Health Care Costs. Will the government look inward?

The Coffee Shop
1

With all the debate about health care costs, I’ve never heard mention of the fact that the US government is a big reason why drugs are more expensive in the US than Europe. Why let me give you a real life example.

For Europe. We are audited once every 11 - 13 months by Europe regulatory. We pay for this audit. Before they audit they propose a date about 4 months in advance. For buisness needs we can move it, but it must stay in the 11 - 13 month window. They provide us with a agenda, and an estimated time frame. Day 1 they show up at 8AM, we have a working lunch, and we usually have to kick them out around 6. Every day is like this until they are done.

For the US. You never know when they will show up. You feel lucky if you get a couple of days notice. There is no wiggle room on the start date. If your a small company, and your head of quality is on vacation, it sucks being you. This audit is free. Here’s the schedule for our last audit. Day 1 start 9AM, 1 hour lunch, leave at 3PM. Day 2 start at 8:30 AM, 1 hour lunch leave at 2:30. Day 3 start at 9AM, leave at lunch. Day 4 start at 9AM 1 hour luch, leave at 2: Day 5 no audit. Late Day 5 call and tell they will not be there on Day 6. Day 7 9AM, 1 hour luch, gone at 2:30. Day 8 8:30 start, wrap up at lunch.

Now the US audits are Free, but the wasted time on the short days, and no planning costs much more.

Guess where these costs get passed on to?

2

Who is subject to these “Audits”?

I agree completely that dealing with government agencies is a pain in the ass and for the most part most of them are woefully inefficient. That being said it would seem to me that company that is getting audited for as many days as you’re claiming is going to have to have some substantial size and thus is not going to be all that affected by the audit.

OTOH if they tried something like that with my company, only 4-5 people, you’d find your auditor in the dumpster about 1AM on day 2 :slight_smile:

What I’m saying is the “Audit process” usually matches the size and complexity of the company and thus likely does not affect the bottom line all that much.

What likely affects the bottom line far more is the information that you are required to collect, keep provide during the audit process.

This is were the government needs to look inward.

~Matt

3

Who is subject to these “Audits”?

If you produce a drug or device, they will come visit.

as many days as you’re claiming is going to have to have some substantial size and thus is not going to be all that affected by the audit

We are still small, and it affected us. The department heads doing nothing for that many days. The waiting. Short days.

you’d find your auditor in the dumpster about 1AM on day 2 :slight_smile:

4

Audit by who? JACO? Huh? WTF are you talking about? Hospitals PAY to get audited by private companies…then they claim to be “Top 5% based on blah” according to these guys (pick your accrediting company). Govt? Not so much.