Congressional Record, Volume 157 Issue 36 (Thursday, March 10, 2011)

[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.

____________________