CMS Issues Transmittal 192 - Cleaning Up HHA Definition of "Confined to the Home"


On August 1, 2014, CMS issued Transmittal 192, specifically updating section 60.4.1 of Chapter 15 of the Medicare Benefit Policy Manual (Pub 100-02)  to provide clarification of the definition of "confined to the home" (homebound). The update is intended to bring the manual guidance in line with the 2012 HH PPS final rule that was published on November 4, 2011 (76 FR 68599-68600. The clarification was recommended by the Office of Inspector General (OIG).

CMS states that the changes closely align the policy manual with the requirements of the Social Security Act. The new clarification is intended to prevent confusion, promote a clearer enforcement of the statute, and provide more definitive guidance to HHAs in order to foster compliance.

The clarification should help HHAs in the audit process and provide clearer guidance to HHAs and auditors going forward.

A copy of the manual transmittal can be found here - http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R192BP.pdf 

The associated MLN - MedLearn Article can be found at - http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8818.pdf

For more information on home health care and Medicare, please feel free to contact Ari Markenson at amarkenson@duanemorris.com or 212.692.1012.

 
 
 
 

CMS Extends Moratoria for the Enrollment of New Home Health Agencies and Ambulance Suppliers and Providers


Earlier in July of 2013 and February of this year, CMS flexed its regulatory muscle to establish temporary moratoria on the enrollment of certain providers and suppliers under its recent authority pursuant to 42 USC §42 U.S.C. 1395cc(j)(7) and 42 CFR §424.570. CMS is now extending those moratoria in a new notice to be published on August 1, 2014. In the Notice, CMS explains that it continues to see risk in the areas affected by the moratoria and it has also confirmed its findings with the OIG.

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HIPAA Enforcement on the Rise, Criminal Prosecutions Become More Prevalent


As the Federal Government has moved to more aggressive enforcement of the Health Insurance Portability and Accountability Act  ("HIPAA")  privacy provisions, providers and payers are experiencing significant challenges responding to and addressing privacy violations. A subset of aggressive enforcement efforts is the effort in specific circumstances to bring criminal prosecutions.

[Read More]
 
 
 
 

Duane Morris Special Counsel Michael E. Clark to Present on "The Physician and Attorney Relationship in a Fraud Audit"


Duane Morris special counsel Michael E. Clark will be speaking on "The Physician and Attorney Relationship in a Fraud Audit: Working Through Related Ethical Issues," during the Physicians Legal Issues Conference presented by the American Bar Association Health Law Section in conjunction with the Chicago Medical Society and the American College of Physician Executives. Mr. Clark's presentation will be on Friday, June 13, 2014 from 8:00 a.m. until 9:15 a.m. at the Palmer House Hilton in Chicago. [Read More]
 
 
 
 

Duane Morris Partner Mitch Goldman to Speak at Digital Health Innovation in Context 2014 Conference


Duane Morris partner C. Mitchell Goldman will speak at the Digital Health Innovation in Context 2014 Conference, to be held on April 24, 2014 from 8 a.m. to 6 p.m. at the Westin Forrestal Village in Princeton, New Jersey.

Digital Health Innovation in Context 2014 is a one-day conference focused on the world of digital health: strategy, opportunities and innovation. The intimate conference setting accompanied by the roster of healthcare executives, entrepreneurs, and investors will not only expose you to the ideas shaping the digital health landscape, but also provide you with the opportunity to meet the people reshaping the healthcare industry.

Mr. Goldman will moderate the discussion on "Big Data: Can New Technology Drive New Insights and Monetization Possibilities?" at 3:40 p.m. With the rapid digitization of records, new data streams and the demand for greater understanding of populations, big data reigns supreme. Hear from industry veterans and new entrants on how they are taking advantage of these opportunities.

For more information, please visit the Duane Morris event page.

 
 
 
 

Duane Morris' Mark J. Silberman and Michael E. Clark Quoted in Physician Risk Management


Duane Morris partner Mark Silberman in the firm's Chicago office and special counsel Michael E. Clark in the firm's Houston office are quoted in two articles in the May 1, 2014, issue of Physician Risk Management.

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Duane Morris' Michael E. Clark Quoted in Modern Healthcare


Duane Morris special counsel Michael E. Clark of the firm's Houston office, is quoted in "AHA Lawsuit over 'Two-Midnight' Rule Called Uphill Battle," which appeared in Modern Healthcare on April 15, 2014.

[Read More]
 
 
 
 

CMS Seeks To Fight Prescription Drug Abuse With Proposed New Rules


The problem of prescription drug abuse is a growing national problem, and one that can have serious consequences for any physician that may be implicated.   Earlier this month, the Centers for Medicare and Medicaid Services (“CMS”) announced proposed new rules to fight fraud and abuse in the federal Medicare Advantage and Part D prescription drug program.  One of the goals of these proposed new rules is to identify Part D enrollees that have “potential opioid or acetaminophen over utilization issues that indicate the need to implement appropriate controls on these drugs for the identified beneficiaries.” 

[Read More]
 
 
 
 

OIG Criticizes CMS For Lack Of Adequate Fraud Detection Practices in Electronic Health Records


In early January, 2014, the Office of Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) issued a report criticizing HHS’s Centers for Medicare and Medicaid Services (“CMS”) for failing to adopt stronger integrity practices governing electronic health records (“EHRs”).  “CMS And Its Contractors Have Adopted Few Program Integrity Practices To Address Vulnerabilities In EHRs,” oig.hhs.gov/oei/reports/oei-01-11-00571.pdf.   Here are some of the OIG’s challenges and concerns: “…clues within the progress notes, handwriting styles, and other attributes that help corroborate the authenticity of paper medical records are largely absent in EHRs. Further, tracing authorship and documentation in an EHR may not be as straightforward as tracing in a paper record. Health care providers can use EHR software features that may mask true authorship of the medical record and distort information in the record to inflate health care claims.” These are legitimate issues for EHR users.  Government health care programs such as Medicare and Medicaid, many insurance laws, and private payer contracts require prior documentation for every encounter as a matter of patient safety and proper billing.  Also, under recent federal law, providers are receiving $22.5 billion in incentive payments to adopt EHRs and must attest to their compliance with EHR standards.   The OIG recommends that CMS, working with their fraud detection contractors, develop more sophisticated EHR integrity and fraud detection standards and tools, and issue best practices and guidance.  The OIG specifically recommends that CMS and contractors look at providers’ EHR audit logs to help authenticate records, and develop approaches to detecting inappropriate cutting-and-pasting.  In its response, CMS indicates that it is aware of these issues and is working diligently to address them.  The agency has also initiated investigations of a number of providers on the grounds that the attestations they provided in order to obtain the EHR incentive monies were not sufficient, which could result in takebacks. Most hospitals, physicians and others have deployed EHR systems that have been designed and are maintained by third party vendors.  Many providers may not have the sophistication to determine whether, for instance, an audit log system is adequate to detect abuse.  Nevertheless, it is incumbent on all providers with EHRs to be aware of potentially unlawful uses; to work with EHR vendors that will represent that their products are fully compliant and that they have installed tools, such as audit logs, access controls and export controls and others as may be required by CMS;  and to properly train all staff and clinicians that use EHRs. 

 

 

 
 
 
 

mHealth App Use: Is Data Truly Protected?


One of the reasons why consumers, healthcare providers, investors, the government and others have been slow to adopt mobile health applications and software (apps), are concerns about the privacy and security of data collected through the apps.  For instance, Appthority, a service provider that offers an app risk management solution, recently reported that the iPharmacy Drug Guide and Pill ID app “is playing fast and loose with your personal info.” www.appthority.com/news/mobile-threat-monday-android-app-leaks-your-medical-info-online.  iPharmacy is a free app that allows consumers to maintain a personal health record on their prescription drugs, look up information on a drug, provide reminders, and maintain pharmacy discount cards. Appthority found that while the app description states that it encrypts personal information, it only uses a common encoding scheme and does not protect user info when the consumer searches for information about a drug through the app.  Appthority also claims that the app sends personal information to advertising networks.  Another example of a legitimate privacy and security concern relates to cloud storage.  Many mHealth apps collect physiological data through sensors affixed to the body, store the data in the cloud, and provide the data to a physician or other provider.  If the cloud storage vendor does not provide adequate security protections, the provider could be implicated as a party to the app’s use.  mHealth apps offer tremendous opportunities to advance a more sophisticated and connected healthcare environment – but the modes of connection need to be solid from a data protection perspective.  Good risk management is key.   

 

 
 
 
 

Duane Morris Attorneys Frederick Ball and Erin Duffy to Present "Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation"


Duane Morris partner Frederick Ball and associate Erin Duffy will present at the "Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation" program on Thursday, November 7, 2013 at the Hyatt Regency New Brunswick in New Brunswick, New Jersey.

This introductory program provides a comprehensive overview of the laws and Food and Drug Administration regulations affecting the drug industry, and will help you and your organization get products approved and navigate regulatory problems. Experts will review the essential elements of FDA drug regulation in a systematic and comprehensive way. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, speakers walk you through key regulations and policies and will help you determine how those regulations and policies are applied.

For more information please visit the Food and Drug Law Institute website.

 
 
 
 

Moody's report: Exchanges negatively impacting non-profit hospitals revenue


Moody's recently downgraged the outlook for non-profit hospitals in 2014 according to its recent study due the employers shifting commerically insured patients to the new, health insurance exchanges.  The study indicated that the downgrade is a result that the payments under many of the health insurance plans sold on the exchanges will have higher deductibles and copayments and lower rates.  With more out of pocket payments there is a risk of higher bad debt.  Also, Moody's report indicated that employers are moving to private exchanges not covered by the Affordable Care Act.  This could also have a similar impact on the hospitals as health insurance premiums for these plans become more competitive and hospital reimbursement is reduced.  The study which is available to subscribers is located at https://www.moodys.com/research/Health-Insurance-Exchanges-Are-A-Modest-Credit-Negative-for-Not-PBM_PBM159234   Even though there hospitals should be better off from more patients with insurance and fewer uninsured patients, Moody's focused on the timing of this transition having negative impact for 2014.
 
 
 
 

Mobile Medical Apps Guidance


Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. [Read More]
 
 
 
 

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs


The U.S. Food and Drug Administration (FDA) on July 15, 2013, released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the integrity of the drug supply chain—specifically, Section 709 of the FDASIA [amending section 304(g) of the Food, Drug, and Cosmetic Act (FDCA)].[Read More]
 
 
 
 

Business Associate Agreements (“BAAs”) Under the New HIPAA/HITECH Omnibus Final Rule ("Final Rule")


Earlier this month, I attended the annual meeting of the American Health Lawyers Association in San Diego.  This meeting was excellent from a networking perspective and the substantive information imparted during the various break-out sessions.  A number of these sessions were devoted to or touched upon the Final Rule that was published on January 25, 2013, those terms that must now be included in BAAs under such Final Rule, and the effect of such Final Rule upon a business associate (“BA”) – someone the Final Rule defines as a person acting on behalf of a covered entity (“CE”) who (i) creates, receives, maintains or transmits protected health information (“PHI”); (ii) for a function or activity regulated by HIPAA; and (iii) provides certain identified services to such CE.

The provisions of the Final Rule are especially important to a BA, considering (a) a BA is now independently liable for violations of HIPAA’s privacy and security requirements, and (b) BAs shall be subject to future audits by the Office of Civil Rights to insure compliance with HIPAA, including those amended privacy, security, enforcement and breach notification provisions that are part of the Final Rule. Essentially, under the Final Rule, BAs must comply with HIPAA’s privacy and security rules in the same manner as a CE, including with respect to breach notification requirements that may represent the greatest risk when negotiating a BAA.

[Read More]
 
 
 
 
 

Duane Morris Health Law

Reporting legal developments in the healthcare industry and the latest on the implementation of
the Healthcare Reform Act impacting providers, employers and physicians.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.