Mr. ROBERTS. Mr. President, I rise today to once again speak out against what I consider to be and many others consider to be a regulatory assault on our Nation's economy. I have previously discussed my concerns with regulations having a negative impact on our agriculture community. That was last week. Earlier this week, I spoke about what I consider to be the egregious regulations that are being promulgated by the EPA, or what Senator Grassley calls the ``end of production agriculture agency.''
Today, I rise to talk about health care regulations that patients and providers have brought to my attention. I have listed a number of these regulations in a letter I sent earlier today to President Obama. I ask unanimous consent that it be printed in the Record.
There being no objection, the material was ordered to be printed in the RECORD, as follows:
Washington, DC, March 10, 2011.
President BARACK OBAMA,
The White House,
DEAR PRESIDENT OBAMA: I write you today to express my sincere appreciation for the Executive Order that you issued on January 18, committing all federal agencies to review regulations and remove any that place unreasonable burdens on our nation's business community and/or impact the ability of our economy to grow. I agree that in light of our current economic crisis, establishing a regulatory environment that promotes growth and job creation should be the number one priority for this Congress and Administration. To that end, I would like to offer some suggested areas related to health care that patients and providers have communicated are of the most concern to them, and would urge you and your Administration to consider these and their impact when implementing your Executive Order.
While the majority of this communication will focus on regulations already on the books, I would also like to take this opportunity to share with you what seems to be an even greater concern within the patient, provider and stakeholder community. When discussing regulations in general and your Executive Order more specifically with my constituents and those representing the patient and provider community, the number one concern that I hear is related to a fear of the impact of future regulations. While there is still a large concern with the burden of regulations that have already been issued, I have heard time and time again that there is an even greater concern with the uncertainty of future regulations, especially those regulations for implementing the ``Patient Protection and Affordable Care Act'' (PPACA) and their potential to have a further and greater impact on jobs and the economy. While I regularly hear concerns about the compounding costs related to implementing any and all of these regulations, the specific areas that are mentioned the most include, but are not limited to:
Individual Mandate and related penalties
Employer Mandate and related penalties
Defining Essential Health Benefits and related coverage mandates
Accountable Care Organizations
New taxes and fees including the ``Cadillac Tax'' and new excise taxes on industries
Additionally, I hear often that patients and providers feel that they do nut have a voice in the regulatory process and, more specifically, that a number of regulations are being issued through a shortened process. This shortened process allows limited or no input from those most affected by the regulations, prior to their implementation, and may result in greater costs and economic impact if changes are necessary based on comments that the Administration receives. It is my understanding that the PPACA rules that have been issued as interim final rules, and therefore with limited input are:
National Provider Identifier
Web Portal Requirements
Early Retiree Reinsurance Program
Coverage of Children to Age 26
Underserved Rural Communities
Grandfathered Health Plans
Pre-Existing Condition Exclusions
Internal Claims/Appeals and External Review Processes
Pre-Existing Condition Insurance Plan Program
Amendment to Grandfathered Health Plans Rule
Medical Loss Ratio Requirements
While there may have been instances in which a shortened process was necessary or appropriate I would strongly encourage your Administration to limit the use of this regulatory process and take every available opportunity to get feedback from those who would be most affected by these regulations and allow for ample time to review and consider that feedback prior to implementing future regulatory priorities. I would also strongly encourage you to review any comments you have received on these regulations for any concerns that indicate a potential to further our economic crisis.
Without fail in my conversations with patients, providers, advocates, and stakeholders, which include my Kansas constituents, I hear about their concerns with the burden of government ``red tape'' and the impact of regulations on their ability to maintain and grow their businesses. While this is not an exhaustive list, I will share the health care regulations that I have been hearing about the most and would ask you to review them for their potential economic impact and modify or remove them to ensure the least burden on our struggling businesses, individuals, and economy.
It should come as no surprise the regulations that I am hearing the most about are related to the impact of PPACA. Although the full impact of recently passed health care legislation is still uncertain, it is clear that additional employer costs will be substantial, as will the burden of what promises to be extreme complexity in compliance. Already patients, providers and advocates have cited a number of regulations related to PPACA that would have profound impact on jobs and our economy. Specifically:
The ``Preexisting Condition Insurance Plan'' and the concern that it is not being utilized efficiently to provide an option for those unable to afford coverage;
The ``Patients Bill of Rights'' and the concern that it has resulted in the loss of child-only insurance markets in over 20 states;
``Grandfathered'' health plan regulation and a concern that the regulation is drafted too narrowly to allow businesses to keep their current coverage and maintain current costs of coverage and are too cumbersome and don't allow plans to comply with ``the early requirements over a period of time'';
``Medical Loss Ratio'' and the concern that the calculation of the standard will increase cost of care for patients and the concern that it will directly result in lost employment and more specifically the omission of health care fraud work as part of ongoing quality improvement activities;
``Rate Review'' and the concern that this requirement will do nothing to control costs and that there are a number of areas within the rule that could cause significant and negative disruption to States and consumers;
``Annual and Lifetime limits'' and the concern over the impact on businesses and individuals the more than 1,000 waivers already issued will have.
Additionally, I have heard that the combination of the regulations being issued to implement the PPACA statute have resulted in an increase in premiums for individuals and businesses, which as you know results in increased costs and tough choices. Related to this, I am deeply concerned by signals from your Administration that regulations being issued to implement the PPACA statute will not be held under the scrutiny of your Executive Order. I would strongly encourage your Administration to review all of the regulations that have been issued, past, present and future, while considering their impact on our economy and jobs.
Finally, patients and providers have expressed a number of concerns related to the regulatory burdens that they face. Generally, they have asked that while the Administration may measure indirect benefits for regulatory proposals, that there is a lack of willingness to analyze and make publicly available the indirect costs to consumers, such as higher energy costs, jobs lost, and higher prices and would request that a reasonable estimate of indirect impact and the methodology used in determining those impacts be made available. They would prefer that agencies be accountable for providing a balanced statement of costs and benefits in public regulatory proposals. Also, I have heard that a number of patients and providers are being buried by the paperwork burden of complying with all of the regulations. Specifically, I have heard about the compliance burden of having to adjust to the sheer volumes of changes that the Administration issues every year and the impact on providers to do their jobs and provide care for patients.
The regulations that I have been hearing about their negative economic impacts and would suggest you review are:
The 2011 Medicare Physician Fee Schedule Final Rule, which requires that laboratory requisition forms are signed by the ordering physician. This rule could have potentially serious implications on patient care and business practice. Under this new policy, laboratories will face a difficult decision when they receive a patient specimen with an unsigned requisition. Laboratories will have to decide not to provide their needed services and therefore be unable to provide a physician the information necessary to make health care decisions--or--provide the services without a guarantee of payment and then work to obtain signatures in order to submit claims to Medicare. As you can imagine, in the former situation, care may be significantly delayed; in the latter scenario the laboratories who serve a high percentage of Medicare beneficiaries could spend a large amount of time contacting providers to gather the required signatures and could see their payments delayed or face the possibility of being unable to receive payment.
On November, 17, 2010, CMS issued a final rule, as directed by PPACA (P.L. 111-148). The rule conditions payment for home health and hospice services based upon a face-to-face encounter between patients and their physicians or certain non-physician practitioners prior to certification for home health or hospice services. This is resulting in burdensome requirements for our rural home health and hospice patients.
Physicians Assistants are an important part of care for rural communities especially hospice and palliative care; however, they are often not considered when drafting regulations related to providers allowed to provide services.
Anti-Switching Rule in Medicare's Competitive Bidding Program (CBP) for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). Specifically, the proposal to enforce the rule in subsequent rounds of the CBP, but not Round 1, may compromise beneficiary access to appropriate diabetes testing supplies and leave beneficiaries vulnerable to pressure from suppliers to switch testing systems.
DMEPOS Competitive Bidding implementation continues to be a concern. We originally had over 400 DME providers in KS; however, now that Round 1 has been implemented I am concerned that patients, especially in rural areas, are facing issues related to access.
Two sets of regulations and guidance--one for hospices and one for rural health clinics--that may have resulted in an oversight in the Medicare billing regulations is creating obstacles for individuals in rural, underserved communities to receive hospice care. In these communities, the primary care physicians are often (and sometimes exclusively) members of Medicare-certified ``rural health clinics.'' However, when a hospice patient's attending physician also happens to be a rural health clinic physician, Medicare is not reimbursing either the physician or the clinic for the physician's services.
Health IT rules related to implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act which I am hearing are creating uncertainty and confusion, jeopardizing the goal of the rapid adoption of electronic health records. Without policy changes, innovation will be marginalized and job creation threatened.
Privacy and security regulations adopted by HHS under the Health Insurance Portability and Accountability Act (HIP AA) and the HITECH Act expand the accounting of disclosures requirement to include all disclosures, even daily, routine disclosures. While patient safety and privacy should be a high priority, businesses are concerned that maintaining detailed records would require an overwhelming amount of information to be stored.
The short amount of time to comply with new ICD10 and 5010 coding requirements impose an incredible administrative burden that I am hearing will increase administrative costs significantly.
CMS regulations that restrict the ability of non-physician practitioners to meeting the CMS requirement for supervision for cardiac and pulmonary rehab. These rules are limiting access to cardiac and pulmonary rehab, particularly in rural and Critical Access Hospitals.
Clearly this is not a comprehensive list, but it represents a number of areas that patients, providers and constituents have expressed concerns on.
Again, thank you for the opportunity to share my recommendations on what rules and regulations pose serious negative consequences to the growth of our nation. As the 112th Congress gets under way, I will continue to identify to your Adminitration regulations that handicap American businesses and halt American job creation. It is my hope that we can create a regulatory environment that provides American businesses with the necessary tools to hire and thrive in this global market.
Mr. ROBERTS. As I have already discussed on the Senate floor, an Executive order was issued by the President on January 18. It was a good order. I applauded that order. It committed all Federal agencies to review regulations and then to try to remove any that placed unreasonable burdens on our Nation's businesses and/or impact the ability of our economy to grow, to recover.
I agree that, in light of our current economic crisis, establishing a regulatory environment that promotes growth and job creation should be the No. 1 priority for this Congress and the administration. I applaud what the President said when he issued the Executive order--that there are some regulations that are duplicative, costly, and unnecessary and, as he said, downright dumb. There was loud applause in farm country, manufacturing, health care, education--you name it. However, after reviewing the Executive order, I remind my colleagues that I was left--and I hope if you read it you are left--with some larger concerns. Specifically, the order left open a number of very large loopholes. It was an Executive order without teeth.
When I was in Kansas over this last work period, I talked to virtually all of our Kansas patients, providers, and advocates about the President's Executive order and my legislation, which is called the Regulatory Reform for Our Economy Act. I held a stakeholder roundtable in Topeka. I held a roundtable in our State capitol, in order to get feedback from patients and provider groups on their thoughts related to health care reform. I was not surprised to hear that every representative at that meeting had a concern with regulations, but the sheer volume of regulatory concerns as seen by my staff and myself was truly extraordinary.
I was already aware of regulations, such as those put forth by the Department of Health and Human Services, along with the Department of Labor and Treasury, that have resulted in the child-only insurance market effectively disappearing in 20 States. Which I believe is the result of overregulation or overrequirements.
I have already sent letters to the administration detailing my concerns with regulations, such as--stick with me now--first, the 2011 Medicare physician fee schedule final rule, which requires that laboratory requisition forms are signed by the ordering physician. This rule could have potentially serious implications on patient care and business practice.
Second, on November 17, 2010, CMS, the Center for Medicare and Medicaid Services, issued a final rule which, as required by the new health care law--the acronym for that is PPACA--conditions payment for home health and hospice services based upon a face-to-face encounter between patients and their physicians or certain nonphysician practitioners prior to certification for home health or hospice services. On top of about a $11 billion cut to hospice, which is rather incredible, this is resulting in burdensome requirements for our rural home health and hospice patients. For those who need this help the most, this is truly hard to understand.
Third, the antiswitching rule in Medicare's competitive bidding program--the acronym is CBP; there is an acronym for everything--for durable medical equipment, prosthetics, orthotics, and supplies. Specifically, that proposal to enforce the rule in subsequent rounds of the competitive bidding program, but not round one, may compromise beneficiary access to appropriate diabetes testing supplies and leave beneficiaries vulnerable to pressure from suppliers to switch testing systems.
I am going to try to get rid of the gobbledygook and say that during the initial round of competitive bidding for medical equipment, some of the suppliers didn't even know there was an initial round of competitive bidding. In Kansas City, there were 424 suppliers, and 20 submitted bids this time around. We delayed it to this year because it was so onerous. Then this year came around and CMS selected 20. What happened to the other 404? What happened to the people who depended on pharmacists and home health care providers for that walker, that crutch, or whatever they need--or oxygen tank, for that matter? We are left with huge holes in the home health care industry and a need for providing DME equipment.
I was surprised to hear that every representative at this stakeholder meeting--and all representative groups were invited, including hospital administrators, doctors, nurses, pharmacists, and hospice folks. I believe it was the first time they met at the same time. I was surprised to hear that every representative at this stakeholder meeting to discuss the impacts of health care reform had concerns with regulations, some of which are buried in the volumes of regulations being put out every day, and many that defy comprehension.
When discussing the President's Executive order and regulations with my constituents and those representing the patient and provider community, the No. 1 concern I heard was a fear not just of the current regulations, which they are trying to keep up with, but of future regulations.
While there is considerable concern with the burden of regulations that have already been issued, I heard time and again that there is an even greater concern with the uncertainty of future regulations, especially those implementing the Patient Protection and Affordable Care Act, or PPACA, and their potential to have further and greater impact on jobs and the economy and health care--even greater than the impacts we discussed during the health care reform debate. At the stakeholder meeting we had meaningful dialog about that. This is akin to a second health care reform earthquake. If you are a health care provider, hang on.
Additionally, I have heard that the combination of the regulations being issued to implement the PPACA statute has resulted in an increase in premiums--to repeat that, an increase in premiums, not cost savings--for individuals and businesses, which, as you know, results in increased costs and very tough choices.
Related to this, I am concerned by reports that I am hearing that staff within the administration have signaled that regulations being issued to implement the PPACA statute already comply with the President's Executive order and would not need to be included in a review. Does that mean all the health care regulations pouring out of CMS are not going to be subject to the President's Executive order? What is that? This is one of the biggest worries we have throughout the country regarding health care, and the President issues an Executive order and says let's take a look. Do the costs outweigh the benefits? Are they duplicative, unnecessary, or just plain dumb?
Those are his words. CMS is exempted? Health care is exempted? That is unreal.
I believe otherwise, and this belief is being verified by personal stories from Kansans. In my letter to the President today, I strongly encouraged him to review all of the regulations that have been issued, past, present, and future, while considering their impact on the economy and jobs. Sure, it would be a tough job. It is time, with the ``Katrina'' of regulations pouring out of the various agencies in Washington.
Understanding this, last month, I, along with Senators BARRASSO and COATS, and with the support of 38 Senate colleagues--have introduced the Regulatory Responsibility for Our Economy Act, S. 358. I urge my colleagues on the other side, who I am going to engage in the next week. We will go face to face and I will try to convince you.
My bill moves to codify and strengthen President Obama's January 18 Executive order that directs agencies within the administration to review, modify, streamline, expand, or repeal those significant regulatory actions that are, in the President's words, duplicative, unnecessary, overly burdensome, or would have significant economic impacts on Americans. I have given President Obama credit for saying that, but I don't give him credit for including the loopholes.
While I agree in principle with the President that we need to take a serious look at both current and proposed Federal regulations, I don't think his Executive order actually does what it purports to do. I have some loopholes listed. In Dodge City, where I come from, coming close to the truth is coming pretty close, but it still ain't the truth. I think this is where this fits.
The Executive order states--and I want everybody in the Senate, if you are listening, or if your staff is listening, provide this to your member. Figure this out:
In applying these principles, each agency is directed to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.
That is a good thing.
Where appropriate and permitted by law, each agency may consider (and discuss qualitatively)--
and this is the part where I had the most concern, and I hope somebody can explain it.
values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.
What is that? ``But,'' as the Wall Street Journal captured so eloquently in their response to President Obama's editorial, ``these amorphous concepts are not measurable at all.'' They are not.
On the surface, I feel this language has the potential to be a very large loophole--probably is already. I believe this is the loophole being used to exempt the PPACA regulations from this review. That is unfortunate. In fact, upon reading and rereading it, it could be better described as gobbledygook.
As a matter of fact, it got my gobbledygook award of the month this past month. My legislation would close the loopholes in President Obama's Executive order and would close other existing loopholes, including those the administration has been using--or the Secretaries for the various agencies have been using--to bypass valuable stakeholder input on regulations. In fact, I hear often that patients and providers believe they do not have a voice in the regulatory process.
More specifically, I hear that a number of regulations are currently being issued through a shortened process which allows limited or no input from those most affected by the regulations prior to their implementation--that is wrong--and they may result in an even greater confusion and burden which then results in greater costs and economic impact, especially if changes are necessary based on later comments that the administration does receive.
It is my understanding the PPACA rules that have been issued as interim final rules and, therefore, with limited input--and they will probably become final--are the national provider identifier, Web portal requirements, Early Retiree Reinsurance Program, coverage of children to age 26. Underserved rural communities, grandfathered health plans, preexisting condition exclusions, preventive services, internal claims/appeals and external review processes, Pre-existing Condition Insurance Plan Program, amendment to grandfathered health plans rule, and medical lost ratio requirements. That is a bunch of them--all regulations through a shortened process.
While there may have been instances in which a shortened process was necessary or appropriate, this lengthy list is why passage of my legislation is so critically important.
I ask the Presiding Officer if I have exceeded my time. If I have, I would like 2 additional minutes to close.
The PRESIDING OFFICER. The Senator has 30 seconds remaining.
Mr. ROBERTS. May I have 2 additional minutes, and I will close.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. ROBERTS. In my letter to the President today, I have encouraged the administration to limit the use of this shortened regulatory process and take every available opportunity to get feedback from those who would be most affected by these regulations--that just makes sense--and allow for ample time to review and consider that feedback prior to implementing the future regulatory priorities. We are going to have better regulations if, in fact, you ask folks: Is this going to work? Maybe tweak it, maybe repeal it. Who knows. The President himself said that.
In addition, I have encouraged the administration to review any comments received on these regulations that have already been issued for any concerns that indicate a potential to further our economic problems and crises.
In closing, I invite my friends on both sides of the aisle to sign on as a cosponsor of my legislation, realizing the immense opportunities it creates for meaningful review and possible revocation of regulations counter to our Nation's growth.
Mr. President, I yield the floor, and I suggest the absence of a quorum.
The PRESIDING OFFICER. Will the Senator withhold his suggestion of the absence of a quorum?
Mr. ROBERTS. I will be delighted to.