Prepare for Changes to CMS’ Five Star Quality Rating System for Nursing Homes

Posted by Health Law Informer Author on October 10, 2014
CMS, Medicare / No Comments

Choosing a nursing home can be a daunting task for consumers who often have myriad questions regarding the quality of care available at the nursing homes in their areas. To help answer these questions, CMS has created the Nursing Home Compare website, which provides consumers with easy-to-compare ratings of nursing homes’ staffing, quality measures, and health inspections, as well as an overall rating, of each nursing home in the country. To help consumers make informed decisions about nursing home quality, CMS uses the Five Star Quality Rating System, by which CMS compares data from nursing home inspections, self-reports, and assessments.  Based on this information CMS calculates nursing homes’ star levels on a scale of one to five, with five stars being much above average and one star being much below average.

However, there has been concern over the accuracy of the self-reported data that CMS uses in calculating its star ratings. To improve the Five Star Quality Rating System, and to standardize the results, Congress recently passed the Improving Medicare Post-Acute Care Transformation Act (“IMPACT Act”). The IMPACT Act will require providers to submit standardized data to allow CMS to compare quality across different post-acute care settings, and will provide funding for the quarterly electronic submission of nursing home staffing information that is tied to payroll data. CMS will also increase both the number and type of quality measures used in the Five Star Quality Rating System. The first additional measure, starting January 2015, will be the extent to which antipsychotic medications are in use. Future additional measures will include claims-based data on re-hospitalization and community discharge rates. Continue reading…

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“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

Posted by Health Law Informer Author on September 26, 2014
ACA, CMS, HHS, HIPAA, HITECH, Privacy / No Comments

 

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement.  Cozen O’Connor attended Ms. Peters’ presentation at the Safeguarding Health Information: Building Assurance through HIPAA Security conference on September 22-23, 2014.  The conference was hosted jointly by OCR and the National Institute of Standards and Technology (“NIST”).  Below are a few discussion points worth mentioning from the conference:

  • Between September 2009 and August 31, 2014, OCR investigated 1176 reports involving breach of Protected Health Information (“PHI”) where more than 500 individuals were affected and approximately 122,000 reports affecting less than 500 individuals.
  • According to Ms. Peters, 60% of the large breaches could have been prevented by encrypting the covered entities and business associates’ laptops and mobile devices.
  • Theft and loss continues to be the most common cause of breaches but OCR expects that IT hacking will continue to rise as a significant breach risk.
  • Since 2009, consumer complaints regarding HIPAA violations continue to rise.
  • Covered entities and business associates should already have in place business associate agreements that have been updated for the Omnibus Rule.
  • Business associates must comply with all of the HIPAA Security Rules applicable to covered entities, “PERIOD.”
  • Given the known risks of hacking, theft and loss and the direct guidance from OCR, covered entities and business associates must recognize that inadequate security, inadequate physical and technical safeguards is not acceptable.
  • OCR expects that covered entities and business associates will be familiar with recent corrective actions, resolution agreements such as Parkview, NYP/Columbia, Concentra, QCA, Skaget County, Adult & Pediatric Dermatology, P.C., and Affinity Health Plan, Inc.

Continue reading…

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CMS Approves Pennsylvania’s Medical Assistance (Medicaid) Waiver

Posted by Health Law Informer Author on September 08, 2014
Medicaid, Medical Assistance / No Comments

CMS approved Pennsylvania’s Medical Assistance (“Medicaid”) waiver request entitled Healthy Pennsylvania (“Waiver” or “Healthy Pennsylvania”) by letter dated August 28, 2014.  Governor Tom Corbett and the Pennsylvania Department of Welfare submitted the waiver application in February. The approval paves the way for a five-year demonstration project that begins on January 1, 2015 and is intended to “expand access to coverage to adults in Pennsylvania with incomes through 133 percent of the federal poverty level.” The Waiver includes changes that will be implemented through state Medicaid plan amendments and the demonstration project.

Waiver Priorities

  • Improving access;
  • Ensuring quality; and
  • Providing affordability.

Waiver Objectives

  • Promoting access to health insurance through the private insurance marketplace;
  • Encouraging healthy behaviors and appropriate care, including early intervention, prevention, and wellness; and
  • Increasing quality of care and efficiency of the health care delivery system.

Waiver Highlights (applicable to individuals enrolled in Medicaid and Healthy PA PCO)

  • Inclusion of a private coverage option, Healthy PA PCO, which will make coverage available through a private commercial market that will operate outside of the Pennsylvania’s federally-run exchange
  • Commercial insurance carriers, who are likely to be HealthChoices MCOs, will offer at least two health plans for individuals eligible for Healthy PA PCO
  • Inclusion of Medicaid plan options categorized as “low risk” or “high risk” (these plans are not yet finalized and the parameters will be subject to negotiation with CMS)
  • No premiums are required in year one
  • Monthly premiums are required in year two for eligible individuals who have incomes greater than 100% of the federal poverty level (up to 2% of their income with the ability to reduce the premium based on healthy behaviors)
  • Individuals enrolled in Healthy PA PCO and Medicaid will pay an amount equal to currently existing Medicaid copayments in year one of Healthy Pennsylvania’s implementation
  • Elimination of copayments, except for $8 co-payments for non-emergency visits to emergency rooms, beginning in year two of Healthy Pennsylvania’s implementation

The Hospital & Healthsystem Association of Pennsylvania recently announced its support of Healthy Pennsylvania’s goals. Despite those who oppose Healthy Pennsylvania because among other reasons, it is viewed as not being the “traditional” Medicaid expansion as envisioned by the Affordable Care Act, Governor Tom Corbett anticipates that Healthy PA PCO will increase access to health care for over 600,000 eligible Pennsylvanians. Notably, CMS did not approve the proposed work search requirement, which would have required certain adults to undertake work search activities in order to qualify and remain eligible for health coverage under Healthy Pennsylvania. According to CMS, the approval of Pennsylvania’s Waiver makes it one of 28 states, including the District of Columbia, to expand Medicaid.

For more information regarding the Waiver, please contact Mark Gallant, Chris Raphaely, or J. Nicole Martin.

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Special (Limited) CMS Offer to Settle Claims on Appeal

Posted by Mark H. Gallant on September 03, 2014
CMS, Medicare, OMHA / No Comments

With little fanfare just before the Labor Day weekend, CMS announced a program in which it would enter into administrative agreements with eligible providers in exchange for the providers’ withdrawal of pending appeals (“Settlement Process”). This announcement follows massive backlogs in administrative appeals resulting from retroactive denials of inpatient claims by Medicare contractors, including recovery auditor contractors (“RAC”), as well as a lawsuit brought by the American Hospital Association challenging these delays. Under the Settlement Process, CMS is willing to pay “68% of the net allowable amount” for eligible claims within 60 days. According to CMS, eligible providers should submit requests to participate in the Settlement Process by October 31, 2014, and eligible providers may file for an extension of time to request a settlement if they are unable submit requests by the end of October. Although this Settlement Process holds promise for certain providers, it does not apply to all providers or all claims.

Eligible Providers

Only acute care hospitals and critical access hospitals may participate in the Settlement Process. The following providers are not eligible to participate:

  • Cancer hospitals;
  • Children’s hospitals;
  • Inpatient rehabilitation facilities;
  • Long-term care hospitals; and
  • Psychiatric hospitals that are paid under the inpatient psychiatric facility prospective payment system.

CMS may exclude eligible providers from participating in this Settlement Process if they are subject to pending False Claims Act litigation or investigations.

Eligible Claims

Only the following claims are eligible:

  • Claims for dates of admissions prior to October 1, 2013;
  • Claims for patients that were not Medicare Part C enrollees; and
  • Claims that are pending appeals of inpatient-status claim denials, which were rejected by Medicare contractors, including RACs.

An eligible provider may select the eligible claims it would like to settle, while continuing to appeal certain other claims.

For more information regarding the Settlement Process, please contact Mark Gallant, Chris Raphaely, or Ryan Blaney.

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CMS and ACOs: A Busy Summer and a Busier Fall

Posted by Chris Raphaely on August 05, 2014
ACA, Accountable Care Organizations, Affordable Care Act, HIPAA, HITECH, Medicare, Privacy / No Comments

 

It has been a busy summer so far for the Centers for Medicare & Medicaid Services (CMS) with respect to Accountable Care Organizations (ACOs), as the agency has proposed altering the quality reporting measures under the Medicare Shared Savings Program (“MSSP”) for 2015 and beyond.  Expect an even busier fall as other, potentially broader, proposed rule changes for ACOs are analyzed by the Office of Management and Budget (OMB) and both sets of proposals wind their way through the public comment process.

The proposed changes concerning quality reporting would revise and update the measures used to evaluate MSSP ACOs’ performance. Overall, the CMS says it would like to focus more on outcome-based measures (as opposed to process-based measures), reduce duplicative measures, and reflect current clinical practices without increasing ACO’s reporting burden.

More specifically, the CMS proposes to add 12 new measures and remove eight, which would increase the total number of quality measures from 33 to 37. The new measures relate to “avoidable” admissions for patients with multiple chronic conditions, heart failure, and diabetes; depression readmission; readmissions to skilled nursing facilities; patient discussion of prescription costs; and updated composite measures for diabetes and coronary artery disease.

The CMS would like to modify the scoring system to award bonus points toward shared savings to ACOs that make year-over-year improvements on individual measures. Moreover, the agency would like to modify its benchmarking methodology to use flat percentages to establish the benchmark for a measure when the national FSS data results in the 90th percentile being greater than or equal to 95 percent. And, finally, the CMS proposes several ways to align MSSP reporting requirements with other reporting programs, including Medicare’s Electronic Health Records Incentive Program and the Physician Quality Reporting System.

Fewer details are available about the next set of proposed rules changes, which were submitted to OMB on June 26 and will be printed in the Federal Register after review. It is expected that these regulations will include changes to the MSSP’s payment provisions. The proposed changes would apply to existing ACOs and approved ACO applicants starting January 1, 2016. As soon as the text of the rule becomes publicly available, the Health Law Informer will provide more information.

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Recent OCR Reports Illustrate Past and Future Compliance and Enforcement Efforts

Posted by Health Law Informer Author on July 29, 2014
HIPAA, HITECH / No Comments

Daily news stories about data breaches and enforcement actions seem to be the new norm, so it’s no surprise that people may start to believe that hackers have won the war and that no personal health information is safe. But exactly how many breaches have been reported in the last several years? And were the breaches the result of nefarious plots or just plain incompetence? About how many HIPAA investigations has the government actually launched?

Rest assured, Congress has been asking similar questions as well. The HITECH Act requires the Department of Health and Human Services Office for Civil Rights (OCR) to submit annual reports to Congress that provide contextualized information about incident rates and government action; OCR published its most recent two reports on Breaches of Unsecured Protected Health Information (Breach Report) and HIPAA Privacy, Security, and Breach Notification Rule Compliance (HIPAA Compliance Report).  In addition to including cumulative data, the reports cover relevant activities that occurred between January 1, 2011, and December 31, 2012. Continue reading…

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ACOs and Pay for Value … All About the Data

Posted by Chris Raphaely on July 24, 2014
Accountable Care Organizations, Affordable Care Act, HIPAA, Privacy / No Comments

It has been over three years since the Centers for Medicare and Medicaid Services (CMS) announced its proposed rule and guidance on the development and implementation of Accountable Care Organizations.  About four million Medicare beneficiaries are now in an ACO, and over 400 provider groups are participating in ACOs.  See February 19, 2013 Health Affairs Blog. An estimated 14% of the U.S. population is being treated within an ACO. See April 16, 2014 Kaiser Health News.

By all indications, these numbers will continue to grow as the US health system moves away from the fee-for-service model to pay for value models that reward quality and cost savings and require clinical coordination among different types of providers, in many cases providers who are unrelated other than through an ACO or other similar arrangement.  The seamless sharing of data, patient information and collaboration among large, medium and small physician practices, hospitals, post-acute providers, and even private companies like pharmacy chains is critical to the success of these organizations. Continue reading…

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We Don’t Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without DOJ

Posted by Health Law Informer Author on July 23, 2014
DOJ, False Claims Act, Whistleblower / No Comments

The United States Department of Justice (DOJ) recently announced the settlement of two qui tam whistleblower lawsuits against Omnicare Inc., the largest nursing home pharmaceutical and pharmacy services vendor in the nation. The suits alleged that Omnicare gave significant discounts to skilled nursing facilities in exchange for lucrative referrals and pharmacy provider contracts. This $124.24 million settlement is the largest ever in a “swapping” case brought under the Anti-Kickback Statute.

In addition to its size, this settlement is noteworthy because DOJ had initially declined to intervene in the underlying suits and relators pursued the claims independently. That go-it-alone decision was so resoundingly vindicated in Omnicare, it is likely that this case will encourage other whistleblowers to follow a similar course of action. Relators have long had the right to continue False Claims Act litigation without governmental participation. DOJ’s decision whether to intervene or not was traditionally (although not explicitly stated) viewed as a reflection of the strength of the whistleblower’s allegations.  With the increase in whistleblower complaints, the limitations on the number of cases that DOJ can put resources on, statutory changes, the rise of a specialized qui tam bar, and big dollar victories like this may significantly increase the number of independent qui tam lawsuits. Continue reading…

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The American Medical Association Releases New Telemedicine Recommendations

Posted by Health Law Informer Author on July 09, 2014
Telemedicine / No Comments

Recently, the American Medical Association (AMA) released a report on telemedicine (Report) that, among other things, (i) outlines coverage and payment rules; (ii) summarizes various specialty society practice guidelines/position statements; and (iii) presents its own position and recommendations regarding the role of telemedicine in the provision of health care. The Report provides a current overview of barriers (e.g., reimbursement and licensure) that prevent further implementation of telemedicine in the provision of health care in our society, and it also emphasizes the importance of ensuring quality of care, patient safety, and coordination of care. The AMA’s publication of this Report will hopefully continue the important dialogue regarding the promise of telemedicine.

Look for an upcoming more detailed client alert analyzing this Report, other updates concerning telemedicine, and the general role of telemedicine in our healthcare system.

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Begin Preparing for Pennsylvania’s Enforcement of Act 122

Posted by Health Law Informer Author on July 02, 2014
Pennsylvania Department of Health / No Comments

The Pennsylvania Department of Health (“DOH”) Bureau of Laboratories (“Bureau”) recently announced that it will begin to phase-in enforcement of Act 122, which amended the Pennsylvania Clinical Laboratory Act (“Lab Act”), even though Act 122 became effective on December 18, 2013. The Bureau also issued additional guidance regarding Act 122 in its Frequently Asked Questions, Volume 1 and Volume 2 (“FAQs”).

According to its Senate Co-Sponsorship Memoranda, the purpose of Act 122 was to: (1) prohibit the “placing of phlebotomists or specimen collectors in physician and other health care provider offices in the Commonwealth;” and (2) afford Pennsylvania laboratories “the ability to compete on a level playing field with out-of-state labs” who had been able to place staff in providers’ offices “without fear of sanction.” However, the broad language of Act 122 will also affect laboratories’ ability to collect specimens from skilled nursing facilities (“SNFs”). Continue reading…

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