Governor Markell urges Delaware lawmakers to do more to address prescription drug abuse

The focus on prescribing narcotics and other controlled substances for the management of pain is nothing new, but Delaware has recently taken initiatives to bring that focus into perspective. In a post on October 14, I wrote about the recently proposed rule on the use of controlled substances in the treatment of pain. That rule establishes the Board of Medical Licensure and Discipline’s (“Board”) formal recognition of use of controlled substances in the treatment of pain. After a recent series of articles in the News Journal about the abuse of prescription pain killers in Delaware, pain management physicians should be alerted to all of the changes coming to state and participate in the processes to fight this epidemic.

In a November 10th article, the News Journal reported that. Governor Markell indicated that he would either propose specific legislation or ask the Board to pass a regulation. Once Delaware establishes its electronic prescription systems next year, Governor Markell pledges to work with the governors of the surrounding states to share data in Delaware’s new prescription monitoring program. Delaware is currently one of fifteen states without such a system already in place. The Governor also indicated that a public awareness campaign may strengthen the requirements of this new program.

Investigations into the practice of prescribing controlled substances are on the rise, and since January of 2010, the Board has suspended or reprimanded nine doctors for violations. In what has become a prescription drug abuse epidemic, such prescription habits will also draw attention from state and federal authorities fighting against health care fraud.

Developing new prescription monitoring systems will provide doctors who prescribe controlled substances with a valuable tool for identifying drug-seeking patients, which in the end should serve to reduce some of the abuse that has plagued Delaware and other states.

DMMA Issues Regulations Regarding Non-Payment for Provider Preventable Conditions

As required by the federal health care reform law passed in March 2010, Delaware’s Division of Medicaid and Medical Assistance issued final regulations on November 1, 2011, that provide, as of July 1, 2011, that DMMA will not reimburse hospitals for provider preventable conditions (PPCs), which include foreign objects retained after surgery, blood transfusions with incompatible blood, falls and trauma occurring in the hospital, and the like. A full list of PPCs can be found at http://www.dmap.state.de.us/downloads/bulletins/federal.prohibition.payment.provider.pdf. The payment bar does not apply to services related to pre-existing conditions, i.e., those “present on admission” (“POA”).

The final regulations also require Delaware hospitals that are Medicaid providers to report the occurrence of a PPC “through the appropriate claim(s) type submission process.” The regulation does not elaborate on the mechanics of reporting but DMMA has promised that more information on the reporting requirement will follow.

The OIG Issues its 2012 Work Plan

Each October marks the height of playoff baseball, the changing of the leaves, and the beginning of a new fiscal year for the Federal government. With the beginning of each new fiscal year, health care providers of all sizes and types are informed of the audit and enforcement plans of the Federal regulators charged with overseeing the federal health care programs. The Office of Inspector General (“OIG”) at the Department of Health and Human Services (“HHS”), the entity tasked with protecting HHS programs by detecting and preventing health care fraud and abuse, released its 2012 Work Plan this month, providing insight on the reviews and activities that the OIG will pursue during the next twelve months and beyond.

The Work Plan offers health care providers a glimpse into the future and an opportunity to see the issues that the OIG plans to focus its investigative resources on. Knowing what to expect in the coming year regarding enforcement and audits can be a useful tool in providers’ own internal compliance efforts. Providers may take a look at their own practices in these related areas in order to assess compliance with the applicable federal laws. Some of the key areas affecting Delaware health care providers are listed below, and the entire plan can be viewed at the OIG website. ( http://oig.hhs.gov/reports-and-publications/workplan/index.asp#current)

HOSPITALS

Medicare Inpatient and Outpatient Payments to Acute Care Hospitals
OIG will review Medicare payments to hospitals to determine compliance with selected billing requirements. OIG will utilize data mining techniques to select hospitals for focused reviews and will then recommend recovery of overpayments and identify those providers deemed high-risk, who routinely submit improper claims.

Acute-Care Hospital Inpatient Transfers to Inpatient Hospice Care
OIG will review Medicare claims for inpatient stays where the beneficiary was transferred to hospice care. The relationship (financial or common ownership) between the entities will be examined, as well as how Medicare treats reimbursement for similar transfers to other settings.

Medicare Outpatient Dental Claims
Medicare hospital outpatient payments for dental services will be reviewed to determine if payment was proper under Medicare requirements. Dental services are only covered under a few exceptions, but based on OIG audits, providers received significant overpayments.

Hospital Claims with High or Excessive Payments
OIG will review high payments to determine whether they were appropriate. Specifically, OIG’s work will include outpatient claims in which payments exceeded charges.

Inpatient Prospective Payment System: Hospital Payments for Nonphysician Outpatient Services
OIG will review the appropriateness of these payments for services that were provided to beneficiaries shortly before or during covered stays at acute care hospitals. Prior reviews have revealed a significant number of improper claims.

Medicare Inpatient and Outpatient Hospital Claims for the Replacement of Medical Devices
Medicare is not responsible for the full cost of a replaced medical device if the hospital receives a partial or full credit from the manufacturer. As such, OIG will review whether claims for the insertion of replacement devices utilized the proper modifier when a credit is received.

Observation Services During Outpatient Visits
Improper use of observation services may result in high cost sharing for beneficiaries, so OIG will review Medicare payments for observation services provided by outpatient departments.

Hospital Admissions With Conditions Coded Present on Admission
OIG will review Medicare claims to determine which facilities (e.g., SNF or rehabilitation facilities) most frequently transfer patients with certain diagnoses that were coded as being present on admission.

Accuracy of Present-on-Admission Indicators Submitted on Medicare Claims
Beginning in 2008, CMS required hospitals to submit present-on-admissions indicators with each diagnosis code on inpatient claims. The Affordable Care Act provides that hospitals with high rates of hospital-acquired conditions will receive reduced payments, and as such, accurate present-on-admission indicators are necessary for CMS to carry out this new law. OIG will review the accuracy of the present-on-admission indicators that were submitted by hospitals in 2008.

NURSING HOMES

Nursing Home Compliance Plans
OIG will begin to review nursing homes’ compliance plans after Section 6102 of the Affordable Care Act mandated compliance and ethics programs to detect and prevent criminal, civil, and administrative violations. CMS must issue regulatory requirements for the programs by 2012, but OIG will begin to review those programs already in place.


OTHER PROVIDERS

Physicians: Incident-To Services
OIG will review physician billing for “incident-to” services to assess whether payment had a higher error rate than the rate for non-incident-to services. OIG believes such services may be vulnerable to overutilization, and as such, the services will be subject to closer scrutiny.

Physicians: Place-of-Service Errors
OIG will review physicians’ coding on Medicare Part B claims for services performed in ambulatory surgical centers and hospital outpatient departments to determine whether they properly coded the places of service. Federal regulations provide for different levels of payments to physicians depending on where services are performed.

Evaluation and Management Services: Use of Modifiers During the Global Surgery Period
OIG will review the use of certain claims modifier codes during the global surgery period to determine whether the use was appropriate and in accordance with Medicare requirements.

Diagnostic Radiology: Excessive Payments
OIG will review payments for high-cost diagnostic radiology tests to determine whether they were medically necessary. Additionally, the review will target whether, and to what extent, the same diagnostic tests are ordered both by the primary care physician and specialists for the same treatment.

Medicare Payments for Part B Claims with G Modifiers
OIG will review payments from 2002 to 2010 for claims where certain modifier codes were used to indicate that Medicare denial was expected. The review will identify the extent to which Medicare paid those claims and the providers with atypically high billing related to the modifiers.

Delaware Board of Medical Licensure and Discipline Issues Proposed Rule on Use of Controlled Substances for the Treatment of Pain

On September 30, the Delaware Board of Medical Licensure and Discipline issued a proposed rule, “Use of Controlled Substances for the Treatment of Pain,” and has asked for comments preceding a public hearing in November. The proposed rule adopts the Federation of State Medical Board’s Model Policy for the Use of Controlled Substances for the Treatment of Pain and is meant to “alleviate licensed practitioner’s uncertainty, to encourage better pain management, and to minimize practices that deviate from the appropriate standard of care.”

The Board recognizes that the appropriate treatment of pain is fundamental to the practice of medicine, but it notes that practitioners may lack knowledge regarding pain management or may fear investigation or sanction by federal, state and local agencies, which have been focusing on pain management practices. These factors contribute to the “inappropriate treatment of pain.” The rule implies that the failure to become knowledgeable about treating pain is considered inappropriate just as the failure to follow statutory requirements in prescribing controlled substances. The proposed rule will consider the inappropriate treatment of a pain “a departure from standards of medical practice,” and such departures will result in investigations and potential discipline. Thus, the purpose of the proposed rule is to establish specific requirements for using controlled substances to treat chronic pain as well as the required safeguards to minimize risks of drug abuse and diversion. The comment period, which is open up to and including the date of the public hearing, November 1, 2011, is the provider’s opportunity to influence the final regulation.

The preamble to the rule states that the Board will not discipline a licensed practitioner for ordering, prescribing, dispensing or administering controlled substances “for a legitimate medical purpose and in the course of professional practice.” The prescribing of a controlled substance must be in the course of a practitioner-patient relationship and “should be based on a diagnosis of unrelieved pain.” The decision to prescribe controlled substances will be considered “a legitimate medical purpose” if it is based on “sound clinical judgment.” The takeaway for providers from the preamble is an emphasis on documentation. While the Board recognizes the place for controlled substances in the treatment of pain, the overriding concerns of abuse and diversion require extensive documentation of the practitioner-patient relationship. Under the rule:

“[t]he practitioner’s conduct will be evaluated to a great extent by the outcome of pain treatment, recognizing that some types of pain cannot be completely relieved, and by taking into account whether the drug used is appropriate for the diagnosis, as well as improvement in patient functioning and/or quality of life.”

The proposed rule requires a documented evaluation of the patient and a treatment plan. The benefits and risks of controlled substances must be discussed and if a patient is considered “high risk” for medication abuse, the patient must enter into a treatment agreement with the practitioner and submit to, among other conditions, random urine drug screening.

Importantly, the proposed rule does not envision the decision to treat pain with controlled substances as the end of the treatment continuum; practitioners shall review the course of pain treatment on a continued basis to determine whether alternative treatment modalities are more appropriate for the patient. This raises a few issues. First, it is possible that pain patients being treated with controlled substances may have different goals than their provider. There is any number of reasons that a patient may refuse alternative treatment options, such as invasive surgeries. Communication will be of the utmost importance, but the rule does not envision potentially common scenarios where the patient and practitioner disagree on the continued use controlled substances days, weeks, or months into the treatment relationship. And when patient and practitioner disagree during an ongoing treatment regimen, the specter of abandonment looms overhead.

Again, documentation requirements are stressed, and a section of the proposed rule addresses the maintenance of accurate and complete medical records. However, practitioners can look at these requirements as protective measures to assure compliance not only with appropriate standards of treatment, but also pain treatment coding and billing, which is receiving high levels of scrutiny from government payers and enforcement agencies.

A public hearing will be held on November 1, 2011 at 3:00 PM in the second floor conference room A of the Cannon Building, 861 Silver Lake Boulevard, Dover. Those in attendance will be invited to share their comments. Written comments may also be submitted to this address up to the date of the public hearing. For more information and to read the full proposed rule, visit http://regulations.delaware.gov/register/october2011/proposed/15%20DE%20Reg%20498%2010-01-11.htm.

Delaware Health Insurers Required to Provide Free Coverage for Immunizations

As required by the federal Health Care Reform law (the Patient Protection and Affordable Care Act), the Delaware General Assembly passed amendments to the state’s insurance code requiring health insurance carriers providing coverage in Delaware to cover certain immunizations and preventive services without requiring enrollees to pay copayments, coinsurance or deductibles. Governor Markell signed the bill into law on September 23rd, and it applies to policies issuing or renewing after June 30, 2011. A complete list of the immunizations and services covered under the new law can be found at http://www.healthcare.gov/news/factsheets/2010/07/preventive-services-list.html
While the Delaware insurance code previously mandated coverage for many of these services, such as mammograms and colonoscopies at certain ages, it did not prevent insurers from imposing co-pays or other charges on individuals receiving them.

Fraud Investigations Aiming for the Top: Government Scrutiny of Health Care Executives

In his testimony before a House of Representatives subcommittee, Chief Counsel for the HHS-OIG Lewis Morris expressed the Federal Government’s frustration with repeat offenders and indicated a new strategy for fighting fraud and abuse among health care enterprises:

“We are concerned that the providers that engage in health care fraud may consider civil penalties and criminal fines a cost of doing business. . . . One way to address this problem is to attempt to alter the cost-benefit calculus of the corporate executives who run these companies. By excluding the individuals who are responsible for the fraud, either directly or because of their positions of responsibility in the company that engaged in fraud, we can influence corporate behavior without putting patient access to care at risk.

HHS, the Justice Department, and the Food and Drug Administration have been independently shifting their target to individual executives in health care fraud investigations and prosecutions. Executives at drug companies, medical device companies, nursing homes, and other health care groups now have more to worry about than the hefty fines their companies are forced to pay; these executives could face criminal charges even if they were not involved in the scheme and exclusion from the Federal programs.

Morris continued, saying that “when there is evidence that an executive knew or should have known of the underlying misconduct of the organization, OIG will operate with a presumption in favor of exclusion of that executive.” To be sure, exclusion from the federal programs is a career ender, as the enterprise would no longer be able to bill the federal programs with the excluded executive at the helm. The authority the OIG points to for this power is under section 1128(b) of the Social Security Act, which allows OIG to hold responsible individuals accountable for the misconduct of their organization. It is only recently, however, that OIG has been focusing on using this power on the top executives of these organizations. It used to be that only executives who had been charged and entered pleas were excluded. Last year, however, the inspector general excluded the owner/executive of drug manufacturer Ethex Corporation even though the Justice Department did not charge him.

But this theory was recently tested and HHS retreated. Howard Solomon, chief executive of drug company Forest Laboratories, received notice from HHS-OIG that he would be excluded from the Federal programs. Solomon received the letter because a Forest subsidiary pleaded guilty to marketing violations in 2010 and agreed to a $313 million settlement, but Solomon was not personally charged and there was never any alleged wrongdoing on his part. According to a press release from Forest, the “only basis given in the letter notifying Mr. Solomon of the potential action is that he is ‘associated with’ Forest.” Ultimately, after protest from the business community, HHS retreated from its exclusion letter.

Despite HHS backing down against Solomon and Forest, the climate of investigations and prosecutions against executives is still heating up. As Morris said in a May Associated Press interview, “[t]he behavior of a company starts at the top." In the ever growing culture of compliance coming out of Washington, it is more important than ever for executives to become involved in their organization’s ongoing compliance efforts, and to hold subordinates accountable for running a compliant organization.

Health Care Practices Must Inform Employees of Labor Rights

On August 30, 2011, the National Labor Relations Board (NLRB) issued a final rule that will require all private employers, including health care practices, covered by the National Labor Relations Act (NLRA) to notify employees of their rights under the Act. This notification’s substance is included on a poster provided by the NLRB, which informs employees of their rights, among others, to join a union and collectively bargain. The poster may be downloaded and printed in either black-and-white or color, and must be posted in the workplace. In addition to physically posting the notice, if personnel rules are customarily posted on the Internet or an intranet site, the notification must also be posted there. Translated versions must be posted where at least 20% of employees are not proficient in English. A failure to post this notice will be deemed an unfair labor practice under the NLRA. The rule goes into effect on November 14, 2011.