2016 Pharmacy Law Review law tablet.pdf · Pharmacy Technician CPE HB3271 • Sponsor: Rep. Michael Zalewski (D-Riverside) • Amends Pharmacy Practice Act • Clarifies Technician

2016 Pharmacy Law ReviewGarth K. Reynolds, BSPharm, RPh

Executive DirectorIllinois Pharmacists Association

Disclosure and Conflict of Interest

Garth K. Reynolds, BSPharm, RPh declares no conflicts

of interest, real or apparent, and no financial

interests in any company, product, or service

mentioned in this program, including grants,

employment, gifts, stock holdings, and honoraria.

CPE Activity Information

• Target Audience: Pharmacists and Technicians

• Activity Type: Knowledge-Based

• Contact Hours: 2.0

• UAN: 0135-0000-16-026-L03-P / 0135-0000-16-026-L03-T

Pharmacist Objectives

At the conclusion of this program, the pharmacist will be able to:

• Discuss pharmacy-related legislation from the 2016 session of the 99th

General Assembly.

• Describe proposed revisions to the Illinois Administrative Code in relation to the Pharmacy Practice Act.

• Describe the status of pharmacy-related Federal legislation, including Pharmacist Provider Status.

• Discuss the regulatory changes and updates for Medicare Part D for 2017.

• Discuss status of IPhA sponsored legislation initiatives.

Technician Objectives

At the conclusion of this program, the technician will be able to:

• Discuss pharmacy-related legislation from the 2016 session of the 99th

General Assembly.

• Describe proposed revisions to the Illinois Administrative Code in relation to

the Pharmacy Practice Act.

• Describe the status of pharmacy-related Federal legislation, including

Pharmacist Provider Status.

• Discuss the regulatory changes and updates for Medicare Part D for 2017.

• Discuss status of IPhA sponsored legislation initiatives.

According to SB3336, what is the responsibility of the

pharmacist in charge if an employee is terminated for

a patient safety issue?

a) Call surrounding pharmacies not to hire

b) Contact NABP about the individual and report the medication error

c) Contact the Chairman of the BOP to report the individual

d) Complete the online DFPR form to inform of the termination

What reimbursement rate would pharmacists be paid

under H.R.592/S.314?

a) 90% of Physician Rate

b) 85% of Physician Rate

c) 100% of Pharmacist Rate

d) 50% of Physician Rate

What is the name of the IPhA naloxone training program

developed to meet the standards of PA 99-0480?

a) Illinois State Opioid Antagonist Training

Program

b) IPhA Naloxone First Program

c) Illinois State Naloxone Dispensing Program

d) Naloxone Patient Education and Training

Program

Which is not a component of the HB5591/SB2515?

a) PBM Registration

b) Audit Protections

c) MAC Transparency

d) Medication Synchronization

e) Patient Data Protections

f) All of the Above are components

When is the General Election?

a) November 8, 2016

b) November 8, 2016

c) November 8, 2016

d) November 8, 2016

99th General Assembly

http://www.ilga.gov

99th General Assembly

• Senate: 39 Democrats | 20 Republicans

• House: 71 Democrats | 47 Republicans– Democrats have Super Majority in both chambers

• Currently – 10,044 bills | 3,762 resolutions– Usually monitoring between 150-300 bills/resolutions

• 99th General Assembly– January 1, 2015 – December 31, 2016

Senate Leadership

• Senate President John Cullerton (D-Chicago)

• Majority Leader James Clayborne (D-East St. Louis)

• Minority Leader Christine Radogno (R-Lemont)

House Leadership

• Speaker of the House Michael Madigan (D-Chicago)

• Majority Leader Barbara Flynn Currie (D-Chicago)

• Minority Leader Jim Durkin (R-Burr Ridge)

General Assembly Committees

• House– Appropriations – Human Services

• Greg Harris | Patricia Bellock

– Health & Healthcare Disparities • William Davis | David Leitch

– Health Care Availability Access • Mary Flowers | Chad Hays

– Health Care Licenses • Michael Zalewski | Michael McAuliffe

– Human Services • Robyn Gabel | Patricia Bellock

– Insurance • Monique Davis | David Reis

– Labor and Commerce • Jay Hoffman | Dwight Kay

– Revenue & Finance • John Bradley | David Harris

• Senate– Appropriations

• Heather Steans | Dale Righter• Donnie Trotter | Chapin Rose

– Human Services • Daniel Biss | Dave Syverson

– Insurance • William Haine | William Brady

– Licensed Activities and Pensions • Iris Martinez | Pamela Althoff

– Public Health • John Mulroe | Dave Syverson

– Revenue • Toi Hutchinson | Pamela Athoff

http://www.ilga.gov

Illinois Departments that impact Pharmacy

• Department of Financial and Professional Regulation - DFPR

• Department of Healthcare and Family Services - HFS

• Department of Human Services - DHS

• Department of Insurance - Insurance

• Department of Public Health - DPH

• Department of Central Management Services - CMS

http://www.ilga.gov

Pharmacy Related Statutes and Administrative Code

• Illinois Pharmacy Practice Act & Rules

• Illinois & Federal Controlled Substance Act & Rules

• Illinois Hypodermic Needle and Syringe Act

• Illinois & Federal Food, Drug and Cosmetic Act & Rules

• Wholesale Drug Distribution Licensing Act and Rules

• Illinois Poison Prevention Packaging Act

• Poison Prevention Packaging Act of 1970

• Cannabis Control Act

• Compassionate Use of Medical Cannabis Pilot Program Act

http://www.ilga.gov

2016 Spring Session

http://www.ilga.gov/legislation/billstatus.asp?DocNum=5809&GAID=13&GA=99&DocTypeID=HB&LegID=95273&SessionID=88

Oral Contraceptives HB5809

• Sponsor(s): Rep. Michelle Mussman (D-Schaumburg)

• Add prescribing and dispensing of hormonal contraceptives to the definition of “Practice of Pharmacy”.

• Requires completed training course.

• Requires patients complete a self‐screening risk assessment tool prior to dispensing.• Requires the pharmacist to refer the patient to their primary care provider or

women’s health care practitioner.

• Prohibits continued prescribing and dispensing if the patient has not visited their primary care provider within 3 years after initial prescription.

• STATUS: Re-referred to Rules 04/22

SB2461: http://www.ilga.gov/legislation/billstatus.asp?DocNum=2461&GAID=13&GA=99&DocTypeID=SB&LegID=94302&SessionID=88HB4970: http://www.ilga.gov/legislation/billstatus.asp?DocNum=4970&GAID=13&GA=99&DocTypeID=HB&LegID=94279&SessionID=88

Deputy Coordinators SB2461/HB4970

• Sponsor(s): Sen. Jason Barickman (R-Bloomington), Rep. Brian Stewart (R-Freeport)

• Removes the statutory requirement for two deputy pharmacy compliance coordinators.

• Removes the limitations on the number of pharmacy investigators from the practice act.

• STATUS: – Senate 55-0-0 04/20 / Re-referred to Rules (House) 04/20SB2461

– Rules Comm 04/08HB4970

http://ilga.gov/legislation/billstatus.asp?DocNum=2628&GAID=13&GA=99&DocTypeID=HB&LegID=88158&SessionID=88

Good Samaritans HB2628

• Sponsor: Rep. Laura Fine (D-Glen View)

• Amends the Good Samaritan Act

• Recognize Volunteer Medical Reserve Corp under

definition of “free medical clinic”.

• Status: Referred to Assignments10/10/2015

Unused Medications SB1811

• Sponsor: Sen. Iris Martinez (D-Chicago)

• Amends Pharmacy Practice Act

• Provide any pharmacy with one or more locations to

collect and discard unused prescription medications

(including controlled substances).

• STATUS: Referred to Assignments10/10/2015

http://ilga.gov/legislation/billstatus.asp?DocNum=1811&GAID=13&GA=99&DocTypeID=SB&LegID=88627&SessionID=88

Pharmacy Legislation Enacted


Quality Assurance SB3336/HB6180

• Sponsor(s): Sen. Dale Righter (R), Rep. Mike McAuliffe (R)

• Requires all pharmacies to establish quality assurance programs.

• Protects reports and other documents from discovery for arbitration, civil and criminal proceedings.

• Does allow access to the Department of Financial and Professional Regulation.

• STATUS: – Public Act 99-0863SB3336 Effective 08/19/2016

– Rules Comm 04/08HB6180


Medication Locking Caps SB2901/HB5949

• Sponsor(s): Sen. Iris Martinez (D-Chicago),

– Rep. Michael Zalewski (D-Riverside)

• Extends the medicine locking closure package pilot an additional year to

January 1, 2018.

• STATUS:

– Re-referred to Rules 06/30SB2901

– House 111-0-0 04/12 / Senate 50-0-0 5/29 HB5949

• Public Act 99-0654 – Effective 07/28/2016

HR944: http://www.ilga.gov/legislation/billstatus.asp?DocNum=944&GAID=13&GA=99&DocTypeID=HR&LegID=93458&SessionID=88HJR139: http://www.ilga.gov/legislation/billstatus.asp?DocNum=139&GAID=13&GA=99&DocTypeID=HJR&LegID=97130&SessionID=88

E-prescribing HR944 / HJR139

• Sponsor(s): Rep. Michael Zalewski (D-Riverside)

• Urges IDFPR to study the impact of a mandatory mechanism within e‐prescribing systems to transmit all discontinuation, stop and cancel orders to pharmacies.

• Urges IDFPR to study the impact auto‐refill programs have on continued filling of discontinued medications.

• Amended to urge IDPH coordinating with CSU, SIUE, UIC COPs to study the promoting and encouraging interprofessional communication between health care providers.

• Amended to urge IDPH to examine and recommend solutions for a mechanism or process for e-prescribed prescription orders.

• Amended to urge IDPH to examine overall benefits of pharmacist led medication reconciliation upon admission & discharge and in transition between healthcare settings.

• STATUS: House 113-0-0 04/14 / Senate 59-0-0 05/31– Resolution Adopted


Epinephrine SB2878 / HB4462

• Sponsor(s): Sen. Chris Nybo (R-Lombard) / Rep. Michelle Mussman (D-Schaumburg)

• Urges law enforcement officers to carry epinephrine auto-injectors and administer in good faith in needed.

• Provide training for storage and proper administration.

• Standing orders issued by physician, PA, or APN for the law enforcement department.

• STATUS: – Re-referred to Assignments 07/31SB2878

– House 115-0-0 04/19 / Senate 55-0-0 05/11HB4462

• Public Act 99-0711 Effective January 1, 2017

Pharmacy Technician CPE HB3271

• Sponsor: Rep. Michael Zalewski (D-Riverside)

• Amends Pharmacy Practice Act• Clarifies Technician registration• Establishes that CPhT to obtain 20 contact hours of CPE every 2 years (Effective 01/01/2017)

– 1 contact hour in pharmacy law– 1 contact hour in patient safety

• Pharmacy Inspectors (Effective 08/27/2015 )– IPhA supported language from IDFPR to revert that all future pharmacy inspectors must be registered pharmacists.

– Does not impact any currently employed non-pharmacist inspectors.

• Combined with Medication Locking Cap bill HB3219 (Effective 01/01/2016 until 12/31/2016)– IPhA, working with IRMA and ICHP, were able to minimize the impact of this section concerning medication locking caps.

– Creates a one year pilot program – voluntary participation by pharmacy.

– For hydrocodone containing – Schedule II prescriptions.

– Medicaid, Medicare Part D, and LTC patients exempt from pilot program.

– Prescribers may exempt any patient from the pilot program by indicating on the prescription order (This provision was added in the Senate, which is why HB3219 returned to the House for concurrence).

– DFPR may not expend more than $150,000 for this pilot.

• STATUS: Public Act 99-0473 (08/27) HB3219 http://ilga.gov/legislation/billstatus.asp?DocNum=3271&GAID=13&GA=99&DocTypeID=HB&LegID=89435&SessionID=88

Biosimilars SB1611/HB3519/SB455

• Sponsor(s): Sen. Anthony Muñoz (D-Chicago) / Rep. David Harris (R-Mount Prospect)

• Amends Pharmacy Practice Act – Defines Biosimilars, Biologics, Interchangeable

• Requires notification of patient by pharmacist of interchange.

• "The communication shall be conveyed by making an entry that can be electronically accessed by the prescriber through:

– an interoperable electronic medical records system; an electronic prescribing technology;

– a pharmacy benefit management system; or a pharmacy record.“

• "Entry into an electronic records system as described in this subsection (c) is presumed to provide notice in accordance with this subsection

(c). Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic

transmission, or other prevailing means, except that communication shall not be required where:

– there is no United States Food and Drug Administration-approved interchangeable biological product for the product prescribed; or

– a refill prescription is not changed from the product dispensed on the prior filling of the prescription."

• STATUS: Postponed - Executive (03/26)SB1611 / Re-referred to Rules (04/24)HB3519 / Public Act 99-0200 (07/30)SB455

SB1611: http://ilga.gov/legislation/billstatus.asp?DocNum=1611&GAID=13&GA=99&DocTypeID=SB&LegID=88324&SessionID=88HB3519: http://ilga.gov/legislation/billstatus.asp?DocNum=3519&GAID=13&GA=99&DocTypeID=HB&LegID=89707&SessionID=88

SB455: http://ilga.gov/legislation/billstatus.asp?DocNum=455&GAID=13&GA=99&DocTypeID=SB&LegID=84418&SessionID=88

Heroin Crisis Act HB1

• Sponsor: Rep. Lou Lang (D-Skokie)

• Medication Take Back program to be established by 06/01/2016. Pharmacy participation will be voluntary. All Pharmacies will display a sign of local state-approved drop-off sites.

• Pharmacies need to have in place and post a policy regarding the type of identification, if any, necessary to receive a prescription.

• Requires for sequential C-II prescriptions that prescribers must document reason of medical necessity for the (2) additional 30-Day supply in patient’s medical record.

• Additional data element of Days Supply required to be transmitted to the Prescription Monitoring Program (PMP).

• Reporting to the Prescription Monitoring Program (PMP) changes from within 7 days to the end of the next business day.

• Statewide standing order, developed by the Department with Dept of Public Health and Dept of Human Services, for pharmacists to dispense opioid antagonist (naloxone); pharmacists will need to complete a training program.

• Exemption of civil liability for dispensing or administering an opioid antagonist without fee or compensation.

• STATUS: Public Act 99-0480 (09/09)

http://ilga.gov/legislation/publicacts/99/PDF/099-0480.pdf

Pharmacist Role with Opioid Antagonist

• Pharmacist as Educator:– Motivating people to be obtain an opioid antagonist;

• Pharmacist as Facilitator:– Working with other healthcare providers and community organizations

to increase access to opioid antagonists;

• Pharmacist as Practitioner:– Protecting vulnerable people, consistent with state law.

Kelly Gable, PharmD, BCPP, Chris Herndon, PharmD, BCPS,Jessica Kerr, PharmD, CDE, & Garth Reynolds, BSPharm, RPh

Illinois State Opioid Antagonist Training Program

• Released: March 11, 2016 | 1.75 Contact Hours of CPE

• The Illinois State Opioid Antagonist Training Program has been approved by the Illinois Department of Public Health, the Illinois Department of Financial and Professional Regulation, and the Illinois Department of Human Services and meets the requirements set forth in PA 99-0480.

• Training Program Objectives1. Describe the opioid abuse and overdose epidemic on a state and national level.

2. Review unique pharmacological properties of commonly prescribed opioids and heroin.

3. Discuss the neurobiology of addiction and opioid use disorder.

4. Understand risk factors, signs of an opioid overdose, and the role of opioid antagonist therapy.

5. Describe the role of pharmacy personnel in opioid overdose management.

6. Evaluate key elements of patient and caregiver education on opioid overdose management.

7. Discuss standardized procedures, naloxone standing order sets, and clinical documentation.

http://prescribetoprevent.org/wp2015/wp-content/uploads/naloxone-access.pdf

http://prescribetoprevent.org/wp2015/wp-content/uploads/Naloxone-product-chart.16_01_21.pdf

http://www.idfpr.com/Forms/DPR/NaxoloneStdProcOpioidAntInit.pdf

Right to Try HB207/HB496/HB1335/HB2508/SB29

• Sponsor(s): Rep. Mary Flowers (D-Chicago)/ Sen. Michael Connelly (R-Wheaton)/ Rep. Daniel Beiser (D-Alton)/ Rep. Greg Harris (D-Chicago)

• Creates the Right to Try Act.

• Allows patients, who are terminally ill, to obtain an investigational medication that has completed Phase 1 clinical trials, but not yet approved by the Food and Drug Administration.

• Manufacturers may charge the patient for the medication. Manufacturers are not required to make the medication available.

• Insurers are not required to cover, but are encouraged.

• STATUS: Public Act 99-0270 (08/05)HB1335

HB1335: http://ilga.gov/legislation/billstatus.asp?DocNum=1335&GAID=13&GA=99&DocTypeID=HB&LegID=85988&SessionID=88

APN – Collaborative Practice HB421/SB1315

• Sponsor(s): Rep. Sara Feigenholtz (D-Chicago) / – Sen. Heather Steans (D-Chicago)

• Amends Nurse Practice Act• Eliminates requirement for written collaborative agreements• Eliminates requirement for anesthesia plan for certified registered

nurse anesthetists

• STATUS: – Public Act 99-0173 (07/29)HB421

– Postponed - Licensed Activities & Pensions Committee (04/29)SB1315

HB421: http://ilga.gov/legislation/billstatus.asp?DocNum=421&GAID=13&GA=99&DocTypeID=HB&LegID=84781&SessionID=88SB1315: http://ilga.gov/legislation/billstatus.asp?DocNum=1315&GAID=13&GA=99&DocTypeID=SB&LegID=87795&SessionID=88

Controlled Substances SB689

• Sponsor(s): Sen. Matt Murphy (R-Palatine)

• Amends Pharmacy Practice & Controlled Substances Act.

• Allows APN/Practical Nurse/RN/PA to pick up, delivering, and possessing controlled substances for a patient utilizing hospice services or home health services.

• STATUS: Public Act 99-0163 (07/28)


Eye Drops HB499/HB3137

• Sponsor: Rep. Dan Brady (R-Normal)

• Creates the Topical Eye Medication Act.

• Removes early refill restrictions, individual and group policies, for eye drops, being used to treat a chronic condition of the eye.

• Refill to be requested prior to the last day of prescribed eye drops or after 75% of predicted days of use.

• Number of early refill may not exceed total number of refills prescribed.

• STATUS:– Re-referred to Rules Committee (03/27)HB499

– Public Act 99-0226 (08/03)HB3137


Screening Act SB661

• Sponsor: Sen. John Mulroe (D-Chicago)

• Creates Hepatitis C Screening Act

• Individuals born b/w 1945-1965 who receive services from inpatient or ER be offered a hepatitis C related test

• STATUS: Veto by Governor (08/21) – Veto Sustained (09/24)


MCPP Medical Condition SB33

• Sponsor: Sen. Michael Hastings (D-Matteson)

• Amends the Medical Cannabis Pilot Program

• Adds Post-traumatic Stress Disorder - PTSD

• STATUS: Governor Vetoed (09/10) | Veto Sustained (11/04)


IPhA Legislative And Regulatory Initiatives

Immunizations HB3627 / HB4213

• Sponsor: Marcus Evans (D-Chicago)

• Amends Pharmacy Practice Act

• Changes ability to administer all vaccines from 14 years to 10 years of age

• Failed to obtain votes to get out of committee

• STATUS: Re-referred to Rules Committee (03/27)

HB3627: http://ilga.gov/legislation/billstatus.asp?DocNum=3627&GAID=13&GA=99&DocTypeID=HB&LegID=89823&SessionID=88HB4213: http://ilga.gov/legislation/billstatus.asp?DocNum=4213&GAID=13&GA=99&DocTypeID=HB&LegID=91283&SessionID=88

Pharmacist Provider Designation HB4051

• Sponsor: Rep. Dan Brady (R-Normal)

• Amends Care of Students with Diabetes Act, the Health Maintenance Organization Act, the Limited Health Service Organization Act, the Managed Care Reform and Patient Rights Act, the

Voluntary Health Services Plans Act, and the Health Care Services Lien Act

• Add pharmacy or pharmacist-provided services to the types of health services under the Acts.

• Add pharmacists as health care providers or health care professionals under the Acts

• STATUS: Pass – Human Services Committee (03/25) / Re-referred to Rules Committee (04/24)


Managed Care HB4079 HB5591/SB2515

• Sponsor: Rep. Kelly Cassidy (D-Chicago)

– Rep. Lou Lang (D-Skokie) / Sen. Anthony Muñoz (D-Chicago)

• Amends Insurance Code

• Establish registration/oversight for PBMs

• Provides contracting for pharmacist provided care services

• Audit protection conditions

• Increased transparency for pricing

• Strengthens any willing provider

• Allows medication synchronization

• STATUS: Re-referred to Rules Committee (04/08)HB5591 | Insurance Committee SB2515

HB5591: http://ilga.gov/legislation/billstatus.asp?DocNum=5591&GAID=13&GA=99&DocTypeID=HB&LegID=95026&SessionID=88SB2515: http://ilga.gov/legislation/billstatus.asp?DocNum=2515&GAID=13&GA=99&DocTypeID=SB&LegID=95015&SessionID=88


Managed Medicaid Reimbursements HB4095

• Sponsor: Rep. Sara Feigenholtz (D-Chicago)

• Amends the Public Aid Code• Fair and reasonable reimbursement rate to pharmacy providers for

pharmaceutical services, prescription drugs and drug products, and pharmacy or pharmacist-provided services.

• Fair and reasonable professional dispensing fee • Reimbursement rate shall not be less than the reimbursement rate

utilized by the Illinois Department for reimbursement for prescription and pharmacy or pharmacist-provided services

• STATUS: Re-referred to Rules Committee (03/27)


Proposed Compounding Rules

68 IAC 1330.640

• Proposed at this time

– IPhA provided comments to DFPR (ISMS and ISVMA)

– Establish USP 795 and 797 into Rule

• USP Compounding Compendium (USP 800)

– Allows for “office use” (even though contradicted by DCSA

• Sets up rules for “office use”

– Establishes between human and non-human compounding

O Budget, Where Art Thou

FY2016 Budget

• IPhA continues to have discussions and contact with the Governor’s office, HFS, and CMS.

• Dispensing Fee (March 2015)– $5.50 (multiple source)

– $2.40 (single source)

– $12.00 for both single source and multiple source drugs purchased through the 340B Drug Pricing Program

• Dispensing Fee (May 2015)– $4.50 (multiple source) 16.75% reduction

– $1.40 (single source) 16.75% reduction

– $12.00 for both single source and multiple source drugs purchased through the 340B Drug Pricing Program

• SB788 (Democrats Alternative Proposal)– Dispensing Reduction of 2.5% ($5.38 multiple source, $2.35 single source)

• Court Decision and Consent Decrees (July 2015)– Directs HFS to continue to pay Medicaid providers for services during FY2016

– Dispensing Fees return to March 2015 levels

• State Employee Prescription Plans– Payments ceasing to medical providers for the self-insured plans

– Unions have sued to continue payments to healthcare providers for the state employee plans (September 18th)

FY2016/2017 Budget

• SB2059 – provides emergency funding to higher education in Illinois

affected by the budget impasse.

– Appropriates $600 million to public universities.

– $167 million goes toward the Monetary Aid Program, or MAP grants.

– Effective 04/25/2016

• SB2047 – General Assembly passed a stopgap measure

– Provides funding until 12/31/2016

– Funding focused on schools, colleges, and human service programs

– Effective 06/30/2016

• Next Step(s)?

SB2059: http://ilga.gov/legislation/billstatus.asp?DocNum=2059&GAID=13&GA=99&DocTypeID=SB&LegID=90603&SessionID=88SB2047: http://ilga.gov/legislation/billstatus.asp?DocNum=2047&GAID=13&GA=99&DocTypeID=SB&LegID=90591&SessionID=88

Federal Legislation and Regulation

114th Congress

• House

– 246 Republicans

– 186 Democrats

– 3 Vacancies

• Senate

– 54 Republicans

– 44 Democrats

– 2 Independents

Senate Leadership

• Senate President – Vice President Joe Biden

• President Pro Tempore – Orrin Hatch (R-UT)

• Majority Leader – Mitch McConnell (R-KY)

• Majority Whip – John Cornyn (R-TX)

• Minority Leader – Harry Reid (D-NV)

• Minority Whip – Richard Durbin (D-IL)

Senate Committees

• Finance Committee

– Chairman Orrin Hatch (R-UT)

– Ranking Member Ron Wyden (D-OR)

• Health, Education, Labor & Pensions Committee (HELP)

– Chairman Lamar Alexander (R-TN)

– Ranking Member Patty Murray (D-WA)

House Leadership

• Speaker of the House – Paul Ryan (R-WI)

• Majority Leader – Kevin McCarthy (R-CA)

• Majority Whip – Steve Scalise (R-LA)

• Minority Leader – Nancy Pelosi (R-CA)

• Minority Whip – Steny Hoyer (R-MD)

House Committees

• Energy and Commerce Committee

– Chairman Fred Upton (R-MI)

– Ranking Member Frank Pallone (D-NJ)

• Ways and Means Committee

– Chairman Kevin Brady (R-TX)

– Ranking Member Sander Levin (D-MI)

Pharmacists Provider Status

• H.R. 592: Pharmacy and Medically Underserved Areas Enhancement Act

• Rep. Brett Guthrie (R-KY), G.K. Butterfield (D-NC), Todd Young (R-IN), and Ron Kind (D-WI) – Introduced January 28, 2015

• Cosponsors – 293 (17 Illinois, including Rep. Schock) as of 09/08/2016Republican – 160 | Democrats – 133

– Rep. Pete Roskam (R-6) & Rep. Randy Hultgren (R-14) needed

• S. 314: Pharmacy and Medically Underserved Areas Enhancement Act

• Senators Chuck Grassley (R-IA), Sherrod Brown (D-OH), Robert Casey (D-PA), and Mark Kirk (R-IL) - Introduced January 29, 2015

• Cosponsors – 49 as of 09/08/2016– Democrats – 27 | Republican – 21 H.R.592: https://www.congress.gov/bill/114th-congress/house-bill/592

S.314: https://www.congress.gov/bill/114th-congress/senate-bill/314


• Both bills amend Section 1861 of the Social Security Act to recognize pharmacists services within Medicare Part B.

• Pharmacist services to be provided only in areas that HRSA defines as – Medically Underserved Areas (MUAs),

– Medically Underserved Populations (MUPs),

– Health Professional Shortage Areas (HPSAs).

• Does not expand existing scope of practice; based on individual States.

• Pharmacist services would be reimbursed at 85% of the physician fee schedule. – Similar with Nurse Practitioners (NPs) and Physicians’ Assistants (PAs)

H.R.592: https://www.congress.gov/bill/114th-congress/house-bill/592S.314: https://www.congress.gov/bill/114th-congress/senate-bill/314

http://pharmacistsprovidecare.com/node/836419


• Congressional Budget Office (CBO) Scoring– Must score low for legislation to advance

• Demonstrate successes achieved under Medicare Part D – MTM

• Share your experience and encourage your patients to share their stories

• Pharmacistscare.org – Patient Access to Pharmacists’ Care Coalition (PAPCC)– IPhA is a member of PAPCC through NASPA.

Path to Provider Status

• Federal– Social Security, Medicare Part B & D, CMMI, ACO

– Federal Regulations (CMS, AHRQ, HRSA)

• State– Medicaid

– Health Insurance Exchanges, State Health Plans

– Existing provider status and collaborative practice

• Private Payer– Accountable Care Organizations (ACOs)

– Private or Employer-based Insurers

– Medical Homes

Any Willing Provider | Preferred Networks

• H.R.793: Ensuring Seniors Access to Local Pharmacies Act of 2015

• Rep. Morgan Griffith (R-VA) and Rep. Peter Welch (D- VT) – Introduced 02/05/2015

• Cosponsors – 98

– Republican – 59 | Democrats – 39

– Rep. Cheri Bustos (D-17), Rep. Rodney Davis (R-13), Rep. Daniel Lipinski (D-3) , Rep. Bobby Rush (D-1), Rep.

Jan Schakowsky (D-9)

• S.1190: Ensuring Seniors Access to Local Pharmacies Act of 2015

• Sen. Shelly Moore Capito (R-WV), Sen. Joe Manchin (D-WV), Sen. Tom Cotton (R-AR), and Sen.

Sherrod Brown (D-OH)

• Cosponsors – 10

– Republican – 7 | Democrats – 3H.R.793: https://www.congress.gov/bill/114th-congress/house-bill/793

S.1190: https://www.congress.gov/bill/114th-congress/senate-bill/1190

Any Willing Provider | Preferred Networks

• Amend the Social Security Act to ensure that Medicare patients have equal access to community pharmacies in MUAs, MUPs, and HPSAs as network pharmacies under Medicare prescription drug coverage.

• IPhA is part of a pharmacy and patient organization coalition being spearheaded by NCPA.

• Patient access experiences with Preferred Networks

MAC Transparency

• H.R.244: MAC Transparency Act

• Rep. Doug Collins (R-GA) and Rep. Dave Loebsack (D-IA) – Introduced 01/09/2015

• Cosponsors – 48– Republican – 41 | Democrats – 7

– Rep. Rodney Davis (R-13)

• Increase transparency of generic drug payment rates under:– Medicare Part D

– Federal Employees Health Benefits program (FEHB)

– TRICARE

• PBMs required to: – Pricing updates at least once every 7 days.

– Disclose the MAC price sources.

– Notify of any changes in individual drug prices, in advance.

– Establish an appeals process.

• Drug Price Standard would specifically includes MAC .

https://www.congress.gov/bill/114th-congress/house-bill/244

Home Infusion - Medicare

• H.R.605: Medicare Home Infusion Site of Care Act of 2015

• Rep. Eliot Engel (D-NY) – Introduced 01/28/2015

• Cosponsors – 79– Democrats – 46| Republicans – 33

– Rep. Jan Schakowsky (D-9), Robert Dold (R-10), and Luis Gutierrez (D-4)

• S.275: Medicare Home Infusion Site of Care Act of 2015

• Sen. Johnny Isakson (R-GA) – Introduced 01/28/2015

• Cosponsors – 28– Democrats – 14 | Republican – 13 | Independent – 1

– Sen. Mark Kirk (R)

• Reimbursement method for the professional services, supplies and equipment associated with infusion therapy in the home under Medicare Part B

• No change to infusion medication coverage under Medicare Part D

H.R.605: https://www.congress.gov/bill/114th-congress/house-bill/605S.275: https://www.congress.gov/bill/114th-congress/senate-bill/275

Medication Therapy Management (MTM)

• S.776: Medication Therapy Management Empowerment Act of 2015

• Sen. Pat Roberts (R-KS), Sen. Jeanne Shaheen (D-NH), Sen. Mark Kirk (R-IL), and Sen. Sherrod Brown (D-OH) – Introduced 03/18/2015

• Cosponsors – 15– Democrats – 11 | Republicans – 4

• Amend eligibility for MTM to include a single chronic disease of cardiovascular disease, chronic obstructive pulmonary disease, hyperlipidemia, or diabetes.

https://www.congress.gov/bill/114th-congress/senate-bill/776

CMS 2017 Call Letter

• Increased recognition of MTM– Refined CMR measure for monitoring purposes

• High Risk Medication measure removed

• CMMI model tests | Enhanced MTM Model

• Plans allowed to develop morphine equivalent dose for point-of-sale edits (after a pilot project is successful)– Opioid and Buprenorphine

– Opioid Benzodiazepines

– CDC Guidelines will be review in 2016 for CY 2018

• Increasing access rates for pharmacies in Preferred Cost-Sharing Networks (No changes for 2017)– 2016: Urban 71% | Suburban 95% | Rural 82%

– 2015: Urban 62% | Suburban 92% | Rural 77%

• Mail Order protocols to be established for urgent fill needs (decrease gaps in therapy)

https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf

CMS AMP Rule

• 02/01/2016: Published final rule – Medicaid outpatient medications

• Effective 04/01/2016 – States have until 04/01/2017 to implement reimbursement changes for

pharmacy

• Pharmacy Reimbursement– Actual Acquisition Cost – AAC

– Professional Dispensing Fee (vs Dispensing Fee)

– Reimbursement for 340B

– Federal Upper Limit

CMS AMP Rule

• AAC – determined pharmacy actual price paid

to acquire product

• Replaces estimated acquisition cost with AAC

• Reflects a more accurate reference price

CMS AMP Rule

• Brands or medications w/o an established FUL– Not to exceed the lower of

• AAC plus a professional dispensing fee

• U&C

• AAC reimbursement model determination– State Survey of pharmacy providers

– National Survey of pharmacy providers (NADAC)

– Compendia Pricing (WAC)

– AMP

• Dispensing Fee replaced w/ Professional Dispensing Fee– CMS position the fee to reflect pharmacist’s professional services and cost

CMS AMP Rule

• Professional Dispensing Fee determination– National Survey

– Regional/Neighboring State Survey

– State Survey

• Reimbursement proposals– Change to either ingredient cost or professional

dispensing fee

– States to file SPA for CMS review

CMS AMP Rule

• 340B/FSS Pharmacies reimbursement– Not to exceed 340B/FFS ceiling price

– Medication purchased outside 340B not to exceed AAC

• FUL– ACA: no less than 175% of weighted AMP (monthly reports)

– At least three “A rated” products

– Will not include not rated FDA products

– Will not include terminated/discontinued products for weighted AMP

– Not calculated when multiple NADAC prices

– At least one corresponding NADAC NDC for comparsion

– New FUL list published 04/01/2016

Drug Abuse – S.483

• Sponsor: Sen. Orrin Hatch (R-UT)

• Ensuring Patient Access and Effective Drug Enforcement Act of 2016

• Registrant (including pharmacies) may submit a corrective action plan to revocation or suspension

– Failure to maintain effective controls against diversion or other comply with obligations.

• Order to show cause

– Contain statement of basis for denial, revocations, or suspension

– Direct registrant to appear before Attorney General (no less than 30 days)

– Notify opportunity to submit corrective action plan

• DHHS to submit report to Congress

– Obtablces to legitimate patient access to controlled substances

– Issues with diversion

– Collaboration efforts of law enforcement and pharmaceutical industry

– Medical education and training opportunities

– Beneficial enhancements of state PMPs (reporting requirements)

• Signed by President Obama – April 19, 2016 https://www.congress.gov/bill/114th-congress/senate-bill/483

Prescription Monitoring Programs

http://www.cdc.gov/drugoverdose/pdmp/

Prescription Monitoring Programs

http://www.nabp.net/system/rich/rich_files/rich_files/000/001/270/original/pmpmap-2-16-16.pdf

www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf

Comprehensive Addiction and Recovery Act (CARA)

S.524/H.R.953

• Sponsor: Sen. Sheldon Whitehouse (D-RI) | Rep. F. James Sensenbrenner (R-WI-5)

• Expand prevention and educational efforts and to promote treatment and recovery.

• Expand the availability of naloxone to law enforcement agencies and other first responders.

• Expand resources to identify and treat incarcerated individuals suffering from addiction disorders.

• Expand disposal sites for unwanted prescription medications.

• Launch an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country.

• Launch a medication assisted treatment and intervention demonstration program.

• Strengthen prescription drug monitoring programs.

• Signed by President Obama – July 22, 2016http://www.cadca.org/comprehensive-addiction-and-recovery-act-cara

S.524: https://www.congress.gov/bill/114th-congress/senate-bill/524H.R.953: https://www.congress.gov/bill/114th-congress/house-bill/953

Lali’s Law H.R.4586

• Sponsor: Rep. Robert Dold (R-10)

• Amends the Public Health Service Act

• Develop standing orders for opioid overdose reversal medication for pharmacists;

• Encourage pharmacies to dispense medication pursuant to such a standing order;

• Implement best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients;

• Develop training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and

• Educate the public on the availability and public health benefits of opioid overdose reversal medication.

• Passed House

https://www.congress.gov/bill/114th-congress/house-bill/4586

https://www.pharmacist.com/node/1016381?is_sso_called=1

Non-Discrimination Rule

• Starting 10/01/2016

• Designation of responsible employee (only 15 or more employees)

• Adoption of grievance procedures (only 15 or more employees)

• File assurance of compliance form when applying for Federal funding

• Training (Recommended but not required)

• Notice of Non-Discrimination and Taglines– Give notice regarding non-discrimination and available services

– 15 taglines must be included in notices

– Language Access Plans (Recommended but not required)

• Reasonable steps to provide meaningful access (free of charge) and in a timely manner

• Reasonable Facility modifications to avoid discrimination base on disability

Election 2016

Presidential Candidates

• Hillary Clinton – Democrat

• Gary Johnson – Libertarian

• Jill Stein – Green Party

• Donald Trump – Republican

Congressional

• Senate

– 10 Democrats

– 24 Republicans

• House

– All 435 Seats

State

• Senate

– 39 Democrat

– 20 Republican

• House

– 71 Democrat

– 47 Republican

According to SB3336, what is the responsibility of the

pharmacist in charge if an employee is terminated for

a patient safety issue?

a) Call surrounding pharmacies not to hire

b) Contact NABP about the individual and report the medication error

c) Contact the Chairman of the BOP to report the individual

d) Complete the online DFPR form to inform of the termination

What reimbursement rate would pharmacists be paid

under H.R.592/S.314?

a) 90% of Physician Rate

b) 85% of Physician Rate

c) 100% of Pharmacist Rate

d) 50% of Physician Rate

What is the name of the IPhA naloxone training program

developed to meet the standards of PA 99-0480?

a) Illinois State Opioid Antagonist Training

Program

b) IPhA Naloxone First Program

c) Illinois State Naloxone Dispensing Program

d) Naloxone Patient Education and Training

Program

Which is not a component of the HB5591/SB2515?

a) PBM Registration

b) Audit Protections

c) MAC Transparency

d) Medication Synchronization

e) Patient Data Protections

f) All of the Above are components

When is the General Election?

a) November 8, 2016

b) November 8, 2016

c) November 8, 2016

d) November 8, 2016

References

• Illinois General Assembly – www.ilga.gov

• Pharmacy Practice Act - http://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1318&ChapterID=24

• Administrative Rules to the Pharmacy Practice Act –

http://ilga.gov/commission/jcar/admincode/068/06801330sections.html

• Illinois Controlled Substances Act – http://ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1941&ChapterID=53

• Administrative Rules to the Illinois Controlled Substances Act –


• Administrative Rules to the Electronic Prescription Monitoring Program –


• Administrative Rules to the Electronic Prescription Monitoring Program – Long Term Care -


References

• Drug Enforcement Administration

– www.DEADiversion.usdoj.gov

• Office of National Drug Control Policy

– www.whitehouse.gov/ondcp

• CDC: Guideline for Prescribing Opioids for Chronic Pain

– www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf

• FDA: Medicines Recommended for Disposal by Flushing

– www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafel

y/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf

References

• Prescribe to Prevent

– prescribetoprevent.org

• APhA: Pain Relief in Brief – OTC Oral Analgesic Selection and Patient Education

– pharmacist.com/sites/default/files/files/15-

183_PainReliefBrief_FINAL%20with%20SME%20statement%20070215.pdf

• ACPA: Opioid Induced Constipation Conversation Guide

– theacpa.org/uploads/ACPA-Opioid_Constipation_Chart-V4.pdf

• CPNP: A Practical Guideline for Pharmacists

– cpnp.org/_docs/guideline/naloxone/naloxone-access.pdf

Contact Information/Questions

Garth K. Reynolds, BSPharm, RPhExecutive Director

Illinois Pharmacists Association

[email protected]

Illinois Pharmacists Association – IPhA

204 West Cook Street

Springfield, Illinois 62704

P: 217/522-7300 | F: 217/522-7349

www.ipha.org

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Documents

2016 Pharmacy Law Review law tablet.pdf · Pharmacy Technician CPE HB3271 • Sponsor: Rep. Michael Zalewski (D-Riverside) • Amends Pharmacy Practice Act • Clarifies Technician