New OTC Recommendations Survey by Pharmacists

Pharmacy Times recently released an interesting new Web site that provides pharmacist recommendations regarding certain OTC products: http://otcguide.net/

New HIPAA Rules Coming Soon

In addition to moving HIPAA enforcement over to the Office of Civil Rights (OCR), HHS proposed new rules regarding HIPAA. The "breach notification" regulations, as part of the economic stimulus package, will require health providers, health plans and other entities covered by HIPAA to notify impacted individuals, HHS and the media of breaches impacting more than 500 individuals. Those entities that properly secure information through encryption or destruction will not be required to give notification.

These regulations will now cover business associates of covered entities. This is a big change to HIPAA.

New Texas Health Care/Hospital/Medical Practice Laws (Effective 09.01.09)

The following is an analysis of health care bills signed into law by Governor Rick Perry. Specifically, these bills are of interest to hospitals and medical practices. In addition, bills that failed to pass have been included as well. They will probably make an appearance in the 2011 Texas Legislature.

Insurance Issues -Signed Into Law:

HB 2256 (Hancock) - Relating to requirements between physicians, hospitals, and health benefit plans. The bill became the "negotiated" balance billing bill. A health plan enrollee may request mediation of a settlement of an out-of-network health benefit claim if the enrollee is responsible to the facility-based physician for more than $1,000 and if the health benefit claim is for a medical service or supply provided by a facility-based physician in a hospital that is a preferred provider or that has a contractor with the plan administrator.

Except in the case of an emergency, a facility-based physician shall, prior to a service, provide a complete disclosure that explains that the facility-based physician does not have a contract with the health plan, disclose projected amounts for which the enrollee might be responsible and discloses the circumstances under which the enrollee would be responsible. As a result of disclosing this, the facility-based physician will not be required to mediate a billed charge if the amount billed is less than or equal to the maximum amount projected in this disclosure.

"Facility-based physician" refers to a radiologist, an anesthesiologist, a pathologist, an emergency department physician or a neonatologist. Each facility must develop, implement and enforce written policies for the billing of facility health care services and supplies. The policy must address: any discounting of facility charges to an uninsured patient, any discounting of facility charges provided to a financial or medically indigent patient, the providing of an itemized statement (whether interest will be applied to any billed service not covered by a third-party payor), the procedure for handling complaints and the providing of a conspicuous written disclosure to a consumer at the time they are first admitted to a facility.

HB 1342 (Menendez) - It requires a health insurance company to have information concerning co-payment, deductibles and covered plans and services available in a real-time manner. In addition, a provider that receives an overpayment from an enrollee must refund it within 30 days of when that overpayment was officially identified.

HB 389 (John Zerwas) - Clarifies the definition of a "medical group."

HB 1888 (John Davis) - Relating to standards required for certain rankings of physicians by health benefit plans. The bill would prohibit health plans from ranking physicians unless the plan uses standards prescribed by the TDI Commissioner in conformance with nationally recognized standards.

Nursing Issues - Signed Into Law

SB 476 (Jane Nelson) - SB 476, which will prohibit mandatory overtime for hospital nurses, will go into law on September 1, 2009. This does not prevent nurses from working voluntary overtime. In addition, there are exceptions for emergencies. Texas will now join Pennsylvania in banning mandatory overtime.

As you may remember, this bill competed against a bill that was endorsed by a California nursing union. The union bill did not make it out of a committee hearing.

Scope of Practice/Facility Issues - Signed Into Law

HB 643 (John Zerwas) - Regarding surgical technologists. All surgical technologists hired after September 1, 2009 must complete an accredited educational program for surgical technologists and hold and maintain certification as a surgical technologist by: the National Board of Surgical Technology and Surgical Assisting, the National Center for Competency Testing or another surgical technologist certification program approved by the program. Or the person can complete an appropriate training program for surgical technology in the U.S. Military or U.S. Public Health Service. All of those who were employed prior to September 1, 2009 or are in the service of the federal government will be grandfathered.

SB 911 (Tommy Williams) - Relating to the certification and regulation of pain management clinics. Hospitals and clinics owned and operated by a physician who treats patients within the physician's area of specialty and who uses other forms of treatment, including surgery, with the issuance of a prescription for the majority of the patients are exempted. This act will require pain management clinics that don't meet the exemptions to obtain a certificate from the state. The owner/operator must be on-site at the clinic at least 33 percent of the clinic's total number of operating hours and review at least 33 percent of the total number of patient files of the clinic.

SB 532 (Dan Patrick) - Amends a physician's delegation of prescriptive authority to physician assistants or advanced practice nurses.

HB 1357 - (Carl Isett) - Regulation of freestanding emergency departments.

Health IT (Medicaid) - Signed Into Law

HB 1218 (Donna Howard) - Relating to programs to exchange certain health information between the Health and Human Services Commission and certain health care entities and facilities.

HB 1996 (John Davis) - Relating to an e-prescribing implementation plan under the Medicaid and child health plan programs.

Reporting Requirements/Data Collection - Signed Into Law

HB 1362 (Gutierrez) - Amends the 2007 MRSA registry pilot program that tracks MRSA infections in Bexar, Brazos, Potter, and Randall counties. The extension will allow the San Antonio Metropolitan Health District to continue tracking these infections.

SB 203 (Shapleigh) - Relating to the reporting of MRSA infection rates in general hospitals (pediatric hospitals have different requirements). Requires a general hospital to report to DSHS the incidence of surgical site infections, including the causative pathogen if the infection is laboratory-confirmed, occurring in certain procedures. It amends SB 288 (from the 2007 Legislature) that handled HAI. SB 203 will require hospitals to report each HAI adverse condition for which the Medicare program will not provide additional payment and also includes adverse events identified by the National Quality Forum. In addition, it changes the HAI advisory panel.

Other Hospital Issues - Signed Into Law

HB 2585 (Will Hartnett) - Updates the state's advance medical directives laws by stating that electronic and digital signatures are acceptable (this was not completely clear in the past).

SB 2577 (Mike Jackson) - Requires the board of trustees of the Employee Retirement System of Texas to develop a cost-neutral or cost-positive plan for providing bariatric surgery coverage to eligible employees. Stakeholders and the Employees Retirement System of Texas have been meeting about this issue for the past two years.

Insurance Issues - Did Not Pass:

HB 223 (Eiland)/SB 714 (Van de Putte) - Relating to regulation of the secondary market in certain physician and health care provider discounts.

HB 531 (Anchia) - Relating to medical loss ratios of certain health benefit plan issuers. The bill would require health plans to report their medical loss ratios and set minimums requiring rebates to the insureds.

SB 863 (Harris) - Relating to adoption of certain information technology. The bill would take a step toward real-time claims adjudication by the health plans.

HB 1369 (Rodriguez) - Relating to unfair claim settlement practices by an insurer that issues a preferred provider benefit plan. The bill would set the out-of-network provider's billed charges as the amount the PPO must use to computer out-of-network co-insurance.

HB 1370 (Rodriguez) - Relating to the use of certain insurance policy forms in connection with a PPO plan. The bill would create a DTPA cause of action against the health plan that does not use the out-of-network billed charge to calculate the co-insurance amounts.

HB 1442 (Hancock)/SB 586 (Carona) - Relating to the operation of certain managed care plans regarding out-of-network health care providers. The bill would prohibit health plans from removing or otherwise punishing in-network physicians for referring their patients to out-of-network providers.

HB 2431 (Todd Smith) - Relating to mediation of out-of-network health benefit claim disputes between enrollees and health benefit plan issuers. This is the "model bill" for dispute resolutions regarding balance billing.

SB 1007 (Hegar) - The Texas Department of Insurance (TDI) sunset bill failed to pass. Instead, a temporary extension was passed during a special session. The sunset bill will be taken up again in a few years.

HB 1929 (Jim Jackson) - Relating to payment of claims of certain out-of-network physicians and health care providers. The bill punishes the out-of-network provider by limiting their out-of-network payment to the health plan's in-network rates if the enrollee has made a "reasonable" effort to find an in-network provider.

HB 1930 (Jim Jackson) - Relating to health services provided to health benefit plan enrollees by certain out-of-network health care providers. The bill punishes the out-of-network by banning balance billing if the referring provider does not give the patient notice of the out-of-network provider's out-of-network status and have the patient sign a document in which the patient states that they know the out-of-network provider is out-of-network and agrees to pay the out-of-network provider the balance bill. This measure was opposed by most medical groups.

SB 351 (Shapleigh) - Relating to payment of certain emergency room physicians for services provided to enrollees of managed care health benefit plans. The bill would ban balance billing in ER situations. This measure was opposed by most medical groups.

Integrated Care Models/"Evidence-Based Medicine" - Did Not Pass:

SB 10 (Robert Duncan) - This bill would authorize the board of trustees of the Employees Retirement System of Texas to establish one or more pilot programs that would resemble a physician-hospital organization (PHO). The pilot program would be established in at least one region and reimburse the state health insurance plan with an alternative model that focuses on "quality-based" reimbursement. The pilot program would have been located in Lubbock.

SB 7 - Nelson - Senator Jane Nelson's bill includes 10 elements that she believes would improve Texas health care. Although the bill failed, several items, such as the HAI reporting, were amended to other bills that were signed into law. Among the sections that would be of interest to hospitals:

· Uncompensated hospital care data - Increased hospital and state reporting requirements regarding uncompensated care.
· A quality-based reimbursement program for Medicaid.
· "Preventable events" reporting - Additional measures would be added to the current Health-Care Associated Infection Reporting System (which should receive funding for enforcement this Legislature). "Never events" would not be reimbursed under the state's Medicaid program.

Uncompensated Care/Charity Care - Did Not Pass:

HB 3473 (Garnet Coleman) - Relating to charity care requirements by for-profit hospitals. The bill would require for-profit hospitals that receive tax abatements to provide charity care or government-sponsored indigent health care. A hospital that qualifies would be required to provide charity care in an amount equal to at least five percent of the hospital's gross patient revenue, and government-sponsored indigent health care in an amount equal to at least four percent of the hospital's gross patient revenue.

SB 2278 (Rodney Ellis) -Relating to charity care. The bill would require a hospital to report total gross revenue, including: Medicare gross revenue, Medicaid gross revenue, other revenue from state programs, revenue from local governments, local tax support, charitable contributions, other third party payments, gross inpatient revenue, and gross outpatient revenue. Hospitals would also have to report DSH payment revenue, UPL payment revenue, tobacco settlement proceeds, federal grant funding, charity care, bad debt expenses. In addition, they would have to report total admissions, including: Medicare admissions, Medicaid admissions, admissions under a local government program, charity care admissions, any other type of admission, total discharges, total patient days, average length of stay, total outpatient visits, total assets, total liabilities, estimates of unreimbursed costs of unreimbursed costs of services reported separately (emergency and trauma care, neonatal intensive care, free-standing community clinics, collaborative efforts with local government or private agencies in preventive medicine), donations, total costs of reimbursed and unreimbursed research, education of faculty, and community health education through informational programs and publications. Also, the hospital would have to submit its charge description master or charge master.

The bill would require hospitals electing to provide charity or government-sponsored indigent health care make sure that the charity care and community benefits are provided in a combined amount equal to or at least 10 percent of the hospital's or hospital system's net patient revenue, provided that charity care and government-sponsored indigent health care are provided in an amount equal to at least eight percent of net patient revenue.

Scope of Practice/Facility Issues - Did Not Pass:

HB 2028 (John Zerwas)/SB 2427 (Bob Deuell) - Regarding the delegation of cosmetic and certain dermatological treatments. Only a physician or a physician may delegate to a qualified physician assistant: the administration of botulinum toxin injections, administration of dermal fillers, cosmetic or aesthetic medical treatments or the use of a laser or intense pulsed light device that is a prescriptive device.

Facility Issues - Did Not Pass

HB 3749 (Coleman) - Relating to itemized statements provided by certain health care facilities. The bill would require facilities to itemize their billing statements with regards to medical devices and drugs.

Nursing Issues - Did Not Pass

HB 1489 (Senfronia Thompson) - Relating to the practice of nursing; providing civil penalties. This bill is supported by the National Nurses Organizing Committee and establishes a mandatory nurse to patient ratio. This is similar to the nursing laws in California.

Ownership/Imaging - Did Not Pass

HB 2279 (Thompson) - Relating to the provision of and billing for certain diagnostic imaging services. The bill would create new burdens on physician imagers and new billing requirements.

HB 2259 (Thompson)/SB 1461 (Duncan) - Relating to the registration of diagnostic imaging equipment, the accreditation of diagnostic imaging facilities, and the regulation of diagnostic imaging providers. The bill would require a burdensome and costly (a) registration of MRI, CT, and PET and (b) reporting of patient referrals and study.

Health IT (Medicaid) - Did Not Pass

SB 288 (Jane Nelson)-Relating to the review of a Medicaid recipient's electronic medication history by a Medicaid provider.

SB 289 (Jane Nelson) - Relating to ensuring that health information technology used in the medical assistance and child health plan programs conforms to certain standards.

SB 286 (Jane Nelson) - Also referred to as the "Medicaid Health Passport."

Latest health IT regulations from the federal government for practices and health care facilities

"As the web continues its torrid growth, we simply have too many web sites to sort through, too many places to buy products from, too many software providers to pick from." - Anonymous Blogger

Health Care Information Technology Update

The health care industry is not immune to the vast array of information technology (IT) choices to sort through in the "Web 2.0" era. The following is an attempt by CAB Strategies to sort through the latest health IT laws and regulations that will impact Texas medical practices and health facilities in the near future. Please note that the following is for information purposes only and does not serve as legal advice.

American Recovery and Reinvestment Act of 2009 (HR 1/P.L. 111-5)

Signed into law by the president in February 2009 (also known as the Stimulus Act), this law incorporated the Health Information Technology for Economic and Clinical Health (HITECH) Act.

What does HR 1 do?

Beginning in January 2011, HR 1 provides Medicare reimbursements incentives to physicians (eligible professionals) and hospitals who are "meaningful users" of electronic health records (EHRs). (More about meaningful users down below.) Beginning in 2015, payment penalties will begin for physicians and facilities who are not meaningful users of EHRs.

Medicare incentive payments for hospitals

Incentive payments for eligible hospitals that are meaningful EHR users will begin in October 2010. Reduced payments for hospital that fail to become meaningful EHR users will begin in FY 2015.

The incentive process for determining hospital incentive payments is a little complicated. According to CMS, the incentive payment for each eligible hospital would be based on the product of (1) an initial amount, (2) the Medicare share, and (3) a transition factor.

The initial amount

It is the sum of a $2 million base year amount plus a dollar amount based on the number of discharges for each eligible hospital.

The Medicare share

It is a fraction based on estimated Medicare fee-for-service and managed care inpatient bed-days and modified by charges for charity care.

The transition factor

It phases down the incentive payments over the four-year period. The factor equals 1 for the first year, ¾ for the second payment year, ½ for the third payment year, and ¼ for the fourth payment year. The transition factor is modified for hospitals that wait until 2014 to become a meaningful EHR user (their first year transition factor would be ¾ instead of 1).

What does this mean for ASCs?

The law does not provide incentives for ASCs to adopt EHRs. Only eligible professionals (physicians) and hospitals can take advantage of the incentives. However, many ASCs will want to adopt the EHRs in order to connect to the medical office.

Payments for eligible professionals

The incentives for eligible professionals, such as physicians, will begin in January 2011. Hospital-based physicians who furnish their services in a hospital setting will not be eligible. Eligible providers who furnish most of their services in a health professional shortage area would see their incentive payments increased by 10 percent.

The incentive payment formula is a little complicated. Key highlights of the payment formula:

· You must take advantage of the incentive payments during the time window of 2011 - 2016 (penalties set in after that).

· The payment is equal to 75 percent of Medicare allowable charges for the covered services (or maximum amounts on the sliding scale). We'll focus on the maximum amounts.

· Note that eligible professionals who utilize EHRs in 2011 or 2012 will have a maximum payment of $18,000 for the first year (instead of $15,000).

Incentive disbursements (top row is the year that the EHR is implemented):

	2011	2012	2013	2014	2015
2011	$18,000	$0	$0	$0	$0
2012	$12,000	$18,000	$0	$0	$0
2013	$8,000	$12,000	$15,000	$0	$0
2014	$4,000	$8,000	$12,000	$12,000	$0
2015	$2,000	$4,000	$8,000	$8,000	$0
2016	$0	$2,000	$4,000	$4,000	$0

Payment penalties for eligible professionals

A physician who does not utilize a meaningful EHR by 2015 would start seeing Medicare payment reductions in 2015. They include:

· 1 percent reduction in 2015

· 2 percent reduction in 2016

· 3 percent reduction in 2017

· 3 to 5 percent reduction in subsequent years.

The Secretary of Heath & Human Services would then re-visit the issue in 2018.

What must the EHR look like and what is a meaningful user?

Unfortunately, the federal government often waits until the last minute to release necessary regulations for implementing a law (it will be late 2009 when HHS releases the final EHR guidelines). However, there are three key factors to look for when determining if your system could qualify for the EHR incentives: meaningful user, qualifying EHR technology and certified EHR technology.

Meaningful user

The law sets out three basic standards for defining a meaningful user of EHR technology for purposes of meeting the incentive requirements:

· Certified or qualified EHR technology use.

· Electronic exchange of health information.

· Using the EHR to report clinical data and other quality measures.

HHS will release the final meaningful user guidelines in late 2009.

Qualifying EHR technology

You must have qualifying EHR technology in place in order to receive the incentive payments. In addition, qualifying technology is the first step to take in order to reach certification.

HR 1 provides an outline of what functionality will be required for qualifying EHR technology:

· Provide clinical decision support.

· Support provider order entry.

· Capture and query information relevant to health care quality.

· Exchange electronic health information with and integrate it with other sources.

All EHR systems must meet the qualifying standards.

Certified EHR technology

Certified EHR technology will be a qualified health record that is certified as meeting the standards adopted by the Office of the National Coordinator for Health Information Technology (ONCHIT). The Certification Commission for Health Information Technology (CCHIT) will certify products. There is a possibility that EHRs currently certified by CCHIT may not meet the new incentive standards. However, that remains to be seen and will be addressed in late 2009.

Currently, CCHIT does not certify products specific to ASCs. It is mostly focused on the physician practice environment.

Medicaid programs will determine their own requirements (closely following the Medicaid measures set out in HR 1).

What grants are available?

HR 1 authorizes $19 billion grants and incentives to help providers purchase health IT systems. Much of the money will likely flow to the state agencies and provide them with the ability to provide the grants. Of the $19 billion, $2 billion will be used to develop infrastructure to increase health IT adoption (ASCs will be eligible for these funds). The other $17 billion will be used for low-cost loans for the meaningful use of certified EHRs (ASCs will not eligible for this).

Keep in mind that it is very difficult to obtain a state or federal grant. It is a very long process in which you compete with a large number of sophisticated competitors for a relatively small pot of money. It is not like a congressional earmark in which a member of Congress directs the money to a certain entity.

Does it create health care "best practices" endorsed by the federal government?

HR 1 gives the Office of the National Coordinator for Health Information Technology (ONCHIT) within the U.S. Department of Health and Human Services more authority.

This new authority includes:

· Developing vocabulary, messaging and functional standards for interoperability.

· Criteria to make sure that the IT systems meet those needs.

· Privacy and safety criteria.

· "Helping facilitate the creation of prototype health information networks."

E-Prescribing (As Part of the Medicare Modernization Act of 2003)

The Medicare Modernization Act of 2003 required the Centers for Medicare and Medicaid Services (CMS) to develop a set of standards for electronic-prescribing (e-prescribing). The Medicare Improvement for Patients and Providers Act of 2008 took e-prescribing one step further by authorizing incentive bonus payments (and eventual penalties for failing to do so) under Medicare.

What are the bonuses and penalties?

Physicians who use e-prescribing will be provided Medicare bonuses between the years 2009 and 2013. Physicians who fail to do so (beginning in 2012) would witness reductions in the Medicare payments.

The e-prescribing incentives:

· 2 percent bonus in 2009 and 2010

· 1 percent bonus in 2011 and 2012

The e-prescribing penalties:

· 1 percent reduction in 2012

· 1.5 percent reduction in 2013

· 2 percent reduction in 2014

Physician Quality Reporting Initiative (PQRI)

A 2006 law established the first physician quality reporting system for CMS (including an incentive payment). A 2008 law made the PQRI permanent. However, Congress only authorized incentive payments through 2010. (Congress will likely add new incentive payments in the future.)

Eligible providers who meet the requirements and submit the necessary information will receive a 2.0 percent bonus from CMS for the reporting period of January 1, 2009 through December 31, 2009.