I hope everyone had a great 4th of July holiday and enjoyed what I call the three Fs – food, fireworks, and family. I always try to find some time during the festivities to reflect back on our great country and the freedoms we enjoy. Our Founding Fathers wanted a country where the power to decide how we are governed came, not from any government or king, but from the unalienable rights possessed by each of us, and the individual was the most important part of our nation. I think that sometimes we forget that the authors of the constitution worked extremely hard to set up the checks and balances necessary such that no entity or governing body could infringe on those rights. It’s from this point of view that I write this blog that discusses how our government is shaping how we will access our healthcare going forward and whether government actions adhere to the words and spirit of the constitution.
I’ve discussed in earlier blogs the Inflation Reduction Act (IRA) and how it impacts our healthcare, especially Medicare. I’ve also warned that the follow-up implementation guidance would have a big impact on how the new law affect us. The cap on Medicare prescription drug out-of-pocket costs in the IRA was a much-needed benefit, and I’ve spent almost 15 years lobbying for its passage. There were, however, other parts of the legislation that, in many people’s minds, infringed on some of the basic rights of the constitution. I’m referring to the part of the law that allowed the government to set the price of an ever-expanding list of drugs in the Medicare Part D prescription drug program. In earlier blogs I predicted that this ability to set prices was very possibly the first step in the government’s expanding control of how we access our healthcare in this country. As I’ve detailed in past blogs, legislating lower prices for drugs may seem like an honorable pursuit, but this approach, according to the Congressional Budget Office (CBO), would have a minimal effect on the price you and I pay at the drug store. It would, however, have a chilling effect on the number of research dollars that would be invested and cause a substantial reduction in the discovery and development of new drugs. Because the language in the IRA was so broad that it gave the government great latitude on how the law was implemented, it made the implementation guidance especially important.
Last week the Centers for Medicare and Medicaid Services (CMS) released IRA implementation guidance. The guidance seemed to be reactionary and did little to clarify or reduce our worry about the government’s increased involvement in our healthcare. For instance, CMS added more regulatory burdens by requiring “preferential approval” for certain drugs. Plan sponsors will have to justify coverage for certain medicines and be granted approval. The guidance also indicated that the listening sessions for stakeholders would be nothing more than a one-way comment period, not the two-way back and forth discussion that was hoped for.
Another of the disturbing attributes of the IRA was the gag order placed on the drug manufacturers concerning how CMS calculated the “fair” price or any other aspects of the discussion process between CMS and the manufacturer. This gag order prohibited any public release of data concerning how the fair price was calculated or details of the discussions. This gag order and other processes dictated in the IRA led multiple drug manufacturers and the manufacturer’s association, PhRMA, to file a lawsuit against the Department of Health and Human Services (HHS) and CMS stating that the IRA infringed on their first, fifth and eighth amendment rights.
It is interesting to me that the recently released guidance removed some of the restrictions on disseminating information, a change that seemed to be a direct response to the earlier lawsuits. Now, I’m not a constitutional lawyer or a lawyer of any kind but I wonder how mere changes in guidance may be able to change a law in such a way it reduces its exposure to lawsuits concerning the infringement of rights under the constitution. It would seem that only Congress would have the power to make such a change.
These may seem like small innocuous details, and some would say that the drug companies would use any approach, including lawsuits, to stop the price fixing scheme. But lawsuits cost money, and I don’t think these manufacturers would waste money on a lawsuit that had no chance. What really concerns me is the fact that legislation that was voted into law had veered so close to restricting our rights that it was deemed open to a constitutional lawsuit. This is not the first time that healthcare legislation was exposed to lawsuits. As you might remember the Patient Protection and Affordable Care Act (Obamacare) had to weather a Supreme Court decision.
It scares me when I step back and consider the direction Washington is headed when it comes to our healthcare. Why could a panel of unelected bureaucrats under Obamacare make decisions on who could have access to healthcare? How come the IRA can be challenged on the basis of infringement of our constitutional rights? This is a path toward more government control, more government between me and my doctor, less choices, and fewer options. It seems each new piece of legislation takes us further down the path of government intervention and control.
We at Senior Speak Out will continue to stay in the details of all aspects of the proposed legislation and the implementation of each new law. If you commit to staying involved, we will have a chance to alter the direction our government is headed. We need to convince them we are the ones that have unalienable rights to make our own decisions and have less government involvement in our lives.