Legislative Symposium Update - PowerPoint Presentation

Slide1

Legislative Symposium Update

Ally Storla, MLS(ASCP)CMSlide2

Learning Objectives

By the end of this presentation attendees will be able to:

Know the history of Legislative

Symposium

Understand

the process of Legislative Symposium as a tool for informing and influencing legislative

proceedings

Describe

what ASCLS Government Affair Committee is and what ASCLS Political Action Committee is and how these committees serve ASCLS members in government affairs on behalf of the

Clinical

L

aboratory

S

cience

P

rofession

Discuss

the current 2017 Legislative Symposium issues presented in Washington,

DC

Explain

how to be involved and contribute to this process through either attending a future Legislative Symposium or from being informed at a local level through ASCLS

Government Affairs Committee

call to action events, special elections, and general electionsSlide3

History of Legislative Symposium

Began in 1989The American Society for Clinical Laboratory Science

came

together

with several Laboratory Organizations and

met with their Representatives and Senators on Capitol Hill as a unified front on behalf of our professionSlide4

It

takes a VillageASCLS is proud to work with: the Clinical Laboratory Management Association (CLMA), the American Society for Clinical Pathology (ASCP), Association of Genetic Technologists (AGT),

and

the American Medical Technologists (AMT)

on the Legislative Symposium each

year

 Slide5

Legislative Symposium

Every March ASCLS, ASCP, CLMA, AMT, and AGT come together annually for Legislative SymposiumThe first day is a Monday and prepares attendees by introducing current issues and giving backgroundThe next day, Tuesday, attendees visit their congressional representatives and their senators and discuss the issues presentedEvery attendee receives leave behinds which are also available on ascls.org to give to their representatives after the meetingsSlide6

ASCLS Committees: GAC/PAC

GAK??? PAC???Slide7

ASCLS Committees

Government Affairs Committee (GAC)Our voice in Washington, D. C.Political Action Committee a.k.a. Positive Action Committee (PAC)Our influence in Washington, D. C.Slide8

ASCLS Government Affairs Committee

Key element of the ASCLS Mission and Vision: serving as the voice of all clinical laboratory professionals Keeping abreast of and influencing the formulation of appropriate public (governmental) policy on health care issues vital to the profession and the public is a crucial component of serving as the

voiceSlide9

ASCLS Positive Action Committee

ASCLS/PAC: Working for Your Best InterestsEstablished in 1976, the ASCLS/PAC is administered by its own Board of Trustees

Campaign

contributions must be approved by the Chair or by the full Board of

Trustees

Contributions are decided heavily on a candidate’s history and understanding of healthcare issues and likelihood of supporting clinical laboratory science

Any

solicitation for contributions to ASCLS/PAC is intended solely for members of the American Society for Clinical Laboratory

ScienceSlide10

ASCLS Positive Action Committee

ASCLS/PAC is supported solely by donations from ASCLS membersUnder federal law, these donations must be voluntary, and cannot be listed as a charitable contribution for tax

purposes

The

PAC files financial reports with the Federal Election Commission on a quarterly

basis

Your support of ASCLS/PAC demonstrates your support of hard-working and responsible candidates for public

office

Your

contribution decision will in no way affect your rights as a member of ASCLSSlide11

ASCLS Government Affairs

Alerts 2016Using Emails/Social Media to communicate quickly and efficientlySending out Urgent InitiativesInforming Members of PetitionsProviding a Quick way for Members to be InvolvedSlide12

Hanlon’s Razor

“Never attribute to malice that which can be adequately explained by ignorance”Our Elected

O

fficials rely on us, the experts, as much as our Patients, Doctors, and Nurses

They don’t know what they don’t know especially when it comes to our profession

We are EDUCATORS (for nurses, for doctors, for patients, for each other)Slide13

ASCLS Government Affairs AlertSlide14

Veterans Affairs Sides with Laboratory Professionals

ASCLS, ASCP, Laboratory Community objected to proposed rule“Advanced practice registered nurses (APRNs) lack the clinical training necessary to perform laboratory testing”

December 2016

The U. S. Department of Veterans Affairs released a Final

Rule: advanced

practice registered nurses (APRNs) would

NOT

be authorized to perform and supervise laboratory

testingSlide15

CMS Memorandum April 1, 2016Slide16

ASCLS Government Affairs AlertSlide17

30,000 Laboratory Professionals Urge CMS to reverse Nursing Policy

Sept 27, 2016 BOC, ASCLS, ASCP meet with CMSPresented petition signed by more than 30,000 laboratory professionals opposed to CMS policyFeb 15, 2017 a letter sent to CMS noting the Department of Veterans Affairs recent decision regarding the scope of practice of Advanced Practice Registered Nurses not including performing/supervising high complexity laboratory testing

The CMS memo would let individuals with less training perform or supervise tests in non-VA facilitiesSlide18

CMS Rejects Requests to Reverse Nursing Degree Equivalency Policy

March 13, 2017CMS formally responds to ASCLS, ASCP, BOC: will not reverse policy released in April 1, 2016 memoCMS believes a rule is necessary to change the Agency’s policyThe Laboratory Community is concerned as rule changes can take years

Protecting patient health is urgent and a timely action is needed to fix this policySlide19
Slide20

2017 Legislative Issues Discussed

Laboratory Developed TestsPersonnel ShortageProtecting Access to Medicare Act (PAMA)Slide21

Laboratory Developed Tests

What is a Laboratory Developed Test(LDTs)?Tests which are developed, evaluated, and validated within one laboratory instead of the most common tests which are commercial, manufactured and marketed to multiple labsLabs often choose to develop and use an LDT because a commercial test is not available

Genetic Tests for Rare Diseases

No manufacturer incentive to develop (i.e. Huntington disease

)

Example: Chemistry Glucose/Protein testing on body fluids such as CSF/Pleural instead of blood

Tests

still go through rigorous validation procedures before results can be used for decisions regarding patient

care

The Clinical Laboratory Improvement Amendments (CLIA)Highly regulates the evaluation and use of laboratoy

tests including lab-developed assaysSlide22

Laboratory Developed Tests

What are Laboratory Developed Test(LDTs)?FDA Definition: In vitro diagnostic tests that are designed, manufactured, and used within a single laboratoryPrior to July 31, 2014 the FDA allowed these products to enter the market without approval

Many laboratories perform good validation of their LDTs and provide high-quality, professional management of their operations

Patients and providers have recently been unable to uniformly rely on all tests offered for clinical use as some are not subject to active premarket oversight hence the FDA becoming involvedSlide23

Laboratory Developed TestsSlide24

Laboratory Developed TestsSlide25

2016 Laboratory

Developed Tests Should Be Carefully RegulatedPosition:

We as clinical laboratory professionals agree that laboratory developed tests (LDTs) must be regulated to ensure their accuracy and overall patient

safety

The ask:

Congress and the Administration to provide stakeholders in the laboratory community with sufficient time to develop a consensus

on how the regulatory

approach for the oversight of

LDTs should be developed

With estimates that FDA may have to review 60,000 or more LDTs, we are concerned that the guidance advanced by the FDA and the draft legislation

may exacerbate the slow, resource-intensive FDA oversight that manufacturers have complained has constrained the ability to update and modify commercial test kits in a timely manner

We believe that enhanced oversight requires a coordinated, streamlined, patient-centered modernization of the oversight by FDA as well as by CMS

Congress should urge the FDA to release the latest version of LDT guidance immediately, but as proposed rather than final so a consensus approach can be pursuedSlide26

2017 Laboratory Developed Tests Position

Update:On January 13, 2017, the FDA released a discussion paper on LDTs and announced that it would not issue a final guidance on the oversight of LDTs at the request of various stakeholders to allow for further public discussion on an appropriate oversight approach, and to give congressional authorizing committees the opportunity to develop a legislative

solutionSlide27

Laboratory Developed Tests Should Be Carefully Regulated

Position: We as clinical laboratory professionals agree that laboratory developed tests (LDTs) must be regulated to ensure their accuracy and overall patient safety Patients

and health care providers need accurate, reliable, and clinically valid tests to make good health care

decisionsSlide28

Laboratory Developed Tests

We share the FDA’s goal to balance patient protection with continued access and innovationWe urge the FDA to address the issue of health system laboratories that may use the same methods and equipment

If

an LDT is validated in one laboratory within a health system, we urge that the other system laboratories be allowed to adopt the method without repeating the full

validationSlide29

Laboratory Developed Tests

FDA Discussion Paper on LDTConversation, very appreciative of FDA to listen to our communities’ concernsFDA acknowledges difficulty in finding a solution that will appeal to all stakeholdersDue to extensive community engagement the positions of many groups (including the FDA) have evolved

FDA intents are to “appropriately balance patient protection with continued access and innovation”Slide30

Laboratory Developed Tests

https://xkcd.com/1706/Slide31

Growing Crisis in the Clinical Laboratory WorkforceSlide32

Growing Crisis in the Clinical Laboratory Workforce

Bureau of Labor statistics: need of 12,000 Medical Laboratory Professionals per year to meet demandAcademic programs currently produce 5,000 graduates per yearAverage age of Laboratory Workforce: aging at a 78% faster rate than entire U. S. labor marketMLS/MLT academic programs declined in 1970 from 1000 to less than 450 in 2006

Since 2008 programs increased from 427 to 479 but still not enough to meet the demandSlide33

Growing Crisis in the Clinical Laboratory Workforce

September 28, 2016 VA Office of Inspector General determined largest critical need occupations were: Medical Officer, Nurse, Psychologist, Physician Assistant, Physical Therapist, and Medical Technologist (Clinical Laboratory personnel

)

VALOR program (VA Learning Opportunities Residency) provide paid internships for Armed Forces Laboratory PersonnelSlide34

Growing Crisis in the Clinical Laboratory Workforce

The Ask:To ensure access to quality health care services the healthcare system must have an adequate supply of clinical laboratory personnel Today that supply is in serious

question

This

shortage hampers the ability of clinical laboratories to meet patient testing demands, posing problems for patient health and

welfare

Growing

numbers of patients and the

increasing number

and complexity of medical laboratory tests are putting strains on an already short staffed professionSlide35

Growing Crisis in the Clinical Laboratory Workforce

Congress must do the following: Enhance recruitment and retention efforts within the Veterans Health Administration Authorize and appropriate funding for a program to within the Public Health Service Act to ensure training for citizens seeking to enter the clinical laboratory workforce

Authorize

the Government Accountability Organization (GAO)

to study the shortage of clinical laboratory personnel and make recommendations to Congress Slide36

2016 Protecting Access to Medicare Act (PAMA)Slide37

Committee on Ways and MeansSlide38

2017 PAMA

The Ask: Congressional Support for Administrative Delay of Implementation of Sec. 216 of PAMA until January 2019 Sec.

216

of PAMA – Protecting Access to Medicare Act – requires CMS to calculate and establish a new Medicare Clinical Lab Fee Schedule (CLFS) based on private payer payment data submitted by “applicable labs

”

The

intent was to revise the CLFS based on true market based

pricing

The

project as laid out by CMS is flawed and does reflect true marked based reimbursement rates as intended by Congress Slide39

Applies to more than just Medicare

Concerns: 1. New reimbursement rates will be set based on incomplete and inaccurate data

a

. Centers for Medicare/Medicaid Services

(CMS)’s

current definition of “applicable lab” excludes virtually all hospital labs and physician office labs and about half of independent

labs

b. Per the

Office of the Inspector General,

Medicare spends $7B yet how CMS

defined “applicable lab”, only $2B of payment data is being reported and will be used to set new payment rates leaving out 72% of payment data c. The new CLFS will apply to all labs, not just those who reported data

d. As recently as March 13, 2017 CMS was still providing conflicting information to labs as to whether they were an applicable lab and should report their data. The deadline to report is March 31, 2017. Slide40

Applies

to more than just Medicare2. The new CLFS will not just affect Medicare and Medicaid: a

lmost

all private

payors

base their contracted fees for lab services on the Medicare

CLFS

If the Medicare CLFS is decreased by 10%-15%, the private

payor rates will also be lowered, cutting ALL reimbursements Slide41

Garbage in, Garbage out

3. The OIG in September 2016 voiced significant concerns regarding PAMA a. Only 5% of labs would be reporting data, skewing the data used to calculate the new fee schedule

b. CMS has no plans to conduct audits to:

i

. identify applicable labs

ii. identify whether all labs reported

iii. verify completeness or accuracy of data Slide42

CMS has not communicated well

4. CMS promised the lab community transparency in their calculation of new payment rates, but has yet to specify how they would provide this 5

. The Medicare CLFS is the oldest fee schedule and has not been seriously reviewed and revised since it was implemented in 1986!

Using

the flawed data collection process set under PAMA is not the way to rationalize and modernize the

CLFS

6

. Under PAMA, CMS can lower current reimbursement rates up to 10% in 2018, 2019 and 2020 and up to 15% in 2021, 2022 and

2023

If PAMA is allowed to move forward, it has the

potential to be the single most financially disruptive event for clinical labs, already subjected to repeated and severe reimbursement cuts for the last three decades! Slide43

The

opposite of PROTECTING Access to Medicare7. The financial impact on clinical laboratories if PAMA is implemented is significant, especially for community based hospitals, rural hospitals and nursing homes. With typical profit margins of 3% to 5%, a 10% to 15% cut in reimbursement will mean:

a

. No money for raises, inability to be competitive and recruit staff

b. No money for new equipment and new technology

c. Less testing done in-house and more sent to outside reference labs

leading to

possible

layoffs

d. Increased delay in getting results if sent out causing delay in diagnose and in inpatients: increased length of stay e. Labs no longer financially viable - possible lab closings and bankruptcy

f. Selling off the lab business to a national reference lab – already seen in the industry with PAML (LabCorp purchased) and others. This results in a loss of hundreds of high paying, technical jobs as well as significant local economic impact and loss of locally available lab services. Slide44

Much is at stake

8. Access to care for both the community and nursing home patients served by the community hospital lab will be compromised less access to quality lab services exactly the opposite of PROTECTING Access to Medicare

For

all these reasons, setting a new Medicare CLFS based on the flawed data collection process under PAMA must be delayed.Slide45

CMS Extends PAMA Reporting Deadline

March 30, 2017 CMS agreed to extend the reporting deadline to May 30, 2017 for applicable laboratoriesExtension is good but we really need CMS to delay PAMA implementation by one year as “applicable laboratories” definition fails to capture entire laboratory marketMajor concern is the new payment rate will be heavily influenced by laboratories with significant economies of scale and not congruent with smaller independent laboratories and hospital outreach laboratories

We want reform to the current Medicare CLFS payment system but we want it done correctly so as to not hinder patient accessSlide46
Slide47

Meeting with Senator Perdue & Senator Isakson’s Healthcare AidsSlide48

Call to Action—What can I do?

“Get involved” what does that mean?How can I make a difference?Slide49

Call to Action—What can I do?Slide50

Call to Action—What can I do?Slide51

Questions?Slide52

Sources

https://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/laboratorydevelopedtests/ucm536965.pdfhttp://www.ascls.org/advocacy-issues/legislative-symposium

http

://

www.ascls.org/government-affairs-main

http://

www.ascls.org/advocacy-issues/pac

https://

www.ascp.org/content/Newsroom/va-sides-with-ascp-laboratory-professionals-on-nursing-scope-of-practice

https://

www.ascp.org/content/functional-nav/boc-newsroom/epolicy-news-april-2017https://www.ascp.org/content/Newsroom/epolicy-news-march-2017#NewsroomGrid

https://labtestsonline.org/understanding/features/ldt/