New Regulations for Supplier & Service Provider Enrollment in Centers for Medicare & Medicaid Services

On December 3, the Centers for Medicare & Medicaid Services (CMS) issued a final rule with new provisions for supplier and service provider enrollment in CMS programs. In sum, three provisions are applicable to healthcare providers who participate in CMS billing.

First, CMS expanded the right to deny or revoke CMS enrollment if the provider or supplier has a previous felony conviction in the preceding 10 years. The crimes that qualify include crimes against persons, financial crimes, and malpractice felonies. Each potential violation will be reviewed under the lens of what is detrimental to CMS programs and beneficiaries.

Second, CMS may deny enrollment to a new CMS service provider, supplier, or owner if they had previously had an ownership relationship with an entity that had Medicare debt. This coincides with another rule enabling CMS to revoke billing privileges of a CMS entity if they have a demonstrated practice of submitting claims that do not fully meet Medicare billing requirements.

Third, for ambulatory service providers, the “back bill” provisions have been eliminated. This means that the services rendered while the application to CMS is pending will no longer be billable to CMS. CMS will save approximately $327 million dollars annually with this change.

The CMS rule will be published on December 5 in the Federal Register, becoming effective 60 days later on February 3, 2015. The final rule is available as a PDF at the following link:

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Provider Preparation for Infectious Diseases

Most hospitals and health-care providers have protocols and procedures for contending with infectious diseases, including those creating public-panic, such as the Ebola outbreak. However, when a new crisis hits, many of these protocols may have been forgotten or ignored. This was seen with the Nebraska Medical Center firing two health workers that treated an Ebola patient because they violated the Health Information Portability and Accountability Act (HIPAA). In light of a public health scare, maintaining current policy standards will help limit liability.


Beyond existing rules and regulations, with each specific outbreak, both federal and state agencies may update protocols and guidance to contend with the unique nature of that disease. As an example of outbreak specific guidance, in response to Ebola, the Center for Disease Control and Prevention (CDC) issued new guidance on personal protection equipment (PPE) for use in connection with the disease. Other guidance includes new Occupational Safety and Health Act (OSHA) standards, designed to protect the healthcare worker. This was seen at Texas Health Presbyterian Hospital in Dallas, when two nurses were infected with the disease. Failure to properly comply with newly issued, as well as existing, OSHA and CDC regulations may result in significant potential liability both to patients and workers.


Although many providers may believe they are properly equipped to handle potential Ebola patients, careful consideration must be paid to the newest guidance and regulations, without forgetting existing policy. Failure to do so could result in significant civil liability. As the examples in Texas and Nebraska teach us, hospital and health-care providers should take extra steps to limit their potential liability.


*CDC Guidance: ;

*OSHA Guidance: 

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HHS Proposes New Rules on Civil Monetary Penalties

HHS’s Office of the Inspector General (OIG) has issued a new proposed rule that makes a number of changes to its civil monetary penalty authority. Among other changes, this rule would increase the maximum reduction of penalties when providers can show mitigating circumstances. It also makes providers who cause more than $15,000 of losses to Medicare/Medicaid subject to increased penalties.

The rule also explains the factors that OIG will consider in determining how much in penalties it will assess. These include the provider’s history and whether other wrongful conduct was involved. OIG will also consider whether the provider followed self-disclosure protocols and took corrective action. Providers should review their self-disclosure policies to determine whether they reflect the new factors.

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OSHA Audits Target Needlestick Prevention

OSHA is currently conducting surprise audits emphasizing the prevention of needlestick injuries.  The initial focus is on ambulatory surgical centers and primary care medical facilities in the southeast portions of the United States, but the audits could expand to other geographical areas soon.  OSHA regulations on needlestick injuries include:

  • Reviewing and updating your Exposure Control Plan at least annually.  The Plan must also identify and implement effective safer medical devices to help eliminate occupational exposures;
  • With certain exceptions, employees should receive the Hepatitis B vaccination;
  • Requiring gloves to be worn at all times that an employee may have hand contact with blood;
  • Attaching warning labels to containers with blood or other potentially infectious material;
  • Providing initial and thereafter annual employee training on dealing with occupational exposures; and
  • Establishing and maintaining a sharp injury log.

To help prevent employee injuries and avoid OSHA penalties, review your practice’s safety procedures to ensure it includes these and other OSHA safety procedures.

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OIG Releases 2012 Work Plan

Among the new areas of focus for the Office of Inspector General (the “OIG”) is increased scrutiny for incident-to services performed by non-physician practitioners.  Specifically, the OIG is planning on investigating whether the non-physician practitioners are qualified to be performing the incident-to services that are being billed by physicians.  This concern and others are highlighted in the recently published 2012 OIG Work Plan.  Your practice can use this Work Plan to help keep your compliance plan current.  Doing so allows your practice to be prepared for any audit or investigation by the OIG.

The Work Plan contains 349 new and continuing initiatives.  Others include:

  • Ensuring that physicians who have opted out of Medicare are no longer submitting claims;
  • Reviewing the qualifications to become a critical access hospital;
  • Investigating whether physician’s services were properly coded to the appropriate place of service (i.e. provided in a hospital vs. the physician’s office); and
  • Examining the safety and quality of care for patients having surgeries and procedures in ambulatory surgical centers.

The entire Work Plan can be read at: OIG 2012 Work Plan

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Same Day Surgery Restrictions Removed for Ambulatory Surgical Centers

A new rule allows ambulatory surgical centers to provide patient notifications on the day of the surgery, effectively eliminating the so-called prior-day notification requirement.  Prior to this rule, same day surgeries were only allowed in emergencies.  The final rule is expected to take effect on December 23, 2011.

The rule, provided by the Center for Medicare & Medicaid Services, can be viewed at: Final Rule

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Ambulatory Surgery Centers (‘ASC’s”) may be required to notify patients of their rights and of the facility’s ownership before the day of surgery under a rule be considered by the Department of Health and Human Services (“HHS”).  An exception would be made when the referring physician indicates that it is medically necessary for the patient to undergo surgery that day.

Other regulations undergoing review include the ASC rules related to the list of operating room emergency equipment required to be available and a duplicative infection control program requirement.

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A new website hyping ambulatory surgery centers (“ASCs”) is the showpiece of a new campaign launched by the Ambulatory Surgery Center Advocacy Committee (“ASCAC”).  The ASCAC includes the national and state ASC associations as well as representatives of all types of ASC operators and physicians.

The campaign is called “Advancing Surgical Care” and kicked off on March 9, 2010.  The goal of the campaign is raising awareness about the high-quality, patient-centered care that ASCs provide and the significant savings they create for both patients and the healthcare system. 

Andrew Hayek, chair of the ASCAC and President and CEO of Surgical Care Affiliates, says “At a time when healthcare costs are skyrocketing and access to quality patient care is a national priority, ASCs continue to offer high-quality, patient-centered care to communities throughout the country and create a cost savings for both the individual and the health care system as a whole.  As an industry, we are committed to providing patients the highest quality care in the safest environment possible and are working with physicians, hospitals and other stakeholders throughout the healthcare system to ensure that we continue to advance surgical care.”

“Patients report a 92% satisfaction rate in the healthcare services they receive at ASCs throughout the country,” says Kathy Bryant, President of the ASC Association. “We are proud to come together as an industry to lead this much-needed dialogue around the care, value and superior patient outcomes associated with ASCs.”

Quotations taken from Outpatient Surgery Magazine Staff.

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The Centers for Medicare & Medicaid Services (“CMS”) has announced that most hospitals will receive an inflation update of 2.1 percent in their payment rates for services provided to Medicare beneficiaries in outpatient departments.  Due to a Medicare requirement, CMS will reduce the update by 2.0 percentage points for hospitals that did not participate in quality data reporting for outpatient services or that did not report the quality data successfully, resulting in only a 0.1 percent update for those hospitals. 

CMS also announced that ambulatory surgical centers (“ASCs”) will receive a 1.2 percent inflation update starting January 1, 2010.  CMS projects that the aggregate Medicare payments to more than 4,000 hospitals and community mental health centers in calendar year (“CY”) 2010 will be approximately $32.2 billion, while aggregate Medicare payments to approximately 5,000 ASCs will total $3.4 billion.

The payment updates are included in a final rule with comment period that revises payment policies and updates the payment rates for services provided to beneficiaries during CY 2010 in hospital outpatient departments under the Outpatient Prospective Payment System (“OPPS”) and in ASCs under a revised rate-setting methodology that was established January 1, 2008.

The updated payment rates are meant to ensure that Medicare beneficiaries continue to receive high quality and efficient care in the most appropriate setting.

The CY 2010 OPPS/ASC final rule with comment period will be included in the November 20, 2009 Federal Register.  Comments on designated provisions are due by 5:00 p.m. EST on December 29, 2009.  CMS will respond to comments in the CY 2011 OPPS/ASC final rule.

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CMS Proposes Medicare Payment Increase for ASCs in 2010

CMS recently issued a notice of proposed rulemaking that includes proposals for policy changes and payment rates for services in ambulatory surgical centers (“ASCs”), which would continue the expansion of surgical procedures that Medicare would cover for services performed in ASCs. The proposed rule seeks to make sure that beneficiaries have access to outpatient services in all appropriate settings, while improving the quality and efficiency of service delivery.

Since January 1, 2008, ASCs have been paid under a revised payment system that aligns ASC payment rates with the rates paid for similar services when provided in hospital outpatient departments. The revised system also increases the number and types of surgical services that are covered by Medicare when performed in ASCs.  Calendar year 2010 is the third year of a four-year phase-in of the ASC payment rates calculated under the standard rate-setting methodology and the first year in which CMS is authorized to apply an update to the conversion factor.  CMS is projecting the percentage increase in the Consumer Price Index for All Urban Consumers that would update the ASC conversion factor to be 0.6 percent. Total 2010 payments to ASCs are estimated to be $3.4 billion.

CMS will accept comments on the proposed rule until August 31, 2009, and will respond to comments in a final rule to be issued by November 1, 2009.

To review the proposed rule and for instructions about how to submit comments, go to:

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