Obra Is a Set of Federal Laws That

Sta­tes respond with laws or regu­la­ti­ons As the­se man­da­tes reached the sta­tes, Medi­caid offi­cials, as well as heads of the Phar­ma­cy Coun­cil or a simi­lar admi­nis­tra­ti­ve body, began for­mu­la­ting their respon­ses. Several decisi­ons had to be made – the cas­ca­ding federal man­da­te only app­lied to Medi­caid bene­fi­cia­ries, but should it be exten­ded to all pati­ents? Should the offer of coun­sel requi­re­ment be limi­ted to new­ly issued orders or should it also inclu­de rene­wals? Does the con­sul­ta­ti­on offer have to be exten­ded by a phar­ma­cy employee or would a sign suf­fice? Does the con­sul­ta­ti­on have to be car­ri­ed out per­so­nal­ly with the pati­ent by the phar­macist? Should pati­ents‘ medi­ca­ti­on records be pre­scri­bed? How sta­tes are cur­r­ent­ly divi­ded on the­se issu­es, as repor­ted by sta­te phar­ma­cy com­mit­tees to the Natio­nal Asso­cia­ti­on of Boards of Phar­ma­cy, is in TABLE 2.4 Courts inter­pret OBRA ‘90 in a varie­ty of con­texts Rea­son­ab­le nur­sing home staff gene­ral­ly adhe­re to federal OBRA regu­la­ti­ons. If the employees who cau­sed your inju­ries did not com­ply with the OBRA or sta­te regu­la­ti­ons, this could be important evi­dence that the employees vio­la­ted their duty of care. This can help you pro­ve one of the most dif­fi­cult parts of a case of negli­gence. Howe­ver, you will still have to pro­ve the other ele­ments of your claim. We can learn a varie­ty of les­sons from how courts view phar­maci­es and phar­macists from decisi­ons whe­re laws or regu­la­ti­ons have been inter­pre­ted. But the­re is one important caveat to note. The fol­lowing cases deal only with mat­ters dealt with by the courts of appeal in publis­hed opi­ni­ons. Out­side of cases in federal district courts, the­re is no direct way to review the decisi­ons of the sta­te tri­al courts, as very few opi­ni­ons are publis­hed or repor­ted in the lite­ra­tu­re. | The­re are many other federal regu­la­ti­ons and the Com­mon­wealth of Ken­tu­cky has its own regu­la­ti­ons that app­ly to the safe­ty of nur­sing home resi­dents. Nur­sing homes are requi­red by law to com­ply with all of the­se regu­la­ti­ons. If a nur­sing home or its staff does not com­ply with app­li­ca­ble regu­la­ti­ons, serious inju­ries can result.

OBRA man­da­tes are con­si­de­red mini­mum stan­dards of care accep­ted in nur­sing home set­tings. A nur­sing home‘s fail­u­re to com­ply with the OBRA‘s rules of care with respect to the qua­li­ty of a resident‘s care con­sti­tu­tes a fail­u­re to exer­cise the rea­son­ab­le level of care and skill that should be expec­ted. The Omni­bus Bud­get Recon­ci­lia­ti­on Act (OBRA), also known as the Nur­sing Home Reform Act of 1987, has signi­fi­cant­ly impro­ved the qua­li­ty of nur­sing home care over the past twen­ty years by set­ting federal stan­dards for how care should be pro­vi­ded to resi­dents. Pre­si­dent Geor­ge H.W. Bush signed the law into law on Novem­ber 5, 1990, and the effec­ti­ve date for phar­ma­cy prac­ti­ce requi­re­ments was Janu­a­ry 1, 1993. 3 The federal legis­la­ti­on had several main ele­ments: 1) Pro­spec­ti­ve Review of Drug Use, 2) Retro­spec­ti­ve Review of Drug Use, 3) Eva­lua­ti­on of Drug Use Data, and 4) Edu­ca­ti­on Awa­reness Pro­grams. The first com­po­nent (Pro­spec­ti­ve Drug Use Review) had the grea­test impact on dai­ly pro­fes­sio­nal prac­ti­ce. TABLE 1 pro­vi­des an over­view of the phar­ma­cy acti­vi­ties requi­red. To par­ti­ci­pa­te in the Medi­ca­re and Medi­caid pro­grams, nur­sing homes must meet federal nur­sing home requi­re­ments. The India­na Sta­te Depart­ment of Health is respon­si­ble for ensu­ring nur­sing homes fol­low the­se war­rants through the state‘s inves­ti­ga­ti­ve pro­cess. The Depart­ment of Health and Human Ser­vices (DHHS) and sta­tes can impo­se pen­al­ties on nur­sing homes that fail to meet the mini­mum stan­dard of care set out in OBRA regulations.

In 1987, the federal government pas­sed important legis­la­ti­on to pro­tect nur­sing home resi­dents. The law, known as the Omni­bus Bud­get Recon­ci­lia­ti­on Act (OBRA) or Nur­sing Home Reform Act, sets out spe­ci­fic health and safe­ty rules that nur­sing homes and nur­sing home staff must fol­low to pro­tect nur­sing home resi­dents. Cases invol­ving the stan­dard of care to be prac­ti­sed by phar­macists In a case that occur­red befo­re 1. In Janu­a­ry 1993, when the offer man­da­te came into effect, the Geor­gia Court of Appeals ruled that a phar­macist is not requi­red to warn a pati­ent of a poten­ti­al­ly serious side effect or refu­se to dis­pen­se a drug resul­ting from an exces­si­ve dose. Sum­ma­ry judgment on behalf of the defen­dant phar­ma­cy was upheld on appeal, but the court sta­ted that it would “not set a pre­ce­dent for cases invol­ving phar­macist duties ari­sing after Janu­a­ry 1, 1993.” 5 In ano­t­her case occur­ring befo­re 1. In Janu­a­ry 1993, when OBRA ‘90 went into effect, the Flo­ri­da Court of Appeals ruled that a phar­macist who pro­per­ly dis­pen­sed medi­ca­ti­ons, but did not inform the pati­ent or pre­scrib­ing phy­si­ci­an of poten­ti­al­ly serious adver­se drug inter­ac­tions, had no duty to warn.6 A pediatric pati­ent was inju­red and the ques­ti­on impo­sed on the phar­macist was whe­ther the duty to coun­sel par­ents as care­gi­vers and repre­sen­ta­ti­ves. of the pati­ent estab­lis­hes a legal obli­ga­ti­on to the par­ents for his emo­tio­nal well-being as oppo­sed to the actu­al well-being of the pati­ent. The Cali­for­nia Supre­me Court ruled that this would be an “unwar­ran­ted exten­si­on of poten­ti­al lia­bi­li­ty.” 7 The Mis­sou­ri Court of Appeals set asi­de a sum­ma­ry judgment of the tri­al court in favour of the defen­dant phar­macist, in which the lower court held that the pharmacist‘s “only duty was to fill pre­scrip­ti­ons accu­rate­ly.” The case invol­ved a “power­ful hyp­no­tic drug pre­scri­bed in three times the dose of the nor­mal dose”. The court said: “Phar­macists are trai­ned to reco­gni­se the cor­rect dose and con­tra­in­di­ca­ti­ons of pre­scrip­ti­ons, and doc­tors and pati­ents should wel­co­me their fin­dings to make the dan­gers of drug the­ra­py safer.” The sum­ma­ry judgment was set asi­de and the case was remit­ted to the tri­al court for a deter­mi­na­ti­on as to whe­ther the phar­macist had ful­fil­led his legal obli­ga­ti­on on the facts of the case. 8 In ano­t­her case, a woman suf­fe­ring from an acu­te asth­ma attack ent­e­red the phar­ma­cy and asked the phar­macist to eit­her give her an inha­ler, for which she did not have a pre­scrip­ti­on at that phar­ma­cy, or to call the doc­tor or hos­pi­tal to obtain a pre­scrip­ti­on. The phar­macist did neit­her, and the pati­ent was trans­por­ted to hos­pi­tal by ambu­lan­ce. The ques­ti­on was whe­ther the phar­macist had a legal obli­ga­ti­on to act on the basis of OBRA ‘90.

The court ans­we­red in the nega­ti­ve; The obli­ga­ti­ons of OBRA ‘90 ari­se upon rece­i­pt of a “pre­scrip­ti­on drug pre­scrip­ti­on”. In the absence of a pre­scrip­ti­on or a pre-exis­ting phar­macist-pati­ent rela­ti­ons­hip, the phar­macist had no legal obli­ga­ti­on to act.9 In an offi­cial­ly unpu­blis­hed noti­ce (which, howe­ver, was repor­ted in a legal data­ba­se), a pati­ent who refu­sed a con­sul­ta­ti­on and signed a wai­ver could not later claim that he or she should have been noti­fied any­way. This was a very inte­res­ting case whe­re the pati­ent put for­ward all sorts of con­vo­lu­t­ed argu­ments as to why he was allo­wed to main­tain this request, but in the end, not only did he lose, but he had to bear the cos­ts of the phar­ma­cy chain call.10 Cases invol­ving the issue of “man­da­to­ry” co-pay­ments that redu­ce reim­bur­se­ment to phar­maci­es This case con­cer­ned the pro­vi­si­on of the OBRA ‘90, Federal and sta­te governments can­not “lower limits on cove­r­ed ambu­la­to­ry drugs” if the state‘s Medi­caid plan com­plied with app­li­ca­ble federal regu­la­ti­ons when cer­tain emer­gen­cy regu­la­ti­ons were enac­ted. The focus was on whe­ther Pennsylvania‘s plan was con­si­de­red “com­pli­ant,” mea­ning no reduc­tion in reim­bur­se­ment was allo­wed. The court ruled that yes, the sta­te was com­pli­ant, and the­re­fo­re pro­hi­bi­ted from redu­cing pay­ments for cove­r­ed ambu­la­to­ry drugs.11 The four-year mora­to­ri­um on redu­cing drug reim­bur­se­ment limits was also con­tro­ver­si­al in this case in U.S. District Court in Flo­ri­da. After OBRA ‘90 went into effect, the Flo­ri­da legis­la­tu­re pas­sed an allo­ca­ti­on bill that intro­du­ced a co-pay­ment func­tion for the state‘s Medi­caid drug pro­gram. Reim­bur­se­ment rates for phar­maci­es were not chan­ged, but the sta­te aut­ho­ri­ty respon­si­ble for admi­nis­te­ring the pro­gram auto­ma­ti­cal­ly redu­ced pay­ments to pro­vi­ders of the amount of the co-payment.

In addi­ti­on, federal pro­gram requi­re­ments pro­hi­bit a par­ti­ci­pa­ting pro­vi­der from refu­sing ser­vices to a pro­gram par­ti­ci­pant who is unab­le to pay the cost-sharing amount. The Flo­ri­da Phar­ma­cy Asso­cia­ti­on argued that this amoun­ted to a reduc­tion in reim­bur­se­ment, which con­sti­tu­ted a vio­la­ti­on of the OBRA ‘90 mora­to­ri­um. The court dis­agreed. Accord­ing to him, phar­maci­es now have two sources of reim­bur­se­ment – the sta­te and the pati­ent – ins­tead of one as befo­re, exp­lai­ning that “the fact that one of the sources, the bene­fi­cia­ries, can­not be so accom­mo­da­ting in reim­bur­se­ment does not chan­ge the fact that the reim­bur­se­ment limits have not been chan­ged”. 12 The co-pay­ment intro­du­ced for drugs cove­r­ed by Medi­caid in Nebras­ka rai­sed pro­blems simi­lar to tho­se in the Flo­ri­da case dis­cus­sed abo­ve. The court noted that aut­ho­riz­a­ti­on for sta­tes to intro­du­ce co-pay­ments under the Tit­le XIX drug pro­gram had been in place sin­ce 1982 and ruled that respon­dent sta­te offi­cials “orde­red that, in cer­tain cases, a phar­macist could never reco­ver reim­bur­se­ment limits, even though the phar­macist would theo­re­ti­cal­ly be enti­t­led to maxi­mum reim­bur­se­ment. The clear terms of the federal law pro­hi­bit this prac­ti­ce. Poe­ti­cal­ly, the judge in char­ge of the case con­ti­nued: “This case is remi­nis­cent of Ger­tru­de Stein‘s well-known words: ‘A rose is a rose is a rose‘.

A dis­count is a reduc­tion, whe­ther by chan­ging a for­mu­la or other­wi­se. 13 Indiana‘s plan at the time cal­led for a 50-cent co-pay­ment for gene­ric drugs and a dol­lar co-pay­ment for brand-name products.