On October 18, the Centers for Medicare & Medicaid Services (CMS) took steps to 
reduce unnecessary, obsolete, or burdensome regulations on American hospitals 
and healthcare providers.  These steps would help achieve the key goal of 
President Obama's regulatory reform initiative to reduce unnecessary burdens on 
business and would save nearly $1.1 billion across the health care system in 
the first year for a total of over $5 billion over 5 years.

CMS proposed two sets of regulatory reforms today, and finalized a third. All 
are designed to improve transparency and help providers operate more 
efficiently by reducing their regulatory burden.   One set proposes updates to 
the Medicare Conditions of Participation (CoPs) for hospitals and critical 
access hospitals (CAHs).  The second set addresses regulatory requirements for 
a broader range of health care providers and suppliers who are regulated under 
Medicare and Medicaid.   CMS also finalized a third rule reducing regulatory 
burden for ambulatory surgical centers (ASCs).

CMS estimates that annual savings to hospitals from the proposed revisions to 
the Conditions of Participation could exceed $900 million in its first year as 
hospitals increasingly use this new flexibility.  The Medicare Regulatory 
Reform rule could save up to $200 million in the first year.  The final rule 
for ASCs could generate an extra $50 million in savings per year.

Taken together, these three rules would reduce hospital and other healthcare 
provider costs by nearly $1.1 billion the first year. These cost savings would 
come directly from reduced regulatory burdens, and are not accompanied by 
reimbursement reductions. As such, all of these savings would be available to 
help providers improve the quality of care they provide to Medicare 
beneficiaries and all Americans.

Background

The proposed rules were developed through a retrospective review of existing 
regulations called for by President Obama's  January 18, 2011 Executive Order 
13563, to "modify, streamline, or repeal" regulations which impose unnecessary 
burdens, including on hospitals and other providers that must comply with 
requirements under Medicare.

The rules take into consideration numerous burden reduction recommendations 
from hospitals, critical access hospitals, and patient advocates, among others.


Medicare Conditions of Participation

The Conditions of Participation are federal health and safety requirements 
ensuring high quality care for all patients.  Hospitals and critical access 
hospitals must meet these conditions to participate in the Medicare and 
Medicaid programs.  The proposed rule is designed to reduce the regulatory 
burden on hospitals by the following:

*        Eliminating burdensome requirements that do not permit hospital 
patients or their caregivers/support persons to administer certain medications.
*        Allowing hospitals to determine the best ways to oversee and manage 
outpatients by removing the unnecessary requirement for a single Director of 
Outpatient Services.
*        Increasing flexibility for hospitals by allowing one governing body to 
oversee multiple hospitals in a single health system.
*        Enabling hospitals to have a single, interdisciplinary care plan that 
supports coordination of care instead of requiring a separate stand-alone 
nursing care plan.
*        Allowing CAHs to provide certain services, including laboratory and 
radiology services, under arrangement.

Medicare Regulatory Reform

The Medicare Regulatory Reform rule would identify and begin to eliminate 
duplicative, overlapping, outdated, and conflicting regulatory requirements for 
health care providers and suppliers, including hospitals, ambulatory surgical 
centers, end-stage renal disease facilities, durable medical equipment 
suppliers, and a host of other healthcare providers and suppliers regulated 
under Medicare and Medicaid.  The goal of this proposed rule is to both reduce 
regulatory burdens and help providers improve care for patients.

This rule would help reduce unnecessary burdens on health care providers, 
allowing them to dedicate more resources to improving patient care.  Some of 
the more than two dozen proposed regulatory changes include:

*        Eliminating obsolete regulations, including expired OMB paperwork 
control numbers; outmoded infection control instructions for Ambulatory 
Surgical Centers; outdated Medicaid qualification standards for physical and 
occupational therapists; and
          duplicative requirements for governing bodies of Organ Procurement 
Organizations.
*        Clarifying which higher risk End Stage Renal Disease (ESRD) facilities 
are required to comply with the full federal Life Safety Code requirements.  
CMS estimates that this burden reduction could save an estimated $108.7 million 
for the ESRD program.
*        Eliminating the current Medicare requirement that automatically 
deactivates a provider or supplier who has not submitted a claim for 12 
consecutive months, keeping providers from inadvertently being barred from 
re-enrolling in Medicare for a certain
         period.  Savings from this regulatory reform are projected to be $26.7 
million annually.
*        Eliminating the specific list of emergency equipment Ambulatory 
Surgical Centers must have on hand, and allowing facilities, in conjunction 
with medical staff and their governing bodies, to develop policies and 
procedures that specify emergency
         equipment appropriate to the services they provide.
*        Replacing inflexible time-limited agreements which govern Intermediate 
Care Facilities for the Mentally Retarded participation in Medicaid, with 
open-ended agreements and reducing states' paperwork burden by requiring 
inspection of these facilities
         once a year.  The regulation also takes up a recommendation from 
stakeholders to replace the term "mental retardation" with the term 
"intellectual disability," which has gained wide public acceptance in recent 
years.
*        Updating e-prescribing technical requirements so Medicare Prescription 
Drug Plans meet current standards.

Regulatory Reform for Ambulatory Surgical Centers

This announcement also includes a final rule from CMS that would update the 
conditions for coverage regulations for Ambulatory Surgical Centers (ASCs), 
based on a proposed rule CMS issued in April 2010.

This new final rule simplifies requirements that ASCs must follow in notifying 
patients about their rights. Specifically, the final rule will allow ASCs to 
provide the patient, the patient's representative, or the patient's surrogate 
with patient rights information prior to the start of the surgical procedure. 
Before this final rule 
(CMS-3217-F<http://www.gpo.gov/fdsys/pkg/FR-2011-10-24/html/2011-27171.htm>), 
ASCs were required to notify patients in advance of the date of the procedure. 
This caused particular logistical problems and inconveniences for patients who 
needed ASC services on the same day they received a physician referral.


For More Information

To view the proposed rules, please visit 
CMS-9070-P<http://www.gpo.gov/fdsys/pkg/FR-2011-10-24/html/2011-27176.htm> or 
CMS-3244-P<http://www.gpo.gov/fdsys/pkg/FR-2011-10-24/html/2011-27175.htm>. To 
submit a comment, visit www.regulations.gov<http://www.regulations.gov>, enter 
the ID number CMS-9070-P or CMS-3244-P, and click on "Submit a Comment."
For additional information on hospital and critical access hospital Conditions 
of Participation, visit 
http://www.cms.gov/CFCsAndCoPs/06_Hospitals.asp<http://links.govdelivery.com:80/track?type=click&enid=bWFpbGluZ2lkPTE0ODI3MjgmbWVzc2FnZWlkPVBSRC1CVUwtMTQ4MjcyOCZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTEyNzY2ODE3MDcmZW1haWxpZD1saXNhLnNtaXRoQGNtcy5oaHMuZ292JnVzZXJpZD1saXNhLnNtaXRoQGNtcy5oaHMuZ292JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&103&&&http://www.cms.gov/CFCsAndCoPs/06_Hospitals.asp>

The proposed rule also invites public comment on a broad range of 
recommendations to improve patient safety and hospital quality of care beyond 
those specified in the Conditions of Participation.

CMS' final rule on Ambulatory Surgery Centers was effective on Tuesday, October 
18, 2011. More information about ASCs is online at 
http://www.cms.gov/CFCsAndCoPs/16_ASC.asp<http://links.govdelivery.com/track?type=click&enid=bWFpbGluZ2lkPTE0ODI3MjgmbWVzc2FnZWlkPVBSRC1CVUwtMTQ4MjcyOCZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTEyNzY2ODE3MDcmZW1haWxpZD1saXNhLnNtaXRoQGNtcy5oaHMuZ292JnVzZXJpZD1saXNhLnNtaXRoQGNtcy5oaHMuZ292JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&104&&&http://www.cms.gov/CFCsAndCoPs/16_ASC.asp>.


The Department of Health and Human Services also has launched the Partnership 
for Patients initiative, a national collaboration with hospitals, employers, 
physicians, nurses, patient advocates, and State governments to protect patient 
safety, provide better care, and reduce costs.  For more about the Partnership 
for Patients, go to:  
http://www.healthcare.gov/center/programs/partnership/index.html<http://links.govdelivery.com:80/track?type=click&enid=bWFpbGluZ2lkPTE0ODI3MjgmbWVzc2FnZWlkPVBSRC1CVUwtMTQ4MjcyOCZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTEyNzY2ODE3MDcmZW1haWxpZD1saXNhLnNtaXRoQGNtcy5oaHMuZ292JnVzZXJpZD1saXNhLnNtaXRoQGNtcy5oaHMuZ292JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&105&&&http://www.healthcare.gov/center/programs/partnership/index.html>

-------------------------------------------------
Vaccination is the Best Protection Against the Flu

The Centers for Disease Control and Prevention is encouraging everyone 6 months 
of age and older to get vaccinated against the seasonal flu.  The risks for 
complications, hospitalizations, and deaths from the flu are higher among 
individuals aged 65 years and older.  Medicare pays for the seasonal flu 
vaccine and its administration for seniors and others with Medicare with no 
co-pay or deductible.  And remember, vaccination is particularly important for 
healthcare workers, who may spread the flu to high-risk patients; don't forget 
to immunize yourself and your staff.  Protect your patients. Protect your 
family. Protect yourself. Get the Flu Vaccination - Not the Flu.

Remember - The flu vaccine plus its administration are covered Part B benefits. 
 CMS has posted the 2011-2012 seasonal flu vaccine payment limits at 
http://www.CMS.gov/McrPartBDrugAvgSalesPrice/10_VaccinesPricing.asp.  Note that 
the flu vaccine is NOT a Part D-covered drug.

For more information on coverage and billing of the flu vaccine and its 
administration, as well as related educational provider resources, visit 
http://www.CMS.gov/MLNProducts/35_PreventiveServices.asp and 
http://www.cms.gov/immunizations.



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