MASA

April 3rd, 2017

Paul Parker
Director, Center for Health Care Facilities Planning & Development
Maryland Health Care Commission
4160 Patterson Avenue
Baltimore, Maryland 21215

Dear Mr. Parker:

On behalf of the Maryland Ambulatory Surgery Association members, we appreciate the opportunity to both participate in the MHCC’s Workgroup, as well as, comment on the Maryland Health Care Commission’s proposed revisions to the State Health Plan for General Surgical Services.

Proposed Changes

MHCC has proposed several changes to the State Health Plan for ambulatory surgery centers and the conversion of a hospital to a free-standing medical facility. These changes propose that the commission be allowed to issue an exemption from Certificate of Need review for the following:

  • An existing physician office surgery center (POSC) with one operating room that has operated for a minimum of one year may be issued an exemption that permits it to establish an ambulatory surgical facility (ASF) through the addition of a second operating room
  • Two existing physician office surgery centers (POSC) that each has operated no more than one operating room for a minimum of one year may be issued an exemption that permits it to establish an ambulatory surgical facility (ASF) through the consolidation of the two surgery centers to create a single ambulatory surgical facility with two operating rooms
  • When a single-room surgery center proposes to expand to a two-room ASF or two single-room surgery centers combine into a single, two-room ASF, the new ASF may only be located at the current location or an immediately adjacent location. If the applicant demonstrates it is not feasible to for the proposed ASF to be established at the same location, it may propose a nearby location
  • A general hospital that seeks to convert to a freestanding medical facility (FMF) may be issued an exemption that permits it to establish of an ambulatory surgical facility (ASF) with two operating rooms on the same campus as the freestanding medical facility, if it seeks such an exemption in conjunction with an exemption to convert to a freestanding medical facility

Recommendations

The proposed changes address assumptions that a dedicated outpatient general purpose operating room capacity should have an optimal capacity at 80% of full capacity.  MASA would recommend flexibility of capacity that would encourage the most efficient use of the surgeon’s time. Often surgeons will operate using two operating rooms in order to work more efficiently.  There is no risk to the state’s health system by allowing this flexibility.  This should remain a business decision of the entity as to how to best utilize the operating rooms.

MASA and its members support the MHCC’s proposed changes to the General Surgical Services State Health Plan. We certainly appreciate the MHCC’s consideration of our input. Should you have any questions, please call me at 410-340-6644.

Sincerely,

Andrea M. Hyatt, CASC
President, Maryland Ambulatory Surgery Association

Anna Jeffers, Esq. from the Maryland Board of Pharmacy shared with us at last week’s conference the release for informal comment draft regulations to implement HB 986 State Board of Pharmacy - Sterile Compounding - Permits, for the sterile compounding permit requirements.  Click here to view.  Click here to view the Draft Sterile Drug Product and Waiver.

These regulations will be incorporated into the existing COMAR 10.34.19 Sterile Pharmaceutical Compounding.

This draft contains revisions to some of the existing regulations to accommodate the new law:

.03 Definitions. (same as last release)

.04 [Pharmacy] Sterile Compounding Facility Environment

.05 General Requirements.

.06 Special Handling, Packaging, Labeling, and Beyond Use Dating

.07 Record-Keeping Requirements.

.08 Batch Preparation

.09 Minimum Facility Requirements

.11 Minimum Requirements for Supplies

.14 Training of Staff, Patient, and Caregiver

.16 Reference Library

This draft also contains new regulations:

.19 Sterile Compounding Permit Application Requirements

.20 Minimum Requirements for Inspections of Sterile Compounding Permit Holders.

.21 Reporting Requirements for Sterile Compounding Permit Holders.

The final numbering of the regulations will be determined before submitting for DHMH sign-off and publication.

Please send any comments or suggested revisions to Anna D. Jeffers by close of business on November 8th.  Feel free to share with any interested stakeholders.  Her contact information is:

Anna D. Jeffers, Esq.
Legislation and Regulations Manager
Maryland Board of Pharmacy
4201 Patterson Avenue
Baltimore, MD 21215
Phone: (410) 764-3833
FAX: (410) 358-6207
anna.jeffers@maryland.gov

MASA recently sent a letter to CMS providing comments on the proposed quality reporting indicators for 2014.  Click here to view MASA’s comments.

MASA is currently drafting a letter to comment on the increased state licensing fees (Notice of final action posted below).  Please show your support and send a letter on your center’s letterhead to:

MARY-DULANY JAMES
Democrat, District 34A, Cecil & Harford Counties
House Office Building, Room 404
6 Bladen St., Annapolis, MD 21401
(410) 841-3331, (301) 858-3331
1-800-492-7122, ext. 3331 (toll free)
e-mail:
mary.dulany.james@house.state.md.us
fax: (410) 841-3002, (301) 858-3002

Title 10

DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Subtitle 05 FREESTANDING AMBULATORY CARE FACILITIES

10.05.05 Freestanding Ambulatory Surgical Facilities

Authority: Health-General Article, 19-3B-01, et seq., Annotated Code of Maryland

Notice of Final Action

[12-184-F]

On July 26, 2013, the Secretary of Health and Mental Hygiene adopted amendments to Regulation .03 under COMAR 10.05.05 Freestanding Ambulatory Surgery Facilities. This action, which was proposed for adoption in 39:15 Md. R. 976—977 (July 27, 2013), has been adopted with the nonsubstantive changes shown below.

Effective Date: August 19, 2013.

Attorney General’s Certification

In accordance with State Government Article, 10-113, Annotated Code of Maryland, the Attorney General certifies that the following changes do not differ substantively from the proposed text. The nature of the changes and the basis for this conclusion are as follows:

Regulation .03: The decrease in the proposed fee is not substantive because it could have been reasonably anticipated by the participants in the regulatory process that comments received during the process would lead the Department to adopt a smaller fee increase than originally proposed. In addition, the decrease in the proposed fee does not decrease the benefits that will be achieved by this regulation and does not increase, but in fact decreases, the burden on the regulated industry.

.03 Licensing Procedure.

In addition to meeting all of the requirements of COMAR 10.05.01.03A—C, the applicant shall submit a nonrefundable fee of [[$4,000]] $3,000 for a 3 year period, with an application for initial licensure, or submit a nonrefundable fee of [[$4,000]] $3,000 with an application for license renewal for a 3 year period.

JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene

ASCA submitted their comments on the proposed changes to the Ambulatory Surgery Center payment system and the 2013 calendar year payment rates on September 4th, 2012.  The letter may be viewed by clicking here.

On August 23, 2012 MASA submitted comments to the Maryland Health Care Commission’s repeal and proposed changes to the State Health Plan on Facilities and Services: General Surgical Services under COMAR 10.24.11.  Click here to view the comments.

In response to the State’s proposal to increase licensing fees for Ambulatory Surgery Centers, Andrea Hyatt, MASA’s president submitted comments on behalf of Maryland ASCs mid-August. The proposed increase would result in fees being raised from $700.00 to $4000.00 every three years. Many thanks to the centers that submitted comments! MASA’s comments may be viewed by clicking here.  (give link to comments on State License increase)

The MHCC Releases 2011 Health Information Technology Assessment of Freestanding Ambulatory Surgical Centers in Maryland

The Maryland Health Care Commission (MHCC) recently released the third annual 2011 Health Information Technology Assessment of Freestanding Ambulatory Surgical Centers in Maryland (report).  Each year, Freestanding Ambulatory Surgical Centers (Centers) complete a health information technology (health IT) adoption survey.  The report  details the progress Centers are making in the adoption of nine health IT functionalities including:  computerized provider order entry ; electronic health records (EHRs); electronic medication administration records (eMARs); barcode medication administration ; infection surveillance software; electronic prescribing (e-prescribing); and electronic health information exchange between Centers and laboratories, exchange with diagnostic centers, and exchange with outpatient physicians.

Results indicate that adoption in eight of the nine health IT categories increased since 2009, with the highest increase in the adoption of EHRs, at around 26 percent.  Survey responses were analyzed to determine differences between Centers within specific geographic regions and between single specialty and multi-specialty Centers.  EHR adoption continues to exceed all other functions, regardless of geography and specialty.  The report also highlights the health IT adoption plans of Centers.  Findings show that Centers are increasingly considering the implemention of barcode medication administration and the electronic exchange of information with laboratories.

The widespread adoption and effective use of health IT has the potential to improve health care quality, prevent medical errors, and reduce costs.  Over the last year, Centers have continued to make notable progress in the adoption of health IT.  The MHCC thanks the Centers for their participation in the 2011 survey.

The full report is available online at the following link:  http://mhcc.dhmh.maryland.gov/hit/Documents/2012_amsurg_hit_report_0712.pdf

On August 16th 2012, Christine Gambrel from the Surgery Center of Rockville met with representatives of ASCA and FDA staff to discuss drug shortages and the labeling of pharmaceutical vials.  Christine shared with FDA representatives the impact on scheduling surgeries, as well as the economic impact shortages have on our centers.  The FDA explained that often our centers are not experiencing drug shortages, but instead local distribution problems that significantly increase the costs of drugs.

The FDA Made the following suggestions:

  1. ASCs that are having difficulty obtaining a drug should email the FDA at drugshortages@fda.hhs.gov , noting the drug, the dosage, the ASC’s location and the name of the distributor involved;
  2. The ASC should contact the drug manufacturer directly to ascertain if this is a localized distribution problem or a shortage; and
  3. Any ASC that is approached by a “gray market” distributor or receives an ad from such a distributor should notify the FDA and forward the ad material to the FDA at drugshortages@fda.hhs.gov

Given the feedback on single dose vials, ASCA believes the FDA is now aware of the issue and will be paying better attention to the labeling of the vials during their approval process.  ASCA will continue to plug away at these issues and will now begin reaching out to the drug manufacturers.

Quality Reporting G-Codes
ASCs will be required to include this list of G-Codes on Medicare claims with dates of service on or after October 1, 2012. ASCs that fail to include these codes will face reductions in their future Medicare reimbursements.
ASCs may begin using the codes on April 1, 2012, on a trial basis.

Corresponding Quality Measure

G-code

Description

All

G8907

Patient documented not to have experienced any of the following events: a burn prior to discharge; a fall within the facility; wrong site/side/patient/procedure/implant event; or a hospital transfer or hospital admission upon discharge from the facility.

Patient burn

G8908

Patient documented to have received a burn prior to discharge

Patient burn

G8909

Patient documented not to have received a burn prior to discharge

Patient fall in ASC facility

G8910

Patient documented to have experienced a fall within ASC

Patient fall in ASC facility

G8911

Patient documented not to have experienced a fall within Ambulatory Surgical Center

Wrong site, wrong side, wrong patient, wrong procedure, wrong implant

G8912

Patient documented to have experienced a wrong site, wrong side, wrong patient, wrong procedure or wrong implant event

Wrong site, wrong side, wrong patient, wrong procedure, wrong implant

G8913

Patient documented not to have experienced a wrong site, wrong side, wrong patient, wrong procedure or wrong implant event

Hospital transfer/Admission

G8914

Patient documented to have experienced a hospital transfer or hospital admission upon discharge from ASC

Hospital transfer/Admission

G8915

Patient documented not to have experienced a hospital transfer or hospital admission upon discharge from ASC

Timing of Prophylactic Antibiotic Administration

G8916

Patient with preoperative order for IV antibiotic surgical site infection (SSI) prophylaxis, antibiotic initiated on time

Timing of Prophylactic Antibiotic Administration

G8917

Patient with preoperative order for IV antibiotic surgical site infection (SSI) prophylaxis, antibiotic not initiated on time

Timing of Prophylactic Antibiotic Administration

G8918

Patient without preoperative order for IV antibiotic surgical site infection (SSI) prophylaxis

On Monday, March 19th 2012, several members of MASA met with Christine Parent and Eileen Fleck at the Maryland Health Care Commission (MHCC) to discuss proposed changes to the 2011 Freestanding Ambulatory Surgical Facilities Survey; soon to be mailed to our facilities. Attendees representing MASA were myself, Don Bartnick, Marjorie Blouin, RN, Shannon Magro, RN and Lynne Foehrkolb, RN.

The proposed changes included revisions to the questions regarding Influenza Vaccinations, which were dramatically down in 2010 and a concern of the Health Acquired Infection Committee of the MHCC. Our group agreed that it was important to report the data and gave comment on potential reasons why the numbers may have decreased.  One explanation given was the fact that many of the hospitals have made the vaccine mandatory, and in doing so may have accounted for PRN staff receiving their vaccinations elsewhere. 

It is important that if your center does offer the vaccine, to keep records as to how many employees you have vaccinated, the number of staff not receiving the vaccine and the reasons for declination (i.e. health reasons, religious reasons, received vaccine elsewhere).

There will be additional questionnaires attached to the survey regarding Electronic Health Records and Charity Care Policies.  These questionnaires are driven by Committees within the MHCC who task is to evaluate trends and write policies for the state healthcare system.

The MHCC is in the process of rewriting policies for Surgical Services offered in Maryland.  The proposed regs include a minimum standard for charity care in centers requesting a Certificate of Need.  Several members of the board of the Maryland Ambulatory Surgery Association have been participants of the Surgical Services Work Group.

CMS Proposes Rate Increases of 0.9% for ASCs, 1.5% for HOPDs in 2012

First-ever quality reporting program for ASCs would begin on volunteer basis next year under proposal. Published July 5, 2011 from Outpatient Surgery Magazine.

Medicare payment rates for outpatient surgical services will increase by a proposed 0.9% for ambulatory surgery centers and 1.5% for hospital outpatient departments in 2012, according to a proposed rule now open for public comment.

Despite lobbying efforts from the ASC industry and members of Congress to base payments for both settings on the hospital market basket update, the Centers for Medicare and Medicaid Services will continue to base ASC payment updates on the consumer price index for all consumers (CPI-U), which the agency estimates to be 2.3% next year. When the projected 1.4% productivity adjustment, a measure of economy-wide productivity gains, for ASCs is applied to that figure as mandated by the Affordable Care Act, the total proposed rate change is 0.9%.

That's a full 0.6 percentage points lower than the projected 1.5% rate increase for HOPDs, which is based on a 2.8% projected market basket increase, a 1.2% productivity adjustment for HOPDs and an additional 0.1% adjustment needed to comply with the Affordable Care Act, according to the proposed rule.

Responding to the proposal, the Ambulatory Surgery Center Association says it's "extremely disappointed that [CMS] has continued to ignore the widening gap in payments for outpatient surgical services in these two settings."

Another notable change for ASCs included in the proposed rule is a new voluntary, confidential quality reporting program. As of next year, ASCs that choose to participate can report 7 outcome and surgical infection control measures on Medicare claims and an additional healthcare-associated infection measure through the National Healthcare Safety Network. Beginning in The proposed quality measures for ASCs, which will be used to determine payment rates for 2014, include patient falls and burns; wrong-site, -side, -procedure or —implant errors; hospital transfers/admissions; selection and timing of prophylactic antibiotics; appropriate hair removal; and surgical site infection rates. CMS is proposing 2 additional measures — safe surgery checklist use and ASC facility volume data on selected procedures — to be added later for determination of 2015 payment rates.

For more details on CMS' proposed policy and payment changes for ASCs and HOPDs in 2012, read the proposed rule here. CMS is accepting comments until Aug. 31, 2011, and will issue a final rule by Nov. 1.
Irene Tsikitas

Ambulatory Surgical Center Quality and Access Act of 2011 Introduced in US House
We need you to encourage additional support of this essential legislation.

Today, US Representatives Pete Sessions (R-TX), John Larson (D-CT), Shelley Berkley (D-NV) and Bill Cassidy (R-LA) introduced the Ambulatory Surgical Center Quality and Access Act of 2011 (H.R. 2108). This important bi-partisan legislation is aimed at preserving patient access to the high quality, cost-effective health care services that our ambulatory surgery centers (ASCs) provide.

Specifically, the bill puts policies in place that would establish reasonable Medicare reimbursement for ASCs while encouraging additional cost savings to Medicare. It would help modernize the way ASCs are paid by tying ASC Medicare payment updates to the Hospital Market Basket, rather than the volatile Consumer Price Index for all Urban Consumers (CPI-U).

In addition, the legislation would require implementation of a value-based purchasing (VBP) program to encourage collaboration between ASCs and the government while generating additional savings for the Medicare system.

Click here for a detailed bill summary. A copy of the bill is available here.

The introduction of this critical legislation is only the first step. We need your help to get the additional Congressional support needed to pass this legislation and make it law.

Please send a letter TODAY urging your member of Congress to become a cosponsor of the Ambulatory Surgical Center Quality and Access Act of 2011. It is vital that you let your legislators know how important this legislation is to you, your ASC, your patients and the community you serve.

For more information, contact Steve Miller at smiller@ascassociation.org

MASA have been working hard to make sure the interests of the ASCs are represented in Maryland.  From attending hearings on healthcare issues in the State House or the Maryland Healthcare Commission to working with provider coalitions, MASA is your ASCs voice in Maryland.  Stay up-to-date on key legislative issues.

House Bill 286 – click here for information on House Bill 286.

COMAR 10.24.11
Last fall, the Maryland Health Care Commission put out a Request for Public Comment on proposed revisions to COMAR 10.24.11, the State Health Plan for Facilities and Services: General Surgical Services.  MASA urged ASCs throughout Maryland to submit comments to MHCC.  The Board of Directors submitted comments on behalf of all the centers in Maryland, and several members have since been asked to participate in a work group focused on amending and updating COMAR 10.24.11. Based on comments received on the replacement draft State Health Plan, the Commission staff has selected a few issues that merit discussion. The work group is scheduled to meet twice.  The first meeting is expected to be held in early May, and the second meeting will be held about a month later.

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Maryland Ambulatory Surgery Association
PO Box 5859
Pikesville, MD 21282
Attention:  Andrea M. Hyatt, CASC