April Legislative Update: CMS Notices, State Legislation

Notices From CMS

Kelly Vyzral, Director of Government Affairs

 Medicare/Medicaid

Were You Sent a Request to Revalidate Your Medicare Enrollment?

Lists of providers sent notices to revalidate their Medicare enrollment may be found on the CMS website at: http://www.CMS.gov/MedicareProviderSupEnroll/11_Revalidations.asp. 

News From CMS

The Centers for Medicare & Medicaid Services’ Office of E-Health Standards and Services (OESS) is announcing that it will not initiate enforcement action for an additional three (3) months, through June 30, 2012, against any covered entity that is required to comply with the updated transactions standards adopted under the Health Insurance Portability and Accountability Act of 1996 (HIPAA): ASC X12 Version 5010 and NCPDP Versions D.0 and 3.0.

Ohio Medicaid Approaching Deadline

Even though CMS has announced that they will not initiate enforcement action against pharmacies that don’t comply with NCPDP Version D.0, Ohio Medicaid has announced that NCPDP version 5.1 claims will only be accepted by ACS through March 29, 2012.  Beginning March 30, 2012, electronic pharmacy claims submitted in any format other than NCPDP D.0 will be denied.  Please call ACS at 877.518.1545 with questions. 

State Legislation

HB 334:  Electronic Tracking of PSE

HB 334 mandates electronic tracking of pseudoephedrine (PSE) sales through a national computer system (NPLEx).  The legislation is sponsored by Rep. Terry Johnson, and is being promoted by the Consumer Healthcare Products Association.  OPA has successfully amended the bill to specify that there are to be no costs to pharmacies to implement, maintain or use this system.  Those pharmacies would continue using paper logs to track PSE sales.  Information can be scanned into the NPLEx system, or entered manually if the pharmacy doesn’t have scanner technology.  If the customer trying to purchase the pseudoephedrine product has already reached the allowable limit, the pharmacist will receive a “stop sale” message.  The system has an override feature that can be used by pharmacists if they feel they are in danger.  Use of the override feature sends an automatic notification to the police. This bill will allow pharmacies to do away with paper logs, as all sales will be tracked by the NPLEx website.   

SB 301:  Pill Mill Clean Up

This bill was introduced to clean up some technical and other issues in HB 93.  There are two provisions of this bill that concern pharmacy.  The first is language that allows the pharmacist to name a delegate for the purpose of requesting information from OARRS.  The second, which is more concerning, adds the phrase: “Failing to practice in accordance with acceptable and prevailing standards for the practice of pharmacy” to the list of unprofessional conduct charges.  There is no definition or list of “acceptable and prevailing standards.”  How will the Board determine this and how will it be applied equally across all practice sites? Will each inspector be using the same standards?  There are a host of other unstated “standards” that could be used to level the serious charge of “unprofessional conduct.”  We need a clearer more concise definition in this section.

HB 373:  Tamper-Resistant Drugs

Pharmaceutical companies are now creating formulations of opioid medications that are tamper-resistant.  For example, the tablet can’t be crushed, dissolved, chewed, or cut. This does not prevent a potential overdose due to the ingestion of a larger amount of medication. Although, proponents of the bill suggest that tamper-resistant technology will deter the abuse of opioid medications, there is no available empirical data to support this claim.

HB 373 would prohibit a pharmacist from substituting another drug for a tamper-resistant opioid analgesic drug, unless the substituted drug is also tamper-resistant or the pharmacist obtains the written and signed consent of the prescriber.  It would require the Board of Pharmacy to create a list of opioid drugs that have tamper-resistant properties, that would be available for substitution.

OPA will fight this transparent attempt by brand name manufacturers to move their product at the expense of the patient.

HB 284:  PA Prescribing Bill

HB 284, introduced by Rep. Ann Gonzales, would allow physician assistants (PAs) who work under physician supervision to prescribe Schedule II controlled-substances in specified locations.  It would allow them to provide medical care in emergencies without physician supervision. 

The bill was stalled when it was amended to prohibit physician assistants from fitting or inserting some birth control devices or removing intrauterine devices, diaphragms and cervical caps. The provisions would reverse the original bill, which apparently reflects current law that does allow the practice by physician assistants.

HB 284 was amended so that the site restrictions in the bill mirror the site restrictions in SB 83, the APN Prescribing bill that recently became law. They include:

(1) hospital (3701.07 ORC);

(2) an entity owned or controlled by a hospital or by an entity owned or controlled by one or more hospitals;

(3) a health care facility operated by the Department of Mental Health or the Department of Developmental Disabilities;

(4) a nursing home (3721.02 ORC or 3721.09 ORC);

(5) a county home or district home certified under the Medicare or Medicaid program (5155 ORC);

(6) a hospice care program (3712.01ORC);

(7) a community mental health facility (5122.01 ORC);

(8) an ambulatory surgical facility (3702.30 ORC);

(9) a freestanding birthing center (3702.51 ORC);

(10) a federally qualified health care center (3701.047 ORC);

(11) a federally qualified health center look-alike (3701.047 ORC);

(12) a health care office or facility operated by a board of health (3709.05 ORC);

(13) physician-owned practices, a direct care medical practice site comprised of one or more physicians, who are also owners of the practice, where the PA has entered into a supervisory agreement with at least one of the physician owners who practices primarily at that site.

The bill prohibits a physician assistant from prescribing any schedule II controlled substance to a patient in a convenience care clinic.

Because of the site restrictions, OPA sought and won an amendment to give liability protection to pharmacists against a PA who might write a schedule II prescription outside the allowable sites.

HB 284 was favorably reported out of the House Health Committee and is awaiting a vote before the full House. OPA is watching this bill closely and will keep members apprised of its progress.

If you have any questions or comments about the issues mentioned in this article, please contact Kelly Vyzral, Director of Government Affairs, at 614.389.3236 or kvyzral@ohiopharmacists.org.