[Congressional Record Volume 157, Number 36 (Thursday, March 10, 2011)]
[Senate]
[Pages S1534-S1537]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    ASSAULT ON THE NATION'S ECONOMY

  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:

                                                  U.S. Senate,

                                   Washington, DC, March 10, 2011.
     President Barack Obama,
     The White House,
     Washington, DC.
       Dear President Obama: I write you today to express my 
     sincere appreciation for the Executive Order that you issued 
     on January

[[Page S1535]]

     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
       1099 reporting

       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
       Preventive Services
       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

[[Page S1536]]

     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.
           Sincerely,
                                                      Pat Roberts,
                                                     U.S. Senator.

  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?

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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.

                          ____________________