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).