Tag Archives: 21st Century Cures

Obama Just Partially Repealed Obamacare, Proving Republicans Can Succeed

Upton(A version of this Health Alert was published by Forbes.)

Since the election, there has been a lot of sturm und drang around what the alternative to Obamacare will look like. It looks like we can be highly confident the Republican-majority Congress will repeal Obamacare very quickly starting in January. However, there is some question about what exactly will be repealed.

Last year’s repeal bill, H.R. 3762, repealed Obamacare’s spending and taxes, but not its over regulation of health insurance. Further, Republican politicians have promised not only to repeal Obamacare, but replace it with a better payment system than existed previously. People’s primary concern about the previous system was that people in the individual market could be denied coverage for pre-existing conditions or charged higher premiums as a result of underwriting.

Politically, it would not be possible for Republicans to walk back from this commitment. According to the Kaiser Family Foundation’s November tracking poll:

Among those who want to see the ACA repealed, 38 percent (meaning 10 percent of the public overall) change their opinion after hearing the argument made by proponents that repealing the ACA would mean that insurance companies would be able to deny coverage to people with pre-existing conditions.

Trump voters react similarly, with a larger share changing their opinion after hearing that repealing the ACA would mean that insurance companies would be able to deny coverage to people with pre-existing conditions (27 percent) than changing their opinion after hearing that more than 20 million Americans could lose their coverage (8 percent).

The economics of health insurance make this very difficult to achieve without some sort of mandate or penalty for not maintaining coverage, which is politically unpopular – and especially toxic to Republicans. This poses a challenge; and we all know Republican politicians have promised to solve this for six years without result. Fortunately, we also have recent evidence that Republicans can lead and succeed on complex health reform legislation. Continue reading Obama Just Partially Repealed Obamacare, Proving Republicans Can Succeed

Divided on Obamacare, Trump and Clinton Both Threaten Medical Innovation

(A version of this Health Alert was published by Forbes.)

Confident Doctors

The recently announced 25 percent rise in Obamacare health insurance premiums has brought renewed attention to health policy. As this is my last column before Election Day, it is time to review how the presidential candidates would address the continuing challenge of skyrocketing health costs.

We should not kid ourselves that Obamacare’s failure is enough to cause the next President or Congress to act energetically to fix the problems Obamacare exacerbated. The interest groups which brought us Obamacare have cut bait and moved on. The health care sector – interests for which the $3.35 trillion spent on health care counts as revenue rather than cost – has bigger fish to fry.

Although insurers are losing money in Obamacare’s exchanges, they are far more concerned with employer-based group benefits, Medicare Advantage, and Medicaid managed care than Obamacare exchanges. Obamacare exchanges cover fewer than 13 million people at any time during the year; and only about four million stick with Obamacare coverage throughout the year. Those poor souls comprise a powerless political constituency, unlike employers or seniors on Medicare. Continue reading Divided on Obamacare, Trump and Clinton Both Threaten Medical Innovation

Who Benefits From The “Right to Try” Experimental Medicines?

doctor-mom-and-sonThe Goldwater Institute has had great success getting states to pass “Right to Try” laws. Right to Try allows a desperately sick patient to take an experimental new medicine before the FDA has approved it.

Since I last wrote about this policy in November 2014, 31 states have passed Right to Try. Further, U.S. Senator Ron Johnson (R-WI) has tried to get a federal Right to Try law through the U.S. Senate.

However, there has been push-back. According to Allison Bateman-House of NYU Langone Medical Center, “there is no confirmed instance of anyone getting a drug through Right to Try.” Jonathan Friedlaender, a survivor of advanced metastatic melanoma, has written a compelling essay in Health Affairs, which concludes Johnson’s proposed federal law would not improve access to experimental medicines.

The problem has two parts: Continue reading Who Benefits From The “Right to Try” Experimental Medicines?

A Health Care Legacy Moonshot for Obama

vaccine-shot(A version of this Health Alert was published by Forbes.)

President Obama has an opportunity to win a positive legacy in health care. Although his attempt at payment reform, Obamacare, has failed in public opinion, he is also encouraging important initiatives in medical innovation. The Cancer Moonshot and Precision Medicine Initiative represent investments in innovation that can bring big payoffs. However, they will not succeed fully unless the Food and Drug Administration allows patients access to new therapies. Legislation modernizing the FDA, the 21st Century Cures Act, is being fumbled inches away from the Congressional end zone. Presidential leadership is needed. Continue reading A Health Care Legacy Moonshot for Obama

First, Do No Digital Harm: Regulating Telemedicine

Laptop and Stethoscope(A version of this Health Alert was published by Forbes.)

Telemedicine, whereby physicians use email, phone, text, or video for prescribing and consultations, is growing rapidly. Seeking to encourage faster uptake of telemedicine, many well-intentioned parties are prodding Congress to take actions which will likely have harmful unintended consequences.

So far, Congress has done well. With respect to regulating actual devices, the 21st Century Cures Act, passed by the House in 2015 with overwhelming bipartisan support, is forward thinking. If passed into law, the policies it would implement would lead to a responsible and responsive regulatory environment for mobile health apps.

However, there are other areas in which a Congressional take-over would do more harm than good. In recent testimony to the House Energy & Commerce Committee’s Subcomittee on Commerce, Manufacturing and Trade, I encouraged Congress to First, Do No Digital Harm. Two of the most important areas of risk are federal interference in the practice of medicine and how Medicare pays for telemedicine. Continue reading First, Do No Digital Harm: Regulating Telemedicine

Jeb Bush Health Reform: Innovation and Patient-Centered Care

Bush2(A version of this Health Alert was published by The Hill.)

By avoiding sound bites and respecting voters’ ability to understand issues, Governor Jeb Bush’s health-reform proposal demonstrates strong leadership. Repeal and replace Obamacare? Sure, Bush is for that, but no Republican politician should win points simply by regurgitating what many citizens fear has become little more than a slogan. Continue reading Jeb Bush Health Reform: Innovation and Patient-Centered Care

Jeb Bush’s Health Plan

BushJeb Bush’s health plan is out – and it is very good. Bush leads with fundamental reform of the Food and Drug Administration. “It should not cost $1.2 billion to $2.6 billion nor take 12 to 15 years to advance a medicine from discovery to patients, but that is the case under the Food and Drug Administration’s current regulatory mess.”

In recent weeks, we’ve read stories about drugs that have been around for decades, for which prices have been hiked sky-high. These price hikes are carried out by executives taking advantage of obscure FDA rules that impede competition. Continue reading Jeb Bush’s Health Plan

21st Century Cures Act Passes House with Overwhelming Bipartisan Support

This morning, the U.S. House of Representatives passed (344-77) the 21st Century Cures Act. This is a monumental achievement, designed to fundamentally restructure the Food and Drug Administration and thereby reverse the staggering decline of productivity in medical research and development.

The bill started as a bipartisan effort in the House Energy & Commerce Committee, where Republican and Democratic leaders moved beyond rhetoric and went right back to the basics, questioning the role of the federal government in spurring innovation and regulating our access to medical technology.

Unfortunately, their achievement is tainted by another fiscal glitch. For the third time (after the Medicare “doc fix” and repeal of the medical device excise tax), the House has voted for spending while weakening its commitment to offsetting cuts. Continue reading 21st Century Cures Act Passes House with Overwhelming Bipartisan Support

Caution: 21st Century Cures Act Has A Suspicious Payment Plan

prescription-drugs(A version of this Health Alert was published by Investors Business Daily.)

The House of Representatives is scheduled this week to consider the 21st Century Cures Act (H.R. 6), a health policy bill designed to improve the economic incentives and streamline the process for inventing new medicines.

We applaud the act. It will go a long way to solving the crisis in pharmaceutical innovation. But we caution against the mandatory funding proposal in the bill and urge Congress to authorize and appropriate the funds instead of creating a new, mandatory spending program. Continue reading Caution: 21st Century Cures Act Has A Suspicious Payment Plan