June-July 2021 State Regulatory Developments
August 11, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in June and July 2021: Read more
April 2021 State Regulatory Developments
July 7, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in April 2021: Read more
May 2021 State Regulatory Developments
July 7, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in May 2021: Read more
February 2021-March 2021 State Regulatory Report
March 16, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in February and March 2021: Read more
New Policy to Remove Barriers to COVID-19 Testing
March 3, 2021
Posted by Anjali Baxi
On February 26, 2021, the Centers for Medicare & Medicaid Services, Department of Labor and Department of Treasury issued guidance removing barriers to COVID-19 diagnostic testing and vaccinations and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. This guidance makes clear that private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health coverage who are asymptomatic, and who have no known or suspected exposure to COVID-19. Such testing must be covered without cost sharing, prior authorization, or other medical management requirements imposed by the plan or issuer. For example, covered individuals wanting to ensure they are COVID-19 negative prior to visiting a family member would be able to be tested without paying cost sharing. The guidance also includes information for providers on how to get reimbursed for COVID-19 diagnostic testing or for administering the COVID-19 vaccine to those who are uninsured. Click here for the newly issued guidance. See press release here.
The new guidance should encourage providers to offer COVID-19 testing at their offices and outpatient locations since private group health plans and issuers must cover and reimburse for COVID-19 testing of asymptomatic individuals and defers to the provider’s individual clinical assessment of the patient to determine whether the patient should be tested for COVID-19. This new guidance should also increase patient access to testing and remove barriers to encourage patients to be tested prior to travel without fears of large out of pocket payment for testing. The provider should check with health plans to confirm that they have implemented this policy prior to starting to administer the test to the newly covered group. Likewise, patients should check their coverage under their health plans.
December 2020/January 2021 State Regulatory Report
March 3, 2021
Posted by Anjali Baxi
Below are the most recent health care related regulatory developments as published in the New Jersey Register in December 2020 and January 2021: Read more
Saga of “Most Favored Nations”
December 29, 2020
Posted by Frank Ciesla
On Wednesday, December 23, 2020, a Maryland Federal District Court Judge issued a TRO blocking the Trump administration’s attempt to institute, pursuant to an administrative rule, a Most Favored Nations approach for dozens of drugs under the Medicare Program.
The challenge made to the administrative rule was that it was issued under the “emergency” provisions of the Administrative Procedure Act. The Plaintiffs argued that the Federal government did not present adequate justification for the use of that provision for the adoption of an administrative rule, rather than use the normal avenue requiring public comment prior to the adoption of the rule.
It is highly unlikely that this issue will be resolved during the remaining couple of weeks of the Trump administration. Therefore, it will be up to the Biden administration as to whether or not they want to (i) continue the litigation to justify the rule, (ii) take the approach of readopting the rule pursuant to the provision for public review and comment prior to the adoption of the rule, or (iii) abandon the entire Most Favored Nations approach to pricing of pharmaceuticals in the United States altogether. What is clear, is that the rule will not be implemented during the remaining couple of weeks of the Trump administration.
As can be seen by our prior blogs we have been an advocate for the “Most Favored Nations” approach for a number of years.
Pharmaceutical Industry Challenges President Trump’s Executive Order Adopting Most Favored Nation Approach
December 8, 2020
Posted by Frank Ciesla
My December 2, 2020 blog was a discussion of President Trump’s adoption of the Most Favored Nation approach for the pricing of certain drugs in various federal programs. On Friday, the pharmaceutical industry filed suit challenging the decision of the Trump Administration. It will be interesting to see what action, if any, the new President takes to defend the concept or whether the incoming President will walk away from the concept of Most Favored Nation.
President Trump issues Executive Order adopting Most Favored Nation Approach
December 2, 2020
Posted by Frank Ciesla
In what appears to be one of President Trump’s last official acts, he has issued an Executive Order adopting, for certain purposes, the Most Favored Nation clause approach to the pricing of drugs in the United States. During the campaign, it was the position of President-Elect Biden that we should be negotiating the price with the drug companies for the sale of drugs in the United States.
Obviously, an Executive Order by one President can be quickly replaced with an Executive Order by the next President. Read more
November 2020 State Regulatory Developments
November 23, 2020
Posted by Anjali Baxi
Here are the most recent health care related regulatory developments as published in the New Jersey Register in November 2020:
- On November 2, 2020, at 52 N.J.R. 1990(a), Department of Law and Public Safety, Division of Consumer Affairs, State Board of Psychological Examiners issued a rule proposal to amend N.J.A.C. 13:42-8.1 to require that a licensee retain records for a minor for seven years from the date of the last entry or until the client turns 25 years of age, whichever is longer.
- On November 2, 2020, at 52 N.J.R. 2008(c), Department of Labor published a notice of administrative change regarding the minimum wage rates as they progress to the $15 minimum wage over For most employees, the rate as of January 1, 2021 is $11.00. There are exceptions for certain employers, i.e., small employers/seasonal workers. N.J.A.C. 12:56-3.1, 3.2, and 3.3.
- On November 2, 2020, at 52 N.J.R. 2010(a), the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee adopted an amendment prohibiting hand-written continuing educations credit certificates. Adopted Amendment: N.J.A.C. 13:44C-6.3.
- On November 16, 2020, at 52 N.J.R. 2038(a), the Department of Health issued notice of emergency adoption of a rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) waiving the continuing education requirements for active health officer and registered environmental health specialist (REHS) licenses set out at N.J.A.C. 8:7-1.11, N.J.A.C. 8:7-1.12, N.J.A.C. 8:7-1.13, and N.J.A.C. 8:7-1.17. Under current rules, active licensed health officers or REHSs who wish to renew their licenses in their respective public health positions must annually obtain 15 contact hours of approved continuing education (CE) and submit verification of the CEs with their annual license renewal application. Due to the pressing demands caused by this public health emergency, it is both necessary and appropriate to temporarily relax these requirements for current active health officers and REHSs who are renewing their licenses as active for the 2021 licensing period by waiving the CE requirement. This waiver will not only provide active licensed health officers and REHSs a reprieve from this obligation so they may focus on the public response to COVID-19 in New Jersey but will also ensure that the State maintains a sufficient number of active licensed health officers and REHSs to carry out essential public health services and respond to the public health emergency.
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