December 2018 Regulatory Developments
December 18, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in December 2018:
- On December 3, 2018, at 50 N.J.R. 2434(a), the Department of Health published a notice acknowledging the receipt of the petition for rulemaking submitted by Laura I. Thevenot, Chief Executive Officer, American Society for Radiation Oncology (ASTRO), Arlington, Virginia, requesting that the Department add ASTRO as an approved accrediting body for radiation oncology. The Department reviewed the petition and determined that additional time is needed to deliberate about this petition. Time is needed to further evaluate the standards for certification of the American Society for Radiation Oncology and compare them with the standards of the American College of Radiology and the American College of Radiation Oncology. The Department has asked the American Society for Radiation Oncology for additional information and has sought input from stakeholders. The matter will be deliberated on for a period of no more than 90 days.
- On December 17, 2018, at 50 N.J.R. 2547(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing published proposed amendments to Board of Nursing rules as a response to the ruling of New Jersey Supreme Court in In re Eastwick College LPN-to Rn Bridge Program, 225 N.J. 533 (2016) regarding the unreasonable interpretation of N.J.A.C. 13:37-1.3(c) 2. The amendment proposes to amend N.J.A.C. 13:37-1.3 to clearly require that 75% of graduates of a nursing education program with provisional accreditation who take the examination in a calendar year must pass the examination the first time they take it. The Board also proposes to amend the regulations to revise standards for nursing education programs with provisional accreditation.
- On December 17, 2018, at N.J.R. 2549(a), the Department of Law and Public Safety, Division of Consumer Affairs Charitable Registrations Unit, the proposes to amend N.J.A.C. 13:48-4.3 and 5.3 to state that charitable organizations exempt from tax under Section 501 of the Internal Revenue Code must continue to report certain information to the Division, regardless of whether the IRS’s new reporting policy excuses an organization from reporting the information to the IRS. The proposed amendments require that, for charitable organizations that do not provide a list of contributors as part of their IRS filings, the annual financial reports filed by such organizations with the State of New Jersey must include a list of every contributor who, during the previous year, gave the organizations, directly or indirectly, money, securities, or any other type of property totaling $ 5,000 or more. The amendments permit separate and independent gifts of less than $ 1,000 to be disregarded. Charitable organizations will be required to provide the name and address of each contributor, the total amount given by each contributor, and a description of noncash property given.Docs #3491369-v1
NJ DOBI Issues Out of Network Guidance
December 11, 2018
Posted by Anjali Baxi
On Tuesday November 20, 2018, the Department of Banking and Insurance (“DOBI”) published Bulletin 18-14 (“Bulletin”) to help carriers, health care providers and other interested parties meet their obligations under the Out of Network Consumer Protection, Transparency, Cost Containment and Accountability Act (the “Act”), which was enacted on June 1, 2018 and became effective on August 20, 2018.
The 29-page Bulletin serves as agency guidance until DOBI proposes regulations for the implementation of the Act. The bulk of the document contains procedures for claims processing and arbitration for out of network (“OON”) services provided on an inadvertent or urgent basis covered under the Act. There is a short mention of OON billing and cost-sharing waivers, which reiterates the requirements under the Act and the Federal law on co-pay waivers. The Bulletin also provides some guidance on the carrier disclosure requirements, including a customizable disclosure form as an attachment. Links to the Bulletin and Attachments can be found below.
Much of the Bulletin focuses on the claims processing/negotiation process prior to arbitration and the arbitration process itself. The Bulletin provides language that must be included in the EOB informing the OON health care provider of its right to reject the payment and negotiate with the carrier, including specific time frames for notice of rejection of payment to be eligible for arbitration.
The Bulletin further provides the conditions under which the OON health care provider may request to enter into binding arbitration: (1) the difference between the carrier and OON health care provider’s final offer is $1,000 or higher; (2) the applicable preauthorization or notice requirements of the health benefits plan were complied with; (3) the matter does not involve a dispute as to whether a treatment or service is medically necessary, experimental or investigational, or cosmetic; or (4) the carrier should have authorized the service to be performed by an OON health care provider through an in-plan exception because the carrier’s network lacks a provider who is accessible and possesses the requisite skill and expertise to perform the needed services.
Until August 30, 2019, DOBI will utilize its current vendor MAXIMUS to administer the OON Arbitration System. Thereafter, a vendor will be engaged through DOBI’s procurement process. Currently MAXIMUS will be accepting OON Arbitration Applications on https://njpicpa.maximus.com/njportal/. Fee information is available on the website.
The deadlines for rejection of initial and final notice of offers of payment and for filing the arbitration application are paramount. For example, MAXIMUS will reject any application that it receives in excess of the 30 days after the provider’s receipt of the carrier’s notification of its final offer of the allowed amount/allowed charge. The Bulletin spells out the evidentiary format and the deadlines for MAXIMUS to issue a decision and for the carrier to make payment, if applicable.
The Bulletin emphasizes its expectation that the OON health care provider will only bill the covered person for the cost-sharing liability for the services once, regardless of whether an increased payment was made by the carrier through negotiation or arbitration.
The links to the Bulletin 18-14 and Attachments are as follows:
Bulletin 18-14 :https://www.state.nj.us/dobi/bulletins/blt18_14.pdf
Arbitration Process Grid: https://www.state.nj.us/dobi/division_insurance/oonarbitration/processgrid.pdf
Arbitration Application: https://www.state.nj.us/dobi/division_insurance/oonarbitration/requestform.pdf
Disclosures to Covered Persons Regarding Out of Network Treatment. https://www.state.nj.us/dobi/division_insurance/oonarbitration/disclosures.pdf
November 2018 Regulatory Developments
November 28, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in November 2018:
- On November 5, 2018, at 50 N.J.R. 2239(b), the Department of Human Services, Division of Family Development published a public notice the Division of Family Development shall increase the rate of the personal needs allowance from $ 110.00 to $ 112.00 effective January 1, 2018, for SSI recipients and Work First New Jersey/General Assistance recipients living in residential health care facilities and for SSI recipients living in boarding homes. This increase is based on the total 2018 Federal Social Security cost-of-living increase. (Amends N.J.A.C. 10:123-3.4(a)).
- On November 19, 2018, at 50 N.J.R. 2281(a), the Department of Community Affairs published a proposal to readopt the existing rules concerning requests for government records were scheduled to expire on October 17, 2018. The Department proposed that the rules be readopted without change. Comments due January 18, 2019.
- On November 19, 2018, at 50 N.J.R. 2328(b), the Department of Human Services, Division of Medical Assistance and Health Services readopted rules for the Medicaid Only eligibility for aged, blind and disabled individuals. The DHS adopted the subchapter (N.J.A.C. 10:71) before the expiration while it works on changes to reflect the Federal requirements under the Affordable Care Act. Those changes will be published under a separate rulemaking. The readopted rules will continue to be in effect for seven years.
- On November 19, 2018, at 50 N.J.R.2329 (a), the Department of Insurance, New Jersey Individual Health Coverage Program Board readopted rules Individual Health Coverage Program Plan of Operations. The mission of the Board administer the New Jersey Individual Health Coverage Program in a manner aimed at increasing access to coverage, protecting consumers, educating key stakeholders and other interested persons, and promoting carrier participation in the market. This includes establishment and modification of standard plans for marketing to individuals and establishing and administering the assessment mechanism. It also includes the regulation of individual health coverage carriers in conjunction with the Department of Banking and Insurance.
- On November 19, 2018, at 50 N.J.R. 2334(a), the Department of Banking and Insurance, Small Employer Health Benefits Program Board adopted amendments to the Small Employer Health Benefits Plan at N.J.A.C. 11:21 Appendix Exhibits F, G, W, Y, HH, and II.
October 15, 2018 Regulatory Developments
November 13, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register on October 15, 2018:
- On October 15, 2018, at 50 N.J.R. 2138(a), the Department of Law and Public Safety. Division of Consumer Affairs, proposed new rules and amendments to the rules for the Prescription Monitoring Program (PMP) (N.J.S.A. 45:1-45 et seq.), to expand delegate access to include athletic trainers and medical scribes employed by a hospital’s emergency department, modifies the conditions under which a prescriber is required to look up a patient’s PMP records, and provides for electronic health systems to access prescription monitoring information, so that PMP information can be directly integrated into electronic medical records, making access more user friendly.
- On October 15, 2018, 50 N.J.R 2150(a), published a recodification of N.J.A.C. 13:49 as N.J.A.C. 8:70. The Office of the Chief State Medical Examiner (Office) was created as an independent agency within the Department of Health. All functions, powers, and duties of the Office of the State Medical Examiner in the Department of Law and Public Safety (OSME) to the new Office and abolished the OSME.
- On October 15, 2018, 50 N.J.R 2153(a), the Department of Law and Public Safety. Division of Consumer Affairs, Board of Medical Examiners adopted amendments to the requirements for the dispensing of drugs and special limitations applicable to the dispensing of drugs for a fee. (N.J.A.C. 13:35-7.5).
- On October 15, 2018, 50 N.J.R 2153(b), the Department of Law and Public Safety. Division of Consumer Affairs, Orthotics and Prosthetics Board of Examiners, adopted amendments to the rules governing the scope of practice and licensure rules for orthotists, orthotist assistants, prosthetists, prosthetist assistants. (N.J.A.C. 13:44H-2.1, 2.2, and 3.5)
- On October 15, 2018, 50 N.J.R 2177(a), the Department of Health received a petition for rulemaking from Laura I. Thevenot, Chief Executive Officer, American Society for Radiation Oncology (ASTRO), Arlington, Virginia, requesting that the Department add ASTRO as an approved accrediting body for radiation oncology.
Pharmaceutical Pricing: Update to May 17, 2018 Blog
November 8, 2018
Posted by Frank Ciesla
In light of the recent midterm election, we will soon have a split federal government, with the Democrats controlling the House and the Republicans controlling the Senate and the White House. In the area of health care, while little may get done, there is an area that appears to be of joint interest to both. Both the President and many Democratic elected officials have suggested that we need to control drug prices. Prior to the election, the Administration indicated that it was considering negotiating drug prices on behalf of certain governmental programs and considering European prices as a guide.
As mentioned in my previous blog of May 17, 2018 (http://njhealthcareblog.com/2018/05/17/pharmaceutical-pricing/), we should go much further than this for a whole host of reasons. I think it is appropriate for the United States, as the major buyer of pharmaceuticals, to enact the Most Favored Nation approach, under which no company could sell pharmaceuticals in the United States at a price higher than the lowest price they are sold anywhere else in the world.
What does that accomplish? Americans would not be encouraged, as we can see from the literature, to purchase drugs in Canada or Mexico, or as what is being hinted at currently in the literature, having employer plans encourage their employees to purchase drugs outside of the United States. If the price of the drugs would be the same, or lower than they would be in Canada or Mexico (or from any other place that you would order them on the Internet), then there is no need to risk purchasing drugs outside of the American secure system of providing effective quality drugs.
In addition, contrary to the approach being considered of negotiating rates for pharmaceuticals, this approach would eliminate a number of problems.
There would be little opportunity under this approach for influencing the negotiations by political contributions, either requested by elected officials or voluntarily provided to elected officials to impact the negotiations.
There would also be no need for developing a specialized purchasing program for small business enterprises, to the extent that they can even exist in this expensive field of pharmaceuticals, minority enterprises or women owned enterprises. All types of purveyors of pharmaceuticals would be subject to the statutory limitation.
In a way, it would also accomplish the objective of having the rest of the world bear their fair share of common expenses. It is clear that the American consumer is bearing the burden of pharmaceutical research and development, with the prices that they have to pay for drugs. However, not only do the consumers in the United States benefit from research and development, but consumers throughout the world benefit as well.
Under a Most Favored Nation approach, all we would need is a government agency to enforce this simple pricing rule: whether or not the pharmaceuticals are being sold in the United States at a price no higher than they are being sold anywhere in the world. This would lead to less regulation, as the government would not need to be involved with negotiating prices for individual drugs.
October 1, 2018 Regulatory Developments
October 18, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register on October 1, 2018:
- On October 1, 2018, at 50 N.J.R. 2043(a), the State Board of Optometrists issued proposed rules to amend the continuing education requirements to require continuing education on prescription hydrocodone or opioids in general.
- On October 1, 2018, at 50 N.J.R. 2044(a), the State Board of Physical Therapists proposed rules that sets forth new standards for wound debridement and general supervision requirements of licensed physical therapist assistants.
September 2018 Regulatory Developments
October 15, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in September 2018:
- On September 4, 2018, at 50 N.J.R. 1926(a), the Department of Banking and Insurance proposed a rule readoption with amendments regarding the standards and practices for the regulation of dental plan organizations (DPOs) and the provision of dental services on other than a pure fee-for-service basis by insurers, DPOs, and dental service corporations (DSCs). Included in the this readoption is new provision that would require that any employee dental plans offered as alternate coverage through an insurance contract intended to be sold as a pediatric dental plan to satisfy the EHB requirement of the ACA and fulfill certain requirements set forth in the proposed rules.
- On September 4, 2018, at 50 N.J.R. 1931(a), the State Board of Medical Examiners proposed rules to amend the continuing education requirements to require physicians and physician assistants to complete one credit of continuing education in topics concerning prescription opioid drugs every biennial renewal period. These topics would have to include responsible prescribing practices, alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addiction, and diversion.
- On September 4, 2018, at 50 N.J.R. 1932(a), the Division of Consumer Affairs proposed rules to increase Controlled Dangerous Substance (CDS) registration fees after 21 years. All registrations fees are proposed to be doubled. Under the proposed rules, the initial and annual registration fee for dispensers and practitioners, it would change from $20 to $40.
- On September 17, 2018, at 50 N.J.R. l987(a), State Board of Massage and Bodywork Therapy issued proposed amendments to existing rules regarding licensure to require applicants to complete a course of study of at least 500 hours in massage and bodywork therapies and to pass a written examination. The Board would no longer allow licensure based on passing a written examination.
- On September 17, 2018, at 50 N.J.R. 1992(b), Department of Human Services, Division of Medical Assistance and Human Services, adopted amendments and new rules regarding home care services. There is a new provision regarding the transfer of beneficiary care to a different service provider. (N.J.A.C. 10:60-3.10).
- On September 17, 2018, at 50 N.J.R. 2030(a), the Department of Health cancelled a call for pediatric intensive beds, citing that there is no current need. The notice stated that the Department issued approval for 22 new beds in response to 2017 pediatric intensive bed call. The next scheduled call is September 2, 2019.
Out of Network Legislation
October 2, 2018
Posted by Anjali Baxi
NJ Department of Consumer Affairs has published informal guidance for health care professionals regarding the requirements of the Out of Network Legislation. https://www.njconsumeraffairs.gov/Documents/PL2018-c32-Provision-Summary.pdf
August 20, 2018 Regulatory Developments
August 21, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register on August 20, 2018:
- On August 20, 2018, at 50 N.J.R. 1877(b), the Office of the Governor issued an Executive Order (32) mandating that NJDOH appoint a Monitor to review the expenditures and access the level of care provided at University Hospital in Newark.
The order for the appointment of a Monitor was based on the findings that University Hospital had mismanaged its appropriated funds because it failed to comply with the State statutes and regulations governing healthcare facilities when it took steps to close its EPU and PICU without DOH’s approval, thereby depriving the City of Newark of essential healthcare services; received the only failing grade in New Jersey for patient safety by the nationally-recognized Leapfrog Group; suffered a bond rating downgrade during this time as a result of its lack of financial stability; and executed a contract with its CEO for $ 900,000 while these financial struggles continue to grow. The Governor order requires that that debt service for the hospital bonds be deducted from the FY 2019 Appropriations to University Hospital. The DOH Monitor will work directly with University Hospital and be responsible for assessing the level and quality of care provided to the community along with the financial health of the hospital and any other matters related to the hospital’s functions.
- On August 20, 2018, at 50 N.J.R. 1896(a), the Department of Health published a notice of administrative correction to rules implementing the Health Care Professional Responsibility and Reporting Enhancement Act on May 15, 2017. The Appendix instructions were published in error and issuance gives the notice of correction.
August 6, 2018 Regulatory Developments
August 7, 2018
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register on August 6, 2018:
- On August 6, 2018, at 50 N.J.R. 1699(a), the State Board of Respiratory Care proposed amendments to its rules regarding standards of practice and licensure requirements. Among the proposed rules codifies the Board’s position that respiratory care practitioners may conduct apnea testing and monitoring and addresses follow up visit timeframes, criminal background check requirements, license renewals and reactivations, education requirements and educational recordkeeping requirements. There is a 60 day comment period on this rule.
- On August 6, 2018, at 50 N.J.R. 1704(a), the Department of Law and Public Safety, Division of Consumer Affairs, issued a proposed rule authorized by the Attorney General to relax certain limitations on prescriber acceptance of compensation from pharmaceutical manufacturers. The rules currently allow pharmaceutical manufacturers to provide a “modest meal” limited to $15.00 at an educational or promotional event for prescribers (NJ licensed physicians, podiatrists, PAs, APNs, dentists/optometrists). The new rules would relax this regulation and allow for $15 for breakfast/$30 limit for dinner as adjusted by CPI. There would be no cap for meals provided at an educational event or to non-faculty prescribers. The regulations enhance the definition of “prescriber,” “modest meal” and add the term “CPI Index”. The proposed amendment is due to Attorney General’s recognition of the educational value of learning about disease states and treatment options to further the educational exchange between practitioners and pharmaceutical manufacturers for the benefit of patient care. There is a 60 day comment period on this rule.
- On August 6, 2018, at 50 N.J.R. 1704(a), the Department of Human Service, Division of Medical Assistance and Health Services, adopted an administrative correction to the maximum fee allowance for independent clinics for HCPCS code for immunizations (90632) to be $80.95. The citation is N.J.A.C. 10:66-6.2(q).
- On August 6, 2018, at 50 N.J.R. 1818(b), Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners issued adopted a rule amending the regulation regarding degrees earned outside of the U.S. The individuals are required to provide the Board with a comprehensive evaluation of their degree performed by a foreign credential evaluation service that is member of the National Association of Credential Evaluation Services (NACES) and acceptable to the Board, and any other documentation the Board deems necessary.
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