Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

On March 19, 2013, CMS published a final rule that adopts, with technical changes and a few clarifications, a February 18, 2011 interim final rule implementing an ACA provision imposing notification requirements in connection with closure of a Medicare skilled nursing facility (SNF) or Medicaid nursing facility (NF). Under the rule, in the case of a long-term care (LTC) facility closure, the SNF or NF administrator must provide written notification of the impending closure and a plan for the relocation of residents to the state survey agency at least 60 days prior to the impending closure (or, if the Secretary terminates the facility’s participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate). Notice and the plan also must be provided to residents, their legal representatives or other responsible parties, and the state LTC Ombudsman. While the ACA authorizes civil monetary penalties (CMPs) of up to $100,000 and exclusion for an administrator's failure to comply with this provision, CMS is finalizing the lower levels of CMPs established in the interim final rule in recognition that there are cases in which an administrator may not have had control over implementing notice procedures. The final rule therefore sets CMPs of: a minimum of $500 for the first offense; a minimum of $1,500 for the second offense; and a minimum of $3,000 for the third and subsequent offenses (CMS states that interpretive guidelines are being developed that will establish criteria for determination of CMP amounts). CMS also provides appeal rights for an individual who is subject to administrator sanctions under the rule. The final rule is effective April 18, 2013 (although note that the statutory closure notice requirements are effective March 23, 2011).

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The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on February 7, 2013 that it estimates would save health care providers $676 million annually by streamlining unnecessary, obsolete, or excessively burdensome regulations and making reforms to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The provisions of the wide-ranging proposal would affect numerous policy areas; among other things, the proposed rule would:

• Revise the requirements ambulatory surgical centers (ASCs) must meet in order to provide radiological services that are integral to procedures offered by the ASC and provide that a qualified doctor of medicine or osteopathy must supervise the provision of radiologic services (eliminating the requirement that ASCs meet the hospital condition of participation (CoP) requirement to have a radiologist supervise the provision of radiologic services);
• Permit qualified dietitians to order patient diets under the hospital CoPs;
• Revise the nuclear medicine services CoP to remove the requirement for direct supervision of hospital in-house preparation of radiopharmaceuticals;
• Eliminate a requirement that critical access hospitals (CAHs), rural health clinics (RHCs), and federally qualified health centers have a physician on site at least once in every two-week period, and eliminate the requirement that a CAH develop its patient care policies with the advice of at least one member who is not a member of the CAH staff;
• Allow long-term care facilities to apply for an extension of the August 13, 2013 deadline for installing automatic sprinkler systems;
• Eliminate a transplant center data submission requirement and an automatic re-approval survey process.
• Make a number of clarifications pertaining to CMS regulations governing proficiency testing referrals under CLIA, including establish policies under which certain PT referrals by laboratories would not generally be subject to revocation of a CLIA certificate.
• Address a variety of other issues, such as hospital reclassification of swing-bed services, hospital medical staff, hospital governing bodies, practitioners permitted to order hospital outpatient services, and potential changes to reduce barriers to the provision of telehealth, hospice, or home health services in an RHC.

CMS will accept comments on the proposed rule until April 8, 2013.

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On January 31, 2013, CMS is hosting a call on its National Partnership to Improve Dementia Care in Nursing Homes. The partnership is focused on improving dementia care through the use of individualized, person-centered care approaches, which CMS hopes will reduce the use of unnecessary antipsychotic medications in nursing homes and eventually other care settings. The CMS call will provide information on the goals of the national partnership, quality measures, and ongoing outreach efforts. The target audience for the call includes consumer and advocacy groups, nursing home providers, surveyors, prescribers, professional associations, and other interested stakeholders.  Registration is required to participate in the call.

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On December 13, 2012, the Senate Finance Committee held a hearing to focus on improving care for beneficiaries dually eligible for Medicare and Medicaid. In addition, the House Energy and Commerce Subcommittee held a hearing entitled "State of Uncertainty: Implementation of Patient Protection and Affordable Care Act Exchanges and Medicaid Expansion." On December 20, 2012, the Senate Judiciary Committee was scheduled to consider S. 1560, the Nursing Home Resident Pain Relief Act of 2011, which would make amendments to the Controlled Substances Act that are intended to help ensure that nursing home residents have timely access to pain medication in emergency situations.  Note that the markup has been postponed and not rescheduled at this time.

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A new OIG study provides baseline information for an ACA-mandated report on the extent to which nurse aides with substantiated findings of abuse, neglect, and/or misappropriation had previous criminal convictions that could have been detected through background checks. Based on a review of state records, the OIG found that 19% of nurse aides who received a substantiated finding of abuse, neglect, and/or misappropriation of property during 2010 had at least one conviction in their criminal history records prior to their substantiated finding (the majority of which was for crimes against property, including, burglary, shoplifting, and writing bad checks). The OIG calculates that nurse aides with substantiated findings of abuse or neglect were 3.2 times more likely to have a conviction of crime against persons than nurse aides with substantiated findings of misappropriation, who in turn were 1.6 times more likely to have a conviction of crime against property than nurse aides with substantiated findings of abuse or neglect. The report, “Criminal Convictions for Nurse Aides with Substantiated Findings of Abuse, Neglect, and Misappropriation,” is available here. 

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The OIG recently followed up on a 2010 report which found that CMS did not report all adverse actions against providers to the Healthcare Integrity and Protection Data Bank (HIPDB) as required. The OIG found that as of April 1, 2012, CMS improved its reporting of adverse actions for durable medical equipment (DME) suppliers, but not for other types of providers. For instance, the HIPDB contains no reports of nursing home terminations since June 2010, and it still did not contain adverse actions that CMS imposed against laboratories, managed care plans, prescription drug plans, and monetary penalties against nursing homes. The OIG therefore restated its 2010 recommendation that CMS report all required adverse actions to the HIPDB within required timeframes. 
 

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On July 23, 2012, the Department of Health and Human Services (HHS) published a notice soliciting public comments on the development of a new long-term care facilities strategy module of the National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination. This module will be part of a broader plan to reduce healthcare-associated infections (HAIs) in acute care hospitals, ambulatory surgical centers, and end stage renal disease facilities, and to increase healthcare personnel influenza vaccination coverage. Comments on the draft document will be accepted until August 22, 2012.

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CMS has released its 2012 Nursing Home Action Plan, which discusses CMS strategies to: (1) enhance consumer engagement; (2) strengthen survey processes, standards, and enforcement; (3) promote quality improvement; (4) create strategic approaches through partnerships; and (5) advance quality through innovation and demonstration.

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The OIG has issued a report entitled “Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs.”  Based on a small random sample of nursing facility resident records (375 records) from 2007, the OIG found that few records included evidence that the facilities met all federal requirements related to resident assessments and/or care plans for residents receiving antipsychotic drugs. In particular, most of the records in the sample did not contain evidence of compliance with federal requirements for care plan development, while smaller percentages of records lacked evidence of compliance with federal resident assessment requirements, evidence that planned interventions for antipsychotic drug use actually occurred, or documentation that staff considered the Resident Assessment Protocol for psychotropic drug use as required. The OIG therefore recommends that CMS: (1) improve the detection of noncompliance with federal requirements for residents receiving antipsychotic drugs; (2) address noncompliance with these requirements, and (3) provide methods for nursing facilities to enhance the development and usefulness of resident assessments and care plans. CMS concurred with all of the recommendations. The agency noted that subject to resources, CMS intends to pilot-test a focused review of resident assessments, care plans, and medication use in a sample of nursing homes in FY 2013 to help identify needed improvements in the survey process.

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On May 30, 2012, CMS announced the “Partnership to Improve Dementia Care” to reduce unnecessary antipsychotic drug use in nursing homes. Under the Partnership, federal and state agencies, nursing homes and other providers, advocacy groups, and caregivers have committed to working together to reduce the use of antipsychotics in nursing homes by 15% by the end of 2012. As part of this initiative, CMS: is making available new training for nursing homes and surveyors; posting data on each nursing home’s antipsychotic drug use on Nursing Home Compare (starting in July) of this year; and emphasizing non-pharmacological patient management alternatives for nursing home residents with dementia.

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The OIG has issued a report entitled “Gaps Continue To Exist in Nursing Home Emergency Preparedness and Response during Disasters: 2007–2010.” According to the OIG, most nursing homes nationwide met federal requirements for written emergency plans and preparedness training. Some gaps in nursing home preparedness and response continue, however, including unreliable transportation contracts, lack of collaboration with local emergency management, and residents who developed health problems during evacuation. The OIG recommended that CMS establish specific regulatory requirements for emergency plans and training, update the State Operations Manual to provide detailed guidance for survey agencies on nursing home compliance with emergency plans and training, and promote use of previous CMS emergency preparedness checklists. The OIG also outlined guidance that CMS can consider when revising its checklist for health care facilities. In addition, the OIG recommended that the Administration on Aging (AOA) develop model policies and procedures for long-term care ombudsmen to protect residents during and after disasters. CMS and AOA agreed with the recommendations.
 

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The Occupational Safety and Health Administration (OSHA) has launched a National Emphasis Program for Nursing and Residential Care Facilities intended reduce occupational illnesses and injuries in these settings. OSHA notes that safety and health hazards of particular interest for nursing and residential care workers include exposure to blood and other potentially infectious material; exposure to communicable diseases; ergonomic stressors related to lifting patients; workplace violence; and slips, trips and falls.

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The GAO has issued a report entitled “Nursing Home Quality: CMS Should Improve Efforts to Monitor Implementation of the Quality Indicator Survey.” CMS developed the Quality Indicator Survey (QIS) to improve the efficiency, accuracy, and consistency of the nursing home survey process. CMS expects the QIS to be implemented nationally by 2018. According to the GAO, CMS does not have the means to routinely monitor, such as through the use of performance goals and measures, the extent to which the QIS is helping improve the survey process as intended. CMS also has not established a timeline for implementing plans to develop a more systematic process for monitoring states’ implementation progress. GAO recommends that CMS develop a means to routinely monitor progress in meeting QIS objectives, along with systematic methods for monitoring and facilitating states’ efforts to implement the QIS.

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On December 5, 2011, CMS opened the registration process for suppliers interested in participating in Round 2 of the Medicare DMEPOS competitive bidding program and/or the national mail order bidding for diabetic testing supplies.  By way of background, under competitive bidding, only suppliers which are winning bidders, meet licensing and other standards, and enter into a contract with CMS may furnish selected categories of DMEPOS to Medicare beneficiaries in the competitive bidding areas (CBAs), with very limited exceptions.  Contract suppliers are paid based on winning bids in the CBA, rather than the DMEPOS fee schedule.  The Round 1 “Rebid” went into effect January 1, 2011 in nine CBAs and nine product categories.  Round 2 will take place in 100 CBAs, covering 91 metropolitan statistical areas.  As previously reported, Round 2 will include the following product categories:

• Oxygen Supplies and Equipment
• Standard (Power and Manual) Wheelchairs, Scooters, and Related Accessories (note that CMS has announced it is removing ultra lightweight manual wheelchairs, gimbaled ventilator trays, and push activated power assist devices from Round 2, although these items may be included in a future round)
• Enteral Nutrients, Equipment and Supplies
• Continuous Positive Airway Pressure (CPAP), Respiratory Assist Devices (RADs), and Related Supplies and Accessories
• Hospital Beds and Related Accessories
• Walkers and Related Accessories
• Support Surfaces (Group 2 mattresses and overlays)
• Negative Pressure Wound Therapy (NPWT) Pumps and Related Supplies and Accessories

As noted, CMS also will be conducting a national mail-order competition for diabetic testing supplies concurrent with the Round 2 competition.  Registration is the first key step in Round 2; suppliers that do not register and receive a password will not be able to submit bids.  Registration closes on February 9, 2012.  Other key target dates in the Round 2/national mail order bidding process include the following: 

1/30/2012 -- CMS opens 60-day bid window for Round 2 and National Mail-order Competitions
 
2/29/2012 -- Covered Document Review Date for bidders to submit financial documents

3/30/2012 -- Bid window closes

Fall 2012 -- CMS announces single payment amounts, begins contracting process

Spring 2013 -- CMS announces contract suppliers, begins contract supplier education campaign

July 1, 2013 -- Implementation of Medicare DMEPOS Competitive Bidding Program Round 2 and National Mail-order Competition contracts and prices

CMS and the Competitive Bidding Implementation Contractor (CBIC) have begun the first stage of their supplier educational campaign.  A variety of information has been posted at the CBIC website, including the request for application and bid forms, a new National Mail-Order 50 Percent Compliance Form, information on required financial documents, and a variety of fact sheets on such issues as change of ownership,  financial measures, contract supplier obligations and eligibility requirements, capacity and expansion plans, the national mail-order competition for diabetic supplies, specialty suppliers (SNF/NF), prescriptions for specific brand/mode of delivery, bona fide bids, and subcontracting rules.  Reed Smith also has been compiling information on the competitive bidding program.  Suppliers interested in bidding are reminded to ensure their enrollment files at the National Supplier Clearinghouse are up-to-date; that they have all required state licenses; and that they are accredited for any product category for which they will bid. 

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On November 15, 2011, the Energy and Commerce Health Subcommittee approved by voice vote H.R. 1173, the “Fiscal Responsibility and Retirement Security Act of 2011,” which would repeal the ACA’s Community Living Assistance Services and Supports (CLASS) program. As previously reported, while the CLASS program was included in the ACA as a national voluntary, self-financed program to provide insurance for long-term care services and supports, the Obama Administration announced last month that it was suspending implementation of the CLASS program because it could not identify a benefit plan that was both actuarially sound and consistent with the statutory requirements.

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The Senate Health, Education, Labor, and Pensions Committee recently held a hearing on “Medical Devices: Protecting Patients and Promoting Innovation” (a Reed Smith write-up of the hearing is available here). In addition, a recent House Ways and Means Oversight Subcommittee hearing focused on the ACA’s small business health insurance tax credit. Two hearings are scheduled for November 30: a Senate Special Committee on Aging hearing entitled “Overprescribed: The Human and Taxpayers' Costs of Antipsychotics in Nursing Homes” and a House Oversight and Government Reform Health Care Subcommittee hearing on “Drug Shortage Crisis: Lives Are In The Balance.” The Senate Judiciary Antitrust Subcommittee also is holding a hearing on December 6 to examine the proposed Express Scripts/Medco merger, and the Senate Aging Committee is holding a hearing December 15 entitled “Parting the Clouds: Implementing the Physician Payment Sunshine Act” (this hearing originally was scheduled for Dec. 8). 

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The Medicare Payment Advisory Commission (MedPAC) will be meeting November 3-4, 2011 to discuss a number of Medicare policy issues, including: reforming Medicare’s benefit design; Medicare Part D/beneficiaries with high drug spending; coordinating care for dual-eligible beneficiaries through the PACE program; reforming the Medicare SNF PPS; hospitals’ capacity to serve Medicare patients; payment rate differences across ambulatory sectors; and Medicare coverage of and payment for home infusion.

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This post was written by Debra A. McCurdy and Susan A. Edwards.

On September 19, 2011, President Obama presented his deficit reduction plan – including $320 billion in proposed federal health spending cuts – to the Joint Select Committee on Deficit Reduction, which was created by the Budget Control Act of 2011 to craft a legislative package to cut the federal deficit by at least $1.5 trillion. If legislation is not adopted to achieve deficit reduction targets by January 2012, $1.2 trillion in across-the-board spending cuts (sequestration) would be triggered, effective January 2013.

The health care industry has a significant stake in the outcome of the Joint Select Committee’s work, since Medicare spending in particular is expected to figure prominently in the Committee’s package. Under President Obama’s plan (which the Joint Select Committee is not obligated to follow), Medicare spending would be cut by about $248 billion over 10 years, with more than half of the savings coming from new Medicare drug rebates. Medicaid and other health funding also would be reduced by about $72 billion. If sequestration ultimately is triggered, on the other hand, Medicare provider payments also would be subject to reduction; but the Congressional Budget Office (CBO) recently estimated that the level of Medicare cuts under sequestration would be approximately $123 billion between 2013 and 2021.

This Alert provides an overview of the Budget Control Act, including the two possible mechanisms for lowering the federal deficit: (1) enactment of the Joint Select Committee’s proposal; and (2) sequestration. In addition, this Alert discusses recent developments, including President Obama’s deficit reduction plan, and provides a timeline for action under the Budget Control Act.

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On September 1, 2011, CMS will host a Special Open Door Forum on FY 2012 Skilled Nursing Facility (SNF) Prospective Payment System (PPS) policy changes relating to the Minimum Data Set (MDS) 3.0. Note that this session will cover the same material as the August 23 national provider call on the same topic.

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On July 29, 2011, the Centers for Medicare & Medicaid Services (CMS) released its final update to Medicare skilled nursing facility (SNF) prospective payment system (PPS) rates and policies for fiscal year (FY) 2012. Under the final rule, SNF rates would be reduced by 11.1% -- or $3.87 billion – compared to FY 2011 levels. The rate reduction results from adoption of a controversial plan to “recalibrate” SNF PPS rates to correct what CMS characterizes as an “unexpected spike” in payments in FY 2011, when CMS implemented the Resource Utilization Groups, version four (RUG-IV) patient classification system. Although CMS intended implementation of RUG-IV to be budget-neutral, CMS maintains that claims under the updated system show a significant increase in Medicare expenditures, primarily due to changes in therapy use under the new classification system. CMS declined to phase in the reductions over several years, as had been recommended by commenters, since it “would continue to reimburse facilities at levels that significantly exceed intended SNF payments.” Instead, CMS is applying a 12.6% recalibration reduction, which is partially offset by a 1.7% standard rate update (which represents a 2.7% market basket update reduced by a 1.0% percentage point “multifactor productivity adjustment” mandated by the Affordable Care Act, or ACA). CMS observes that despite the recalibration, payments in FY 2012 will be 3.4% higher than in 2010, before the adoption of RUG-IV. In addition to these payment policies, the final rule establishes a standard for group therapy, defined as therapy provided simultaneously to four patients, regardless of payer source, who are performing the same or similar activities and are supervised by a therapist or assistant who is not supervising any other individuals. The rule also adopts policies related to the reporting and allocation of group therapy minutes, and requires new reporting when changes occur in the intensity of therapy. CMS also has adopted other modifications to the schedule for completing the MDS 3.0 patient assessment instrument. In addition, CMS has revised its policy regarding supervision of therapy students to provide that a therapy student working in an SNF will no longer be required to be in the supervising therapist’s “line of sight.” Note that CMS is deferring the adoption of the proposed rule to implement an ACA provision requiring Medicare SNFs and Medicaid nursing facilities to disclose certain information regarding the ownership and organizational structure of their facilities; these requirements will be finalized in a separate rule early in CY 2012.  The official version of the rule will be published on August 8, 2011.

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