the fiscal crisis that includes both increased tax revenues and entitlement reform.

The Gang’s revised plan proposes deep cuts in Medicare and other health spending, while – sorry Rep. Ryan — apparently maintaining the structure of Medicare and Medicaid. It would achieve about $1 trillion in savings by capping domestic spending, including defense, over the next decade. These cuts are way beyond cosmetic.

The new plan also embraces the fiscal commission’s key proposal on tax reform. It would raise around $1 trillion over the next decade by closing tax loopholes, using the savings both to dramatically lower income and corporate tax rates, and reduce the deficit. Spared are tax credits for low-wage workers and families with children. More affluent taxpayers will welcome the Gang’s call to abolish the Alternative Minimum Tax.

The fiscal commission achieved a political breakthrough when Republicans Senators embraced tax reform, and some Democrats agreed to cut Social Security benefits for affluent retirees and raise the retirement age. Here the new blueprint disappoints. Basically it punts to the Senate Finance Committee, which is charged with drafting a plan to assure Social Security’s solvency over the next 75 years. The Gang also says efforts to reform Social Security should only take place “on a separate track – any savings from the programs must go toward solvency.” This may placate liberals, but could alienate conservatives who suspect Democrats aren’t really serious about entitlement reform.

The big question, of course, is whether the Gang’s plan could ever get through the House. For starters, it violates the Tea Party’s Prime Imperative — that revenues can be raised for no other purpose than cutting tax rates. Moreover, Ezra Klein reports that it also appears to assume the expiration of the Bush tax cuts for the wealthy. If House Republicans won’t yield on taxes, don’t expect House liberals to deal on entitlement reform.

Still, a lot depends on how the debt limit battle plays out. New polls show voters are more likely to see Republicans as standing in the way of compromise than Obama and the Democrats. If things get really ugly – if the federal government can’t pay salaries or mail benefit checks on Aug. 3 – such suspicions could quickly turn into a furious backlash.

In any case, the Gang’s initiative illuminates a growing rift between House and Senate Republicans, both on taxes and negotiating tactics. By saying, in effect, “Hell no” to balanced proposals to cut deficits, House Republicans are forfeiting a rare opportunity to get Democrats to swallow huge, multi-trillion-dollar cuts in federal spending. Apparently, real conservatives prefer big government to tax hikes.

On the other side, progressives aren’t likely to get a better offer than the one Warner and company are offering. No one knows this better than President Obama, who’s been beating his head against the wall of GOP recalcitrance for weeks. And that’s why, once the debt limit is raised, he ought to throw in with the Gang of Six.

Photo Credit: TalkMediaNews

Family Planning Fight Moves to States

Back in April, House Republicans tried to kill funding for a couple of the right’s favorite bête noires: Planned Parenthood and the Title X federal grant program for family planning. Stymied by Senate Democrats, conservative culture warriors have moved on to what they see as more promising battlegrounds: states with GOP governors or legislatures.

 

Measures to defund Planned Parenthood already have passed in North Carolina, Indiana, Kansas, and Wisconsin, and are pending in several other states. The states have different strategies for cutting Planned Parenthood out of the action. Mostly, they bar state governments from contracting with the organization for family planning services using federal Medicaid and Title X dollars. Planned Parenthood notes that some states are withholding federal grants specifically earmarked for the organization.

New Hampshire’s Executive Council recently voted to reject a $1.8 million contract with Planned Parenthood. Council Member Raymond Wieczorek explained, “I am opposed to abortion. I am opposed to providing condoms to someone. If you want to have a party, have a party but don’t ask me to pay for it.”

As Weiczorek’s comment makes clear, conservatives aren’t just aiming at their usual target, abortion, but at contraceptives as well. Scott Walker, Wisconsin’s Republican Governor boasted during his campaign of “trying to defund Planned Parenthood and make sure they didn’t have any money, not just for abortion, but any money for anything.”

The right’s jihad against Planned Parenthood and family planning is likely to cause the opposite of its intended effect. Making it harder for people to get access to contraception will result in more unintended pregnancies, some of which undoubtedly will end in abortion. And if such bans are not reversed, there’s a high risk of collateral damage to a cause Republicans presumably support: reducing the epidemic of teen and unplanned pregnancy in America.

With over 400,000 girls aged 15 to 19 giving birth each year, America’s teen pregnancy rate is among the highest of all industrialized countries. Nearly one-quarter of teen mothers go on welfare within three years of having a child, and according to the CDC, lack of access to contraceptives is a key factor contributing to high teen pregnancy rates, a problem that costs taxpayers nearly $11 billion a year.

As I wrote here, teen pregnancy also plays a large role in the nationwide dropout crisis—30 percent of girls who drop out of high school cite pregnancy or parenthood as a key reason they left school. The close connection between teen pregnancy and dropping out of school is another compelling reason not to cut funding for family planning programs.

Contraception, which Planned Parenthood and other family planning clinics provide at a low cost, significantly reduces unplanned pregnancy and in turn reduces the number of abortions. Studies show that easier access to birth control pills decreases abortion rates drastically. In fact, most of the decline in teen pregnancy rates in the U.S. is due to teens’ more consistent contraceptive use.

Republicans want to punish Planned Parenthood for providing legal abortions, even though abortion accounts for only 3 percent of its services. In addition to affordable contraception that prevents teen and unplanned pregnancy and abortions, Planned Parenthood also provides other vital health services for women, like cancer screening and prevention, STD testing and treatment, and prenatal care.

According to a Guttmacher Institute study, 1.94 million unintended pregnancies are prevented each year by services provided at family planning clinics. Of these averted pregnancies, 400,000 would have occurred among teens. Defunding Planned Parenthood would deal a huge blow to crucial efforts to prevent teen pregnancy, undermining clinics’ capacity to provide sex education and teen pregnancy prevention initiatives. The same study finds that 810,000 abortions were prevented by services provided at family planning clinics. Without these services, the abortion rate in the U.S. would be two-thirds higher than the current rate.

Planned Parenthood isn’t taking this lying down. The organization has already won lawsuits defending abortion rights in Kansas and South Dakota. In Indiana, it won a legal battle when a district judge blocked enforcement of the defunding measure. The Obama Administration has made it clear to Indiana that cutting off Medicaid funds to Planned Parenthood is illegal—the law says that Medicaid beneficiaries can choose any qualified healthcare provider they wish. Planned Parenthood is also suing over North Carolina’s budget provision that cuts the organization off from any federal and state funds.

 

Cutting the number of abortions ought to be a goal that unites progressives and conservatives. Instead of slashing funding for clinics that provide fundamental health services for young and low-income women, Republicans should put their focus on reducing the need for abortions. The GOP’s moral guardians may not like it, but this means encouraging responsibility through safe sex and contraceptive use and continuing to fund family planning programs that help prevent teen and unplanned pregnancy and abortion.

Photo Credit: WeNews