Saturday, December 1, 2012

Political and Healthcare Policy Changes:
Post-2012 Election


With the election behind us and President Obama settling in for a second term, the healthcare industry can look forward to a more certain regulatory landscape in which the federal government will likely move full steam ahead on health reform. In this post-election landscape, the following issues and challenges come into focus:

  • The rapid implementation schedule for state and federally-run health insurance exchanges;  
  • State government decision-making on expanding Medicaid programs; 
  • The fiscal cliff’s effect on the American healthcare system and the urgent need to rein in medical costs; 
  • A muddled verdict on voter preferences for Medicare reform; and 
  • The Patient Protection and Affordable Care Act’s (PPACA’s) remaining legal and legislative challenges.

The Kentucky Health Benefit Exchange:
How Obamacare is Changing the Health Insurance Marketplace

Now that the President has been re-elected and the Supreme Court has upheld most of the Accountable Care Act (“ACA”), Obamacare will not be repealed. So, what does that mean for Kentuckians?  Several things including an individual mandate to buy health insurance and a health benefit exchange where Kentuckians can buy insurance.

The component of healthcare reform that was most at risk had President Obama not been re-elected to a second term was the individual mandate.  Under ACA, individuals are required to obtain health insurance starting in 2014.  To make this easier, state insurance exchanges are to be created to provide subsidized insurance products for low and middle income individuals.  The belief is that if more people have insurance, then hospitals, and especially emergency rooms, will not have as many no-pay patients who are treated.  This should mean that the high volume of uninsured patients seeking care in hospital emergency rooms will be significantly reduced and hospital bad debt will also be significantly reduced.  Kentucky, particularly Eastern Kentucky, has extremely high rates of emergency room use when compared to the rest of the state and the nation.  This high emergency room use is coupled with low rates of payment collection.  This makes it very expensive for hospitals to provide services to a population that is often the group that most needs healthcare because of the incidence of chronic diseases, like obesity, more often associated with those from low-income backgrounds.

Wednesday, November 21, 2012

An Effective Compliance Program: Preventive Medicine for the
Individual and Small Physician Group Practice


With federal and state fraud and abuse enforcement efforts on the rise, all health care providers must be vigilant in identifying areas of risk and putting in place mechanisms to ensure regulatory compliance.  This holds true not just for larger institutional providers, but for individual and small physician group practices as well.  With the proliferation of federal and state contractors tasked with performing audits of coding and  billing practices, physician practices must be prepared to demonstrate proper coding and billing practices and proper documentation to support those practices.  The best preventive medicine for the individual and small physician group practice is a carefully drafted compliance program to identify and address areas of risk and to promote a culture of compliance within the practice.

Monday, November 12, 2012

Reforming Medicare Audits


On October 16, 2012, the Medicare Audit Improvement Act of 2012[1] was introduced in the U.S. House of Representatives by Representative Sam Graves. The purpose of this legislation is to reform the Medicare auditing program. This legislation aims to improve the accuracy and transparency of Medicare audits of hospitals as well as increase the accountability of Recovery Audit Contractors (“RAC”).[2]

RACs have a financial incentive to be overzealous and find unnecessary billing errors, because they are paid contingency fees based upon the amount of money they recover.[3] As a result, the RAC process has resulted in burdensome document requests, unjust recoupments, and inappropriate denials, many of which have been overturned upon appeal.


Tuesday, November 6, 2012

The Kentucky Health Benefit Exchange:
Little Gnome Facts

"Like Travelocity but for health insurance” is how Executive Director Carrie Banahan and Deputy Director Bill Nold of the Office of Kentucky Health Benefit Exchange describe the developing Kentucky Exchange.

Historically, small businesses have struggled to provide quality, affordable health insurance for their employees.  According to the United States Bureau of Labor Statistics, this problem persists.  In fact, March 2012 data indicates that access to employer-provided benefits was significantly greater in medium and large businesses (500 employees or more) than in small businesses (100 employees or less), with health benefits available to only 57% of small business employees as compared to 89% of employees in larger businesses.  A “primary beneficiary” of the Exchange could be small businesses.

Thursday, November 1, 2012

The “Wild Wild West” Of SMS

SMS text messaging is fast becoming the preferred method of communication for many people who find it a quick and convenient way to share information with friends, family and, increasingly, colleagues.  This is true in the health care space as well with patients increasingly using text messaging to communicate with providers and to receive health-related reminders and updates, including for healthcare appointments, medication therapies and health news.  For example, anyone can text the word HEALTH to 87000 and begin receiving text messages from the Center for Disease Control regarding emergency alerts, new research and reports, as well as health information and tips.

Wednesday, October 31, 2012

Changes to Deadlines for Stage Two: Meaningful Use in the
Medicare and Medicaid EHR Incentive Programs


Under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, incentive payments may be provided to eligible professionals, eligible hospitals and critical access hospitals (“CAHs”) provided they adopt, implement, upgrade or demonstrate meaningful use of certified electronic health records (“EHR") under a three-stage process. Eligible professionals can receive up to $44,000 through the Medicare EHR Incentive Program and up to $63,750 through the Medicaid EHR Incentive Program.

Here Comes the Sun, Are You Prepared?:
Tips for Navigating the New Sunshine Provisions

The Sunshine Act was enacted as part of the Patient Protection and Affordable Care Act (the “ACA”) to reduce the risk that inappropriate financial incentives would interfere with medical judgment and patient care, by enhancing the transparency of financial relationships between certain healthcare providers (i.e., physicians and teaching hospitals) and manufacturers of covered drugs and devices.

Because these relationships are now being scrutinized more closely than ever, those involved in clinical research with manufacturers of drug and device companies may find the following general guidelines helpful in avoiding risks of non-compliance and other legal complications.

Friday, September 21, 2012

Is a Cloud Vendor a Business Associate?


Before a covered entity can use cloud storage for ePHI, the covered entity must enter into a business associate agreement (BAA) with the cloud vendor.[1]   It seems that there is some uncertainty surrounding this requirement, with some cloud vendors taking the position that a BAA is unnecessary for passive storage of ePHI or that they qualify for an exception under HITECH Act as a personal health records vendor.

HIPAA defines a business associate as anyone that performs on behalf of a covered entity a function or activity regulated under HIPAA privacy and security regulations.[2]   HIPAA regulates a covered entity’s passive storage of ePHI by imposing on the covered entity strict requirements to ensure the confidentiality, integrity and availability of ePHI maintained by the covered entity.[3]   Because HIPAA regulates a covered entity’s passive storage of ePHI, disclosure of ePHI by the covered entity to a cloud vendor for the purpose of storing the ePHI makes the vendor a business associate.[4]   Because the cloud vendor is a business associate, a BAA is required prior to the vendor assuming responsibility for the ePHI.[5]

Tuesday, September 18, 2012

Is HIPPA in the Clouds?


Virtual or “cloud” data storage is an increasingly popular method for storing data electronically in a safe and yet conveniently accessible manner that may also represent a cost savings over traditional onsite data storage options.  Health care providers, including hospitals, pharmacies and physicians, have been slow to avail themselves of the benefits of “cloud computing” due in part to concerns about whether the cloud offers the rigorous privacy and security safeguards required for storing electronic protected health information (ePHI) under Federal and State privacy laws, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and implementing regulations.

Sunday, September 9, 2012

Guess Who’s Coming to Visit?
Long-Term Care Facility Inspections


Compliance and preparedness are two very real, everyday concerns for long-term care facilities. Not only are these important aspects of daily operations for the safety of the employees and patients, they are paramount because any day a visitor from the Office of the Inspector General (OIG”) or Occupational Safety and Health Administration (“OSHA”) could show up for an inspection.  Is your facility prepared?

The OIG will soon be conducting unannounced inspections of long-term care facilities as part of an increased crackdown on fraud, waste and abuse in the Medicaid and Medicare programs. The purpose of the OIG inspection will be to determine if the facility is in compliance with the new federal regulations outlined in the Patient Protection and Affordable Care Act (“PPACA”). The inspections focus on the management and evaluate the programs looking for any vulnerability, inefficiency or violation that could be considered fraud or abuse. With more funds earmarked for the enforcement of the fraud, waste and abuse controls, facilities can expect inspections to be very intense.

Wednesday, September 5, 2012

Passive Payer No More: In Final 2013
IPPS Rule,CMS Officially Launches Payment
Adjustments for Quality Performance


On August 1, 2012, the Centers for Medicare & Medicaid Services (CMS) issued its final inpatient prospective payment system (IPPS) rule for fiscal year (FY) 2013 (the final rule was published in the Federal Register on August 31, 2012).[1]  In addition to the annual Medicare payment updates, the final rule gives notice that the Medicare program will, for the first time beginning in FY 2013, adjust IPPS payments based on quality performance under the Hospital Value-Based Purchasing Program and the Hospital Readmissions Reduction Program.  Both programs were created as a part of the Patient Protection and Affordable Care Act (ACA). The following is a brief overview of some of the final rule’s significant provisions.

Friday, August 31, 2012

Compliance Plan: A Provider’s Defense


The Office of the Inspector General (“OIG”) has always encouraged Medicare and Medicaid providers to implement a compliance program. For 14 years, as a matter of fact, OIG has provided compliance guidance in 11 healthcare sectors, including hospitals, nursing facilities, home healthcare, hospice and third-party billers. With the passing of the Patient Protection and Affordable Care Act (“PPACA”), compliance plans and programs are now mandatory for any provider enrolled in a Federal health care program, including Medicare.

Thursday, August 30, 2012

How Many Calories Are in That Burger?:
PPACA Makes Sure You Know


We all occasionally grab a quick bite on the go. But what if your favorite drive-through restaurant posted calorie information and you could see that the Hardee’s Thickburger you planned to order contained 910 calories?  A healthy caloric intake for an average person is 2,000 calories per day, something which would also be stated on the menu.  The burger just became one-half of your recommended daily allotment of calories. That information would definitely prompt anyone to reconsider their choices.

Wednesday, August 29, 2012

The Perils of Prescribing Controlled Substances


As the Kentucky Board of Medical Licensure’s (“KBML”) implementing regulations for House Bill 1 are now effective on an emergency basis for the next six months, physicians, nurse practitioners, and other licensed prescribers have specific statutory and regulatory requirements establishing when and how they may prescribe controlled substances.  These rules must be followed or physicians and others may face serious consequences that include criminal misdemeanor offenses, loss of prescribing privileges, and disciplinary actions against professional licenses. All practitioners must pay careful attention to these rules because even minor violations may create problems.

Monday, August 27, 2012

Kentucky Health Cooperative Insurance Available in 2014


The Supreme Court decision of June 28, 2012, upholding the Patient Protection and Affordable Care Act (“PPACA”) in National Federation of Independent Business, et al., v. Sebelius , Secretary of Health and Human Services, et al., reignited the creation and implementation of Consumer Operated and Oriented Plan programs (“CO-OPS”).  CO-OPs are aimed at offering small businesses and individuals more affordable health insurance options, especially in states where there are a few insurance carriers capitalizing the market with plans that are not economically targeted at the smaller insurance market.

Affordable Insurance Exchanges


Affordable insurance exchanges seek to ease the navigation and financial burdens of both individual and small business health insurance.  As part of the Affordable Care Act (“ACA”), state-based exchanges are a “one-stop-shop” to compare and find affordable health coverage in a competitive insurance market.  The transparency of exchanges allows consumers to compare private and public health plans based on price and quality. The ACA created the notion, but on August 12, 2011 the Department of Health and Human Services and Treasury awarded establishment grants to 13 states and the District of Columbia to facilitate the implementation of the exchanges.

Fraud, Waste and Abuse Controls
Under the Affordable Care Act


The Affordable Care Act (“ACA”) strives to improve our health care system in three main areas:  by expanding consumer protections, strengthening Medicare and reducing health care costs.  One key way the government hopes to achieve these goals is through tougher fraud and waste controls.

Given the focus on prevention, penalty and recovery, compliance plans are of the utmost importance for all health care providers. First we examine all of the elements incorporated in the ACA that pertain to fraud, abuse and waste before we can begin to develop a compliance plan for our facilities. The new law contains a host of tools aimed at enforcing fraud and waste prevention.

Monday, August 20, 2012

A Quick Primer on Health Insurance Exchanges

In the same way that Expedia or Travelocity showcases travel deals offered by a variety of hotels and airlines, health insurance exchanges allow consumers to compare private health insurance policies. The Patient Protection and Affordable Care Act of 2010, as amended by the Healthcare Education and Reconciliation Act of 2010 (PPACA), calls for the implementation of state-based health insurance exchanges by 2014. The Congressional Budget Office (CBO) estimates that 20 - 23 million individuals could receive coverage through these exchanges by 2016.[1]

Thursday, August 16, 2012

"The Ruling:" As the Constitutional Debate Ends,
How Will the Healthcare Industry Be Affected?

As everyone in the healthcare industry (and the rest of the country) knows by now, on June 28, 2012, the U.S. Supreme Court upheld the provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Healthcare Education and Reconciliation Act of 2010 ("PPACA"), with the provision that the Department of Health and Human Services ("HHS") may not withhold existing Medicaid funding from states that refuse to adopt the Medicaid expansion, but rather only new Medicaid funding associated with the expansion.  In this post, we’ll address some of the major effects of the ruling on the healthcare industry, including primarily the effect of limiting the penalties for those states that do not adopt the Medicaid expansion. We will also discuss the industry impacts of the ruling.

Wednesday, August 1, 2012

Health Research Good Practices Guidelines Issued


The Commission for Protection against Sanitary Risks issued new guidelines in June 2012 regarding good practices in health research activities.  These guidelines were not published in the Federal Official Gazette, but they are expected to be mandatory for those individuals or legal entities engaged in activities related to health research as defined in the General Health Law Regulations in Health Research Matters (“Regulations”).

These new guidelines establish various definitions, among which we note the Sponsor and Contract Research Organization provisions that are not currently included in the Regulations:

New Resolution Establishes Use and Sanitary Provisions
for Additives in Food, Beverage and Dietary Supplements


A new resolution establishing use and sanitary provisions for additives in food, beverages, and dietary supplements (the “New Resolution”) was published in the Federal Official Gazette on July 16, 2012, and will become effective October 8, 2012.

This New Resolution replaces the resolution that previously regulated the substances permitted as additives in food, beverages, and dietary supplements, which was published in the Federal Official Gazette on July 17, 2006.

The New Resolution establishes a considerable number of new definitions, references to international and foreign provisions, and a biannual review of the New Resolution.

COFEPRIS Issues Guidelines for Keeping Information
Regarding Pharmochemical Medicines Confidential


The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) in June 2012 issued guidelines regarding confidential information filed when registering a marketing authorization (sanitary registry) for human-bound medicines (Official Letter  No. CAS / 01/OR/896/2012).

In accordance with these guidelines, authorities must deem information that meets certain requirements, outlined below, as confidential and subject to protection against unfair use and disclosure to third parties when filing a marketing authorization registry for pharmochemical medicines.  This information must be kept confidential for a term of five years following the date of issuance of the corresponding marketing authorization (in addition to the period between the filing of the request and the issuance of the marketing authorization).

Thursday, June 7, 2012

The New Business of Prescribing Controlled Substances


Out of the heated debate between the Attorney General representing law enforcement and the Kentucky Medical Association representing physicians, the Legislature enacted Kentucky’s “Pill Mill Bill,” which is  sweeping legislation designed to combat prescription drug abuse through increased regulation of pain clinics and greater scrutiny of prescribing practices by various agencies of state government.  The Pill Mill Bill becomes effective on July 20, 2012 and imposes requirements not just for doctors practicing pain medicine, but for all practitioners who prescribe controlled substances.  In addition to placing significant limits on who can own a pain clinic and how a pain clinic is operated, the legislation requires Kentucky’s licensing boards, including the Kentucky Board of Medical Licensure and the Kentucky Board of Nursing, to enact new regulations that impose standards for physicians, nurses and other practitioners when a Schedule II or Schedule III controlled substance is prescribed. Because the Pill Mill Bill imposes sweeping changes for pain clinics and prescribing practices, all health care providers and their patients will  face new challenges as procedures change.  Regardless of whether the legislation stops the shifting pattern of drug abuse from illicit to prescription drugs, physicians are at the center of the Pill Mill Bill and are now required to reduce the risk of diversion and abuse of prescription drugs when treating a patient’s pain. Whether the collateral effect of the Pill Mill Bill is the serious under treatment of pain is yet to be seen.

Wednesday, June 6, 2012

Health Care Quality Assurance Issues: Is Your Smartphone Secure -- from Infection?


Recent health care technology surveys indicate that the use of hand-held devices is increasing dramatically among physicians and other health care providers. According to a recent industry study, 38 percent of physicians use health-related mobile apps daily on smart phones or tablets, and they expect that number to increase above 50 percent within the next year.  A study from Manhattan Research found that 71 percent of physicians they surveyed already consider a smartphone essential to their practice.