Category Archives: Policy and politics

Hepatitis C drug battle: I’m quoted

The chess game among Gilead, AbbVie, pharmaceutical benefit managers and health plans on expensive but effective Hepatitis C treatments is well underway. I’ve been following the story for quite a while –and asked all of the candidates for Massachusetts Governor about it a year ago.

Now I’m being interviewed about it, most recently for AIS’s Health Plan Week (Health Plans Join in Action as PBMs Make Exclusive Deals for Competing Hep C drugs). The publication is behind a firewall but includes my skepticism that Express Scripts will accomplish very much with its tough stance.

I’m expecting to be quoted in other articles soon, and may write about the topic later this week.

By healthcare business consultant David E. Williams, president of Health Business Group.

Small ball with no leverage: GOP’s 40-hour workweek folly

The allure of 40

The allure of 40

The Cato Institute’s Michael F. Cannon is a foe of the Affordable Care Act, which means I disagree with him most of the time. But he’s right on the money with his ten-point teardown of the Republican Congress’ first salvo against Obamacare.

The bill would redefine a full-time worker as someone who works 40 hours per week, rather than 30. That makes it easier for employers to meet the mandate to offer health insurance to full-time workers. It’s essentially a loosening of the mandate, which will benefit low-wage service companies.

Cannon thinks this move is a bad idea. I strongly agree with his first and last points:

  • The legislation would increase government spending by pushing more people onto the exchanges and Medicaid
  • It would create an incentive to reduce employees’ hours to just under 40 per week. A whole ton of people would be affected by that maneuver; orders of magnitude more than the number near the current 30 hour threshold

His other eight points are about why the 40-hour bill weakens the overall Republican attempt to dump Obamacare. (At one point he writes, “House Republicans are playing small ball with no leverage. How is that strategically smart?”) I agree with his analysis, but unlike him I’m not bothered that the GOP continues to flail.

photo credit: quinn.anya via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.

 

California law prevents price-gouging of the uninsured

Hospital bills add up fast

Hospital bills add up fast

Medical bills are a major source of personal bankruptcy in the US. One reason is that hospitals typically bill uninsured patients wildly inflated “charges.” These prices are often double or triple the negotiated rates that insurance companies pay or that Medicare pays for the same services.

Historically hospitals defended this practice, claiming they needed high prices to compensate for the fact that few uninsured pay their bills, or even claiming to be prohibited from discounting to those who lacked a contract. There’s some truth to the first claim, yet the punishment fell upon those conscientious folks who actually tried to pay what they were billed.

As a new Health Affairs article (California’s Hospital Fair Pricing Act Reduced The Prices Actually Paid By Uninsured Patients) states:

“The pricing policies of US hospitals leave the most vulnerable patients least protected from high medical bills.”

California passed a comprehensive law to address this issue in 2006, effectively capping prices for moderate income uninsured patients at Medicare rates. According to the author’s analysis, the impact has been substantial. Hospitals have reduced their prices to the uninsured; low to moderate income patients have benefited.

The findings are important, because while the federal Affordable Care Act also addresses the issue of pricing to the uninsured, its provisions are much weaker. For example, nonprofit hospitals have the discretion to determine who is eligible for discounted charges and for-profit hospitals are exempted from the requirements.

My own view is that it’s especially important to regulate prices that are charged to uninsured people who are not covered by the ACA, such as undocumented immigrants.

I have less sympathy for those who are eligible for coverage but choose to remain uninsured. Ironically, the threat of ruinous hospital bills could be just what we need to encourage everyone to sign up for coverage.

photo credit: urbanbohemian via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.

 

In praise of FDA collaboration: the cardiac safety example

Making it happen

Making it happen

The Food and Drug Administration gets a lot of grief. Some think the FDA is too restrictive, keeping useful drugs and devices off the market and thus harming patients. Others complain that the agency is too lax, letting dangerous products get through. What many people don’t realize, however, is that FDA has established an excellent track record of collaboration with stakeholders that’s leading to better, faster development pathways.

I’m directly aware of FDA’s longstanding constructive, collaborative efforts in the areas of HIV and HCV through the Forum for Collaborative HIV Research. Those efforts are now expanding into liver fibrosis and beyond.

So I was encouraged to to receive the following correspondence over the weekend from Mikael Totterman, founder of iCardiac Technologies, where I’m a board member.

On Friday, I attended the Cardiac Safety Research Consortium meeting hosted by the Food and Drug Administration announcing the results of a new study that promises significant advances and improvements to the way cardiac safety is assessed for new drugs being developed by pharmaceutical companies.

It was a great opportunity to review  over a decade of work that had gone into enhancing one of the key areas of drug development and to reflect on how industry and government collaboration can lead to dramatic enhancements for all parties, especially patients.

Where It All Started – The FDA’s Critical Path Initiative

Back in March of 2004, the FDA launched the Critical Path Initiative to “drive innovation in the scientific process through which medical products are developed, evaluated and manufactured.” The document identified broad critical bottlenecks in drug development that, if tackled, promised to deliver significant improvements to the process of developing new drugs.

Specific Opportunities – Cardiac Safety – Traditionally Very Costly and Hard to Assess Well

By March of 2006, and as result of broad-based industry support, the FDA continued their collaborative work, and rolled out a highly targeted list of specific opportunities for industry collaboration to improve the overall effectiveness of drug development.

One of the key areas highlighted by the FDA across several specific opportunities was how drugs were assessed for cardiac safety issues, specifically for the potential to cause potentially lethal cardiac safety side effects.

“#18. Predicting Cardiac Toxicity. New tools for early identification of cardiac toxicity would improve product development for a wide array of conditions. Research investments that could produce tangible benefits quickly include creation of an ECG library from clinical trials that could be used for identifying potential early predictors of cardiac risk.

#46. Identification and Qualification of Safety Biomarkers. …For example, a robust database of preclinical and clinical data on cardiac arrhythmic risk could help us understand the clinical significance of QT interval prolongation, reduce the need for clinical studies, and, possibly, help identify individuals who are at risk for this side effect….”

Cardiac Safety – Consortia are Born

The level of interest in these opportunities was intense and so two separate industry/FDA consortia were developed to provide a venue and process for validating tools and methods that could tackle the issues in cardiac safety.

The Cardiac Safety Research Consortium was formed in 2006 through an FDA Critical Path Initiative Memorandum on Understanding and the Telemetric Holter ECG Warehouse was formed in 2008.

Significant Progress Unveiled at Cardiac Safety Research Consortium Meeting at the FDA

The Cardiac Safety Research Consortium meeting this past Friday was particularly exciting as it was the culmination of many years of work on the part of the FDA as well as many industry participants and thought leaders.

As the recommendations from the meeting are rolled out, the expectation is that cardiac safety testing in clinical trials will become ever more thorough and at the same time accomplished at a lower cost.

This is something that everyone should celebrate; patients, drug developers and regulators are all better off as a result of this long-term collaborative approach.

photo credit: ePublicist via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.

 

An expensive $25

One of the most visible benefits of the Affordable Care Act is that preventive services are covered with no out-of-pocket cost. So I was happy not to be charged a co-pay when I visited my doctor’s office for my routine physical in April. Not that $25 is a lot of money in comparison with my premium, but hey I’ll take it.

So I was unhappy when I started getting bills for a $25 co-pay from the doctor. I used the patient portal to send an administrative note in May, which was ignored. After a lot of back and forth with the office and my health plan the charge was finally dropped yesterday. But it makes me wonder just how much money the physician’s office and health plan spent to push this $25 around.

This is just one small example of the administrative costs imposed by the US’s convoluted healthcare financing system. Here’s the play by play from my case:

August 29, 2014

Dear [Physician Practice]:

I keep receiving bills for a $25 co-pay for 4/4/14 date of service. This was a routine physical. Under the ACA I am not supposed to be charged a co-pay for this preventive service, which I confirmed with BCBS MA. I sent a message about this months ago on the provider portal but have never received a reply, just more bills.

Please reverse the charge.

Thank you,

David

——

September 2, 2014

Good Morning Mr. Williams,

Thank you for your email inquiry regarding the balance of $25, for service date 4.4.14.  Upon review of the account, I confirmed Dr. X billed a medical office visit in conjunction with the annual physical.  Per the Affordable Care Act, you may still be required by your insurance company to pay a copayment if the physician treats you for any new medical issues discussed during the physical, or if she needs to change medication, order tests, or refer you to a specialist to deal with a pre-existing issue.  I have attached the ACA for your review.

 I have taken the liberty of asking our Medical Coder to review Dr. X’s medical notes for your visit on 4.4.14.  She will determine if the documentation supports the charge of the office visit.  If it does not, then and only then, will we reverse the charge.  This may take up to 7 business days.  I will email you as soon as I receive this back.  Please let me know if I can be of further assistance at this time.

Kind regards,

[Practice Administrator]

—–

December 1, 2014

Good Morning Mr. Williams.

This email is in follow up to my email sent on 9/2/14, regarding the balance of $25, for the service date 4/4/14.  Our medical coder determined Dr. X’s notes do not support the office visit.  Therefore, we are refunding your insurance company and reversing the charge.  You may disregard the statement.  Please let me know if you have any further questions.

Kind regards,

[Practice Administrator}

By healthcare business consultant David E. Williams, president of Health Business Group.