MAY 2016 - HIDA · 2020-04-24 · MAY. 2016. Flu Vaccine Distribution Tracking Closely To 2015. The amount of influenza vaccine distributed during this flu season is tracking closely

MAY2016

Flu Vaccine Distribution Tracking Closely To 2015The amount of influenza vaccine distributed during this flu season is tracking closely to the 2015 season, according to the Centers for Disease Control and Prevention. HIDA recently published its latest Utilization Update, analyzing flu trends, retail clinic growth, extended care occupancy, and other key healthcare statistics. For more information on HIDA’s quarterly Utilization Update or Commodities Update, contact Gina Smith ([email protected]) or visit www.HIDA.org/Updates.

Zika Now Present In More Than Half Of U.S.With the recent national news that several states most susceptible to the spread of the Zika virus are underprepared to respond to a health emergency, HIDA has expanded its Zika Virus Resource Center to keep members up-to-date on this developing issue. This free site includes the latest supply chain news and information of particular interest to distributors and manufacturers, helping you prepare for important customer conversations in the coming months. According to the Centers for Disease Control and Prevention, the mosquito carrying the Zika virus is now present in approximately 30 states. For more information, visit www.HIDA.org/Zika.

Class II UDI Deadline Approaching QuicklyWith the Unique Device Identifier (UDI) implementation deadline for Class II medical device labels and packaging quickly approaching, HIDA has developed a new UDI infographic to provide an overview of current UDI requirements and therule’s ongoing implementation timeline. HIDA recently provided comments to theFood and Drug Administration (FDA) in response to proposed guidance regardinghow the agency intends to apply the UDI regulation to medical convenience kits. HIDA members have also provided their perspective on compliance requirements, most recently at the 2016 UDI Conference in Baltimore, MD. To access the UDI infographic, a free member resource, visit www.HIDA.org/Infographics.

Washington Summit To Spotlight Hospital, Physician, LTC Customer TrendsShawn Martin, American Academy of Family Physicians (AAFP), and Jeff Micklos, Healthcare Transformation Task Force, are the latest healthcare policy experts to be featured at HIDA’s Washington Summit, June 29-30, Washington, D.C. The two will join Sen. Richard Burr (R-NC) and Ed Gabriel, Department of Health and Human Services, for a full morning of education to discuss recent hospital and physician innovations in response to health reform policies, as well as future market choices for these providers. The summit agenda also offers a political forecast, an analysis of U.S. emergency preparedness and response policies, and networking events. Visit www.HIDA.org/Summit for more details.

Jeff Micklos Healthcare

Transformation Task Force

GPOs To Participate At Streamlining Healthcare ConferenceNew in 2016, HIDA’s Streamlining Healthcare Conference (September 27-29, Chicago, IL) includes various national and regional group purchasing organizations (GPOs) in the conference program. Leading industry organizations such as Premier, Inc., Provista, and Intalere, along with leading regional players, will participate in HIDA’s popular Reverse Expo, Contract Administration Workgroup, and multiple networking opportunities. The 2016 conference will feature several new additions, such as Innovation Pavilions in Diagnostics and MedSurg. Registration for the event is now open. Visit www.HIDASHC.com to learn more.

www.HIDA.org

UDI, SUDs, Distribution and Patient Care Delivery

Implementation TimelineSeptember 2016

Class II Devices

September 2018Class I Devices

September 2020reusable/reprocessed devices

not classified I, II, III

Single Use Device (SUD) Packaging Exception and the Supply Chain

Manufacturers DistributorsSUDs

UDI

Distributor Low Unit of MeasurePrograms Provide Customer Value by . . .• Supporting just in time medical needs• Allowing products to go straight to patient care areas• Optimizing provider inventory levels to improve

cash flow• Maximizing provider focus on the delivery of care• Reducing total costs of doing business to offset

reimbursement impacts

Device Packaging LevelsThe FDA requires a UDI at every level of packaging exceptshipping containers; however devices that meet the SUDexception are mostly exempt from the rule because theyare assumed to be distributed together in a package to thehealthcare provider.

Examples of SUDs

Syringes Drain bags Scalpels

Sutures Needles PPE barriers

Bandages Cannulas Otoscope tips

Blades Catheters Hot/cold disposable packs

What is a UDI? The Unique Device Identifier(UDI) is a series of numeric or alpha numericcharacters required on a medical device label,its packaging or directly on the device itself.

Goal: The FDA’s UDI rule sets the foundation for use of UDIacross healthcare through implementation and adoption of UDIfor operational, financial, clinical and post-market surveillancepurposes. The FDA’s intent is that every medical device betracked down to patient use, with few exceptions.

Distributor Value Facilitates:

PatientCare

InventoryManagement

Supply ChainEfficiencies

FDA Says: SUDs are not completely exempt from the UDI requirements; the final rule created a packaging exception wherein all classes of individual SUDs that are distributed together in a package and intended to be stored in that package until use do not need a UDI on the individual device itself. Rather, the UDI can go on the next higher level of packaging.

Impact on Provider/Patient: The FDA’s SUD exception does not take into consideration the role of healthcare distributors in the supply chain. Distribu-tors ensure healthcare providers across the continuum

have what they need when they need it and are integral to patient care delivery. Many distributors operate Low Unit of Measure (LUM) programs where SUDs are broken down to less than case quantities and delivered directly to patient care areas, minimizing hospital labor involvement in inven-tory processing.

Case of SUDs (e.g., syringe)

Inner pack

Each syringe within inner pack

Shipping container

STREAMLINING HEALTHCARE SM

DISTRIBUTIONDownload the Q2 2016 Report at www.HIDA.org

Utilization Update Q2 2016 & ANALYTICS

NEWS CLIPSUMMARY

1. REFERENCE LAB

2. FLU VACCINE DISTRIBUTION 3. EXTENDED CARE OCCUPANCY

1. Reference Lab: Both Labcorp and Quest show increases in Q4 2015.

2. Flu Vaccine Distribution: UP approx. 11.9M from February 2015

3. Extended Care Occupancy: Average occupancy DOWN 0.2% to 90.0% in Q1 2016 from Q1 2015

4. Healthcare Employment:Total healthcare UP 3.1% from March 2015Total U.S. employment UP 1.8% from March 2015

5. Unemployment Rate:Remains at 5.0%

6. Retail Clinics Grow:Desire for convenience drives retail clinic growth

7. Electronic Health Records (EHR) on the Rise:3 out of 4 hospitals have a basic Electronic Health Records (EHR) system

Healthcare Mergers and Acquisitions in 2016: Runnning List (Healthcare Finance, April, 2016)

Source: Quest & LabCorp Quarterly Financial Statements

Reference Lab Testing Volume(2014-2015: Q/Q)

Testing volumes (measured by requisitions): Change over same quarter previous year

■ LabCorp ■ Quest Diagnostics

2.6%

5.3%

6.9%

5.3%

6.2%

5.1%

2.2%

3.2%

0.7%

7.7% 7.8%

6.3%

5.6%

-0.40% -0.20%

1.20%

-1.0%

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

9.0%

Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015

89.8%90.0%

90.2%

91.3%

89.1%

88.3% 88.4%

87.4%

85.0%

86.0%

87.0%

88.0%

89.0%

90.0%

91.0%

92.0%

Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016

Independent LivingAverage Occupancy RateAssisted LivingNursing Care

Extended Care Occupancy Rates(National Investment Center for Seniors Housing)

0

20

40

60

80

100

120

140

160

7/10 8/29 10/18 12/7 1/26 3/17

2015-2016

2014-2015

2013-2014

2012-2013

Vaccines Distributed During Flu Season (in millions) (Centers for Disease Control and Prevention)

Shawn Martin AAFP

310 Montgomery Street • Alexandria, VA 22314-1516

MARK YOUR CALENDAR FOR OUR UPCOMING EVENTS

January 17-18, 2017Biltmore Hotel Coral Gables, FL

June 29-30, 2016Hyatt Regency Washington, D.C.

Post-Acute: Customer Needs & Market Trends

HIDA Presenter: Gina Smith, CMRP Director, Business Development and Research & Analytics

The Changing Face of Primary Care within Health Systems

Featured Presenter: Anthony Stavola, MD Vice Chair, Carilion Clinic Department of Family & Community Medicine

Visit www.HIDA.org/Webinars for additional webinar updates and access to past recordings.

May 18 2016

HIDA Distributor Financial Performance SurveyNow open

In-depth distributor market study offering free profit reports and individual performance analyses for participating organizations. Participate today.

HIDA Executive Briefing Coming June 2016Top-level, in-depth knowledge for member executives on key supply chain business trends and government policy.

WEBINARS

In This Issue

Zika Now Present In More Than Half Of U.S.

www.HIDA.org

UDI, SUDs, Distribution and Patient Care Delivery

Implementation TimelineSeptember 2016

Class II Devices

September 2018Class I Devices

September 2020reusable/reprocessed devices

not classified I, II, III

Single Use Device (SUD) Packaging Exception and the Supply Chain

Manufacturers DistributorsSUDs

UDI

Distributor Low Unit of MeasurePrograms Provide Customer Value by . . .• Supporting just in time medical needs• Allowing products to go straight to patient care areas• Optimizing provider inventory levels to improve

cash flow• Maximizing provider focus on the delivery of care• Reducing total costs of doing business to offset

reimbursement impacts

Device Packaging LevelsThe FDA requires a UDI at every level of packaging exceptshipping containers; however devices that meet the SUDexception are mostly exempt from the rule because theyare assumed to be distributed together in a package to thehealthcare provider.

Examples of SUDs

Syringes Drain bags Scalpels

Sutures Needles PPE barriers

Bandages Cannulas Otoscope tips

Blades Catheters Hot/cold disposable packs

What is a UDI? The Unique Device Identifier(UDI) is a series of numeric or alpha numericcharacters required on a medical device label,its packaging or directly on the device itself.

Goal: The FDA’s UDI rule sets the foundation for use of UDIacross healthcare through implementation and adoption of UDIfor operational, financial, clinical and post-market surveillancepurposes. The FDA’s intent is that every medical device betracked down to patient use, with few exceptions.

Distributor Value Facilitates:

PatientCare

InventoryManagement

Supply ChainEfficiencies

FDA Says: SUDs are not completely exempt from the UDI requirements; the final rule created a packaging exception wherein all classes of individual SUDs that are distributed together in a package and intended to be stored in that package until use do not need a UDI on the individual device itself. Rather, the UDI can go on the next higher level of packaging.

Impact on Provider/Patient: The FDA’s SUD exception does not take into consideration the role of healthcare distributors in the supply chain. Distribu-tors ensure healthcare providers across the continuum

have what they need when they need it and are integral to patient care delivery. Many distributors operate Low Unit of Measure (LUM) programs where SUDs are broken down to less than case quantities and delivered directly to patient care areas, minimizing hospital labor involvement in inven-tory processing.

Case of SUDs (e.g., syringe)

Inner pack

Each syringe within inner pack

Shipping container

Class II UDI Deadline Approaching Quickly

Jun 15 2016

September 27-29, 2016Hyatt Regency O’Hare Chicago, IL

January 17-18, 2017Biltmore Hotel Coral Gables, FL